CINA
AVICENNA.AICINA is an AI-based software that assists radiologists by analyzing head CT scans and CT angiographies to flag suspected cases of intracranial hemorrhage and large vessel occlusion. It provides timely notifications with preview images to help prioritize cases for quicker evaluation, improving workflow and patient care without altering original images or making direct diagnoses.
Intended Use
CINA is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images and CT angiographies of the head to assist workflow triage by flagging suspected positive findings of intracranial hemorrhage and large vessel occlusion.
Technology
CINA operates on standard server/workstations, processing DICOM images through AI algorithms specifically for intracranial hemorrhage (ICH) and large vessel occlusion (LVO) detection. It includes image processing applications and a worklist platform that delivers notifications of suspected findings with compressed preview images for informational use only.
Performance
Retrospective, blinded, multicenter study on 814 non-contrast head CTs and 476 CTA head cases showed sensitivities of 91.4% for ICH and 97.9% for LVO, with specificities of 97.5% and 97.6% respectively. Time-to-notification was 21.6 seconds for ICH and 34.7 seconds for LVO, demonstrating substantial equivalence to predicate and reference devices and fulfilling performance goals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2020
2 months - 2
FDA Approval
6/24/2020
Other devices from AVICENNA.AI
- CINA-CSpine2024 • 510K
- CINA-VCF2024 • 510K
- CINA-ASPECTS2024 • 510K
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