Intended Use

A fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals at least 4 years old with suspected or present spinal deformities, such as scoliosis.

Technology

Uses machine learning algorithms (convolutional neural networks) for landmark detection on spine radiographs, followed by classic angle calculations to provide automated Cobb angle measurements. Processes DICOM format images and outputs results as annotated DICOM secondary captures.

Performance

Clinical standalone performance on 345 frontal spine radiographs demonstrated mean absolute errors of ~2.5-2.8 degrees for Cobb angle measurements, meeting acceptance criteria and supporting reliable, reproducible measurements in adults, children, and adolescents.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/3/2024

    8 months
  • 2

    FDA Approval

    2/5/2025

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