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510(k) Data Aggregation
(88 days)
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
These devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.
The Zimmer Unicompartmental Knee System Vivacit-E Articular Surface is a medical device. The provided text describes the non-clinical performance and conclusions for this device, focusing on material characteristics and mechanical properties. There are no clinical performance studies described.
1. Table of Acceptance Criteria and Reported Device Performance
| Property or Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effect of prolonged aging on the wear performance of vitamin-E IT Liner | (Implied) Wear performance should not be significantly affected by prolonged accelerated aging. | Demonstrated that prolonged accelerated aging does not significantly affect wear performance of Vivacit-E material. |
| Delamination Resistance of Vivacit-E Ultra High Molecular Weight Polyethylene | (Implied) The material should be delamination resistant. | Demonstrated that Vivacit-E material is delamination resistant. |
| Wear Testing of Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surfaces under Load and Motion Curves from the ISO-14243 Standard | (Implied) Wear characteristics should be sufficient to survive expected in vivo loading conditions. | Demonstrated that the wear characteristics of the Zimmer Unicompartmental Knee Vivacit-E articular surfaces are sufficient to survive expected in vivo loading conditions. |
| Fatigue Evaluation of the Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surface Locking Mechanism | (Implied) The locking mechanism should have adequate resistance to disassembly. | Demonstrated adequate resistance of the modular articular surfaces to disassembly. |
| ZUK VE Posterior Edge Crush Fatigue Strength Evaluation | (Implied) Posterior edge crush fatigue strength should be sufficient to survive expected in vivo loading conditions. | Demonstrated posterior edge crush fatigue strength is sufficient to survive expected in vivo loading conditions. |
| Human Factors Comparison of Manual Assembly of the Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surfaces | (Implied) Assembly force required to insert the articular surfaces should be appropriate for users (e.g., within ergonomic limits for surgeons). | Demonstrated that assembly force required to insert the Zimmer Unicompartmental Knee Vivacit-E articular surfaces is appropriate for users. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text details non-clinical performance and conclusions based on bench testing. Therefore, there is no human "test set" or associated patient data from which to derive sample size or data provenance (country of origin, retrospective/prospective). The "test set" in this context refers to the physical samples of the device components and materials subjected to laboratory testing. The document does not specify the number of samples used for each bench test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As this is a non-clinical, bench-testing study, the concept of "experts" establishing ground truth in the context of clinical interpretation or diagnosis does not apply. The ground truth for these tests is based on the physical and mechanical properties of the device components as measured by standardized testing methods and engineering principles. The experts involved would be engineers, material scientists, and quality assurance personnel who design, conduct, and interpret these tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes. Since this report describes non-clinical bench testing, no such adjudication method was used. The "results" are objective measurements against predefined engineering specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done. The description explicitly states: "Clinical data and conclusions were not needed for this device." The study focuses on the physical properties and performance of the device's material and components through bench testing, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question relates to AI/algorithm performance. No AI/algorithm standalone performance study was done. The device is a physical knee prosthesis component, not an AI software or system.
7. Type of Ground Truth Used
The ground truth used for these non-clinical performance studies is derived from established engineering standards, material science principles, and functional requirements for knee prostheses. Results from bench tests (e.g., wear rate measurements, fatigue strength, delamination resistance, assembly force) are compared against these predetermined specifications and accepted industry benchmarks to determine if the device meets its performance objectives.
8. Sample Size for the Training Set
Similar to the "test set," the concept of a "training set" is not applicable here as this is a non-clinical, bench-testing study of a physical medical device. There is no machine learning model being trained.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned in the context of this non-clinical bench study, this question is not applicable.
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