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The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.

The provided text describes a 510(k) premarket notification for the Arthrosurface WristMotion Total Wrist Arthroplasty System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving the device meets specific performance criteria as would be found for a novel device.

Therefore, many of the requested details, particularly regarding acceptance criteria with reported performance, sample sizes for test and training sets, expert qualifications, and specific AI-related comparative effectiveness or standalone studies, are not applicable or not explicitly provided in this type of regulatory document.

However, based on the information given, here's what can be extracted and inferred:

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

This information is not explicitly provided in a quantified table format in the document. The submission focuses on demonstrating substantial equivalence through non-clinical tests. The "Conclusion" states: "The results have demonstrated the safety and effectiveness of the Arthrosurface Total Wrist Arthroplasty System along with substantial equivalence to the predicate devices." This implies that the device met the performance expectations for these tests, but the specific acceptance criteria (e.g., maximum torque, minimum cycles) and the reported values are not detailed.

Specific Non-Clinical Tests Conducted (without acceptance criteria or reported 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 mentions "non-clinical tests and/or analysis" but does not detail the number of samples used for each test.
• Data Provenance: The tests are non-clinical, likely performed in a laboratory setting, so country of origin or retrospective/prospective nature of patient data is not applicable.

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):

This information is not applicable as this submission is for a medical implant (arthroplasty system), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for non-clinical device testing refers to engineering standards and physical measurements.

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

Not applicable for this type of non-clinical device testing. Adjudication methods are typically used in clinical studies or for interpreting ambiguous cases in AI/software performance evaluations by humans.

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 submission is for a medical implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This submission is for a medical implant.

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

The "ground truth" for the non-clinical tests listed would be based on engineering standards, material properties, and physical measurements performed in a laboratory. For example, for "torsion to failure," the ground truth would be the objectively measured torque at which the screw failed, compared against a pre-defined standard or predicate device performance. For the LAL test, the ground truth is whether the endotoxin level meets the specified USP and AAMI standards.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is for a physical implant, not an AI/ML device.

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