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VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision k nee a rthroplasty w here the collateral ligaments a re intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.

The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems.

The VKS/TC-PLUS Revision femoral component is available in five size and right and left configurations. It has a post in the box into which is machined a female Morse type taper to receive an intramedullary stem. It is also configured to received posterior and distal augmentation blocks.

The VKS/TC-PLUS Revision tibial baseplate has five sizes, right and left, and has the same outer profile as the VKS baseplates cleared in K022204. The tibial insert locking mechanism is the VKS Knee. The inferior surface of the baseplate has a short post with a female type taper machined into it to receive modular stems and a hole through the baseplate to receive a screw to augment the baseplate/stem connection. The stems are as used on the femoral component. The inferior surface of the baseplate also has two fins that extend posterior/laterally from the post.

The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee.

The femoral augmentation blocks are available in distal and posterior configurations, 5mm and 10mm thickness. The tibial augmentation blocks are available in half blocks so that medial, lateral or full augmentation can be achieved. They are also available in 5mm and 10mm thickness.

This document describes a premarket notification (510(k)) for the VKS/TC-PLUS Revision Knee, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria, ground truth, and statistical analysis typically associated with AI/software devices. Therefore, many of the requested categories related to such studies are not applicable.

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Acceptance Criteria and Study Details for K032215

As this is a 510(k) submission for a physical medical device (a knee prosthesis), the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device's performance metrics (like sensitivity, specificity, etc.) is not directly applicable. For this device, acceptance criteria are generally met through substantial equivalence to predicate devices in terms of materials, design, intended use, and engineering analysis demonstrating comparable strength.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device are primarily tied to demonstrating equivalence to predicate devices and meeting established engineering standards and safety requirements. Performance is assessed through engineering analysis and comparison.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as this is a 510(k) for a physical implantable device, not an AI/software device requiring a test set of data. The "test" for this device is primarily via engineering analysis and comparison to predicate devices, not clinical data from a prospective or retrospective study on patients for algorithm performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating diagnostic or prognostic AI/software. For a knee prosthesis 510(k), experts (e.g., orthopedic surgeons, materials scientists, mechanical engineers) would be involved in the design, testing, and regulatory review, but not in establishing "ground truth" for a test set in the way you're asking.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as (2) and (3). There is no "test set" in the context of an AI/software device study.

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in imaging or diagnostic tasks. This device is a surgical implant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This device is a physical knee prosthesis and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable in the context of AI/software performance. For a knee prosthesis, "ground truth" might refer to validated biomechanical models, material property standards, or clinical outcomes from predicate devices, but not in the way it's used for AI validation.

8. The Sample Various Size for the Training Set

This information is not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" or "ground truth" that would be established in this manner for this device.

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