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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

This document, K142942 for the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System, is a 510(k) premarket notification. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Pre-Market Approval) would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance that you are requesting. It's a regulatory submission affirming the device's similarity to existing devices the FDA has already cleared.

Instead, this submission concentrates on non-clinical (bench) testing to demonstrate that the modified device performs similarly to its predicate.

Here's what information can be extracted or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified. The document references non-clinical (bench) testing, not clinical studies. The "test set" in this context refers to the number of physical device samples subjected to mechanical testing.
• Data Provenance: Not applicable. This is not clinical data. The testing would have been performed in a laboratory setting, presumably by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical professionals. The testing described is mechanical (bench) testing. The "truth" is whether the device meets engineering specifications and replicates the performance of the predicate device, typically evaluated by engineers and quality control personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in clinical studies when multiple human observers interpret data. For mechanical testing, the results are typically quantitative measurements against predefined specifications.

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:

• No. This is a mechanical orthopedic implant, not an AI or imaging device. MRMC studies are not relevant here.

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

• No. This is a mechanical orthopedic implant. "Standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device's mechanical test results were compared to establish "substantial equivalence."

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no training set or clinical "ground truth" establishment in this document.

In summary, this 510(k) submission primarily relies on comparing the modified device's non-clinical performance (mechanical testing) and design characteristics to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing new clinical study data with acceptance criteria for a new clinical performance claim.

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