Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Bunkerhill Contrast AVC
BunkerHill Health
Authorized purpose: Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical 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.
Product overview
Start with the essentials
Authorized purpose: Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest/aortic valve Input: DICOM non-gated, contrast-enhanced chest CT images from adult patients age 40 or older, with slice thickness up to 5 mm; the CNN architecture is described as trained on volumes at most 3.0 mm.
- Who uses it? Intended users: Qualified medical professionals, such as physicians.
- What does the software produce? Output: Informational ROI on a copy of the original CT showing detected aortic valve calcium; estimated calcium volume in mm3; binary presence/absence output; results are available in the physician's report or diagnostic viewer/PACS, with optional DICOM Secondary Capture/report insertion.
- What is its most important limitation? Key limitation: The intended input is non-gated contrast-enhanced chest CT with slice thickness up to 5 mm and adults age 40 or older. The ROI is informational only; outputs do not replace the original report or scan and are not for stand-alone use. Pivotal testing was retrospective and its exact case count is not stated in the packet.
Clinical takeaway
Clinical role: Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: stand-alone retrospective pivotal study from multiple sites across three U.S. geographic regions; exact pivotal sample size is not stated. Endpoints covered detection, localization/ROI, precision/recall, correlation, and volume agreement. A 65-case bridging study compared volume on contrast-enhanced images with the same patients' non-contrast images.
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
- Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
- Intended users
- Qualified medical professionals, such as physicians.
- Care setting and population
- Medical facility and clinical-care workflow; exact facility type is not further specified.
- Workflow role
- Background/adjunctive physician-review support for detection, localization, and quantification of aortic valve calcium; not stand-alone diagnosis.
- Required input
- DICOM non-gated, contrast-enhanced chest CT images from adult patients age 40 or older, with slice thickness up to 5 mm; the CNN architecture is described as trained on volumes at most 3.0 mm.
- Output and human action
- Informational ROI on a copy of the original CT showing detected aortic valve calcium; estimated calcium volume in mm3; binary presence/absence output; results are available in the physician's report or diagnostic viewer/PACS, with optional DICOM Secondary Capture/report insertion.
- Limitations
- The intended input is non-gated contrast-enhanced chest CT with slice thickness up to 5 mm and adults age 40 or older. The ROI is informational only; outputs do not replace the original report or scan and are not for stand-alone use. Pivotal testing was retrospective and its exact case count is not stated in the packet.
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
- The packet describes PACS integration without a built-in viewer: DICOM images go to an on-premises Bunkerhill Edge Server, are de-identified and sent to a Bunkerhill Cloud Server for algorithm processing, then results return to the edge server for re-identification and routing into the physician workflow. This is an FDA-described architecture, not a claim about current security or commercial deployment.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Bunkerhill Contrast AVC; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 packet: stand-alone retrospective pivotal study from multiple sites across three U.S. geographic regions; exact pivotal sample size is not stated. Endpoints covered detection, localization/ROI, precision/recall, correlation, and volume agreement. A 65-case bridging study compared volume on contrast-enhanced images with the same patients' non-contrast images.
- Reported sensitivity
- 97.2% (95% CI: 94.0%, 100.0%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 93.3% (95% CI: 89.5%, 97.1%)
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.
Bunkerhill Contrast AVC regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K260167
- IndependenceIndependence not established
K260167
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 K260167 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 K260167. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K260167 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
2026-09-20Last 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, acr ai central product, fda decision summary, 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
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FDA K260167: Bunkerhill Contrast AVC
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Bunkerhill Contrast AVC model card (K260167)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K260167
Scope: postmarketSafety
Research history
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K260167 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
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