ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Clarius Median Nerve AI; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08FDA-cleared profile
Clarius Median Nerve AI
Clarius Mobile Health Corp.
Authorized purpose: Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
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: Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Median nerve in the forearm and wrist Input: Ultrasound data acquired by Clarius linear-array transducers L7 HD3, L15 HD3, or L20 HD3, with transverse median-nerve views at the forearm and wrist; labeled use is adult patients only.
- Who uses it? Intended users: Healthcare professionals trained and qualified in ultrasound, including users with musculoskeletal ultrasound training
- What does the software produce? Output: A segmentation mask on the ultrasound image, automatically placed calipers, a median-nerve cross-sectional-area measurement in mm², and user-adjustable caliper placement with the saved measurement.
- What is its most important limitation? Key limitation: The device is not stand-alone and is integrated into the Clarius App and scanner system. It is for adults only; inadequate-quality images and incomplete anatomy or views were excluded from clinical measurement comparison. The clinician must confirm the measurement using standard practice and judgment, and the device does not replace clinical decision-making.
Clinical takeaway
Clinical role: Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: retrospective clinical verification of 182 ultrasound images from 126 subjects collected across multiple clinical sites, with three expert reviewers. The primary endpoint tested non-inferiority of automated cross-sectional-area measurement against the human-reviewer mean using a 3 mm² equivalence/error margin; a separate simulated-use clinical validation used production-equivalent systems and tested the intended measurement workflow.
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
- Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
- Intended users
- Healthcare professionals trained and qualified in ultrasound, including users with musculoskeletal ultrasound training
- Care setting and population
- Professional musculoskeletal-ultrasound workflow for adult patients; the FDA packet does not specify a particular facility type
- Workflow role
- Real-time, acquisition-time assistive segmentation and measurement; the user can adjust calipers and retains responsibility for clinical validity and decisions
- Required input
- Ultrasound data acquired by Clarius linear-array transducers L7 HD3, L15 HD3, or L20 HD3, with transverse median-nerve views at the forearm and wrist; labeled use is adult patients only.
- Output and human action
- A segmentation mask on the ultrasound image, automatically placed calipers, a median-nerve cross-sectional-area measurement in mm², and user-adjustable caliper placement with the saved measurement.
- Limitations
- The device is not stand-alone and is integrated into the Clarius App and scanner system. It is for adults only; inadequate-quality images and incomplete anatomy or views were excluded from clinical measurement comparison. The clinician must confirm the measurement using standard practice and judgment, and the device does not replace clinical decision-making.
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
- Integrated into the Clarius App and complete Clarius Ultrasound Scanner system on iOS or Android, with the listed L7 HD3, L15 HD3, and L20 HD3 transducers; the FDA packet does not establish a stand-alone PACS/RIS/EHR interface.
- Deployment and data flow
- On-cloud
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.
Evidence
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: retrospective clinical verification of 182 ultrasound images from 126 subjects collected across multiple clinical sites, with three expert reviewers. The primary endpoint tested non-inferiority of automated cross-sectional-area measurement against the human-reviewer mean using a 3 mm² equivalence/error margin; a separate simulated-use clinical validation used production-equivalent systems and tested the intended measurement workflow.
- 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.
Clarius Median Nerve AI regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K250226
- Samplen=182
- IndependenceIndependence not established
K250226
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 K250226 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 K250226. 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 K250226 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, 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 K250226: Clarius Median Nerve AI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Clarius Median Nerve AI model card (K250226)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies
-
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 K250226
Scope: postmarketSafety
Research history
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K250226 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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