EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered software tool designed to assist radiation oncology professionals by automatically outlining critical organs at risk on CT scans. It helps radiation therapists plan treatments more efficiently by providing initial organ contours that clinicians can review and adjust, improving workflow while ensuring safety and accuracy.
Intended Use
Software device intended to assist trained radiation oncology professionals during radiation therapy treatment planning by providing initial contours of organs at risk on non-contrast CT images for adult patients.
Technology
Standalone software using deep learning algorithms to automatically contour organs at risk on CT images. Processes DICOM input, generates RTSTRUCT output, and integrates with DICOM-compliant radiation therapy treatment planning systems. Installed on specialized local servers, no user interface provided within the device itself.
Performance
Performance validated on 1,846 adult cases from radiation oncology, covering multiple body regions, via deep learning model development and testing. Clinical validation on 157 independent CT cases demonstrated high accuracy with mean Dice Similarity Coefficient of 0.83 overall, exceeding non-inferiority margins versus comparison device. Detailed organ-wise metrics and subgroup analyses show consistent and reliable performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/30/2023
2 months - 2
FDA Approval
9/25/2023
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