Brainomix 360 e-ASPECTS

Brainomix Limited

510k2/23/2023

FDA #

K221564

Product Code

POK

Panel

Radiology

Modality:CT Task:Classification Body Region:Neurological Target Condition:Stroke

Brainomix 360 e-ASPECTS is an AI-powered software that analyzes non-contrast CT brain scans to assist clinicians in detecting and characterizing ischemic brain tissue injuries, particularly in cases of acute stroke caused by MCA or ICA occlusions. It automatically provides an ASPECTS score, highlights affected brain regions, and visualizes voxel contributions to the score, helping clinicians make timely and more accurate assessments to guide stroke treatment.

Intended Use

Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. It provides an ASPECTS score for patients with known MCA or ICA occlusion within 6 hours from time last known well.

Technology

The software uses machine learning (random forest algorithm) on non-contrast CT brain scans to analyze voxels and register images to an atlas to identify ASPECTS regions. It visualizes affected areas with heat maps and allows manual edit of scores by clinicians. It integrates with PACS via DICOM for image transfer and notifications.

Performance

Performance testing includes software validation against user needs and phantom data, stand-alone performance showing high accuracy (AUC 83%, sensitivity 68%, specificity 97%) on 256 diverse clinical cases, digital phantom testing validating heatmaps accuracy, and a clinical multiple-reader study demonstrating statistically significant improvement in ASPECTS scoring accuracy with the software aiding clinicians.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
5/31/2022
8 months
2
FDA Approval
2/23/2023

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