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 2026-09-09FDA-cleared profile
BriefCase-Triage
Aidoc Medical, Ltd.
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 transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of linear lucencies in the cervical spine bone in patterns compatible with fractures. 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. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase-Triage are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
- 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 transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of linear lucencies in the cervical spine bone in patterns compatible with fractures. 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. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase-Triage are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Clinical-use display mirrors the best exact-submission purpose source because the reviewed FDA packet did not provide a more specific usable abstraction.
- Intended users
- Hospital networks and appropriately trained medical specialists
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- CT/CTA images or data involving Spine; consult the FDA labeling for exact protocol, series, and quality requirements.
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The AI model outputs a prioritization alert (pop-up notification) and a compressed, low-quality, grayscale, unannotated preview image when a suspected cervical spine fracture is detected. The output is intended for triage/prioritization purposes only and is not for diagnostic use. The device flags cases with linear lucencies in the cervical spine bone in patterns compatible with fractures.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: All studies that have an inadequate field of view. Slice thickness: 0.625 mm - 2.5 mm axial or 2-3 mm sagittal or 2-3 mm. coronal reconstructions with bone kernel.. Reconstruction kernel: Smooth;Medium;Sharp
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- 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
- Study type: Stand-Alone Performance. Cases: 487. Sites: 6. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 92.1% (95% CI: 87.5%, 95.4%). Reported specificity: 92.6% (95% CI: 89.0%, 95.4%)
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- 92.1% (95% CI: 87.5%, 95.4%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 92.6% (95% CI: 89.0%, 95.4%)
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-C-Spine Fracture Triage regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested version3
- Samplen=487
- Sites6
- IndependenceIndependence not established
K242837
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 K242837 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 K242837. 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 K242837 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.
Automated sources checkedStatus
2026-09-09Last searched
24Fields 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 and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. 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 history
Source ledger
-
FDA K242837: BriefCase-Triage
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-C-Spine Fracture Triage model card (K242837)
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 K242837
Scope: postmarketSafety
Research history
-
K242837 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
automated sources checked
Alternatives
Related tools to compare
FDA-cleared K190896
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine on CT images. The device is intended to assist...
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2019-05-31
FDA-cleared K253628
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2026-06-29
FDA-cleared K242295
BunkerHill BMD
BunkerHill Health
Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold,...
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2025-04-08
FDA-cleared K240942
CINA-CSpine
Avicenna.AI
Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...
- Modality
- CT/CTA
- Anatomy
- Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
- Decision
- 2024-09-12