Objective Lumbar fusion surgery serves as a crucial option for treating lumbar degenerative diseases. However, patient heterogeneity contributes to suboptimal surgical outcomes in a substantial proportion of cases. Therefore, an accurate classification may provide a powerful tool for personalized treatment and enable the identification of individuals at increased risk for unfavorable surgical outcomes (USO). The study aimed to develop a risk stratification model for USO using cluster analysis.
Methods Consecutive patients diagnosed with degenerative lumbar disease who underwent lumbar fusion between April 2019 and January 2023 were enrolled. The outcome of interest was the USO, defined as failure to achieve a minimal clinically important difference in the 36-Item Short Form Health Survey physical component summary score, with the presence of complications. Three machine learning algorithms were employed to identify risk factors associated with USO. Based on these risk factors, we conducted a data-driven clustering analysis to develop a risk stratification model. Furthermore, based on 6 machine learning models, we developed a classification classifier capable of accurately identifying the risk cluster of individual patients.
Results A total of 662 patients were enrolled for risk stratification model, 219 patients were classified as having an USO. Six features were identified as key prognostic predictors, including frailty, depression, PI–LL (pelvic incidence minus lumbar lordosis) match, surgical levels, functional independence measure, and the relative functional cross-sectional area. The K-prototypes clustering algorithm successfully identified 3 distinct clusters. Furthermore, we developed a classification classifier, in which LightGBM (light gradient boosting machine) demonstrated the highest predictive performance (area under the receiver operating characteristic curve, 0.951; 95% confidence interval [CI], 0.814–0.974; area under the precision-recall curve, 0.927; 95% CI, 0.769–0.969).
Conclusion Based on data-driven clustering analysis, we developed a risk stratification model for predicting USO following lumbar fusion surgery, which demonstrated high predictive accuracy. Further studies in larger and more diverse cohorts are warranted to validate the clinical applicability of clustering analysis in USO risk stratification.
This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.
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Objective To develop and evaluate a technique using convolutional neural networks (CNNs) for the computer-assisted diagnosis of cervical spine fractures from radiographic x-ray images. By leveraging deep learning techniques, the study might potentially lead to improved patient outcomes and clinical decision-making.
Methods This study obtained 500 lateral radiographic cervical spine x-ray images from standard open-source dataset repositories to develop a classification model using CNNs. All the images contained diagnostic information, including normal cervical radiographic images (n=250) and fracture images of the cervical spine fracture (n=250). The model would classify whether the patient had a cervical spine fracture or not. Seventy percent of the images were training data sets used for model training, and 30% were for testing. Konstanz Information Miner (KNIME)’s graphic user interface-based programming enabled class label annotation, data preprocessing, CNNs model training, and performance evaluation.
Results The performance evaluation of a model for detecting cervical spine fractures presents compelling results across various metrics. This model exhibits high sensitivity (recall) values of 0.886 for fractures and 0.957 for normal cases, indicating its proficiency in identifying true positives. Precision values of 0.954 for fractures and 0.893 for normal cases highlight the model’s ability to minimize false positives. With specificity values of 0.957 for fractures and 0.886 for normal cases, the model effectively identifies true negatives. The overall accuracy of 92.14% highlights its reliability in correctly classifying cases by the area under the receiver operating characteristic curve.
Conclusion We successfully used deep learning models for computer-assisted diagnosis of cervical spine fractures from radiographic x-ray images. This approach can assist the radiologist in screening, detecting, and diagnosing cervical spine fractures.
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Artificial intelligence (AI) is transforming spinal imaging and patient care through automated analysis and enhanced decision-making. This review presents a clinical task-based evaluation, highlighting the specific impact of AI techniques on different aspects of spinal imaging and patient care. We first discuss how AI can potentially improve image quality through techniques like denoising or artifact reduction. We then explore how AI enables efficient quantification of anatomical measurements, spinal curvature parameters, vertebral segmentation, and disc grading. This facilitates objective, accurate interpretation and diagnosis. AI models now reliably detect key spinal pathologies, achieving expert-level performance in tasks like identifying fractures, stenosis, infections, and tumors. Beyond diagnosis, AI also assists surgical planning via synthetic computed tomography generation, augmented reality systems, and robotic guidance. Furthermore, AI image analysis combined with clinical data enables personalized predictions to guide treatment decisions, such as forecasting spine surgery outcomes. However, challenges still need to be addressed in implementing AI clinically, including model interpretability, generalizability, and data limitations. Multicenter collaboration using large, diverse datasets is critical to advance the field further. While adoption barriers persist, AI presents a transformative opportunity to revolutionize spinal imaging workflows, empowering clinicians to translate data into actionable insights for improved patient care.
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Objective Readmission rates after posterior cervical fusion (PCF) significantly impact patients and healthcare, with complication rates at 15%–25% and up to 12% 90-day readmission rates. In this study, we aim to test whether machine learning (ML) models that capture interfactorial interactions outperform traditional logistic regression (LR) in identifying readmission-associated factors.
Methods The Optum Clinformatics Data Mart database was used to identify patients who underwent PCF between 2004–2017. To determine factors associated with 30-day readmissions, 5 ML models were generated and evaluated, including a multivariate LR (MLR) model. Then, the best-performing model, Gradient Boosting Machine (GBM), was compared to the LACE (Length patient stay in the hospital, Acuity of admission of patient in the hospital, Comorbidity, and Emergency visit) index regarding potential cost savings from algorithm implementation.
Results This study included 4,130 patients, 874 of which were readmitted within 30 days. When analyzed and scaled, we found that patient discharge status, comorbidities, and number of procedure codes were factors that influenced MLR, while patient discharge status, billed admission charge, and length of stay influenced the GBM model. The GBM model significantly outperformed MLR in predicting unplanned readmissions (mean area under the receiver operating characteristic curve, 0.846 vs. 0.829; p < 0.001), while also projecting an average cost savings of 50% more than the LACE index.
Conclusion Five models (GBM, XGBoost [extreme gradient boosting], RF [random forest], LASSO [least absolute shrinkage and selection operator], and MLR) were evaluated, among which, the GBM model exhibited superior predictive performance, robustness, and accuracy. Factors associated with readmissions impact LR and GBM models differently, suggesting that these models can be used complementarily. When analyzing PCF procedures, the GBM model resulted in greater predictive performance and was associated with higher theoretical cost savings for readmissions associated with PCF complications.
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Objective Virtual and augmented reality have enjoyed increased attention in spine surgery. Preoperative planning, pedicle screw placement, and surgical training are among the most studied use cases. Identifying osseous structures is a key aspect of navigating a 3-dimensional virtual reconstruction. To automate the otherwise time-consuming process of labeling vertebrae on each slice individually, we propose a fully automated pipeline that automates segmentation on computed tomography (CT) and which can form the basis for further virtual or augmented reality application and radiomic analysis.
Methods Based on a large public dataset of annotated vertebral CT scans, we first trained a YOLOv8m (You-Only-Look-Once algorithm, Version 8 and size medium) to detect each vertebra individually. On the then cropped images, a 2D-U-Net was developed and externally validated on 2 different public datasets.
Results Two hundred fourteen CT scans (cervical, thoracic, or lumbar spine) were used for model training, and 40 scans were used for external validation. Vertebra recognition achieved a mAP50 (mean average precision with Jaccard threshold of 0.5) of over 0.84, and the segmentation algorithm attained a mean Dice score of 0.75 ± 0.14 at internal, 0.77 ± 0.12 and 0.82 ± 0.14 at external validation, respectively.
Conclusion We propose a 2-stage approach consisting of single vertebra labeling by an object detection algorithm followed by semantic segmentation. In our externally validated pilot study, we demonstrate robust performance for our object detection network in identifying individual vertebrae, as well as for our segmentation model in precisely delineating the bony structures.
Artificial intelligence in spine surgery: a scoping review Anis Choucha, Morgane Evin, Matteo de Simone, Guillaume Dannhoff, Henry Dufour, Valentin Avinens, Kaissar Farah, Florian Saby, Stephane Fuentes Neurochirurgie.2026; 72(1): 101764. CrossRef
Deep Learning-Based Projection Angle Estimation for Lumbar Oblique Radiography: A Two-Stage Object Detection Approach Using Vertebral–Pedicle Ratio Analysis Riria Yamamoto, Kaori Tsutsumi, Takaaki Yoshimura, Hiroyuki Sugimori Applied Sciences.2026; 16(6): 2800. CrossRef
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Objective Computed tomography (CT) imaging is a cornerstone in the assessment of patients with spinal trauma and in the planning of spinal interventions. However, CT studies are associated with logistical problems, acquisition costs, and radiation exposure. In this proof-of-concept study, the feasibility of generating synthetic spinal CT images using biplanar radiographs was explored. This could expand the potential applications of x-ray machines pre-, post-, and even intraoperatively.
Methods A cohort of 209 patients who underwent spinal CT imaging from the VerSe2020 dataset was used to train the algorithm. The model was subsequently evaluated using an internal and external validation set containing 55 from the VerSe2020 dataset and a subset of 56 images from the CTSpine1K dataset, respectively. Digitally reconstructed radiographs served as input for training and evaluation of the 2-dimensional (2D)-to-3-dimentional (3D) generative adversarial model. Model performance was assessed using peak signal to noise ratio (PSNR), structural similarity index (SSIM), and cosine similarity (CS).
Results At external validation, the developed model achieved a PSNR of 21.139 ± 1.018 dB (mean ± standard deviation). The SSIM and CS amounted to 0.947 ± 0.010 and 0.671 ± 0.691, respectively.
Conclusion Generating an artificial 3D output from 2D imaging is challenging, especially for spinal imaging, where x-rays are known to deliver insufficient information frequently. Although the synthetic CT scans derived from our model do not perfectly match their ground truth CT, our proof-of-concept study warrants further exploration of the potential of this technology.
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Neurospine 2023;20(4):1272-1280. Published online December 31, 2023
Objective Although adult spinal deformity (ASD) surgery aims to restore and maintain alignment, proximal junctional kyphosis (PJK) may occur. While existing scoring systems predict PJK, they predominantly offer a generalized 3-tier risk classification, limiting their utility for nuanced treatment decisions. This study seeks to establish a personalized risk calculator for PJK, aiming to enhance treatment planning precision.
Methods Patient data for ASD were sourced from the Korean spinal deformity database. PJK was defined a proximal junctional angle (PJA) of ≥ 20° at the final follow-up, or an increase in PJA of ≥ 10° compared to the preoperative values. Multivariable analysis was performed to identify independent variables. Subsequently, 5 machine learning models were created to predict individualized PJK risk post-ASD surgery. The most efficacious model was deployed as an online and interactive calculator.
Results From a pool of 201 patients, 49 (24.4%) exhibited PJK during the follow-up period. Through multivariable analysis, postoperative PJA, body mass index, and deformity type emerged as independent predictors for PJK. When testing machine learning models using study results and previously reported variables as hyperparameters, the random forest model exhibited the highest accuracy, reaching 83%, with an area under the receiver operating characteristics curve of 0.76. This model has been launched as a freely accessible tool at: (https://snuspine.shinyapps.io/PJKafterASD/).
Conclusion An online calculator, founded on the random forest model, has been developed to gauge the risk of PJK following ASD surgery. This may be a useful clinical tool for surgeons, allowing them to better predict PJK probabilities and refine subsequent therapeutic strategies.
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Sung Hyun Noh, Hye Sun Lee, Go Eun Park, Yoon Ha, Jeong Yoon Park, Sung Uk Kuh, Dong Kyu Chin, Keun Su Kim, Yong Eun Cho, Sang Hyun Kim, Kyung Hyun Kim
Neurospine 2023;20(1):265-274. Published online March 31, 2023
Objective This study aimed to create an ideal machine learning model to predict mechanical complications in adult spinal deformity (ASD) surgery based on GAPB (modified global alignment and proportion scoring with body mass index and bone mineral density) factors.
Methods Between January 2009 and December 2018, 238 consecutive patients with ASD, who received at least 4-level fusions and were followed-up for ≥ 2 years, were included in the study. The data were stratified into training (n = 167, 70%) and test (n = 71, 30%) sets and input to machine learning algorithms, including logistic regression, random forest gradient boosting system, and deep neural network.
Results Body mass index, bone mineral density, the relative pelvic version score, the relative lumbar lordosis score, and the relative sagittal alignment score of the global alignment and proportion score were significantly different in the training and test sets (p < 0.05) between the complication and no complication groups. In the training set, the area under receiver operating characteristics (AUROCs) for logistic regression, gradient boosting, random forest, and deep neural network were 0.871 (0.817–0.925), 0.942 (0.911–0.974), 1.000 (1.000–1.000), and 0.947 (0.915–0.980), respectively, and the accuracies were 0.784 (0.722–0.847), 0.868 (0.817–0.920), 1.000 (1.000–1.000), and 0.856 (0.803–0.909), respectively. In the test set, the AUROCs were 0.785 (0.678–0.893), 0.808 (0.702–0.914), 0.810 (0.710–0.910), and 0.730 (0.610–0.850), respectively, and the accuracies were 0.732 (0.629–0.835), 0.718 (0.614–0.823), 0.732 (0.629–0.835), and 0.620 (0.507–0.733), respectively. The random forest achieved the best predictive performance on the training and test dataset.
Conclusion This study created a comprehensive model to predict mechanical complications after ASD surgery. The best prediction accuracy was 73.2% for predicting mechanical complications after ASD surgery.
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Objective Intradural spinal tumors are uncommon and while associations between clinical characteristics and surgical outcomes have been explored, there remains a paucity of literature unifying diverse predictors into an integrated risk model. To predict postresection outcomes for patients with spinal tumors.
Methods IBM MarketScan Claims Database was queried for adult patients receiving surgery for intradural tumors between 2007 and 2016. Primary outcomes-of-interest were nonhome discharge and 90-day postdischarge readmissions. Secondary outcomes included hospitalization duration and postoperative complications. Risk modeling was developed using a regularized logistic regression framework (LASSO, least absolute shrinkage and selection operator) and validated in a withheld subset.
Results A total of 5,060 adult patients were included. Most surgeries utilized a posterior approach (n = 5,023, 99.3%) and tumors were most commonly found in the thoracic region (n = 1,941, 38.4%), followed by the lumbar (n = 1,781, 35.2%) and cervical (n = 1,294, 25.6%) regions. Compared to models using only tumor-specific or patient-specific features, our integrated models demonstrated better discrimination (area under the curve [AUC] [nonhome discharge] = 0.786; AUC [90-day readmissions] = 0.693) and accuracy (Brier score [nonhome discharge] = 0.155; Brier score [90-day readmissions] = 0.093). Compared to those predicted to be lowest risk, patients predicted to be highest-risk for nonhome discharge required continued care 16.3 times more frequently (64.5% vs. 3.9%). Similarly, patients predicted to be at highest risk for postdischarge readmissions were readmitted 7.3 times as often as those predicted to be at lowest risk (32.6% vs. 4.4%).
Conclusion Using a diverse set of clinical characteristics spanning tumor-, patient-, and hospitalization-derived data, we developed and validated risk models integrating diverse clinical data for predicting nonhome discharge and postdischarge readmissions.
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Outcomes for adult spinal deformity continue to improve as new technologies become integrated into clinical practice. Machine learning, robot-guided spinal surgery, and patientspecific rods are tools that are being used to improve preoperative planning and patient satisfaction. Machine learning can be used to predict complications, readmissions, and generate postoperative radiographs which can be shown to patients to guide discussions about surgery. Robot-guided spinal surgery is a rapidly growing field showing signs of greater accuracy in screw placement during surgery. Patient-specific rods offer improved outcomes through higher correction rates and decreased rates of rod breakage while decreasing operative time. The objective of this review is to evaluate trends in the literature about machine learning, robot-guided spinal surgery, and patient-specific rods in the treatment of adult spinal deformity.
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The potential of big data analytics to improve the quality of care for patients with spine tumors is significant. At this moment, the application of big data analytics to oncology and spine surgery is at a nascent stage. As such, efforts are underway to advance data-driven oncologic care, improve patient outcomes, and guide clinical decision making. This is both relevant and critical in the practice of spine oncology as clinical decision making is often made in isolation looking at select variables deemed relevant by the physician. With rapidly evolving therapeutics in surgery, radiation, interventional radiology, and oncology, there is a need to better develop decision-making algorithms utilizing the vast data available for each patient. The challenges and limitations inherent to big data analyses are presented with an eye towards future directions.
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The artificial neural network (ANN), one of the machine learning (ML) algorithms, inspired by the human brain system, was developed by connecting layers with artificial neurons. However, due to the low computing power and insufficient learnable data, ANN has suffered from overfitting and vanishing gradient problems for training deep networks. The advancement of computing power with graphics processing units and the availability of large data acquisition, deep neural network outperforms human or other ML capabilities in computer vision and speech recognition tasks. These potentials are recently applied to healthcare problems, including computer-aided detection/diagnosis, disease prediction, image segmentation, image generation, etc. In this review article, we will explain the history, development, and applications in medical imaging
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Comparison of Deep-Learning and Conventional Machine-Learning Methods for the Automatic Recognition of the Hepatocellular Carcinoma Areas from Ultrasound Images Raluca Brehar, Delia-Alexandrina Mitrea, Flaviu Vancea, Tiberiu Marita, Sergiu Nedevschi, Monica Lupsor-Platon, Magda Rotaru, Radu Ioan Badea Sensors.2020; 20(11): 3085. CrossRef
Allosteric Regulation at the Crossroads of New Technologies: Multiscale Modeling, Networks, and Machine Learning Gennady M. Verkhivker, Steve Agajanian, Guang Hu, Peng Tao Frontiers in Molecular Biosciences.2020;[Epub] CrossRef
Artificial intelligence for brain diseases: A systematic review Alice Segato, Aldo Marzullo, Francesco Calimeri, Elena De Momi APL Bioengineering.2020;[Epub] CrossRef
Deep Convolutional Approaches for the Analysis of COVID-19 Using Chest X-Ray Images From Portable Devices Joaquim De Moura, Lucia Ramos Garcia, Placido Francisco Lizancos Vidal, Milena Cruz, Laura Abelairas Lopez, Eva Castro Lopez, Jorge Novo, Marcos Ortega IEEE Access.2020; 8: 195594. CrossRef
Data Augmentation Techniques for Deep Learning-Based Medical Image Analyses Mingyu Kim, Hyun-Jin Bae Journal of the Korean Society of Radiology.2020; 81(6): 1290. CrossRef
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