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The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:

• · Pain and weakness of the wrist joint not improved by non-operative treatment
• · Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radio ulnar joint
• · Failed ulnar head resection; e.g. Darrach resection
• · Primary replacement after fracture of the ulnar head or neck.
• · Revision following failed ulnar head arthroplasty.

This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for the Aptis Medical Distal Radio Ulnar Joint Implant. The key information provided relates to its substantial equivalence to a predicate device, regulatory classifications, and indications for use.

Specifically, Section VII, "Performance Data," states: "Evaluation in the MRI environment of the subject device was performed through computational modeling and simulation of radiofrequency induced heating. No clinical data was submitted to support substantial equivalence." This explicitly indicates that a study demonstrating device performance against acceptance criteria, particularly clinical performance, was not conducted or submitted for this specific premarket notification.

Therefore, I cannot extract the requested information from the provided text.

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