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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 (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 semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. With this submission, femoral components made from Titanium alloy (ASTM F136-13) with a Titanium Nitride surface treatment are being added to the system (5050, 5056, 5070, 5076 femoral component families). These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. They are available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Both designs are available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. The PS and CR femoral components, when used with a PS or CR articular surface component, can accommodate a maximum active flexion of 155°. The CR femoral component, when used with an Ultra-Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. The PS femoral component, when used with a Constrained Posterior Stabilized (CPS) articular surface, can accommodate a maximum active flexion of 135°. These femoral components are provided sterile and single use to the healthcare facility/hospital.

The provided document is a 510(k) summary for the Zimmer® Persona® Personalized Knee System. It is a medical device submission to the FDA, and as such, it does not describe a study involving an AI algorithm or software. Instead, it describes non-clinical performance testing for a physical orthopedic implant.

Therefore, many of the requested fields related to AI algorithm performance evaluation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information regarding the acceptance criteria and study results for the physical device's performance, as outlined in the "Non-Clinical Performance and Conclusions" section.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI-specific questions, I must state that these are not applicable to the provided document as it concerns a physical orthopedic implant and its non-clinical performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This document describes non-clinical performance testing of a physical medical device, not an AI algorithm evaluated on a data set. The "test set" would refer to physical prototypes or materials tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: Ground truth, in the context of expert consensus, is not relevant for the physical performance tests conducted for this device. Ground truth for these tests would be established by scientific measurement and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant to the non-clinical physical testing described.

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 type of study is for evaluating AI in diagnostic contexts with human readers, which does not apply to a knee implant.

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

• Not Applicable: There is no AI algorithm discussed in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Analytical/Empirical Standards: For the physical device, the "ground truth" or reference for assessment relies on established international standards (ISO 10993-1 for biocompatibility, ISO 14243-3 for wear testing) and engineering analyses for MRI compatibility.

8. The sample size for the training set

• Not Applicable: There is no AI algorithm or training set discussed in this document.

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

• Not Applicable: There is no AI algorithm or training set discussed in this document.

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