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
CAC (gated) Algorithm
BunkerHill Health
Authorized purpose: Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.
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: Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Coronary arteries and coronary artery calcium within the heart Input: Non-contrast ECG-gated chest CT images in DICOM format from compatible CT systems; the comparison table identifies a default 130 HU calcium threshold.
- Who uses it? Intended users: Interpreting physicians.
- What does the software produce? Output: Four calcium-burden groups (0, 1-99, 100-399, and 400+ Agatston units), exact overall Agatston score, exact vessel-specific scores for LCA, LAD, LCX, and RCA, and a calcium segmentation over a copy of the original CT for informational purposes.
- What is its most important limitation? Key limitation: Use is limited to patients aged 30 years and older and non-contrast ECG-gated chest CT. Segmentation is informational only. Results are not for stand-alone use, do not replace the original report or scan, and must be interpreted by the physician before any patient action.
Clinical takeaway
Clinical role: Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.
Evidence takeaway
Evidence from the reviewed source record: FDA standalone retrospective pivotal testing used gated CT studies from six geographically diverse sites with representation from each calcium category. The primary endpoint was agreement between the four-category cardiovascular disease risk grouping and ground truth. Cohen weighted kappa was 0.972 (95% CI 0.958-0.987) against an acceptance criterion of at least 0.90. The reviewed FDA summary does not report the pivotal sample size.
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
- Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and quantification available to a physician for adjunctive review.
- Intended users
- Interpreting physicians.
- Care setting and population
- Medical-facility standard workflow for adults aged 30 years and older; the FDA comparison table identifies a medical facility but does not establish a specific deployment site.
- Workflow role
- On-demand adjunctive calcium categorization and quantification in the patient report or diagnostic image viewer, with the original report and cardiac CT remaining available for physician review.
- Required input
- Non-contrast ECG-gated chest CT images in DICOM format from compatible CT systems; the comparison table identifies a default 130 HU calcium threshold.
- Output and human action
- Four calcium-burden groups (0, 1-99, 100-399, and 400+ Agatston units), exact overall Agatston score, exact vessel-specific scores for LCA, LAD, LCX, and RCA, and a calcium segmentation over a copy of the original CT for informational purposes.
- Limitations
- Use is limited to patients aged 30 years and older and non-contrast ECG-gated chest CT. Segmentation is informational only. Results are not for stand-alone use, do not replace the original report or scan, and must be interpreted by the physician before any patient action.
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
- Interfaces with compatible CT systems using DICOM; results can be made available on demand in a patient report or diagnostic image viewer, with optional DICOM Secondary Capture/report insertion described in the comparison. Specific PACS, RIS, EHR, and local interface compatibility are not established.
- 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 CAC (gated) Algorithm; 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 standalone retrospective pivotal testing used gated CT studies from six geographically diverse sites with representation from each calcium category. The primary endpoint was agreement between the four-category cardiovascular disease risk grouping and ground truth. Cohen weighted kappa was 0.972 (95% CI 0.958-0.987) against an acceptance criterion of at least 0.90. The reviewed FDA summary does not report the pivotal sample size.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
CAC (gated) Algorithm regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K240369
- Sites6
- IndependenceIndependence not established
K240369
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 K240369 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 K240369. 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 K240369 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
22Fields 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
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FDA K240369: CAC (gated) Algorithm
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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CAC (gated) Algorithm model card (K240369)
Scope: intendedUsers, careSetting, output, 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
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openFDA exact recall query for K240369
Scope: postmarketSafety
Research history
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K240369 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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