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.”

Algorithmlocked artificial intelligence algorithm fine tuned from a foundation model

source quote (p.10)

“Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”

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.”

Validation studies (1)

Retrospective clinical

n=772 scans · 6 site(s)

endpoints: area under the curve (AUC) > 0.95 lower bound 95% confidence interval for the finding level receiver operating characteristic (ROC) curve; sensitivity; specificity; BriefCase time-to-notification compared to the predicate device

Reported performance (16 observations)

sensitivity94.8CI 89.5%-97.9%

source quote (p.11)

“94.8% 89.5%-97.9%”

specificity95.9CI 92.0%-98.8%

source quote (p.11)

“95.9% 92.0%-98.8%”

aurocas written: “auc”98.9CI 97.8-99.7

source quote (p.11)

“98.9 97.8-99.7”

aurocas written: “Pneumothorax AUC”98.9CI 97.8-99.7

source quote (p.11)

“98.9 97.8-99.7”

sensitivityas written: “Pneumothorax Sensitivity”94.8CI 89.5%-97.9%

source quote (p.11)

“94.8% 89.5%-97.9%”

specificityas written: “Pneumothorax Specificity”95.9CI 92.0%-98.8%

source quote (p.11)

“95.9% 92.0%-98.8%”

aurocas written: “Pericardial effusion AUC”99.1CI 98.0-99.8

source quote (p.11)

“99.1 98.0-99.8”

sensitivityas written: “Pericardial effusion Sensitivity”96.4CI 91.7%-98.8%

source quote (p.11)

“96.4% 91.7%-98.8%”

specificityas written: “Pericardial effusion Specificity”96.5CI 92.9%-99.2%

source quote (p.11)

“96.5% 92.9%-99.2%”

aurocas written: “Large aortic aneurysm AUC”99.5CI 98.9-99.9

source quote (p.11)

“99.5 98.9-99.9”

sensitivityas written: “Large aortic aneurysm Sensitivity”97.1CI 92.7%-99.2%

source quote (p.11)

“97.1% 92.7%-99.2%”

specificityas written: “Large aortic aneurysm Specificity”97.2CI 96.2%-100.0%

source quote (p.11)

“97.2% 96.2%-100.0%”

aurocas written: “Shoulder fracture or dislocation AUC”99.9CI 99.7-100

source quote (p.11)

“99.9 99.7-100”

sensitivityas written: “Shoulder fracture or dislocation Sensitivity”97.8CI 93.7%-99.5%

source quote (p.11)

“97.8% 93.7%-99.5%”

specificityas written: “Shoulder fracture or dislocation Specificity”99.3CI 91.3%-98.5%

source quote (p.11)

“99.3% 91.3%-98.5%”

time_to_resultas written: “Mean time-to-notification”49.9CI 46.4-53.5

source quote (p.11)

“The BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation mean time-to-notification for the subject device triage was 49.9 seconds (95% CI: 46.4-53.5).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).