Momentum Spine

The Momentum Spine is a mobile application utilizing optical contour sensing from video and artificial intelligence to reconstruct 3D torso models for quantifying postural asymmetries like scoliosis. Its methodology involves AI-driven analysis of these models to provide accessible, non-invasive measurements such as predicted Cobb angles, intended for both lay users and clinicians to monitor spinal health in individuals aged 8 and older.

The Momentum Spine is a mobile application designed for optical contour sensing to quantify asymmetries, assess body angles, and monitor curve progression associated with postural asymmetries, notably scoliosis. It functions by capturing a video of a patient's torso using a standard mobile device, from which it reconstructs a 3D model. This model is then analyzed using 3D imaging techniques and artificial intelligence to provide its assessments. The application is intended for use by both lay users (such as parents or guardians) and healthcare professionals for patients aged 8 years and older, and can also be used by healthy individuals for general spinal health monitoring. It is available over-the-counter and by prescription. The device provides several quantitative anatomical measurements, including an AI-predicted Cobb angle, shoulder asymmetry, waist asymmetry, trunk shift, and plumb shift, which are reported to the user alongside 3D models (standing and bent-over) and an asymmetry map. Performance validation included extensive software verification and validation (passing unit, system-level, and integration tests), and AI testing against X-ray derived Cobb angles as ground truth, with a target accuracy of within 10 degrees using a dataset of 212 individuals. Usability testing with both lay users and healthcare professionals confirmed the ease of use and successful completion of critical tasks, such as video capture. The device utilizes photogrammetry for 3D surface topography, similar to established methods, but as a software-only mobile solution incorporating AI and not requiring physical body markers.

AI Regulatory Concerns

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• Q1. What is the validated accuracy and precision of the AI-predicted Cobb angle compared to traditional radiographic measurements across different age groups and scoliosis severity levels within the 8+ years patient population?; How does the app's performance vary with different mobile device camera qualities, lighting conditions, and user skill levels in capturing the video?; What is the long-term reliability of the Momentum Spine app in monitoring scoliosis progression compared to serial X-rays, and what is the recommended frequency of use for effective monitoring?; Are there specific types of postural asymmetries, other than scoliosis, for which the app has demonstrated particular utility or validated accuracy?; How does the AI algorithm account for anatomical variability (e.g., body mass index, developmental stage) in patients aged 8 and older to maintain accuracy in its 3D reconstruction and asymmetry quantification?