Intended Use

Software device intended to assist radiation oncology professionals by providing initial contours of organs at risk in the head and neck region on non-contrast CT images, to be used during radiation therapy planning in adult patients.

Technology

Standalone software using deep-learning algorithms to automatically generate organ-at-risk contours from input DICOM CT images and outputting RTSTRUCT files for integration with radiation therapy planning systems. Operates on a server with no user interface and works in conjunction with DICOM-compliant systems to review/edit results.

Performance

The device's contour performance was validated through a non-inferiority test comparing Dice coefficients of organ-at-risk contours against a predicate device (AccuContour). Results showed non-inferior performance within a clinically acceptable margin, demonstrating comparable safety and effectiveness.

Predicate Devices

No predicate devices specified

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