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The Ascension® NuGrip® CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.

The Ascension NuGrip CMC Implant is a single-use, uncemented one-piece implant for the basal thumb joint. It is constructed of a graphite core encased in a layer of pyrolytic carbon. The device is offered in 9 different combinations of 3 head and 4 stem sizes. The NuGrip represents incremental design modifications to the Ascension PyroHemiSphere, including an extended proximal spherical head, a collar at the head base, modified stem geometry, and additional implant sizes.

The provided text is a K112278 510(k) premarket notification for the Ascension® NuGrip® CMC Implant. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. However, it explicitly states that no clinical performance data were needed to support substantial equivalence of the design modifications.

Therefore, there is no information in the provided text to answer most of your questions, as they pertain to clinical studies and performance data.

Here's what can be extracted based on the document:

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

Since no clinical performance data was provided or deemed necessary, there are no specific clinical acceptance criteria or reported device performance metrics in the context of a clinical study. The device's substantial equivalence was based on non-clinical performance data and material/process equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

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:

Not applicable. This device is an implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an implant, not an algorithm.

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

Not applicable, as no clinical performance data was provided. The "ground truth" for this submission was based on the substantial equivalence of the device's materials, design modifications, and non-clinical performance to existing, cleared predicate devices.

8. The sample size for the training set:

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

Summary based on the provided text:

The information explicitly states: "No clinical performance data were needed to support substantial equivalence of the design modifications." This means the regulatory pathway for this device did not require a clinical study with human patients to demonstrate safety and effectiveness for this specific submission. Instead, substantial equivalence was established through:

• Identical materials and processes to the predicate Ascension® PyroHemiSphere® CMC implant.
• Non-clinical performance data and analysis, including:
  • CMC Joint Biomechanics Review
  • Static Compression-Bending Testing
  • Basal Thumb Implant Endurance Testing
  • System Verification Report/Strength Analysis
  • PyroCarbon Wear Characteristics Analysis
• The determination that design modifications do not raise new issues of safety or effectiveness.
• Unchanged indications for use and intended function from the predicate devices.

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