(59 days)
The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): 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 add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.
This document is an FDA 510(k) premarket notification for a medical device, the Klassic® Knee System. This type of document is a regulatory submission to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not typically a study report designed to "prove" a device meets specific acceptance criteria in the way a clinical trial or performance study would. It focuses on engineering analyses and comparisons to predicate devices for safety and effectiveness.
Therefore, the requested information elements related to clinical studies, ground truth establishment, expert review, sample sizes for test and training sets, and MRMC studies are largely not applicable or not present in this type of regulatory filing. The "acceptance criteria" here refer to the engineering performance criteria used to demonstrate substantial equivalence, not clinical performance metrics.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Engineering) | Reported Device Performance |
|---|---|
| Material: Ultrahigh molecular weight polyethylene (UHMWPE) | The new components (All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS®) are manufactured from UHMWPE, consistent with predicate devices and established material for orthopedic implants. |
| Biocompatibility: LAL (Limulus Amebocyte Lysate) testing | The All-Poly Tibias have undergone LAL testing and are in compliance with requirements for orthopedic implants, ensuring they do not cause clinically significant adverse reactions due to endotoxins. |
| Mechanical Performance: Contact Area and Surface Stress | Engineering analyses were performed. The results indicate these aspects are substantially equivalent to the predicate components, suggesting similar wear characteristics and load distribution. (Specific numerical criteria not provided in this summary). |
| Mechanical Performance: Overall Strength | Engineering analyses were performed. The results indicate overall strength is substantially equivalent to the predicate components, suggesting the device can withstand expected physiological loads. (Specific numerical criteria not provided in this summary). |
| Mechanical Performance: Cement Fixation Features | Engineering analyses were performed. The results indicate cement fixation features are substantially equivalent to the predicate components, implying comparable stability and longevity of the cemented implant. (Specific numerical criteria not provided in this summary). |
| Design/Function Equivalence to Predicate Devices | The information summarized in the Design Control Activities Summary demonstrates that the subject All-Poly Tibias met the "pre-determined acceptance criteria for the verification activities" by being substantially equivalent to predicate Klassic Knee System (K112906, K140942, K150105, K153075, K153310) and Natural Knee II All-Poly Tibia (K936159). |
| Intended Use Equivalence to Predicate Devices | The device is intended for prosthetic replacement with bone cement for conditions like NIDJD, IJD, failed previous surgery, correctable varus-valgus deformity, and revision, which are consistent with the predicate indications. |
| Modular Components with Varying Sizes | The new components are available in sizes to match various patient anatomies, consistent with the modular design of the Klassic Knee System. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for a clinical test set. The submission refers to "Engineering analyses" for mechanical performance. These analyses would typically involve simulated testing (e.g., finite element analysis, structural testing) rather than a clinical "test set" of patients.
- Data Provenance: The analyses are based on engineering principles and relevant standards for orthopedic implants, likely conducted by the manufacturer or a contract lab. Specific countries of origin are not mentioned, but the submission is to the U.S. FDA. The data is pre-market verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This document describes engineering verification testing, not a clinical study requiring expert ground truth establishment for a diagnostic output.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results by multiple readers. This document outlines engineering test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done including effect size of improvement with AI vs without AI assistance
- Not applicable. This device is a total knee replacement system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (knee implant), not an algorithm or software. "Standalone performance" in this context would refer to the mechanical performance of the implant itself, which is what the engineering analyses assess.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The "ground truth" for this type of submission is typically established by recognized engineering standards (e.g., ISO, ASTM for orthopedic implants) and the established performance and safety profile of the legally marketed predicate devices. The new device's engineering performance is compared against these benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This document does not describe the development of an algorithm or AI model that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
In summary: This FDA 510(k) summary focuses on demonstrating that a modified knee implant system is substantially equivalent to existing predicate devices through engineering analyses and material compliance, rather than presenting a clinical study with detailed patient data, expert reviews, or AI performance metrics.
§ 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.