ARTHUR

Evidence summary

The FDA summary describes performance and usability studies, including an additional US-clinic study, supporting automatic capture of clinically usable joint images. It does not provide study denominators, participant characteristics or detailed confidence intervals.

FDA source Exact FDA submission Checked 2026-09-06

Joint-acquisition success is not diagnostic sensitivity for arthritis. No numeric clinical accuracy is inferred from the acquisition acceptance statement.

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

• Verify security and privacy controls: Mechanical/electrical safety testing and corporate quality claims do not establish current cybersecurity certification, image retention or network security for the installed robot.
• Verify training: Supervised use is established, but the exact operator curriculum, competency assessment and retraining schedule are not public in reviewed materials.
• Verify pricing and total cost: Reviewed vendor page offers a demo, not a verified robot, ultrasound-system, service or consumable price.
• Verify reimbursement and coding relevance: No applicable payer coverage or payment policy reviewed for robotic joint ultrasound.
• Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

All 20 stored PubMed records were screened as personal-name/biographical ARTHUR matches rather than the ROPCA device. All ten stored trials concern unrelated drug, cancer, pain, endoscopy or lens-solution interventions; none is promoted. Vendor-linked ultrasound papers are separate discovery leads, not these candidates. The current discovery snapshot contains 20 PubMed and 10 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, vendor product page, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

• ARTHUR: K260190 clearance, indications and 510(k) summary U.S. Food and Drug Administration · 2026-09-06
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• 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
• ARTHUR product and ARTHUR-to-DIANA workflow ROPCA · 2026-09-06