EFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.The EFAI RTSuite CT HN-Segmentation System is AI-powered software designed to assist radiation oncology professionals by automatically contouring organs at risk in head and neck CT images. It helps streamline radiation therapy treatment planning by providing initial segmentations that clinicians review and edit, improving workflow efficiency and accuracy.
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
Device Timeline
- 1
Submission
1/31/2022
2 months - 2
FDA Approval
4/28/2022
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