EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.
Intended Use
Radiological computer aided triage and notification software indicated for use in analysis of chest or chest-abdomen CTA in adults aged 22 and older to assist in triage by flagging suspected positive cases of aortic dissection or aortic intramural hematoma.
Technology
The device uses deep learning AI algorithms to automatically analyze chest or chest-abdomen CT angiography images and provides case-level notifications to PACS/RIS workstations for prioritization. It does not mark specific image locations but flags cases suspected of acute aortic syndrome. It operates passively within the radiology workflow.
Performance
A retrospective, blinded, multisite clinical validation study using 380 CTA studies from the US was conducted. The device demonstrated high sensitivity (0.929) and specificity (0.915) in detecting aortic dissection and intramural hematoma, meeting acceptance criteria. Performance was consistent across different patient subgroups, CT manufacturers, and image quality factors. Average processing time was 37.86 seconds per study.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/1/2024
2 months - 2
FDA Approval
4/8/2024
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