Intended Use

AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis). Generates RT-DICOM structure of contoured organs. Rule-based auto pre-processing. Receive/Send/Export medical images and DICOM data.

Technology

Deep-learning-based automatic segmentation of organs-at-risk from CT images of four body parts (Head & Neck, Breast, Abdomen, Pelvis). Generates RT-DICOM structure files and uses rule-based pre-processing. Process involves receiving, sending, and exporting medical images and DICOM data.

Performance

Performance testing involved comparison of AVIEW RT ACS auto-segmented contours against a gold standard created by three expert radiation oncologists on 120 CT cases from Korea and the US, with evaluation metrics including Dice Similarity Coefficient and 95% Hausdorff Distance showing comparable or improved performance relative to predicate devices. Validation included diverse patient populations, vendors, and imaging parameters.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/14/2022

    8 months
  • 2

    FDA Approval

    11/10/2022

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