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
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc.
Authorized purpose: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
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: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Aortic valve/root, LVOT and ventricles, coronary ostia, cardiac structures, and iliac/femoral/abdominal aortic access vessels Input: Contrast-enhanced CTA DICOM images for TAVR candidates, with packet validation using slice thickness <=1.0 mm, 100-120 kVp, systolic 20-30% and diastolic approximately 80% phases, and Canon, Siemens, GE, and Philips scanners.
- Who uses it? Intended users: Cardiologists, radiologists, and clinical specialists.
- What does the software produce? Output: User-editable automatic initialization of selected aortic-root visualizations, landmarks, and measurements using the TAVR Planning Assist feature; the broader software provides 3D segmentation and visualization of heart structures/vessels, calcium, leaflets, and vascular access; C-arm angles, centerlines, tortuosity, delivery-path planning, and reports with approach-planning/device-sizing measurements.
- What is its most important limitation? Key limitation: Validation excluded severe motion artifacts and poor-contrast or non-diagnostic phases. Automatically initialized outputs must be reviewed, edited as needed, and manually approved before reporting. The packet's quantitative validation is retrospective and tied to the tested CT protocols and scanners.
Clinical takeaway
Clinical role: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: 89 independent retrospective TAVR CT cases, with ground truth from two independent board-certified cardiac CT readers. Measurement agreement used ICC and Bland-Altman analyses; optional leaflet coloring had over 93% of cases rated Good or Excellent. The validation included scanner, slice-thickness, kVp, reconstruction, calcification, age, sex, and geographic subgroups.
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
- Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
- Intended users
- Cardiologists, radiologists, and clinical specialists.
- Care setting and population
- Clinical setting for patients identified as candidates for TAVR; the packet also describes use on a radiology workstation and pre-/post-operative planning.
- Workflow role
- AI-assisted segmentation, landmark detection, contouring, measurement, visualization, reporting, and TAVR approach-planning support; all initialized outputs require user review/editing before reporting.
- Required input
- Contrast-enhanced CTA DICOM images for TAVR candidates, with packet validation using slice thickness <=1.0 mm, 100-120 kVp, systolic 20-30% and diastolic approximately 80% phases, and Canon, Siemens, GE, and Philips scanners.
- Output and human action
- User-editable automatic initialization of selected aortic-root visualizations, landmarks, and measurements using the TAVR Planning Assist feature; the broader software provides 3D segmentation and visualization of heart structures/vessels, calcium, leaflets, and vascular access; C-arm angles, centerlines, tortuosity, delivery-path planning, and reports with approach-planning/device-sizing measurements.
- Limitations
- Validation excluded severe motion artifacts and poor-contrast or non-diagnostic phases. Automatically initialized outputs must be reviewed, edited as needed, and manually approved before reporting. The packet's quantitative validation is retrospective and tied to the tested CT protocols and scanners.
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
- Runs on the Vitrea platform, processes CTA DICOM patient images, and can export results to DICOM-capable image-management, archival, or reporting systems, including DICOM Structured Report when licensed. The packet describes a radiology-workstation environment.
- 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 Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning; 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: 89 independent retrospective TAVR CT cases, with ground truth from two independent board-certified cardiac CT readers. Measurement agreement used ICC and Bland-Altman analyses; optional leaflet coloring had over 93% of cases rated Good or Excellent. The validation included scanner, slice-thickness, kVp, reconstruction, calcification, age, sex, and geographic subgroups.
- 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.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K260324
- Samplen=89
- IndependenceIndependence not established
K260324
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 K260324 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 K260324. 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 K260324 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, 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 K260324: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning model card (K260324)
Scope: intendedUsers, careSetting, output, limitations, 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
-
openFDA exact recall query for K260324
Scope: postmarketSafety
Research history
-
K260324 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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