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510(k) Data Aggregation
(105 days)
ZIMMER PERSONA TM PERSONALIZED 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.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
The Zimmer Persona Personalized Knee System is a semiconstrained 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. The addition of the Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.
The Zimmer Persona Personalized Knee System is a medical device. Clinical data and conclusions were explicitly stated as NOT needed for this device. Therefore, the information provided focuses on non-clinical performance (bench testing).
1. Table of acceptance criteria and the reported device performance:
| Property or Characteristic (Acceptance Criteria Implicitly Met by Test Results) | Reported Device Performance (Test Results) |
|---|---|
| Anterior Tibiofemoral Constraint (Evaluation of ability to prevent excessive anterior subluxation) | Demonstrated that the Persona CPS Vivacit-E articular surfaces provide adequate anterior subluxation constraint through the necessary tibiofemoral flexion movements. |
| Anterior and Posterior Liftoff Testing (Evaluation of locking mechanism strength under liftoff conditions) | Demonstrated sufficient locking mechanism strength to survive potential worst case anterior and posterior liftoff loading conditions, respectively. |
| MRI Safety and Compatibility (Evaluation of interactions with magnetic fields) | Demonstrated safety and compatibility of the Persona knee system within the MRI environment. |
| Spine Fatigue and Underspine Fatigue (Evaluation of resistance to fracture and dissociation during walking gait) | Demonstrated sufficient resistance to spine fracture, underspine fracture, and locking mechanism dissociation during worst case walking gait conditions. |
| Spine Fatigue (Evaluation of strength of the articular surface spine) | Demonstrated that the spine of the Persona Vivacit-E CPS articular surfaces has sufficient strength to survive expected in-vivo loading conditions. |
| Spine Fracture and Locking Mechanism Resistance during Varus/Valgus Loading (Evaluation of strength under varus/valgus stress) | Demonstrated sufficient locking mechanism and articular surface spine strength to withstand worst case varus or valgus loading conditions. |
| Tibiofemoral Constraint (Quantification of anterior-posterior, medial-lateral, internal-external, and varus-valgus constraint) | Determined the anterior-posterior, medial-lateral, internal-external and varus-valgus constraint of the Persona CPS Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements. |
| Tibiofemoral Contact Area and Contact Pressure (Evaluation of contact mechanics) | Determined the contact area and contact pressure of the Persona CPS Vivacit-E articular surfaces through the necessary tibiofemoral flexion movements. |
| Wear Testing (Evaluation of wear characteristics) | Demonstrated that the wear characteristics of the Persona CPS Vivacit-E articular surfaces, when articulated against the Persona PS femoral component, are sufficient to survive expected in vivo loading conditions. |
| Ethylene Oxide (EO) Residual Testing (Evaluation of residual levels after sterilization) | Demonstrated acceptable residual levels following EO sterilization. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for individual bench tests. The description refers to "testing" which implies a sample size appropriate for engineering validation (e.g., usually 3-6 samples per test).
- Data Provenance: The data is from "bench testing" conducted by Zimmer, Inc. This is non-clinical, laboratory-based data. No information about country of origin for data or retrospective/prospective nature is applicable as it's not human or animal study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on engineering specifications and validated bench test methodologies, not expert interpretation of clinical data.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench testing, results are typically analyzed against predefined engineering specifications or industry standards.
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 device is a knee prosthesis, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
- The ground truth for this device's performance is based on engineering specifications, established industry standards for orthopaedic implants, and the performance characteristics of predicate devices. Bench tests are designed to simulate in-vivo conditions and measure physical properties against these predetermined criteria.
8. The sample size for the training set:
- Not applicable. This device is a knee prosthesis, not a machine learning model. There is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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