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The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and glenoid vault should be of sufficient bone stock to support loading. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically suited to receive the selected implants.

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.

The OVOMotion Reverse Shoulder Arthroplasty System (RSA) is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The humeral side of the system is comprised of a humeral cup and humeral insert which are attached to the Arthrosurface TSA Humeral Stem using an adapter ring. The glenosphere is implanted with the GlenoidBaseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.

This document describes the OVOMotion Reverse Shoulder Arthroplasty System and its equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence through mechanical and wear testing against established ASTM standards and comparing technological characteristics with a predicate device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of MRMC studies, standalone performance details, type of ground truth used, or training set information.

The document states:

• "No animal or clinical tests were conducted to establish equivalence."
• The performance data provided are primarily mechanical and wear tests against ASTM standards. These tests establish equivalence to a predicate device rather than meeting specific performance acceptance criteria for a novel device.

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