Automatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLCAutomatic Anatomy Recognition (AAR) is a software medical device that uses deep learning to automatically identify and contour anatomical structures from CT scans. It is designed to assist technicians and physicians in radiation therapy planning by providing precise contours of organs at risk in the head, neck, and chest areas. This helps improve the accuracy and efficiency of treatment planning for patients undergoing radiation therapy for cancers in these body regions.
Intended Use
Software-only medical device intended for use by technicians and trained physicians to derive contours of anatomical structures from computed tomography studies for input to a radiation treatment planning system, specifically for anatomical structures in the head & neck and thoracic body regions.
Technology
A cloud-deployed software-only device using deep learning contouring algorithms to automatically process non-contrast CT images and generate anatomical structure contours without human intervention; it operates independently of radiation treatment type or disease type in head, neck, and thoracic regions.
Performance
Performance testing included automated segmentation accuracy evaluation using DICE similarity coefficients and mean 95% Hausdorff Distance calculations, software verification and validation per IEC 62304 standards; no clinical or animal studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/10/2020
4 months - 2
FDA Approval
4/20/2021
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