BriefCase-Triage

K243548

Aidoc Medical, Ltd. · cleared 2024-12-11 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“BriefCase-Triage uses an artificial intelligence algorithm 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.5)
“The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning, deep learning algorithm development consisted of training on labeled ("tagged") images.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=308 cases · 5 site(s)

endpoints: standalone performance goal (PG) of area under the curve (AUC) > 0.95 for the study level receiver operating characteristic (ROC) curve; BriefCase-Triage time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (8 observations)

sensitivity95.2CI 89.1%-98.4%
source quote (p.9)
“Sensitivity was 95.2% (95% CI: 89.1%-98.4%)”
specificity95.1CI 91.2%-97.6%
source quote (p.9)
“Specificity was 95.1% (95% CI: 91.2%-97.6%)”
aurocas written: “auc”97.2CI 95.5%-99.0%
source quote (p.9)
“AUC was 97.2% (95% CI: 95.5%-99.0%)”
npvas written: “NPV”99.4CI 98.7%- 99.8%
source quote (p.10)
“NPV was 99.4% (95% CI: 98.7%- 99.8%)”
npvas written: “unspecified metric from NPV sentence”68.3CI 54.1%- 79.8%
source quote (p.10)
“and 68.3% (95% CI: 54.1%- 79.8%).”
ppvas written: “PLR”19.149CI 10.594-35.595
source quote (p.10)
“PLR was 19.149 (95% CI: 10.594-35.595)”
npvas written: “NLR”0.051CI 0.021-0.119
source quote (p.10)
“NLR was 0.051 (95% CI: 0.021-0.119).”
time_to_resultas written: “mean time-to-notification”41.4CI 40.4-42.5
source quote (p.9)
“The BriefCase-Triage mean time-to-notification for the subject RibFx triage was 41.4 seconds (95% CI: 40.4-42.5).”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
6
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253578 (decision 2026-02-26) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253578

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251195 (decision 2026-01-27) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251195

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252970 (decision 2026-01-07) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-triage CT Body") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252970

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253265 (decision 2025-11-06) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253265

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251406 (decision 2025-05-30) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251406

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250248 (decision 2025-02-14) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250248

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K243548