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

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