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The Metallic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.

Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:

• Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test").
• Decreased motion, normal pinch and grip strength.
• X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal joint.
• Associated unstable, stiff, or painful distal joints.

The Metallic Spherical CMC Implant is made from cobalt chrome alloy.

This document is a 510(k) summary for a medical device called the "Metallic Spherical CMC Implant." It details the device's description, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the format you requested.

The document primarily focuses on regulatory approval rather than a detailed performance study with quantitative results against predefined acceptance criteria. Therefore, most of your requested information cannot be extracted from this text.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot:

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

• Cannot be provided. The document states "The Metallic Spherical CMC Implant demonstrates acceptable material strength," but it does not specify what "acceptable material strength" means quantitatively, nor does it provide a table of criteria or measured performance values.

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

• Cannot be provided. The document mentions "Testing" for material strength but gives no details about the sample size, type of test, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. This type of information is not relevant to the material strength testing mentioned. The document describes patient symptoms (e.g., "grind test," "X-ray evidence") for which the device might be considered, but this is about diagnostic criteria for implant use, not about expert-established ground truth for a device performance study.

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

• Cannot be provided. Not applicable to the type of information presented.

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:

• Cannot be provided. This document describes a physical implant, not an AI or imaging diagnostic device. Therefore, an MRMC study or AI assistance is not relevant.

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

• Cannot be provided. Not applicable. This is a physical implant, not an algorithm.

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

• Cannot be provided. The document does not describe a study involving ground truth establishment for performance evaluation. The "Testing" section is too vague to determine this.

8. The sample size for the training set:

• Cannot be provided. Not applicable to the type of information presented. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Cannot be provided. Not applicable.

In summary, the provided text is a regulatory filing summary that describes a medical device and its intended use, along with a claim of substantial equivalence and acceptable material strength. It does not contain the detailed performance study information with acceptance criteria that you are requesting.

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