Intended Use

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms. The contours generated may be used as input for clinical workflows including external beam radiation therapy treatment planning. The output RTSTRUCT objects are intended to be used by trained medical professionals.

Technology

The device uses deep learning algorithms to automatically contour organs at risk on CT images. It processes CT input data in DICOM format and outputs RTSTRUCT objects compatible with treatment planning systems. A web-based interface provides visualization of contouring results for review and acceptance. The algorithm is locked and validated, designed to be vendor agnostic with configuration of organ templates via an interface. It supports automated workflows, organ template management and web preview.

Performance

Performance validation was conducted on 113 CT datasets from multiple clinical sites across multiple continents. The algorithm's Dice similarity coefficient, absolute symmetric surface distance, and fail rate were evaluated, showing comparable performance to the predicate device (AI-Rad Companion Organs RT VA20) and reference device (Contour ProtégéAI). Results were consistent across different vendors and genders. Validation confirmed the safety and effectiveness of the device with no raise in new safety issues.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/5/2022

    5 months
  • 2

    FDA Approval

    10/14/2022

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