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Trabecular Metal Tibial 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 are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

The NexGen TM Cone Broach, a 2-piece instrument (Broach and Handle), are manufactured from 17-4 stainless steel and designed to provide a multi-functional instrument to streamline the surgical process used when implanting the Trabecular Metal Tibial Cone Implants. The broaches are used to prepare the tibial metaphysis; the broach have teeth that are necessary to cut through bone and form the tibial canal to the correct shape and depth for a Trabecular Metal Tibial Cone Implant. The broaches are manually impacted, using a sequentially larger broach until reaching the final size for the Implant.

The provided document is a 510(k) premarket notification for a medical device called the "NexGen® Complete Knee Solutions Trabecular Metal Cone Broach." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria.

Therefore, the information typically requested regarding acceptance criteria, study design, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this regulatory submission.

The document focuses on demonstrating that the new broach is substantially equivalent to existing, legally marketed broaches by comparing design, materials, function, and principle of operation.

Here's a breakdown of what can be extracted from the document regarding the device and its comparison, but again, this is not an acceptance criteria vs. performance study result:

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

This information is not provided in the document. The document is for a Class II medical device (surgical tools) and relies on substantial equivalence to predicate devices, not on proving clinical performance against specific acceptance criteria with reported metrics.

2. Sample sized used for the test set and the data provenance

This information is not provided. As it's a regulatory submission for a surgical instrument demonstrating substantial equivalence, a "test set" in the context of clinical performance data is not applicable here. The comparison is based on engineering and design characteristics.

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

This information is not provided. Ground truth establishment as described for analytical or clinical studies is not relevant to this regulatory clearance process.

4. Adjudication method for the test set

This information is not provided. An adjudication method is not relevant for this type of regulatory 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

This information is not applicable/provided. This device is a surgical broach, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study related to human readers and AI assistance would not be performed for this type of device.

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

This information is not applicable/provided. As above, this is a surgical instrument, not an algorithm.

7. The type of ground truth used

This information is not provided. Ground truth in the context of clinical outcomes or diagnostic accuracy is not relevant to this regulatory submission. The "truth" being established here is that the device is substantially equivalent to predicates in terms of design, materials, and intended use.

8. The sample size for the training set

This information is not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

This information is not provided. This question is not applicable to the device or the type of regulatory submission.

Summary of Device Comparison (from "Comparison to Predicate" section, which serves as the basis for substantial equivalence, not a performance study):

The document states that the NexGen TM Cone Broach is comparable to its predicate devices based on:

• Function: Both are non-sterile, reusable manual orthopedic instruments that perform the same function (preparation of the tibial metaphysis).
• Materials: Manufactured from identical materials (17-4 stainless steel).
• Design: The design mimics currently marketed cone implants to prepare the tibial canal.
• Principle of Operation: Uses the same principle of manual, sequential impaction with a mallet.
• Improvements: The new device adds design-specific Coupled broaches and Large broach sizes for a full line of Cone Implants and replaces a manual burring step. This additional functionality streamlines the surgical procedure.
• Safety and Effectiveness: The conclusion is that the TM Cone Broach is "as safe and effective" as the predicate instrumentation.

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