ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.
Intended Use
ClearPoint Maestro Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images to automate the process of identifying, labeling, and quantifying brain structures.
Technology
The software uses shape-constrained segmentation of sub-cortical brain regions, hemispheres, and cerebellum from T1-weighted MR images, followed by voxel-wise tissue parcellation. It provides color-coded overlays, 3D triangular mesh representations, and PDF reports comparing volumes to normative data.
Performance
Performance was validated by comparing automated segmentations to manual labels using Dice coefficients >0.7 and relative volume differences <0.3 in 101 subjects, meeting acceptance criteria. Reproducibility was high with volume differences <15% in repeated scans. Machine learning outputs also met accuracy criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2021
8 months - 2
FDA Approval
8/8/2022
Other devices from ClearPoint Neuro, Inc.
- ClearPoint System (Software Version 2.2)2023 • 510K
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