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
MediAI-OA
Crescom Co., Ltd.
MediAI-OA is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedists, physicians and medical technicians.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- MediAI-OA is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedists, physicians and medical technicians.
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
- Intended users
- Trained professionals including, but not limited to, radiologists, orthopedists, physicians and medical technicians
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Detection, localization, or diagnostic support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- XRAY images or data. Inclusion criteria: DICOM compliant images in either digitally computed (CR) or directly digital (DX) formats, jpeg, jpg, png; standing, fixed-flexion radiographs of the knee
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The AI model outputs: Knee OA status as KL grade 0/1, 2, 3, or 4; JSN status as Absent/Present; Osteophyte status as Absent/Present; Sclerosis status as Absent/Present. Results are provided as summary analysis results through the screen, web report, markup images and textual report as static images.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: Should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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.
- FDA submission
- K253172
- Modality
- X-ray/Radiography
Imaging modality reported in the exact-submission ACR AI Central model card.
- Anatomy
- MSK
Anatomy normalized from explicit exact-submission ACR model-card wording.
- Clearance type
- 510(k)
- Decision date
- 2026-06-15
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Research pending
Attach an exact-product deployment and data-flow source.
- Security and privacy
- Vendor documentation pending
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Study type: Stand-Alone Performance. Cases: 1173. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: KL >=2: 87.6% (95% CI: 86.6%, 88.5%); KL 0&1: 86.5% (95% CI: 85.6%, 87.3%); KL 2: 71.7% (95% CI: 70.0%, 73.4%); KL 3: 75.0% (95% CI: 72.8%, 77.0%); KL 4: 90.5% (95% CI: 87.3%, 93.0%); JSN >= OARSI grade 1: 88.0% (95% CI: 87.1%, 88.9%); Osteophyte >= OARSI grade 1: 89.7% (95% CI: 88.8%, 90.5%); Sclerosis: 88.0% (95% CI: 87.0%, 89.0%). Reported specificity: KL >=2: 87.6% (95% CI: 86.6%, 88.5%); KL 0&1: 86.5% (95% CI: 85.6%, 87.3%); KL 2: 71.7% (95% CI: 70.0%, 73.4%); KL 3: 75.0% (95% CI: 72.8%, 77.0%); KL 4: 90.5% (95% CI: 87.3%, 93.0%); JSN >= OARSI grade 1: 88.0% (95% CI: 87.1%, 88.9%); Osteophyte >= OARSI grade 1: 89.7% (95% CI: 88.8%, 90.5%); Sclerosis: 88.0% (95% CI: 87.0%, 89.0%)
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- KL >=2: 87.6% (95% CI: 86.6%, 88.5%); KL 0&1: 86.5% (95% CI: 85.6%, 87.3%); KL 2: 71.7% (95% CI: 70.0%, 73.4%); KL 3: 75.0% (95% CI: 72.8%, 77.0%); KL 4: 90.5% (95% CI: 87.3%, 93.0%); JSN >= OARSI grade 1: 88.0% (95% CI: 87.1%, 88.9%); Osteophyte >= OARSI grade 1: 89.7% (95% CI: 88.8%, 90.5%); Sclerosis: 88.0% (95% CI: 87.0%, 89.0%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- KL >=2: 87.6% (95% CI: 86.6%, 88.5%); KL 0&1: 86.5% (95% CI: 85.6%, 87.3%); KL 2: 71.7% (95% CI: 70.0%, 73.4%); KL 3: 75.0% (95% CI: 72.8%, 77.0%); KL 4: 90.5% (95% CI: 87.3%, 93.0%); JSN >= OARSI grade 1: 88.0% (95% CI: 87.1%, 88.9%); Osteophyte >= OARSI grade 1: 89.7% (95% CI: 88.8%, 90.5%); Sclerosis: 88.0% (95% CI: 87.0%, 89.0%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
MediAI-OA regulatory performance study summary
Stand-Alone Performance · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K253172 · n=1173 · Independence not establishedK253172
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Economics and lifecycle
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
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
- Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Automated sources checkedStatus
2026-09-04Last searched
19Fields reviewed
5Source classes checked
1Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Automated exact-name discovery found 1 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, acr ai central product, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-02.
- K253172 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- MediAI-OA model card (K253172) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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