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The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

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 Fracture ansiountine , separated from its blood supply or where the surgeon's severience 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).
   Glenoid components are intended for cemented use only.

The DePuy Global™ Crosslink Glenoids are offered in an anchor peg and a fin design. The Crosslink Glenoid anchor peg design consists of sizes: 40mm, 48mm, 48mm, 52mm, 56mm and 56mmXL. The Crosslink Glenoid in the fin design consists of seven sizes: 40mmXS, 40mm, 44mm, 52mm, 52mm, 56mm and 56mmXL. Both the anchor peg and fin designs have a lateral surface that is concave and designed to articulate with the DePuy Global™ line humeral heads indicated for ase in total shoulder arthroplasty. The fixation surface has a central fin or peripheral pegs and is intended to be attached to the glenoid fossa of the scapula with bone cement.

The provided text is a 510(k) premarket notification for a medical device, the DePuy Global™ Shoulder Crosslink Glenoid. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets acceptance criteria through a study with the detailed structure you've requested.

Therefore, many of the specific details you've asked for, such as acceptance criteria in the context of a performance study, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI performance, are not applicable and not present in this document.

This submission focuses on justifying that the new device (Crosslink Glenoid) is substantially equivalent to existing, legally marketed devices, primarily by demonstrating similar design and intended use, and emphasizing a material difference (highly cross-linked polyethylene) with an additional claim of reduced wear based on shoulder simulator wear studies.

Here's an attempt to answer your questions based only on the provided text, while highlighting what information is missing:

Acceptance Criteria and Study to Prove Device Meets Them

1. Table of acceptance criteria and the reported device performance:

Note: The acceptance criteria here are inferred from the basis of substantial equivalence. They are not explicit, quantitative performance targets as might be found in a clinical trial or a performance study designed to demonstrate specific metrics (e.g., accuracy, sensitivity, specificity for an AI device). The primary acceptance criterion here is "substantial equivalence" to the predicate devices, with an added claim for improved wear.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. The "study" mentioned is "shoulder simulator wear studies," which refers to in-vitro mechanical testing, not a human-data-based test set in the context of AI. The number of components tested in these simulator studies is not specified.
• Data Provenance: Not applicable for human data. The "study" is a laboratory-based, in-vitro shoulder simulator wear study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a physical implant, not an diagnostic algorithm requiring expert "ground truth" labels.

4. Adjudication method for the test set:

• Not applicable. This device is a physical implant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for the wear reduction claim is based on physical measurements of wear from in-vitro shoulder simulator studies.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI device for this product.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" in the context of an AI device for this product.

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