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The ReUnion RSA Shoulder System is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).

• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis
• Proximal humeral fracture
• Revision of previously failed shoulder joint replacement
• 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 ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a Humeral Cup, Humeral Insert, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws. The ReUnion RSA Shoulder System components are indicated for primary reverse shoulder or revision reverse shoulder replacement procedures having gross rotator cuff deficiency.

The provided document is a 510(k) premarket notification for the ReUnion RSA Shoulder System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria in terms of clinical performance or algorithm accuracy.

Therefore, the requested information, which is typically associated with studies demonstrating the performance of diagnostic algorithms or standalone software, cannot be found in this document.

Specifically, the document states:

• "Clinical Testing: Clinical testing was not required for this submission." (Page 5)

This means there is no study presented in this 510(k) that evaluates the device's clinical performance against specific acceptance criteria in the manner requested. The document primarily focuses on non-clinical testing (e.g., fatigue strength, micromotion) to demonstrate substantial equivalence in design and materials to predicate devices.

As such, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This information is simply not part of a 510(k) for a physical implantable device like a shoulder system, especially when clinical testing is explicitly stated as not required.

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