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The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

The provided document describes a 510(k) premarket notification for the "Catalyst EA Convertible Stemmed Shoulder" device. This is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices, not a study proving the device meets explicit acceptance criteria in the context of a clinical trial or AI performance.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory document. Specifically, there is no mention of acceptance criteria related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the information that is relevant to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

Study Details (Non-Clinical)

Your prompt asks for specific details related to AI/clinical studies that are not present in this 510(k) summary. Here's a breakdown of why and what information is available:

1. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical bench testing of a medical implant, not AI or clinical data. The "test set" would refer to the physical prototypes or samples used for mechanical testing. The specific number of samples for each test (e.g., how many constructs for fatigue testing) is not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and specifications.
3. Adjudication method for the test set: Not applicable. There is no expert review or adjudication process described for the lab-based mechanical tests.
4. 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: No. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices." This is a mechanical implant, not a diagnostic AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an algorithm or AI device.
6. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards (e.g., ASTM F136, ASTM F1537), and predetermined acceptance criteria for mechanical performance (e.g., fatigue life, disassembly forces).
7. The sample size for the training set: Not applicable. No AI training was performed.
8. How the ground truth for the training set was established: Not applicable. No AI training was performed.

Context from the Document:

The document clearly states:

"Non-Clinical Testing: Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device."

And:

"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices."

This indicates that the FDA cleared this device based solely on non-clinical (i.e., lab/mechanical) testing and comparison to predicate devices, and not on AI performance, clinical trials, or human diagnostic studies.

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