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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 and to visualize intervertebral motion via an image registration method called 'stabilization'. The metrics support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients.

Technology

The device is a fully-automated image processing software that calculates distances, angles, and displacements from spine X-ray images. It utilizes AI for vertebral body detection, landmark specification, and registration to produce static and motion metrics, presented as reports and annotated images. It can identify femoral heads for spinopelvic measurements and supports configurable reporting options.

Performance

Software verification and validation testing demonstrated functionality across multiple datasets not used in AI training. Performance was evaluated against the predicate device Spine CAMP v1.0 and a reference device for spinopelvic measurements by statistical correlation and equivalence tests over 447 spine radiographs. Outputs were statistically equivalent and clinically consistent, supporting safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/7/2023

    1 month
  • 2

    FDA Approval

    7/7/2023

Other devices from Medical Metrics, Inc.

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