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The Arthrex VaultLock Glenoid is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatic 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 fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex VaultLock Glenoid is a UHMWPE glenoid designed to be used with the existing Univers II Shoulder Prosthesis system (K071032). The proposed Arthrex VaultLock Glenoid has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes.

This document is a 510(k) Pre-Market Notification for the Arthrex VaultLock Glenoid, a medical device. This document describes a medical device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

The document contains information about the device's performance testing, which serves a similar role to "acceptance criteria" but in the context of device equivalence rather than AI/ML model performance.

Here's the relevant information extracted from the document regarding the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Performance:

• Bacterial Endotoxin Testing: This test ensures that the device is free from harmful levels of bacterial endotoxins, which are a safety concern for implanted devices. The performance indicates that the device met the standards specified in European Pharmacopoeia (EP 2.6.14) and United States Pharmacopeia (USP ).
• Rocking Horse Stability: This test, performed according to ASTM F2028, assesses the mechanical stability of the glenoid component within the joint under simulated loading conditions. This is crucial for evaluating its long-term performance and resistance to loosening once implanted.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML diagnostic system. The "test set" here refers to physical devices undergoing testing, not a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are concepts typically applied to AI/ML model evaluation of data, not to the physical testing of a medical implant. The design and testing standards (e.g., ASTM) are established by groups of experts in biomaterials and orthopedics, but this is a different context.

4. Adjudication method for the test set: Not applicable as this is a physical device testing, not an AI/ML evaluation.

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 document pertains to a physical shoulder prosthesis, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical device. For device performance, the "ground truth" is defined by the objective physical and chemical properties measured against established standards (e.g., freedom from endotoxins, mechanical stability under load).

8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned.

9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned.

Summary of Device Equivalence:

The document concludes that the Arthrex VaultLock Glenoid is "substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex VaultLock Glenoid and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This substantial equivalence is based on the device's design, intended use, and the successful completion of the described performance tests.

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