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The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

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Indications for Persona Partial Knee System:

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJ), e.g., osteoarthritis, avascular necrosis;

• traumatic arthritis;

• previous tibial condyle or plateau fractures with loss of anatomy or function;

• varus deformities; and

• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implantation with bone cement.

Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):

• Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

• The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

• History of patellar dislocation or patella fracture.

• Dysplasia-induced degeneration.

These indications will be used for the combined medial and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.

Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

The Persona Partial Knee (PPK) system is a partial knee replacement system for the medial compartment of the knee and is modular in design consisting of three implant components:

• Unicondylar Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy Femoral components
• Unicondylar Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE) Articular surfaces
• Unicondylar Titanium (Ti-6Al-4V) alloy Tibial components

The Persona Partial Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.

The purpose of this submission is to 1) introduce an alternate surgical technique for proximal tibial resection, accomplished via the introduction of new tibial cut guides and recutters; 2) introduce a new peg drill for preparation of tibial bone; all of which are intended to be used specifically with the Persona Partial Knee system and 3) reclassify the existing tibial cut guides, recutters and the peg drill used with various partial knee systems as Class II devices.

I am sorry, but based on the text provided, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) premarket notification letter from the FDA regarding the "Persona Partial Knee System." It primarily focuses on:

• Indications for Use: What the device is intended for.
• Device Description: The components and general nature of the knee system.
• Comparison to Predicate Device: Arguing for "substantial equivalence" to a previously approved device (K161592).
• Summary of Performance Data (Nonclinical and/or Clinical): This section lists types of non-clinical tests performed (e.g., simulated use verification, cadaveric design validation, biocompatibility assessment) but does not provide any specific acceptance criteria, reported device performance metrics, or details of the studies themselves. It explicitly states, "Clinical data was not deemed necessary to establish substantial equivalence between the subject and predicate devices."

Therefore, the requested information, such as specific acceptance criteria values, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or how ground truth was established for training and test sets, is not present in the provided text.

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Indications for Persona Partial Knee System:

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;

• traumatic arthritis;

• previous tibial condyle or plateau fractures with loss of anatomy or function;

• varus deformities; and

• revision of the articular surface of a previously implanted Persona Partial Knee Systemknee surgeries providing that the tibial plate locking mechanism is not compromised and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implantation with bone cement.

Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):

• Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

• The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

• History of patellar dislocation or patella fracture.

• Dysplasia-induced degeneration.

These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.

Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

The Persona Partial Knee (PPK) System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

The Persona Partial Knee System is compatible with the following devices:

• Zimmer Patellofemoral Joint Prosthesis (K070695)

The provided text is a 510(k) Summary for the Persona Partial Knee System, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study in the way a de novo or PMA submission might.

Therefore, the typical acceptance criteria and study design for validating an AI/ML device's performance are not applicable here. The device is a physical knee implant, not a software algorithm, and the submission does not describe a clinical study in the traditional sense, but rather non-clinical mechanical testing and engineering analyses.

Here's an breakdown based on the information provided, highlighting why many requested points are not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a table format and does not represent clinical "performance" in the sense of accuracy, sensitivity, or specificity as would be expected for an AI/ML device. Instead, it lists mechanical tests and analyses performed to demonstrate the physical device's safety and effectiveness compared to predicates.

Acceptance Criteria: The document states that "Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices." While specific numerical acceptance criteria (e.g., maximum deflection, minimum fatigue cycles) are implied by performing these tests to a standard or internal method and achieving "substantial equivalence," they are not explicitly listed in this summary. The general acceptance is that the device performs comparably or better than the predicate devices under these conditions.

Regarding other requested information points:

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 submission focuses on non-clinical mechanical testing and engineering analyses, not human clinical data or AI/ML model performance on a test set. There isn't a "test set" of patient data in this context.

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. This submission relies on engineering and material science principles, not expert consensus on medical images or diagnoses.

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

• Not applicable. No adjudication process is described as there is no clinical test set involved.

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 implant, not an AI/ML diagnostic or assistive device. No MRMC study was performed. The document explicitly states: "No animal or clinical testing was required to support substantial equivalence."

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable / Implied: For the mechanical tests, the "ground truth" would be established engineering standards (like ASTM F2083, ASTM F1223) or validated internal test methods, and the performance of the predicate devices. The aim is to show the new device meets these engineering benchmarks or performs comparably to the predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" for this device.

Conclusion from document:

The Persona Partial Knee System gained 510(k) clearance (K161592) based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Similar intended use (limited to medial tibiofemoral compartment, cemented use).
• Use of similar materials (Co-Cr-Mo alloy for femoral, Ti-6Al-4V alloy for tibial, Vivacit-E Vitamin E Highly Crosslinked Polyethylene for articular surfaces), which are already used in predicate/reference devices.
• Similar design features.
• Similar sterilization methods.
• Non-clinical mechanical tests and engineering analyses that showed the device performed comparably or acceptably against established engineering standards and predicate device performance. The specific quantitative acceptance criteria for each test are not detailed in this summary document but would have been part of the full 510(k) submission.

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