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Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.

This 510(k) premarket notification for the Zimmer Trabecular Metal Technology, Inc. Trabecular Metal Tibial and Femoral Cone Augments does not contain a study that proves the device meets specific acceptance criteria in the manner you've described (e.g., related to algorithm performance, human reading, or medical outcomes).

Instead, this submission seeks to demonstrate substantial equivalence to previously cleared predicate devices. Substantial equivalence for medical devices like this typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. This is often achieved through non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies with defined acceptance criteria for diagnostic or AI performance.

Therefore, many of the specific questions you've asked about acceptance criteria for device performance with numerical metrics, expert adjudication, or AI performance are not applicable to this type of 510(k) submission.

Here's an assessment based on the provided text:

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

• Not applicable in this context. This 510(k) does not present a table of specific numerical acceptance criteria for a study proving device performance in the way a diagnostic or AI device approval might. The device is a knee implant augment, and its "performance" is primarily assessed through its material properties, design, and biocompatibility, which are implicitly covered by its substantial equivalence to predicate devices.

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. There is no mention of a "test set" for performance evaluation in the context of diagnostic or AI accuracy. The "performance data" mentioned in the submission refers to the characteristics that ensure substantial equivalence, which would typically be derived from engineering specifications and testing, not patient data in the sense of a test set for diagnostic accuracy.

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 in the context of diagnostic accuracy or AI performance is not relevant to this submission. The device is a physical implant.

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

• Not applicable. No test set or human adjudication process is described.

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 a component of a knee implant system, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable. There is no algorithm associated with this physical implant device.

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

• Not applicable. Ground truth for diagnostic performance is not relevant. The "ground truth" for a device like this would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering standards and testing, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. No AI or machine learning model requiring a training set is mentioned.

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

• Not applicable. As no training set is mentioned, this question is not relevant.

Summary of the Document's Approach to "Performance":

The core of this 510(k) submission, regarding "performance," is found in the statement:

"Performance Data: The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756)."

This indicates that the Zimmer Trabecular Metal Tibial and Femoral Cone Augments are considered to have the same "performance characteristics" as their predicate devices because they are described as "identical." In the context of medical devices like these, "performance characteristics" would typically refer to aspects such as:

• Material properties: Strength, ductility, fatigue resistance, porosity, etc.
• Biocompatibility: Demonstrated through standard biocompatibility tests.
• Mechanical integrity: Ability to withstand loads and stresses inherent in knee joint function.
• Design compatibility: Ensuring proper fit and function with the specified Zimmer knee systems.

Since the devices are stated to be "identical," no new "performance data" is presented in this submission itself; rather, it refers back to the data provided and accepted in the clearance of the predicate devices.

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