AI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.AI-Rad Companion Organs RT is an AI-powered medical imaging software designed to automatically segment organs from CT and MR scans to assist radiation therapy treatment planning. It uses deep learning algorithms to produce contours of organs-at-risk, which clinicians can review and edit before using them in treatment planning systems. This software saves time and improves the accuracy of radiation therapy preparation by providing automated organ delineation, intended for use by trained medical professionals.
Intended Use
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR predefined structures using deep-learning-based algorithms. The contours may be used as input for workflows including external beam radiation therapy treatment planning. Must be used with appropriate software to review, edit, and accept contours; outputs are for trained medical professionals and not intended to detect lesions.
Technology
AI-Rad Companion Organs RT processes CT and MR series using deep learning algorithms to automatically segment predefined organs-at-risk. The software outputs contours in DICOM-RTSTRUCT format for review prior to integration into treatment planning systems. It is vendor agnostic for CT; MR contouring validated on Siemens Healthineers scanners only. Includes algorithm updates for new organs and MR data support compared to previous versions.
Performance
Performance validation included retrospective studies using 66 MR and 414 CT cases from multiple clinical sites. The AI-generated contours were compared to manual expert annotations using Dice coefficient and absolute symmetric surface distance (ASSD), showing equivalent or better performance than predicate devices, including AI-Rad Companion Organs RT predicate and MRCAT Pelvis reference device. Testing adhered to FDA software and cybersecurity guidance and included software verification, regression testing, and validation using multiple industry standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2023
6 months - 2
FDA Approval
4/3/2024
Other devices from Siemens Medical Solutions U.S.A.
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