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icobrain

icometrix NV • Radiology • 11/06/2018

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

icobrain is an automated software tool for quantitative analysis of brain structures from MR and NCCT images, intended to streamline neurological image assessment. It employs classical machine learning and deep learning (Convolutional Neural Networks) for segmentation to provide volumetric data and specific reports for conditions such as dementia and Traumatic Brain Injury, supporting both single time-point analysis (MR/NCCT) and longitudinal tracking (MR).

Summary

icobrain is medical image processing software designed for the automatic labeling, visualization, and volumetric quantification of segmentable brain structures from Magnetic Resonance (MR) or Non-Contrast Computed Tomography (NCCT) images. It aims to automate the manual process of identifying, labeling, and quantifying these brain structures. The software utilizes two distinct image processing pipelines: 'icobrain cross' for analyzing images (MR or NCCT) from a single time point, and 'icobrain long' for assessing changes in brain volumes between two MR images acquired at different timepoints on the same scanner with identical protocols; the results from these two pipelines are not comparable. The software processes input DICOM images by converting them to NIFTI format, then applies image segmentation algorithms, including classical machine learning and deep learning (specifically Convolutional Neural Networks for CT), to calculate measurements of brain structures and abnormalities. A key update is its enhanced CT processing capability, which generates specific reports for potential dementia patients (e.g., whole brain and lateral ventricle volumes) and traumatic brain injury (TBI) patients (e.g., midline shift, basal cistern volumes, hyperdensity volumes). Performance testing on 544 subject datasets, including TBI and dementia cohorts, demonstrated the CT pipeline's accuracy and reproducibility, achieving an average Pearson correlation coefficient of 0.95 and an intraclass correlation coefficient of 0.94 against ground truth or outputs from prior software versions.

AI Regulatory Concerns

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Keywords

Brain volumetryImage segmentationMagnetic Resonance Imaging (MRI)Computed Tomography (CT)Deep LearningConvolutional Neural Networks (CNN)Traumatic Brain Injury (TBI)DementiaMidline shiftAutomated image analysis

Device Metadata

Submission Number
K181939
Company
icometrix NV
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. What specific Convolutional Neural Network (CNN) architectures are employed for the CT image segmentation, and how were they validated across diverse patient populations and CT scanner variations?; How does icobrain handle variations in image quality or common artifacts in clinical MR and NCCT scans, and what is its reported failure rate or the typical need for manual review/correction?; Beyond overall correlation coefficients, what are the quantitative performance metrics (e.g., Dice coefficient, absolute volume difference) of the 'icobrain cross' CT pipeline for specific structures like basal cisterns or hyperdensities when compared to expert manual segmentation?; For the 'icobrain long' MR pipeline, what is the minimum detectable volumetric change for key brain structures, and how does this sensitivity compare to established rates of pathological progression in relevant neurological diseases?; Are there plans to integrate findings from the CT-derived dementia and TBI reports, or to correlate them with MR-derived metrics, for patients presenting with complex or comorbid neurological conditions?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

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.

Cyber Score35/100
SBOM Evidence✓ Detected in Summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned in summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials(software version)
✓ Detected
ML-BOMMachine Learning Bill of Materials(machine learning, deep learning, neural network, algorithm, dataset)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(network)
✓ Detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not detected

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 SBOM, ML-BOM, SaaSBOM 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: HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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icobrain - icometrix NV | ESL FDA AI Device Intelligence