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Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

Synthes Button Plate is a pre-bent plate consisting of seven holes for passing up to #5 sutures. The plate is 0.7 mm thick, 10 mm in width, and is 17 mm in length. The Button Plate is manufactured from titanium and is MRI safe.

The provided text is a 510(k) summary for the Synthes Button Plate, a medical device. This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the detailed information needed to fill out many of the requested fields regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full efficacy study with detailed performance metrics against pre-defined acceptance criteria relevant to AI/device performance as requested.

Therefore, I can only fill out the table and provide information that is explicitly stated in the document.

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 for test set: Not mentioned in the document.
• Data provenance: Not mentioned in the document. This document primarily focuses on regulatory submission for substantial equivalence based on device design and intended use, not a clinical study with a test set.

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)

• Number of experts: Not mentioned in the document.
• Qualifications of experts: Not mentioned in the document.

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

• Adjudication method: Not mentioned in the document.

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

• MRMC study: Not mentioned in the document. Since this is a physical implant device, an MRMC study comparing human readers with and without AI assistance is not applicable in this context.

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

• Standalone performance study: Not mentioned in the document. This is a physical device, not an algorithm, so a standalone performance study in the context of AI is not relevant.

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

• Type of ground truth: Not mentioned in the document. The substantial equivalence determination is based on the comparison of specifications, materials, and intended use with a predicate device, rather than a "ground truth" as typically understood in AI performance studies.

8. The sample size for the training set

• Sample size for training set: Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would typically have a "training set."

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

• How ground truth was established: Not applicable, as this is not an AI/ML algorithm.

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