(195 days)
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis - . avascular necrosis of femoral condyle - . post traumatic loss of joint configuration - primary implantation failure, .
The Evolis Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior stabilized design of six sizes. The tibial baseplates are offered in six sizes. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 9 -19 mm each. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three sizes and the resurfacing patella is offered in four sizes. The femoral components and the tibial base plates are offered in coated options with a plasma spray titanium coating.
Here's an analysis of the provided text regarding acceptance criteria and study details for the Evolis Total Knee System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Adherence to international standards and FDA guidance documents for knee prostheses. | "The testing met all acceptance criteria and verifies that performance of the Evolis Total Knee System is substantially equivalent to the predicate devices." |
| Biocompatibility | (Not explicitly stated, but implied by regulatory requirements for implantable devices) | (Not explicitly stated in the provided text, but implied to be met for 510(k) clearance) |
| Design Verification | Performance against "written protocols with pre-defined acceptance criteria." | "The testing met all acceptance criteria..." |
| Substantial Equivalence | The device must be as safe and effective as legally marketed predicate devices. | "The data and information provided in this submission support the conclusion that the Evolis Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "The testing was conducted on the worst case component size and option/design." It does not specify the exact number of components or iterations tested, which is common in 510(k) summaries where detailed testing reports are referenced rather than directly included.
- Data Provenance: The studies were retrospective in the sense that they were conducted before submission for regulatory clearance to demonstrate performance. The data's geographical origin is not specified, but the manufacturer is MEDACTA International SA in Switzerland, suggesting the testing likely occurred in Europe or accredited labs serving the European market, conforming to "international standards and FDA guidance documents."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The performance testing described is engineering-based (mechanical, design verification) rather than clinical. Therefore, "ground truth" derived from expert clinical assessment is not applicable in this context. The "ground truth" here is adherence to engineering specifications and performance benchmarks.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation involved engineering testing against pre-defined criteria, not an assessment requiring adjudication by human experts for clinical "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies described are engineering performance tests, not clinical trials comparing human readers with and without AI assistance. This device is a physical knee implant, not an AI software device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance testing was based on pre-defined acceptance criteria derived from "various international standards and FDA guidance documents" for mechanical and material performance of knee prostheses. This would likely include:
- Mechanical stress and fatigue limits.
- Wear rates.
- Material properties.
- Dimensional accuracy.
- Biocompatibility standards.
8. The Sample Size for the Training Set
- Not applicable. This document describes the regulatory submission for a physical medical device (total knee system), not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI/ML algorithm.
§ 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.