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 BMD
BunkerHill Health
Authorized purpose: 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, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
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: 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, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: 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, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Spine Input: CT images or data. Inclusion criteria: CT scan images in DICOM format from adults 30 years and above; spinal bone CT images
- Who uses it? Intended users: Healthcare provider
- What does the software produce? Output: The device outputs an estimated DXA-measured average areal bone mineral density of spinal bones, a flag for low bone density below a pre-specified threshold, a calibrated BMD score, and a T-score group. Results can be copied to clipboard, inserted in report, or output as DICOM Secondary Capture.
- What is its most important limitation? Key limitation: The output is a finding of interest and not a primary decision input; it does not replace DXA or dedicated BMD testing, and existing CT quality, DICOM routing, and local report integration require site validation.
Clinical takeaway
Clinical role: 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, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
Evidence takeaway
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 371. Sites: 4. Reported sensitivity: 81% (95% CI: 74%, 86.8%). Reported specificity: 78.4% (95% CI: 72.3%, 83.7%)
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
- 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, including opportunistic scans without a phantom; it does not replace DXA or other dedicated BMD testing.
Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.
- Intended users
- Healthcare provider
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
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- CT images or data. Inclusion criteria: CT scan images in DICOM format from adults 30 years and above; spinal bone CT images
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The device outputs an estimated DXA-measured average areal bone mineral density of spinal bones, a flag for low bone density below a pre-specified threshold, a calibrated BMD score, and a T-score group. Results can be copied to clipboard, inserted in report, or output as DICOM Secondary Capture.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- The output is a finding of interest and not a primary decision input; it does not replace DXA or dedicated BMD testing, and existing CT quality, DICOM routing, and local report integration require site validation.
Exact-product limitations and clinician-review boundary from the FDA 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.
- FDA submission
- K242295
- Modality
- CT/CTA
Imaging modality reported in the exact-submission ACR AI Central model card.
- Anatomy
- Spine
Anatomy normalized from explicit exact-submission ACR model-card wording.
- Clearance type
- 510(k)
- Decision date
- 2025-04-08
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Research pending
Attach an exact-product deployment and data-flow source.
- Security and privacy
- Vendor documentation pending
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Existing-CT opportunistic workflow
The official Bunkerhill BMD page describes use of existing non-contrast abdominal CT without additional imaging hardware, a calibration phantom, or additional radiation.
product family · checked 2026-09-06Exact FDA labeling controls supported CT inputs and patient criteria.
Family Carebricks navigation
The official page describes integration within the Bunkerhill Carebricks platform to support follow-up care navigation after a low-density flag.
product family · checked 2026-09-06Family-platform statement; interface and local implementation terms require 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: 371. Sites: 4. Reported sensitivity: 81% (95% CI: 74%, 86.8%). Reported specificity: 78.4% (95% CI: 72.3%, 83.7%)
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- 81% (95% CI: 74%, 86.8%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 78.4% (95% CI: 72.3%, 83.7%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
Sensitivity
81 percent
- EndpointLow-bone-density flag sensitivity against the regulatory reference
- Population371 CT studies from 4 geographically diverse sites
- Tested versionBunkerHill BMD; FDA submission K242295
Specificity
78.4 percent
- EndpointLow-bone-density flag specificity against the regulatory reference
- Population371 CT studies from 4 geographically diverse sites
- Tested versionBunkerHill BMD; FDA submission K242295
BunkerHill BMD regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K242295
- Samplen=371
- Sites4
- IndependenceIndependence not established
K242295
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
- Not established in reviewed sources
Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
- Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored exact-submission candidate metadata had zero PubMed and ClinicalTrials.gov identifiers; this metadata screening is not a full paper or registry-record review. 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, vendor product page, 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
-
K242295 FDA decision source
Scope: regulatoryIdentity, purpose, modality, anatomy
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BunkerHill BMD model card (K242295)
Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
FDA 510(k) decision material K242295: BunkerHill BMD
Scope: identity, clinical, evidence, implementation
-
Bunkerhill BMD FDA clearance
Scope: buyer_workflow, clinical, implementation
Research history
-
K242295 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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