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The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity: .
• Revision procedures where other treatments or devices have failed. .

The Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.

The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm

This document describes the 510(k) submission for the OMNI life science Apex Knee System Tibial Baseplate Augment. It is a premarket notification to demonstrate substantial equivalence to previously marketed devices, not a study proving device safety and effectiveness through clinical trials with specific acceptance criteria as might be expected for an AI/clinical diagnostic device. Therefore, much of the requested information regarding AI device evaluation is not applicable here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) because this is a mechanical medical device (a knee implant component). Instead, the acceptance criteria are related to mechanical and material properties and a demonstration of substantial equivalence to predicate devices.

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

This information is not applicable. The device is a mechanical implant, and its evaluation does not involve "test sets" or "data provenance" in the way an AI diagnostic device would. The "performance testing" and "bench testing" mentioned are likely mechanical tests performed in a lab setting, not on patient data.

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 is not applicable. Ground truth for mechanical device performance is established through engineering specifications, material properties, and physical testing, performed by engineers and technicians, not clinical experts establishing diagnostic ground truth from patient data.

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

This is not applicable. Adjudication methods are used for resolving disagreements in expert opinions, typically in diagnostic or clinical trial settings. Mechanical testing results are objective measurements.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is an implant, not an AI diagnostic tool.

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

This is not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and the results of the bench testing demonstrating mechanical integrity, fit, and function as being equivalent to legally marketed predicate devices. This is a regulatory pathway (510(k)) focused on demonstrating substantial equivalence, rather than proving clinical efficacy through extensive outcomes data, which would typically be required for a PMA application.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" involved in the development or evaluation of this mechanical device.

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

This is not applicable, as there is no training set for an AI model.

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