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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 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 Trabecular Metal™ femoral component will provide surgeons with the ability to implant with, or without cement (biological fixation).

The Zimmer® Persona™ Personalized Knee System is a medical device for knee replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an extensive study report with detailed acceptance criteria and performance metrics typically found in efficacy trials.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Clinical data and conclusions were not needed for this device" because it is a Class II device demonstrating substantial equivalence to existing predicate devices. Therefore, the acceptance criteria are met by demonstrating that the new device exhibits similar or identical performance characteristics to these predicate devices through non-clinical (bench) testing. The acceptance criteria are implicit in the FDA guidance documents followed for testing.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not specify the exact sample sizes (number of components tested) for each non-clinical bench test. These details would typically be found in the full test protocols and reports, but are not included in this summary.
• Data Provenance: The data provenance is "Non-Clinical Performance and Conclusions," meaning the tests were conducted in a laboratory setting (bench testing) rather than on human subjects. This is not retrospective or prospective clinical data. The location of the testing laboratories is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable. For bench testing of medical devices like knee implants, ground truth is established by engineering specifications, material properties, and relevant industry standards (e.g., ISO, ASTM), rather than expert medical consensus on patient cases. The "experts" involved are likely engineering and materials science professionals who design and conduct the tests according to the FDA guidance.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. Since this submission relies on non-clinical bench testing, such an adjudication method is not relevant. The "adjudication" is essentially the adherence to pre-defined test protocols and acceptance criteria based on FDA guidance and engineering 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 implant, not an AI-powered diagnostic tool requiring MRMC studies to assess the impact of AI on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. As above, this is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is established by:

• Engineering Specifications: Designed tolerances, material strengths, and fatigue limits.
• Industry Standards: ASTM, ISO, and other relevant standards for orthopedic implant testing.
• FDA Guidance Documents: The specific guidance documents cited (e.g., Class II Special Controls Guidance Document for Knee Joints, Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces, Guidance for MR Safety) define the methods and performance expectations for validating the device's properties.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be the extensive research and development phases involving finite element analysis, material science studies, and repeated experimental bench testing, but these are not considered "training sets" in the context of AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the AI sense for this device.

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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 tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated 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 submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
• Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

• Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is derived from:
  • Established engineering standards: Such as ISO 14243 for wear testing.
  • FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
  • Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

• Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable. As above, there is no AI training set involved.

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