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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

The Arthrosurface® glenoid components are intended to interface and articulate with the Sponsor's previously cleared and commercially marketed humeral head resurfacing prosthesis (K023096) to repair and replace a shoulder joint when both articular surfaces of the joint are affected. They are comprised of Ultra High Molecular Weight Polyethylene (UHMWPE) and are offered in both a peg and keel design. These components will be available in several sizes and are intended to be implanted using bone cement.

The provided text is a 510(k) premarket notification for a medical device, the GRS™ Glenoid Resurfacing System. It's a regulatory document demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the table of acceptance criteria and device performance, nor can I provide information on sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on:

• Device Description: The GRS™ Glenoid Resurfacing System is an UHMWPE glenoid component, available in peg and keel designs, intended to articulate with Arthrosurface's previously cleared humeral head resurfacing prosthesis.
• Indications for Use: Reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis, with sufficient bone stock and an intact/reconstructable rotator cuff. It's a single-use implant intended for use with bone cement.
• Substantial Equivalence: The key argument for market clearance is that the device is substantially equivalent in intended use, materials, and application to the DePuy Global™ Shoulder Glenoid Component K981487, Biomet Modular Hybrid Glenoid Synthes Epoca Shoulder Prosthesis System K060694, and K072578.

To gather the information you requested, an engineering validation report or a clinical study report (if one were required and performed for this type of device) would be necessary. These documents are generally not part of the initial 510(k) summary provided to the public unless specifically requested or if clinical data was a critical component of the substantial equivalence determination for complex devices. For a Class II orthopedic implant like this, substantial equivalence is often primarily based on material properties, design similarities, and mechanical testing against established standards, rather than extensive clinical efficacy studies in the same way a new drug or an AI diagnostic would be evaluated.

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