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Automatic Anatomy Recognition (AAR) is a 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. It is only intended to work for anatomical structures in the head & neck and thoracic body regions. It is not for use on patients below 18 years of age and it relies on third party treatment planning systems to display and edit the contours.

Automatic Anatomy Recognition product for radiation therapy planning (AAR) is a software-only medical device and is deployed on a cloud-based platform. AAR is intended to be used on adults undergoing treatment that requires the identification of anatomical structures in the body considered to be "organs at risk" (OAR). AAR is intended to be used in the head and thoracic body regions. AAR automatically processes computed tomography (CT) studies and produces contours with no human intervention. AAR does not provide the capability to modify contours. If adjustments are required, they must be performed on another system.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Automatic Anatomy Recognition (AAR) device.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "segmentation accuracy non-inferiority using DICE similarity coefficients" and "mean 95% Hausdorff Distance (HD)" calculations as performance testing methods. However, it *does not explicitly state specific numerical acceptance criteria (e.g., "DICE score > 0.8" or "HD

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