BriefCase

K221330

Aidoc Medical, Ltd. · cleared 2022-11-18 · product code QAS · 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 frontal chest X-ray (CXR) images in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence, deep-learning algorithms
source quote (p.5)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation.”
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=921 cases · 5 site(s)

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

Reported performance (9 observations)

sensitivity0.8681CI 95% CI: 81.02%-91.36%
source quote (p.9)
“Sensitivity was 86.81% (95% CI: 81.02%-91.36%)”
specificity0.9202CI 95% CI: 89.20%-93.87%
source quote (p.9)
“Specificity was 92.02% (95% CI: 89.20%-93.87%).”
npvas written: “NPV at 10% positive prevalence”0.9843CI 95% CI: 97.74% - 98.92%
source quote (p.9)
“NPV was 98.43% (95% CI: 97.74% - 98.92%), 96.54% (95% CI: 95.05% 97.59%) and 94.21% (95% CI: 91.81% 95.94%) at 10%, 20% and 30% positive prevalence.”
npvas written: “NPV at 20% positive prevalence”0.9654CI 95% CI: 95.05% 97.59%
source quote (p.9)
“NPV was 98.43% (95% CI: 97.74% - 98.92%), 96.54% (95% CI: 95.05% 97.59%) and 94.21% (95% CI: 91.81% 95.94%) at 10%, 20% and 30% positive prevalence.”
npvas written: “NPV at 30% positive prevalence”0.9421CI 95% CI: 91.81% 95.94%
source quote (p.9)
“NPV was 98.43% (95% CI: 97.74% - 98.92%), 96.54% (95% CI: 95.05% 97.59%) and 94.21% (95% CI: 91.81% 95.94%) at 10%, 20% and 30% positive prevalence.”
ppvas written: “PPV at 10% positive prevalence”0.5471CI 95% CI: 48.45% 60.83%
source quote (p.9)
“PPV was 54.71% (95% CI: 48.45% 60.83%), 73.11% (95% CI: 67.89%- 77.75%) and 82.33% (95% CI: 78.38%- 85.70%) at 10%, 20% and 30% positive prevalence.”
ppvas written: “PPV at 20% positive prevalence”0.7311CI 95% CI: 67.89%- 77.75%
source quote (p.9)
“PPV was 54.71% (95% CI: 48.45% 60.83%), 73.11% (95% CI: 67.89%- 77.75%) and 82.33% (95% CI: 78.38%- 85.70%) at 10%, 20% and 30% positive prevalence.”
ppvas written: “PPV at 30% positive prevalence”0.8233CI 95% CI: 78.38%- 85.70%
source quote (p.9)
“PPV was 54.71% (95% CI: 48.45% 60.83%), 73.11% (95% CI: 67.89%- 77.75%) and 82.33% (95% CI: 78.38%- 85.70%) at 10%, 20% and 30% positive prevalence.”
time_to_resultas written: “BriefCase Time-to-notification (minutes)”4.93CI 95% CI: 4.64-5.22
source quote (p.9)
“The secondary measure of time-to-notification analysis demonstrated that standard of care time-to-exam-open (157.0 minutes: 95% CI: 155.0-159.0; Median: 50.0 IQR: 156.0) was substantially longer than the parallel time-to-notification of the BriefCase for Malpositioned Endotracheal Tube (ETT) device (4.93 minutes, 95% CI: 4.64-5.22; Median: 4.13 IQR: 0.76).”

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
17
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

  • …and 11 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/K221330