cNeuro cMRI
Combinostics Oy • Radiology • 01/08/2018
Device Purpose
cNeuro cMRI is software that automates the segmentation and quantification of brain structures from T1-weighted and FLAIR MR images, utilizing multi-atlas techniques and statistical comparison against a normative database. Its purpose is to provide quantitative volumetric biomarkers and a visual gray matter concentration map to assist medical professionals in assessing brain anatomy from a single imaging session.
Summary
cNeuro cMRI is medical image processing software designed for the automatic labeling, quantification, and visualization of segmentable brain structures from magnetic resonance (MR) images. The system utilizes T1-weighted (mandatory) and fluid-attenuated inversion recovery (FLAIR) DICOM MR images from a single time point, which can be accessed via a Picture Archiving and Communication System (PACS) or selected from local files. The software's workflow begins with pre-processing, including bias-field correction and brain extraction, followed by segmentation and the calculation of MRI biomarkers. This automates the traditionally manual process of identifying, labeling, and quantifying brain structures. The device quantifies volumes of 133 brain structures from T1 images using multi-atlas segmentation and segments white matter hyperintensities from FLAIR images. These computed biomarkers are then compared to those from a healthy reference population using a statistical model, normalized for age, sex, and head size. A key feature is the generation of a gray matter concentration map, an overlay on T1 images highlighting regions where the patient's local gray matter concentration is lower than that of the reference population. Performance testing, conducted on 1399 subjects including healthy individuals and patients with various neurological conditions, demonstrated high accuracy (e.g., Dice index of 0.88 for hippocampus, 0.91 for thalamus) and reproducibility (intraclass correlation coefficient of 0.96 for all 133 structures, and a 0.97 correlation for FLAIR white matter hyperintensities against manual labeling).
AI Regulatory Concerns
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Device Metadata
Relevant Clinical Questions
- Q1. How does the performance of cNeuro cMRI's 133-structure atlas compare to atlases with a different number of structures in terms of processing time versus clinical detail for various neurological conditions?; What is the specific statistical model used for comparing patient biomarkers to the healthy reference population, and how was this reference population established and validated for diversity?; How does the gray matter concentration map account for individual variations in brain morphology beyond age, sex, and head size, and what is its sensitivity and specificity for detecting subtle atrophy?; What are the performance metrics of cNeuro cMRI when processing MR images with common artifacts (e.g., motion, susceptibility) or from patients with highly atypical brain anatomy (e.g., post-surgical changes, large lesions)?; Given its single time-point analysis, what are the potential applications or limitations of cNeuro cMRI in monitoring disease progression or treatment response compared to systems designed for longitudinal analysis?
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.
• 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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