VBrain-OAR
Vysioneer Inc.VBrain-OAR is a software device from Vysioneer Inc. designed to assist trained radiotherapy personnel in brain tumor radiation therapy treatment planning by automatically generating contours of organs at risk in brain MRI images using AI deep learning. It also provides image registration functions to align multi-modality medical images. This device supports clinicians by providing initial contour outlines to improve the efficiency and consistency of radiation treatment planning, while still requiring final confirmation by qualified personnel.
Intended Use
Assist trained radiotherapy personnel by providing initial object contours of organs at risk in the brain on axial T1 contrast-enhanced brain MRI images during brain tumor radiation therapy treatment planning for adult patients.
Technology
The device uses deep learning neural networks to contour organs at risk in the brain on axial T1 contrast-enhanced MR images and exports contours as DICOM-RT objects. It also features a rigid image registration module for volumetric medical image data (e.g., MR, CT). The modules include image preprocessing, deep learning-based segmentation, postprocessing, and a workflow management module integrated within a PACS network.
Performance
Performance testing includes standalone evaluation of the AI-based segmentation algorithm demonstrating clinically acceptable contours for brain organs at risk, and testing of the registration algorithm across multiple modalities and institutions showing consistent performance. Verification and validation testing confirms software meets FDA guidance for radiation therapy planning software with no new potential risks.
Predicate Devices
No predicate devices specified
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