Seg Pro V3 (RT-300)
Ever Fortune.Ai, Co., Ltd.Seg Pro V3 is a deep learning-based software tool that helps radiation oncology professionals by automatically creating initial contours of organs at risk on medical imaging scans. It supports CT and MR images and integrates with radiation therapy treatment planning systems to improve the efficiency and consistency of treatment planning, while requiring clinician review before final use.
Intended Use
Software device intended to assist trained radiation oncology professionals in clinical workflows of radiation therapy planning by providing initial contours of organs at risk on DICOM images for adult patients only.
Technology
Standalone Linux-based software using deep learning algorithms to automatically contour organs at risk on CT and MR DICOM images. Outputs contours as DICOM RTSTRUCT files for integration with treatment planning systems. Operates fully automatically without user interaction, intended as an adjunct tool requiring clinician review.
Performance
Performance evaluation included software verification and validation per IEC 62304 and FDA guidelines, with clinical validation by independent users showing that Seg Pro V3 functions as intended in clinical workflows. Standalone performance testing on 175 independent cases with ground truth by expert radiation oncologists showed mean Dice Similarity Coefficients of 0.90 (large), 0.86 (medium), and 0.73 (small) volume structures, meeting acceptance criteria. Subgroup analyses demonstrated consistent and reliable performance across diverse clinical scenarios and imaging parameters.
Predicate Devices
No predicate devices specified
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