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. Contours generated may be used for external beam radiation therapy treatment planning, reviewed, edited, and accepted by trained medical professionals.

Technology

The device is a post-processing software using deep learning algorithms for automatic contouring of organs at risk on CT images. It accepts DICOM CT inputs and produces RTSTRUCT objects as outputs, which can be integrated into treatment planning systems. It supports configuration of organ templates, web-based preview of contours, and operates via cloud deployment with a web-based user interface.

Performance

Validated on 113 retrospective CT cases from multiple clinical sites and vendors, the device demonstrated median Dice scores greater than 80% and Hausdorff distances of approximately 2 mm, indicating performance equivalent to predicate device AccuContour (K191928). Extensive software validation, bench testing, and risk management conforming to FDA and international standards were completed. No clinical tests were conducted; validation relies on comparison to ground truth manual annotations and predicate device performance.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/23/2019

    10 months
  • 2

    FDA Approval

    11/6/2020

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