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
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte. Ltd.
Authorized purpose: Adult thyroid ultrasound reporting aid for localizing and characterizing suspicious nodules with ACR TI-RADS descriptors and categories.
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: Adult thyroid ultrasound reporting aid for localizing and characterizing suspicious nodules with ACR TI-RADS descriptors and categories.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adult thyroid ultrasound reporting aid for localizing and characterizing suspicious nodules with ACR TI-RADS descriptors and categories.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Thyroid Input: DICOM thyroid ultrasound images from DICOM-compliant ultrasound imaging devices for adults aged 22 years or older referred for examination.
- Who uses it? Intended users: Trained medical professionals, including physicians and medical technicians such as radiologists; a qualified clinician reviews and approves the report.
- What does the software produce? Output: Regions of interest placed on thyroid ultrasound images, ACR TI-RADS lexicon descriptors for composition, echogenicity, shape, margin, and echogenic foci, a calculated TR-1 through TR-5 category, and a structured report with measurement and annotation tools.
- What is its most important limitation? Key limitation: The report requires qualified-clinician review, quality control, and approval; the software is not an independent source of medical advice and patient-management decisions must not be based solely on its analysis. Exact current interfaces, versions, and local compatibility are not established.
Clinical takeaway
Clinical role: Adult thyroid ultrasound reporting aid for localizing and characterizing suspicious nodules with ACR TI-RADS descriptors and categories.
Evidence takeaway
Evidence from the reviewed source record: FDA performance testing included a standalone study and an MRMC reader study with 600 unique patients/cases and 18 board-certified radiologists. For localization at IoU greater than 0.5, average reader AUC was 0.758 aided, 0.736 unaided, and standalone AUC was 0.703 (95% CI 0.642-0.762). Reader localization accuracy was 95.6% aided, 93.6% unaided, and 95.1% standalone. Standalone descriptor accuracy was 86.7% composition, 68.2% echogenicity, 93.4% shape, 58.4% margin, and 70.3% echogenic foci; standalone overall TI-RADS-level agreement was 63.8% (95% CI 60.0-67.7). Ground truth used FNA or two-year follow-up for benign/malignant status and expert radiologist consensus with adjudication for localization and descriptors.
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
- Adult thyroid ultrasound reporting aid for localizing and characterizing suspicious nodules with ACR TI-RADS descriptors and categories.
- Intended users
- Trained medical professionals, including physicians and medical technicians such as radiologists; a qualified clinician reviews and approves the report.
- Care setting and population
- Adult patients aged 22 years or older referred for a thyroid ultrasound examination in a clinical ultrasound reporting workflow.
- Workflow role
- Stand-alone lesion localization, characterization, and structured-reporting aid; the clinician may modify the report during quality control and patient management must not rely solely on the software analysis.
- Required input
- DICOM thyroid ultrasound images from DICOM-compliant ultrasound imaging devices for adults aged 22 years or older referred for examination.
- Output and human action
- Regions of interest placed on thyroid ultrasound images, ACR TI-RADS lexicon descriptors for composition, echogenicity, shape, margin, and echogenic foci, a calculated TR-1 through TR-5 category, and a structured report with measurement and annotation tools.
- Limitations
- The report requires qualified-clinician review, quality control, and approval; the software is not an independent source of medical advice and patient-management decisions must not be based solely on its analysis. Exact current interfaces, versions, and local compatibility are not established.
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
- Web-based client-server software accessed through a browser on a standard off-the-shelf computer, with DICOM input from ultrasound devices and structured-report output; the FDA packet does not establish a specific PACS, RIS, EHR, or interface version.
- 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 See-Mode Augmented Reporting Tool, Thyroid (SMART-T); 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 performance testing included a standalone study and an MRMC reader study with 600 unique patients/cases and 18 board-certified radiologists. For localization at IoU greater than 0.5, average reader AUC was 0.758 aided, 0.736 unaided, and standalone AUC was 0.703 (95% CI 0.642-0.762). Reader localization accuracy was 95.6% aided, 93.6% unaided, and 95.1% standalone. Standalone descriptor accuracy was 86.7% composition, 68.2% echogenicity, 93.4% shape, 58.4% margin, and 70.3% echogenic foci; standalone overall TI-RADS-level agreement was 63.8% (95% CI 60.0-67.7). Ground truth used FNA or two-year follow-up for benign/malignant status and expert radiologist consensus with adjudication for localization and descriptors.
- 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.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) 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 K240697
- Samplen=600
- IndependenceIndependence not established
K240697
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 K240697 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 K240697. 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 K240697 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 K240697: See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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See-Mode Augmented Reporting Tool, Thyroid (SMART-T) model card (K240697)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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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 K240697
Scope: postmarketSafety
Research history
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K240697 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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