CINA
AVICENNA.AICina is an AI-powered software designed to assist radiologists by automatically analyzing head CT and CT angiography images to detect intracranial hemorrhage and large vessel occlusion. It provides notifications and preview images to help prioritize and triage cases, enhancing workflow efficiency and potentially enabling faster diagnosis and treatment without replacing standard diagnostic procedures.
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 angiography of the head to assist hospital networks and radiologists by flagging suspected positive findings of intracranial hemorrhage and large vessel occlusion to aid in triage/prioritization.
Technology
Cina operates on an off-the-shelf server and includes AI image processing applications specifically for ICH and LVO detection. It receives DICOM images, processes series chronologically using proprietary algorithms to flag suspected findings, and sends notifications with compressed preview images to a Worklist Application for prioritization, without altering the original images.
Performance
Performance testing included a retrospective, blinded, multicenter study on 814 cases for ICH and 476 cases for LVO. Sensitivity and specificity for ICH detection were 91.4% and 97.5%, respectively, and for LVO 97.9% and 97.6%, achieving performance goals comparable to the predicate device. Mean time-to-notification was 13.2 seconds for ICH and 25.8 seconds for LVO, demonstrating rapid triage assistance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/13/2022
5 months - 2
FDA Approval
11/22/2022
Other devices from AVICENNA.AI
- CINA-CSpine2024 • 510K
- CINA-VCF2024 • 510K
- CINA-ASPECTS2024 • 510K
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