ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc. • Radiology • 08/08/2022
Device Purpose
The ClearPoint MaestroTM Brain Model is an advanced software tool utilizing shape-constrained segmentation and machine learning to automatically process T1-weighted MR images for quantifying brain structures. It aims to provide clinicians with accurate volumetric and shape data through intuitive visualizations and comparative reports, enhancing neuroanatomical assessment and streamlining MRI analysis workflows.
Summary
The ClearPoint MaestroTM Brain Model is a software system designed for automated image processing of brain structures from T1-weighted MR images. Its core purpose is to automate the identification, labeling, visualization, and quantification of both the volume and shape of segmentable brain structures, thereby simplifying the MRI segmentation workflow for clinicians. The system features modules for DICOM reading, segmentation, visualization, and exporting, presenting segmented structures as color-coded overlays on MR images or as 3D triangular meshes. It offers tools for anatomical orientation, image manipulation, slice selection, and generates PDF reports comparing segmented volumes to normative brain structure values. The device utilizes a shape-constrained segmentation method for sub-cortical regions, hemispheres, and the cerebellum, followed by voxel-wise tissue parcellation for tissue differentiation within the hemispheres and cerebellum. Machine learning algorithms, trained using data from Philips Research Hamburg, are employed to quantify gray and white matter volumes. Performance validation against manually labeled T1-weighted MRI data from 101 subjects indicated high segmentation accuracy. For 21 brain structures, mean Dice coefficients generally surpassed 0.7 and relative volume differences were below 0.3, with noted exceptions for the third ventricle and lateral ventricles in a specific age subgroup, which were attributed to manual labeling variability rather than device performance. The system demonstrated strong reproducibility, with absolute volume differences under 10% on repeated scans, and its machine learning-derived outputs also met predefined accuracy standards.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does the ClearPoint Maestro's shape-constrained segmentation algorithm specifically handle anatomical variants or pathological distortions compared to atlas-based methods like NeuroQuant?; What were the specific characteristics of the 101-subject validation dataset, and how does the performance (Dice coefficient and relative volume difference) vary across different age groups or in the presence of common neurological conditions?; Could you elaborate on the machine learning models used for gray and white matter quantification, including details about their training, architecture, and validation against diverse MR scanner data?; The device reported higher consistency than manual labeling for the third ventricle; what were the quantitative measures of inter-rater and intra-rater variability for the manual labeling process used as the ground truth?; What is the source and demographic scope of the normative reference data used for volumetric comparisons, and how are potential confounders like age, sex, and intracranial volume accounted for in these comparisons?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of ML-BOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.
• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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