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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II XL Glenoids are manufactured from UHMWPE. The glenoid articular (lateral) surface is concave and is designed to articulate with the humeral head of the Univers II humeral stems. The fixation (medial) surface is convex and is designed either with a keel or with three pegs for cement interdigitation fixation.

The provided document describes a 510(k) Summary of Safety and Effectiveness for the Arthrex Univers II XL Glenoids. This submission is for a medical device (shoulder prosthesis components) and does not involve an AI/ML powered device. Therefore, many of the requested criteria, which are specific to the evaluation of AI/ML devices, are not applicable.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided document.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device clearance based on substantial equivalence and mechanical testing, not a clinical study involving human data in the context of an AI/ML algorithm. The "test set" and "data provenance" as described in the prompt are relevant to AI/ML model evaluation, not mechanical device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert consensus, is not relevant for mechanical testing of a shoulder prosthesis component.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as this is not a study requiring human readers or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an AI/ML device that assists human readers, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI/ML algorithm. The "standalone performance" here refers to the device's mechanical performance in accordance with industry standards.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the Arthrex Univers II XL Glenoids relies on:

• Predicate Device Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate devices (Arthrex Univers II Shoulder System – Pegged Glenoid, K083435; Arthrex Univers Shoulder Prosthesis, K010124). The submission aims to prove the new device is substantially equivalent to these already cleared devices.
• Mechanical Testing Standards: Compliance with industry-recognized mechanical testing standards, specifically ASTM F 2028. This standard serves as the "ground truth" for evaluating the mechanical properties and performance of glenoid components.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML algorithm.

Summary of the Study Proving Acceptance Criteria are Met:

The study proving the device meets the acceptance criteria is based on:

1. Comparison to Predicate Devices: The submission states that "The product labeling, intended use, and the technology, engineering and performance of Univers XL Glenoids are the same as previously cleared glenoid devices." This forms the primary basis for demonstrating substantial equivalence.
2. Mechanical Testing: "The ASTM F 2028 mechanical testing data demonstrated equivalency of the proposed XL glenoids and the predicate device." This testing provides objective evidence that the mechanical properties of the new XL Glenoids are comparable to the previously cleared predicate devices, thus ensuring similar safety and effectiveness in terms of physical performance.

The FDA's decision to clear the device (K120044) is based on the determination that it is "substantially equivalent" to legally marketed predicate devices, taking into account the information provided regarding consistent fundamental features, intended uses, and comparable mechanical performance.

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