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The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.

The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The fracture adapters are manufactured from Titanium with a hydroxyapatite (HA) coating and are offered in 10 sizes. The Fracture Adapters mate with a trunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemi shoulder prosthesis.

Here's an analysis of the acceptance criteria and the study conducted for the Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555), based on the provided document:

Acceptance Criteria and Device Performance

Study Details

The provided document describes two types of performance studies: dynamic fatigue testing and bacterial endotoxin testing.

1. Dynamic Fatigue Testing

• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "the proposed construct" and "the proposed devices" but does not specify the number of units tested.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a mechanical engineering test, not an evaluation requiring expert opinion on diagnostic accuracy.
• Adjudication method for the test set: Not applicable. This was a mechanical engineering test.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a mechanical device, not an AI or imaging diagnostic device that would require an MRMC study.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
• The type of ground truth used: The "ground truth" for this test would be the established mechanical limits and performance characteristics of the predicate device, against which the new device's fatigue strength was compared.
• The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical testing.
• How the ground truth for the training set was established: Not applicable.

2. Bacterial Endotoxin Testing

• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions that the test was "conducted" but doesn't specify the number of devices or samples tested.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a laboratory test following recognized standards (EP 2.6.14/USP ).
• Adjudication method for the test set: Not applicable. This is a standard laboratory test.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: The "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP .
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary regarding AI/ML specifics:

It's important to note that the provided document is a 510(k) clearance letter for a mechanical orthopedic implant (shoulder prosthesis components). The questions about multi-reader multi-case studies, standalone algorithm performance, training sets, data provenance, and expert ground truth establishment are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices or diagnostic imaging devices. This document does not describe an AI/ML device, hence most of those specific questions are not applicable to the context of this submission. The "study" here refers to mechanical and biocompatibility testing to ensure the safety and effectiveness of the physical implant.

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