Spine CAMP�
Medical Metrics, Inc.Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to measure and assess spinal parameters, such as alignment, stability, and motion. It helps healthcare professionals by providing quantitative metrics and visualizations, improving clinical decision-making regarding spinal health and treatments.
Intended Use
Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. It can be used on sagittal plane radiographs of the lumbar and/or cervical spine to assess spinal health, stability, alignment, degeneration, fusion, motion preservation, and implant performance for skeletally mature patients aged 18 and above.
Technology
Spine CAMP™ uses non-adaptive AI models trained from predicate device data to automate vertebral body detection, landmark specification, and image registration. It produces measurements such as distances, angles, displacements, and visualizes intervertebral motion via image stabilization techniques.
Performance
Software verification and validation were performed on multiple datasets not used in training, comparing outputs with a predicate device. Statistical equivalence was demonstrated between Spine CAMP™ and the predicate device across vertebral landmark coordinates, image calibration, and radiographic metrics on a large dataset including cervical and lumbar spine radiographs.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/6/2022
4 months - 2
FDA Approval
10/18/2022
Other devices from Medical Metrics, Inc.
- Spine CAMP� (1.1)2023 • 510K
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