(30 days)
The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- Revision of a previously failed knee arthroplasty
- Patients who require a total knee replacement
The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to expand the size offerings of the Klassic® Knee System to include a Size 7 femoral component. These components are manufactured from Cobalt-Chromium Alloy.
This document is a 510(k) premarket notification for the Klassic® Knee System. It is primarily concerned with establishing substantial equivalence of an expanded size offering (Size 7 femoral component) to a previously cleared version of the same device. Therefore, it does not contain the detailed clinical study information typically provided for novel devices or AI/software-as-a-medical-device (SaMD) clearances.
Based on the provided text, here's what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Not explicitly stated as acceptance criteria, but implied tests: | The information summarized in the Design Control Activities Summary demonstrates that the Klassic Knee Femur, Size 7, met the pre-determined acceptance criteria for the verification activities. |
| Results of engineering analyses indicate that the Size 7 Klassic Knee Femurs are substantially equivalent to the predicate components in terms of: | |
| Tibial-Femoral Instability and Contact Stress | Substantially equivalent to predicate. |
| Patella-Femoral Instability and Contact Stress | Substantially equivalent to predicate. |
Note: The document references "pre-determined acceptance criteria for the verification activities" but does not explicitly list what those criteria were (e.g., specific stress limits, acceptable range of motion, wear rates, etc.) or the detailed quantitative results for each.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This document describes a modification to a medical device (a knee implant) primarily based on engineering analyses rather than clinical study data involving patients. No "test set" of patient data is mentioned. The assessment is based on comparing the new size to existing sizes through engineering principles.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. As above, no patient-based clinical "test set" requiring expert ground truth establishment is described. The evaluation is based on engineering analyses.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication of a clinical test set is relevant to this type of device modification submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not describe an MRMC study. Such studies are typically for evaluating diagnostic imaging or AI-assisted diagnostic tools, not for a physical implant modification directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical knee implant, not an algorithm or software.
7. The Type of Ground Truth Used:
- Engineering principles and predicate device data. The "ground truth" for demonstrating substantial equivalence of the new femoral component size is rooted in established engineering analysis methods, material properties, and the performance characteristics of the previously cleared predicate Klassic® Knee System components.
8. The Sample Size for the Training Set:
- Not Applicable. This document does not describe a machine learning algorithm or an AI model, and therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
In summary: This document is focused on demonstrating the substantial equivalence of a new size of a previously cleared knee implant through engineering analyses and comparison to a predicate device, rather than through a clinical study with patient data or an evaluation of an AI algorithm's performance. Therefore, many of the requested data points related to clinical efficacy, expert review, and AI model evaluation are not applicable or present in this specific regulatory submission.
§ 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.