MR Diffusion Perfusion Mismatch V1.0
Olea MedicalMR Diffusion Perfusion Mismatch V1.0 by Olea Medical is an AI-powered software tool that automatically processes MR Diffusion and Perfusion imaging data to compute parametric maps, extract volume metrics, and calculate mismatch volumes. It assists radiologists and surgeons by providing quantitative imaging data that supports clinical decision-making. The software integrates with medical image platforms to streamline workflow without altering the original images and is intended to be used alongside other clinical information, not as a standalone diagnostic tool.
Intended Use
MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology to compute parametric maps from MR Diffusion-weighted imaging and MR Perfusion-weighted imaging, extract volumes of interest, and compute mismatch automatically as an aid to trained radiologists and surgeons.
Technology
The software operates as a docker container integrated with a Medical Image Communications Device technical platform, which handles DICOM inputs and output visualization. It automatically identifies relevant MR series, applies AI-based algorithms for diffusion brain extraction and perfusion background segmentation, performs 3D rigid motion correction, computes parametric maps, extracts volumes, and calculates mismatch metrics.
Performance
Performance testing involved internal verification, software validation, and a comparative clinical image study versus the predicate Olea Sphere V3.0. Parametric maps showed strong statistical equivalence (Pearson and Spearman correlations >0.8) except some temporal maps. Volume segmentations and mismatch computations demonstrated acceptable bias and variability within ranges considered safe and effective by a US board-certified neuroradiologist. Overall, the device is substantially equivalent in safety and effectiveness to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2022
1 month - 2
FDA Approval
1/13/2023
Other devices from Olea Medical
- MR DWI/FLAIR Measurement V1.02023 • 510K
- breastscape v1.02021 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.