Intended Use

MR Contour DL generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by trained medical professionals. It aids radiation therapy planning by generating initial contours to accelerate workflow. The user is responsible for verifying and correcting contours and labels. It is intended for use with MR images in adult patients.

Technology

MR Contour DL is a post-processing software application that uses deep learning algorithms to segment 37 different organs at risk on MR images to generate RTSS DICOM output. It integrates with other platforms and transfers input/output series to DICOM destinations. The software runs on a server-based deployment (GE Edison HealthLink platform).

Performance

Performance testing included bench testing with 105 retrospectively collected MR exams and a clinical reader study. The software showed high segmentation accuracy (Dice scores averaging ~81%) and clinical adequacy per radiation oncologist review, with results comparable or better than predicate devices. The software was verified under quality system regulation with no safety or effectiveness concerns.

Predicate Devices

No predicate devices specified

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