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510(k) Data Aggregation
(133 days)
ZIMMER PERSONA KNEE SYSTEM
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.
This document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.
| Property or Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fatigue Test of the Persona Tibia Keel and Stem Extension | Sufficient fatigue strength to survive expected worst-case loading conditions. | Demonstrated that the Persona tibia keel and stem extension taper junction provide sufficient fatigue strength to survive expected worst-case loading conditions. |
| Cantilever Fatigue Test of the Persona Cemented Tibia | Adequate fatigue strength in the cantilever loading condition. | Demonstrated adequate fatigue strength in the cantilever loading condition. |
| Wear Testing of Persona CR Conventional Articular Surfaces Under Load and Motion Curves From the ISO 14243 Standard | Sufficient wear characteristics to survive expected in-vivo loading conditions. | Demonstrated that the wear characteristics of the Persona CR articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in-vivo loading conditions. |
| Wear Testing of Persona PS Conventional UHMWPE Articular Surfaces Under Load and Motion Curves from the ISO 14243 Standard | Sufficient wear characteristics to survive expected in-vivo loading conditions. | Demonstrated that the wear characteristics of the Persona PS articular surfaces, when articulated against the Persona PS femoral component, are sufficient to survive expected in-vivo loading conditions. |
| Wear Testing of Persona UC Conventional UHMWPE Articular Surfaces Under Displacement Control with Load and Motion Curves from the ISO 14243-1 Standard | Sufficient wear characteristics to survive expected in-vivo loading conditions. | Demonstrated that the wear characteristics of the Persona UC articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in-vivo loading conditions. |
| Spine Fatigue Evaluation of the Persona PS Conventional UHMWPE Articular Surfaces | Sufficient strength to survive expected in-vivo stress/strain loading conditions. | Demonstrated that the spine of the Persona PS articular surfaces has sufficient strength to survive expected in-vivo stress/strain loading conditions. |
| Tibiofemoral Constraint Evaluation of the Persona Conventional UHMWPE Articular Surface | Constraint values comparable to similar NexGen articular surfaces to provide adequate constraint through needed tibiofemoral flexion angles. | Demonstrated that constraint values for the Persona articular surfaces are comparable to data from similar NexGen articular surfaces. Therefore, the Persona articular surfaces provide adequate constraint through the needed tibiofemoral flexion angles. |
| Lateral Constraint Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona CR and PS Femoral Components | Lateral subluxation force comparable to control testing on NexGen predicate devices. | Demonstrated that the lateral subluxation force of the Persona conventional all-poly patellar component on the Persona CR and PS femoral implants at tibiofemoral flexion angles 0° to 90° was comparable to control testing on NexGen predicate devices. |
| Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CR/UC/PS Conventional Articular Surfaces | Contact area and contact pressure comparable to previous testing on similar NexGen articular surfaces. | Demonstrated that the contact area and contact pressure of the Persona articular surfaces are comparable to data from previous testing on similar NexGen articular surfaces. |
| Contact Area and Contact Stress Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona Primary CR and PS Femoral Components | Contact areas similar between CR and PS femoral components for all flexion angles. | Demonstrated that, for all flexion angles, the contact areas were similar between the CR and PS femoral components. |
| Anterior Liftoff Testing of the Persona Articular Surfaces | Sufficient locking mechanism strength to survive potential worst-case anterior liftoff loading conditions during deep flexion. | Demonstrated sufficient locking mechanism strength to survive potential worst-case anterior liftoff loading conditions during deep flexion. |
| Posterior Liftoff Fatigue Strength of the Persona Articular Surfaces | Sufficient locking mechanism strength to survive potential worst-case shear loading conditions. | Demonstrated sufficient locking mechanism strength to survive potential worst-case shear loading conditions. |
| Assembly Testing of the Persona Tibia Locking Mechanism | Successful assembly of the modular articular surfaces at normal and maximum interference conditions. | Demonstrated successful assembly of the modular articular surfaces at normal and maximum interference conditions. |
| Static Shear Strength of the Persona Tibia Locking Mechanism | Adequate resistance of the modular articular surfaces to disassembly. | Demonstrated adequate resistance of the modular articular surfaces to disassembly. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human adjudication.
5. 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
Not applicable. This is a physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on:
- Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
- Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
- Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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