Momentum Spine
Momentum Health Inc.Momentum Spine is a mobile application that uses a smartphone camera to capture a 3D model of the torso and applies artificial intelligence to measure and track postural asymmetries, including scoliosis. It assists clinicians and patients in monitoring spinal health by providing quantitative assessments such as predicted Cobb angle and asymmetry metrics, enhancing early detection and management of spinal deformities.
Intended Use
Momentum Spine is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis.
Technology
The device uses mobile phone cameras to capture video of the torso and reconstructs a 3D surface topography model using photogrammetry and AI/ML algorithms to quantify anatomical asymmetries and differentiate postural conditions.
Performance
Performance was validated through software verification and validation testing per IEC 62304 and FDA guidance, including AI algorithm evaluation on a dataset of 212 individuals with separation of training and test sets. Usability testing demonstrated successful video capture by lay users and healthcare professionals, confirming safety and effectiveness comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/7/2023
2 months - 2
FDA Approval
10/4/2023
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