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The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.
  The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.

New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735.

This 510(k) summary (K100197) describes the Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or AI device.

Therefore, the requested information elements related to a study proving acceptance criteria (like sample size, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable and cannot be extracted from this document because such a study is not part of this type of submission for this device.

The document states: "The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735." and "The Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts are similar to the following commercially available devices regarding design features, overall indications, and materials: Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735) and Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)."

This indicates that the device's acceptance is based on its substantial equivalence to predicate devices already on the market, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices without raising new questions of safety and effectiveness.

Therefore, here is an attempt to address the request based on the provided document and the nature of a 510(k) submission for a physical medical device like this:

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)

• Not applicable. This document describes a 510(k) submission for a physical orthopedic implant based on substantial equivalence, not a clinical study or a study involving a "test set" as understood for diagnostic or AI devices. The "data" provenance would relate to the design documents, material specifications, and regulatory history of the predicate devices.

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" for a physical implant like this is established through engineering design, material science, and the regulatory history of similar devices. It does not involve expert consensus on interpreting data from a "test set" in the context of an AI or diagnostic study.

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

• Not applicable. No test set or adjudication process of this nature is described or relevant for this type of 510(k) submission.

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 is an orthopedic implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported here.

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

• Not applicable. There is no algorithm or software component described in this 510(k) submission for standalone performance evaluation.

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

• Inferred: The "ground truth" for demonstrating the safety and effectiveness of this device is primarily based on the established safety and effectiveness of the predicate devices (K912735 and K061011) through previous regulatory clearances, and adherence to relevant material standards (for UHMWPe) and design principles for knee prostheses. This involves engineering data, material specifications, and historical clinical performance of similar devices, rather than a "ground truth" derived from patient-specific data in a clinical trial for a new diagnostic.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that utilizes training sets.

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

• Not applicable. As above, no training set is described or utilized for this medical device.

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