(105 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biomechanical Performance | "All test results are sufficient for in vivo loading." |
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):
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.