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The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications Include:

1. Cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
   Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).

These devices are intended for use in patients with an irreparable rotator cuff as a shoulder replacement system that requires minimal bone resection. The Co-Cr-Mo Copeland™ EAS Resurfacing Heads can be used in hemi- or total shoulder replacement surgical procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis, if necessary, due to the initial bone preservation.
The humeral head components are available in eight (8) sizes (1-8). The Copeland™ EAS Resurfacing Heads have a variable spherical radii that range fro 20mm to 27mm. The stem is tapered and fluted to provide maximum stability in the humerus.
The most notable landmark on the Copeland™ EAS Humeral Resurfacing Head is the addition of material to the superior-lateral side of the resurfacing head. This material is added to keep the implant surface in contact with the acromion longer, reducing pain and increasing the amount that the arm can be raised in patients with rotator cuff deficiency.

This document is a 510(k) premarket notification for the Copeland™ EAS Humeral Resurfacing Heads. It is not a study reporting on the performance of an AI-powered device. Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device performance.

The document discusses the substantial equivalence of a medical device (a humeral resurfacing head) to previously marketed predicate devices, focusing on its design, indications for use, and a statement that "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." It also explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

In summary, there is no information in this document about: AI acceptance criteria, AI device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

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