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
DeepHealth ProstateAI
Quantib B.V.
Authorized purpose: Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
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: Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Prostate and lesions within or extending from the prostate Input: T2-weighted, ADC, and DWI MR images plus a binary prostate-gland segmentation from a cleared device; adult males aged 40 years or older with a prostate undergoing MRI, with complete clinical imaging interpreted according to recommendations, including DCE when available.
- Who uses it? Intended users: Healthcare professionals qualified to read and interpret prostate MRI exams, including radiologists or other qualified physicians
- What does the software produce? Output: ROI candidates with segmentations and low, moderate, or high prostate-cancer-likelihood categories: low <=20%, moderate >20% and <80%, high >=80%. Outputs are exported as DICOM Segmentation Objects or NIfTI files for color-coded display in compatible PACS/visualization platforms and are input to a visualization/adaptation tool.
- What is its most important limitation? Key limitation: Not a replacement for physician interpretation or stand-alone diagnosis, and patient management must not rely solely on the output. The FDA use environment requires a compatible DICOM-capable visualization platform, orchestration/data-routing system, secure DICOM network, diagnostic-quality display, and complete imaging data; several non-hospital/mobile/home settings are excluded.
Clinical takeaway
Clinical role: Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
Evidence takeaway
Evidence from the reviewed source record: The FDA packet describes approximately 3,200 training cases from six institutions with 883 lesion-level labels, but the performance evidence uses a separate retrospective set of 250 prostate MRI exams; three cases were excluded from lesion-level reader analysis, leaving 247 primary reader cases. The MRMC reader study improved case-level AUC-LROC from 0.626 to 0.724 (p<0.05). The standalone study reported case-level AUC 0.819, mean DSC 0.535, and mean MSD 1.641 mm. The device description also reports validation-cohort confirmation rates of 10% for low, 46% for moderate, and 86% for high suspicion categories.
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
- Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
- Intended users
- Healthcare professionals qualified to read and interpret prostate MRI exams, including radiologists or other qualified physicians
- Care setting and population
- Professional medical imaging environments, including hospital radiology departments and outpatient imaging centers; not emergency departments, intensive care units, general-practitioner offices, mobile imaging units, or patient homes
- Workflow role
- Concurrent-reading detection and characterization support with ROI segmentation and categorical suspicion classification
- Required input
- T2-weighted, ADC, and DWI MR images plus a binary prostate-gland segmentation from a cleared device; adult males aged 40 years or older with a prostate undergoing MRI, with complete clinical imaging interpreted according to recommendations, including DCE when available.
- Output and human action
- ROI candidates with segmentations and low, moderate, or high prostate-cancer-likelihood categories: low <=20%, moderate >20% and <80%, high >=80%. Outputs are exported as DICOM Segmentation Objects or NIfTI files for color-coded display in compatible PACS/visualization platforms and are input to a visualization/adaptation tool.
- Limitations
- Not a replacement for physician interpretation or stand-alone diagnosis, and patient management must not rely solely on the output. The FDA use environment requires a compatible DICOM-capable visualization platform, orchestration/data-routing system, secure DICOM network, diagnostic-quality display, and complete imaging data; several non-hospital/mobile/home settings are excluded.
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
- Requires a PACS or advanced workstation capable of displaying DICOM Segmentation and Structured Content objects, an orchestration system, secure DICOM communication, and diagnostic-quality displays; output files are DICOM Segmentation Objects or NIfTI.
- 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.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for DeepHealth ProstateAI; 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
- The FDA packet describes approximately 3,200 training cases from six institutions with 883 lesion-level labels, but the performance evidence uses a separate retrospective set of 250 prostate MRI exams; three cases were excluded from lesion-level reader analysis, leaving 247 primary reader cases. The MRMC reader study improved case-level AUC-LROC from 0.626 to 0.724 (p<0.05). The standalone study reported case-level AUC 0.819, mean DSC 0.535, and mean MSD 1.641 mm. The device description also reports validation-cohort confirmation rates of 10% for low, 46% for moderate, and 86% for high suspicion categories.
- 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.
DeepHealth ProstateAI regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K253682
- Samplen=250
- IndependenceIndependence not established
K253682
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 K253682 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 K253682. 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 K253682 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
23Fields 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 K253682: DeepHealth ProstateAI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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DeepHealth ProstateAI model card (K253682)
Scope: intendedUsers, careSetting, output, limitations, 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 K253682
Scope: postmarketSafety
Research history
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K253682 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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