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Total or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.

Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under either the Global Shoulder or Global Advantage Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.

The Global Advantage Shoulder consists of a humeral stem and a humeral head. Like the predicate devices, the components are modular in that they employ a morse-type taper lock system, the modular head having the male taper and the body with the female taper. The humeral stem is manufactured titanium alloy (Ti-6Al-4V), while the humeral head is manufactured from cobalt chromium molybdenum alloy.

The Global Advantage humeral stem is similar to the current Global humeral stem in that there are four proximal fins, a proximal collar, and a fluted distal stem. The fins are perforated with suture holes to accommodate the sutures necessary to reconstruct the proximal humerus.

The Global Advantage humeral head is similar to the current Global head in that it is fitted with an identical locking taper, is semi-spherical in design, and is also available in an offset eccentric head.

The provided text is a 510(k) Pre-market Notification for the Global™ Advantage Shoulder. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, the requested information about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available within this document.

The document explicitly states:

• "The fundamental scientific technologies of the Global Advantage humeral stem and head have not changed from the FDA cleared (K911686, K974044 and K984541) Global Shoulder humeral stem and head."
• "The intended use and indications for use of the Global Advantage humeral stem and humeral head have not changed from the FDA cleared (K911686) Global Shoulder, Global Eccentric Humeral Head (K974044) and Global Fx (K984541)."
• "With the exception of minor design modifications, the Global Advantage humeral stem and humeral head are identical to the Global Shoulder devices cleared in K911686, K974044 and K984541."

This type of submission relies on the established safety and effectiveness of the predicate devices. The "study" here is essentially a comparison to predicate devices to assert substantial equivalence, not an independent performance study against defined acceptance criteria for the new device.

Therefore, I cannot populate the table or answer the subsequent questions with information from this document because it describes a claim of substantial equivalence, not a standalone performance study with acceptance criteria.

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