icobrain aria

icometrix NV • Radiology • 11/07/2024

510(k)IEC 62304 Class B

Device Purpose

Icobrain aria is a software-only computer-assisted detection and diagnosis tool designed to enhance the safety monitoring of Alzheimer's disease patients undergoing amyloid beta-directed antibody therapy by assisting radiologists in the accurate detection and quantification of amyloid-related imaging abnormalities (ARIA) on brain MRI scans. The device employs advanced image processing to generate annotated DICOM images and detailed reports, and its effectiveness has been clinically demonstrated through improved diagnostic accuracy, sensitivity, and efficiency in ARIA detection.

Summary

icobrain aria is a software-only tool designed to assist trained radiologists in detecting and quantifying amyloid-related imaging abnormalities (ARIA), specifically ARIA-E (edema/sulcal effusion) and ARIA-H (hemosiderin deposition), on brain MRI scans. It is intended for use in Alzheimer's disease patients receiving amyloid beta-directed antibody therapy, serving as a computer-assisted detection and diagnosis (CADe/CADx) aid for safety monitoring. The software processes MRI scans from two time points, generating annotated DICOM images and detailed electronic reports that include measurements and automatically derived ARIA radiographic severity levels, complementing a radiologist's professional review. Comprehensive non-clinical and clinical performance testing demonstrated the software's capabilities. Standalone evaluations indicated that icobrain aria detects ARIA findings at both case and individual finding levels consistent with expert human performance. A multi-reader, multi-case study further confirmed that radiologists using the software experienced significantly improved diagnostic accuracy and sensitivity in detecting ARIA, alongside reduced inter-reader variability and faster reading times. The overall assessment concluded that the software is effective and its benefits in enhancing the reliability and efficiency of ARIA detection for patient safety monitoring outweigh any associated risks, such as potential false positives or negatives.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

icobrain ariaAmyloid-related imaging abnormalities (ARIA)Alzheimer's diseaseAmyloid beta-directed antibody therapyBrain MRISafety monitoringComputer-assisted detection (CADe/CADx)Diagnostic accuracyRadiology workflowARIA quantification

Device Metadata

Submission Number

K240712

Company

icometrix NV

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What is the sensitivity and specificity of icobrain aria for different ARIA subtypes (ARIA-E vs. ARIA-H) across various stages of Alzheimer's disease?; How does the quantitative output of icobrain aria correlate with clinical severity or progression of amyloid-related imaging abnormalities?; What are the specific MRI pulse sequences and acquisition parameters that are validated or recommended for optimal performance of the icobrain aria software?; Beyond diagnostic accuracy, how does the integration of icobrain aria impact overall clinician workload and the timeliness of clinical interventions?; Have studies evaluated the generalizability of icobrain aria's performance across different patient populations, MRI scanner vendors, or geographical regions?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

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 Score15/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan✓ Detected in Summary

§524B ApplicableYes

Supply Chain BOM Evidence

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

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not 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.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Not detected in AI-generated device summary: SBOM, ML-BOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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