EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

K240291

Ever Fortune.AI, Co., Ltd. · cleared 2024-04-08 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmdeep learning techniques
source quote (p.5)
“The software uses deep learning techniques to automatically analyze chest or chest-abdomen CTA and alerts the PACS/RIS workstation once images with features suggestive of AD or IMH are identified.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the 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 (1)

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

Reported performance (2 observations)

sensitivity0.929CI 0.878-0.960
source quote (p.7)
“The EFAI AASCTA was able to demonstrate sensitivity and specificity of 0.929 (95% CI=0.878-0.960) and 0.915 (95% CI=0.871-0.945) respectively”
specificity0.915CI 0.871-0.945
source quote (p.7)
“The EFAI AASCTA was able to demonstrate sensitivity and specificity of 0.929 (95% CI=0.878-0.960) and 0.915 (95% CI=0.871-0.945) respectively”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240291