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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2-and.4part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II Shoulder Prosthesis is a 5 mm one-piece titanium alloy humeral stem that is 105 mm long and is designed with a distal conical section, a proximal rectangular section, and with a morsetaper for mating with humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation.

The provided text is for a 510(k) summary for a medical device (Arthrex Univers II Shoulder Prosthesis). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software or AI/ML components, nor does it present any studies proving a device's performance against specific acceptance criteria for such components.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document is a regulatory submission for a physical implant, not a software or AI/ML device.

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