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
ProstatID
ScanMed, LLC
Authorized purpose: Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.
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 CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Prostate Input: DICOM axial prostate MRI using T2W, DWI, and ADC data; DCE is not analyzed. The packet lists compatible Philips 1.5T/3.0T, GE 1.5T/3.0T, and Siemens 3.0T systems and surface or endorectal coils.
- Who uses it? Intended users: Physicians qualified to read and interpret prostate MRI in the context of ACR recommendations and PI-RADS v2.
- What does the software produce? Output: Colorized 2D T2 overlays, post-processed T2W images linked in 3D through DICOM viewing, regional likelihood-of-suspicion scores on a 0-1 scale, a suggested likelihood or PI-RADS exam score, a 3D lesion rendering, a PDF report, prostate volume, and lesion location and extent.
- What is its most important limitation? Key limitation: The algorithm does not analyze DCE images; outputs must be interpreted with all available MR data consistent with clinical recommendations, including DCE when available, and in the PI-RADS v2 context. It is not a replacement for physician interpretation or a sole basis for management.
Clinical takeaway
Clinical role: Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.
Evidence takeaway
Evidence from the reviewed source record: Standalone testing used 150 retrospective cases, 220 biopsy locations (90 cancerous and 130 non-cancerous), and 150 cases including 44 normal cases; lesion-level ROC AUC was 0.710. Standalone FROC sensitivity was 80% at one false positive per patient and 98% at three false positives per patient. The reader study used 150 cases and nine physicians, with 130 complete-follow-up cases; the wAFROC figure of merit was 0.387 without CAD versus 0.430 with CAD (delta 0.043, p=0.034). AUC, FROC sensitivity at stated operating points, and wAFROC are distinct endpoints.
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 CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.
- Intended users
- Physicians qualified to read and interpret prostate MRI in the context of ACR recommendations and PI-RADS v2.
- Care setting and population
- Healthcare facility or hospital prostate MRI workflow for adult males undergoing screening or clinical imaging, including high-risk or family-history populations.
- Workflow role
- Concurrent reading aid for detection, assessment, and characterization of prostate abnormalities; outputs supplement full MR interpretation and must not be the sole basis for patient management.
- Required input
- DICOM axial prostate MRI using T2W, DWI, and ADC data; DCE is not analyzed. The packet lists compatible Philips 1.5T/3.0T, GE 1.5T/3.0T, and Siemens 3.0T systems and surface or endorectal coils.
- Output and human action
- Colorized 2D T2 overlays, post-processed T2W images linked in 3D through DICOM viewing, regional likelihood-of-suspicion scores on a 0-1 scale, a suggested likelihood or PI-RADS exam score, a 3D lesion rendering, a PDF report, prostate volume, and lesion location and extent.
- Limitations
- The algorithm does not analyze DCE images; outputs must be interpreted with all available MR data consistent with clinical recommendations, including DCE when available, and in the PI-RADS v2 context. It is not a replacement for physician interpretation or a sole basis for management.
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 software is not installed on the MRI system, PACS, or workstation; the packet describes cloud-based SaaS on dedicated servers, DICOM input and output to common workstations, PACS, and RIS, and a stated VPN connection requirement. Exact current interfaces and versions are not established.
- Deployment and data flow
- Hybrid
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- 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.
Supported acquisition environment
Scanner manufacturers: GE;Philips;Siemens
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for ProstatID; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- Standalone testing used 150 retrospective cases, 220 biopsy locations (90 cancerous and 130 non-cancerous), and 150 cases including 44 normal cases; lesion-level ROC AUC was 0.710. Standalone FROC sensitivity was 80% at one false positive per patient and 98% at three false positives per patient. The reader study used 150 cases and nine physicians, with 130 complete-follow-up cases; the wAFROC figure of merit was 0.387 without CAD versus 0.430 with CAD (delta 0.043, p=0.034). AUC, FROC sensitivity at stated operating points, and wAFROC are distinct endpoints.
- Reported sensitivity
- Standalone lesion-detection sensitivity: 80% at 1 false positive per patient and 98% at 3 false positives per patient; this is an FROC operating-point endpoint.
The FDA packet supports sensitivity only at the stated false-positive rates, not a single global device sensitivity.
- 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.
ProstatID 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 K212783
- Samplen=150
- IndependenceIndependence not established
K212783
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 K212783 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 K212783. 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 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 K212783 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
24Fields reviewed
9Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 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 K212783: ProstatID
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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ProstatID model card (K212783)
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 K212783
Scope: postmarketSafety
Research history
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K212783 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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