ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for BriefCase-Triage; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
BriefCase-Triage
Aidoc Medical, Ltd.
Authorized purpose: Adult abdominal CT triage for suspected intra-abdominal free gas.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Adult abdominal CT triage for suspected intra-abdominal free gas.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adult abdominal CT triage for suspected intra-abdominal free gas.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Abdomen Input: DICOM abdominal CT studies; adults or transitional adults aged 18 and older; 0.6-5.0 mm slices in the FDA performance study.
- Who uses it? Intended users: Hospital networks and appropriately trained medical specialists.
- What does the software produce? Output: A prioritization alert and compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only when suspected intra-abdominal free gas is detected.
- What is its most important limitation? Key limitation: Not a diagnostic device; inadequate field of view is excluded. The performance dataset was primarily acquired on CT scanners with at least 64 detector rows (388 of 394 cases), with six cases below 64; the FDA states performance may vary with other scanner types.
Clinical takeaway
Clinical role: Adult abdominal CT triage for suspected intra-abdominal free gas.
Evidence takeaway
Evidence from the reviewed source record: FDA retrospective, blinded, multicenter pivotal study: 394 abdominal CT cases from six U.S. sites, ground truth by three senior board-certified radiologists, with sequestered test data. Primary sensitivity was 94.2% (95% CI 89.6-97.2) and specificity 94.6% (90.7-97.2). Secondary mean time-to-notification was 10.4 seconds (95% CI 10.1-10.8) for true-positive cases versus 264.4 seconds for the predicate; five additional operating points were reported.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Adult abdominal CT triage for suspected intra-abdominal free gas.
- Intended users
- Hospital networks and appropriately trained medical specialists.
- Care setting and population
- Hospital imaging networks using DICOM CT, PACS, and radiology workstations for patients aged 18 and older.
- Workflow role
- Notification-only triage and worklist prioritization in parallel with standard of care; it does not change the original image or remove/deprioritize cases.
- Required input
- DICOM abdominal CT studies; adults or transitional adults aged 18 and older; 0.6-5.0 mm slices in the FDA performance study.
- Output and human action
- A prioritization alert and compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only when suspected intra-abdominal free gas is detected.
- Limitations
- Not a diagnostic device; inadequate field of view is excluded. The performance dataset was primarily acquired on CT scanners with at least 64 detector rows (388 of 394 cases), with six cases below 64; the FDA states performance may vary with other scanner types.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Filtered DICOM is received through an image communication/routing module; results are sent to a desktop feed and non-diagnostic viewer for review of the original PACS images; exact local interfaces and versions are not established.
- Deployment and data flow
- On-cloud
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- FDA retrospective, blinded, multicenter pivotal study: 394 abdominal CT cases from six U.S. sites, ground truth by three senior board-certified radiologists, with sequestered test data. Primary sensitivity was 94.2% (95% CI 89.6-97.2) and specificity 94.6% (90.7-97.2). Secondary mean time-to-notification was 10.4 seconds (95% CI 10.1-10.8) for true-positive cases versus 264.4 seconds for the predicate; five additional operating points were reported.
- Reported sensitivity
- 94.2% (95% CI: 89.6%, 97.2%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 94.6% (95% CI: 90.7%, 97.2%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
BriefCase-Intra-abdominal Free Gas Triage regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K253265
- Samplen=394
- Sites6
- IndependenceIndependence not established
K253265
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K253265 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K253265. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K253265 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-19Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K253265: BriefCase-Triage
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-Intra-abdominal Free Gas Triage model card (K253265)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K253265
Scope: postmarketSafety
Research history
-
K253265 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K253163
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
Ever Fortune.Ai, Co., Ltd.
Triage notification of suspected appendicitis on contrast-enhanced abdominal CT
- Modality
- CT/CTA
- Anatomy
- Abdomen
- Decision
- 2026-04-22
FDA-cleared K193298
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital...
- Modality
- CT/CTA
- Anatomy
- Abdomen
- Decision
- 2020-06-19
FDA-cleared K260729
Vascular Assist Occlusion Triage (VAOT) (v1.0)
GuideAI Health
Passive workflow prioritization for studies with imaging patterns consistent with possible total arterial occlusion in the specified vessels; not primary diagnosis, screening,...
- Modality
- CT/CTA
- Anatomy
- Aorta and lower-extremity arteries: common iliac, external iliac, common femoral, superficial femoral, and popliteal arteries
- Decision
- 2026-06-18
FDA-cleared K261317
BriefCase-Triage
Aidoc Medical, Ltd.
Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.
- Modality
- CT/CTA
- Anatomy
- Head/Brain
- Decision
- 2026-05-14