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The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

Use the TC-PLUS patella with the VKS Knee System.

This is a 510(k) premarket notification for a medical device (VKS Knee System), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested items related to study design, acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness are not available in the provided text. The document is an FDA approval letter and a summary of safety and effectiveness, which does not typically include a detailed performance study report.

Here's a breakdown of the information that can be extracted, and where information is not available:

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

• Acceptance Criteria: Not explicitly stated in the provided text as specific numerical thresholds for performance. The approval is based on "substantial equivalence" to a predicate device, meaning it performs similarly and is as safe and effective.
• Reported Device Performance: Not provided as specific performance metrics. The document states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the performance was deemed acceptable relative to the predicate, but specific performance values are not given.

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 as no specific clinical test set is described. The 510(k) process for a knee prosthesis typically relies on non-clinical testing (e.g., mechanical testing, materials characterization, and comparison to predicate) rather than a clinical "test set" in the context of an AI/imaging device.

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 as no specific clinical test set requiring expert ground truth is described.

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

• Not applicable as no specific clinical test set requiring adjudication 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 is not an AI or imaging device. It is a knee joint prosthesis, and such studies are not relevant to its regulatory pathway.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable as no specific study involving "ground truth" (in the context of diagnosis or interpretation) is detailed. The "ground truth" for a prosthetic device would relate to its mechanical properties, biocompatibility, and clinical outcomes, which are typically assessed through non-clinical testing and long-term surveillance rather than a "ground truth" similar to image interpretation.

8. The sample size for the training set

• Not applicable. This is a medical device (knee prosthesis), not an AI or machine learning model that requires a training set.

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

• Not applicable.

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The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

The VKS Knee System is a tri-compartmental total knee prosthesis comprised of femoral, patellar and tibial components with an intrinsic tibial PE-insert. Standard, and Ultra-Congruent tibial components are available.

The provided document for the VKS Knee System (K022204) is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It is important to note that a 510(k) submission for this type of device (a knee joint prosthesis) primarily relies on biomechanical testing and generally does not include clinical performance studies involving human subjects in the same way that software or AI/ML-based medical devices do.

Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of traditional medical device submission.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance

The document states: "Performance data: Biomechanical Testing has been provided. All test results are sufficient for in vivo loading." This implies that the acceptance criteria were met through mechanical testing demonstrating the device's ability to withstand forces anticipated in the human body.

Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Biomechanical Testing." The document does not provide specific details about the methodology, results, or comparison to acceptance criteria thresholds, but it asserts that this testing was sufficient.

Additional Information (based on the provided document):

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

   • Not applicable/Not provided. Biomechanical testing typically involves physical samples of the device, not human data.

2. 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/Not provided. Ground truth for biomechanical testing is typically established by engineering specifications and industry standards, not expert medical consensus on human data.

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

   • Not applicable/Not provided. This concept applies to human reader studies, not biomechanical testing.

4. 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:

   • No. An MRMC comparative effectiveness study was not done. This is not relevant for a knee prosthesis submission.

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

   • Not applicable. This is not an AI/ML algorithm or software device.

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

   • For biomechanical testing, the "ground truth" would be engineering specifications and established standards for mechanical properties and durability, rather than medical ground truth from patient data.

7. The sample size for the training set:

   • Not applicable/Not provided. This type of device does not involve a training set as used in AI/ML.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided.

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