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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.
  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.

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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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.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The NexGen Knee GSF Femoral Components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semiconstrained, nonlinked, condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NexGen® Knee Gender Solutions Female (GSF) Femoral Components:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The submission explicitly states "Clinical data and conclusions were not needed for this device." The primary evaluation relied on non-clinical testing (mechanical testing and Finite Element Analysis) and comparison to predicate devices, rather than a clinical test set with human subjects.
• Data Provenance: Not applicable for a human subject test set. The data provenance for the non-clinical mechanical testing and Finite Element Analysis would be internal laboratory data generated by Zimmer, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No human subject test set was used, and therefore no ground truth established by experts in this context.

4. Adjudication method for the test set

• Not applicable. No human subject test set was used.

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 total knee prosthesis, not an AI-assisted diagnostic tool or imaging device that would involve human readers.

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

• Not applicable. This device is not an algorithm or software. The "standalone" performance here refers to the mechanical and analytical performance of the physical device components, which was assessed through non-clinical testing.

7. The type of ground truth used

• The implicit "ground truth" for the performance evaluation of this medical device is the established performance and safety characteristics of its predicate devices (NexGen LPS-Flex Knee and NexGen CR-Flex femoral component). The device is deemed safe and effective if it can demonstrate substantial equivalence to these legally marketed predicates through mechanical testing and component analysis.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The "training" in product development would refer to engineering design, CAD modeling, and material selection based on established bio-mechanical principles and previous device designs.

9. How the ground truth for the training set was established

• Not applicable. As noted above, this isn't an AI device with a training set. The design was informed by the established anatomical features and performance of prior generations of knee prostheses, particularly those with modifications for "female" anatomical characteristics. The "ground truth" for its design would be anatomical data, biomechanical principles, and the performance history of existing devices.

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