BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

K253578

Aidoc Medical , Ltd. · cleared 2026-02-26 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is a radiological computer-assisted triage and notification software device.”
Algorithmfoundation model-based artificial intelligence (AI) system, deep learning algorithm
source quote (p.5)
“BriefCase-Triage uses a foundation model-based artificial intelligence (AI) system to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation.”
Adaptive (vs locked)No
source quote (p.10)
“Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.16)
“Cybersecurity has been incorporated into the software development lifecycle in alignment with Section 524B of the FD&C Act and FDA cybersecurity guidance. Aidoc has implemented a risk-based approach to cybersecurity, including secure design practices, vulnerability assessments, a Software Bill of Materials (SBOM), and penetration testing. These efforts support the safety, effectiveness, and resilience of the software against cybersecurity threats.”

Validation studies (1)

Retrospective clinical

n=772 scans · 6 site(s)

endpoints: area under the curve (AUC); sensitivity; specificity; BriefCase time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (4 observations)

sensitivity0.948CI 89.5%-97.9%
source quote (p.11)
“94.8% 89.5%-97.9%”
specificity0.959CI 91.3%-98.5%
source quote (p.11)
“95.9% 91.3%-98.5%”
aurocas written: “auc”0.989CI 97.8-99.7
source quote (p.11)
“98.9 97.8-99.7”
time_to_resultas written: “Mean Time-to-notification”49.9CI 46.4-53.5
source quote (p.12)
“BriefCase-Triage and compatible image communication platform Time-to-notification 49.9 536 46.4 53.5 38.8 33.1”

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/K253578