CINA-ASPECTS
Avicenna.AICINA-ASPECTS is a computer-aided diagnosis software designed to assist clinicians in evaluating brain tissue abnormalities using CT scans. It automatically analyzes regions of the brain affected by ischemic stroke, computes a standardized ASPECT score, and provides visual and quantitative data to support timely and accurate diagnosis of early acute stroke injury.
Intended Use
Computer-aided diagnosis software to assist in assessment and characterization of brain tissue abnormalities using CT images, providing an ASPECT score for evaluation of early ischemic (acute) brain injury in patients with known MCA or ICA occlusion.
Technology
The software automatically processes non-contrast head CT images through steps including image reorientation, region segmentation, and voxel analysis to generate an ASPECT score using deep learning AI algorithms. Outputs include highlighted ASPECT regions and a quantitative score displayed in a user interface for clinician review and optional adjustment.
Performance
Performance validation included retrospective, multicenter, multinational clinical studies analyzing 200 NCCT cases from multiple vendors. Results demonstrated the software improves reader accuracy and speed compared to unaided assessment, generalizes across patient demographics, scanners, and clinical sites, and meets design requirements for safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2023
5 months - 2
FDA Approval
3/15/2024
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