BriefCase, RIB Fractures Triage (RibFx)

K202992

Aidoc Medical, Ltd. · cleared 2021-04-14 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast).”
Algorithmartificial intelligence deep-learning algorithms
source quote (p.5)
“Both devices are artificial intelligence deep-learning algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=279 cases · 3 site(s)

endpoints: identifying three or more acute rib fractures; AUC; Sensitivity; Specificity; worklist prioritization (time-to-exam-open vs time-to-notification)

Reported performance (7 observations)

sensitivity0.967CI 95% CI: 90.6%, 99.4%
source quote (p.8)
“Sensitivity was 96.7% (95% CI: 90.6%, 99.4%)”
specificity0.904CI 95% CI: 85.2%, 94.3%
source quote (p.8)
“specificity was 90.4% (95% CI: 85.2%, 94.3%)”
aurocas written: “auc”0.976CI 95% CI: 0.960, 0.991
source quote (p.8)
“AUC was 0.976 (95% CI: 0.960, 0.991).”
npvas written: “NPV”0.996CI 95% CI: 99.2%-100.0%
source quote (p.9)
“NPV was 99.6% (95% CI: 99.2%-100.0%)”
ppvas written: “PPV”0.529CI 95% CI: 39.1%-62.1%
source quote (p.9)
“PPV was 52.9% (95% CI: 39.1%-62.1%).”
time_to_resultas written: “Time-to-exam-open (standard of care)”89.4CI 95% CI: 56.0-122.7
source quote (p.8)
“The standard of care time-to-exam-open (89.4 minutes: 95% CI: 56.0-122.7; Median 66.0, IQR 50.7)”
time_to_resultas written: “Time-to-notification (BriefCase RibFx)”4.2CI 95% CI: 3.9-4.5
source quote (p.8)
“the parallel time-to-notification of the BriefCase device (4.2 minutes, 95% CI: 3.9-4.5; Median 4.2, IQR 1.8)”

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
19
drift signals on this device
  • 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) 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243548 (decision 2024-12-11) 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:K243548

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242837 (decision 2024-10-18) 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:K242837

  • …and 13 more.

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/K202992