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
A CT triage tool that flags suspected cases with three or more acute rib fractures for prompt review.
Overview status: Source-reviewed overview
What does this software do?It analyzes chest CT images and flags suspected cases with three or more acute rib fractures for notification.
Which scans and patients is it intended for?It is for chest CT images, with or without contrast, in the labeled hospital-network workflow.
Who uses it?Appropriately trained medical specialists use it; attending radiologists receive the notifications.
What does the software produce, and what must the clinician do?It sends a suspect-case notice and a low-quality unannotated preview. The radiologist must open and evaluate the original images in the local picture archive (PACS).
What is its most important limitation?It is a triage tool, not a diagnostic device. Unflagged cases keep their usual place in the reading queue.
Clinical takeaway
This tool provides parallel triage for suspected cases with three or more acute rib fractures; it does not replace the radiologist's full review or standard interpretation.
Evidence takeaway
The FDA submission reports sensitivity and specificity in a 279-case pivotal study for the three-or-more-fractures endpoint. It also reports a separate notification-time comparison, distinct from the diagnostic classification metrics.
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
Parallel triage and notification of suspect cases with three or more acute rib-fracture pathologies to assist hospital-network workflow prioritization; not a diagnostic device.
Preemptive triage and notification in parallel with the standard-of-care reading queue; the device does not remove, reorder, or de-prioritize unflagged cases.
Suspect RibFx notification containing patient name, accession number, and pathology; a compressed low-quality grayscale unannotated preview marked not for diagnostic use; and a prompt for the radiologist to open and evaluate the original series in the local PACS.
The indication is limited to suspect cases with three or more acute rib fractures in chest CT. Notifications and compressed previews are informational and not for diagnosis; previews contain no finding marks, the original image is not altered, and full images must be reviewed in the local PACS with other patient information and professional judgment.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The device consists of an Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Worklist desktop application for workflow integration. The packet describes DICOM 3.0-compliant CT scanners, PACS, and radiology workstations, with de-identification before processing and notification return to the desktop worklist; specific local interface compatibility is not established.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-09
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-09
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for BriefCase, RIB Fractures Triage (RibFx); FDA labeling remains controlling for clinical use, limitations, and performance.
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
The retrospective, blinded, multicenter, multinational pivotal study used 279 new cases from three sites, with two radiologists and a third radiologist resolving inconsistencies; 91 cases were ground-truth positive and 188 negative for three or more acute rib fractures. FDA reports AUC 0.976 (95% CI 0.960-0.991), sensitivity 96.7% (95% CI 90.6%-99.4%), and specificity 90.4% (95% CI 85.2%-94.3%). A separate 67-true-positive-case workflow comparison at two US sites reported mean time-to-notification 4.2 minutes versus 89.4 minutes standard-of-care time-to-exam-open; the timing endpoint is distinct from diagnostic classification metrics.
96.7% (95% CI 90.6%-99.4%) for identifying three or more acute rib fractures in 279 chest CT cases.
FDA source
Exact FDA submission
Checked 2026-09-09
The FDA endpoint is subject-device sensitivity; the baseline 80% is only the study acceptance threshold and 99.4% is the sensitivity confidence-interval upper bound, not a second sensitivity result.
90.4% (95% CI 85.2%-94.3%) for identifying three or more acute rib fractures in 279 chest CT cases.
FDA source
Exact FDA submission
Checked 2026-09-09
The FDA endpoint is subject-device specificity; the baseline 99.4% is the sensitivity confidence-interval upper bound and 80% is the study acceptance threshold.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
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
Vendor confirmation
Exact FDA submission
Checked 2026-09-09
No public price or quote for the exact K202992 configuration was established in this review.
Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-09
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 K202992. 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.
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 K202992 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.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-09Last searched
20Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
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 history7 sources - 3 history items
BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...
Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or...