EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
K240291Ever Fortune.AI, Co., Ltd. · cleared 2024-04-08 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer aided triage and notification software indicated for use in the analysis of chest or chest-abdomen CTA in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology.”
source quote (p.7)
“Artificial intelligence algorithm with database of images”
source quote (p.7)
“FDA Guidance documents, “Content of Premarket Submissions for Device Software Functions” and “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.””
Validation studies (2)
Retrospective clinical
n=380 cases
endpoints: identifying positive findings of aortic dissection (AD) or aortic intramural hematoma (IMH); sensitivity; specificity; system processing time per study
standards: IEC 62304:2006/A1:2016, ISO 14971:2019
Reader study (MRMC)
sample size not stated
Reported performance (2 observations)
source quote (p.7)
“sensitivity and specificity of 0.929 (95% CI=0.878-0.960)”
source quote (p.7)
“specificity of 0.915 (95% CI=0.871-0.945)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).