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.

When a kinematic alignment approach is utilized, 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.
Moderate valgus, varus, or flexion deformities.

The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Device Description

The Persona Personalized Knee System is a semiconstrained 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) that undergo the Ti-Nidium nitriding surface hardening treatment are being added to the system. These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. This design is 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. This femoral component, when used with a CR or Medial Congruent (MC) articular surface, can accommodate a maximum active flexion of 155°, and with an Ultra Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. These femoral components are provided sterile and single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Persona® Personalized Knee System," a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving a device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for an AI/ML device is not applicable to this document.

The document explicitly states:

Clinical Tests: "Clinical data was not deemed necessary for the subject device." This strongly indicates that performance metrics, such as those you'd establish for an AI/ML algorithm's accuracy or efficacy in a clinical setting, were not assessed for this submission.
Purpose of Submission: The purpose is for "the addition of the Ti-Nidium cruciate retaining (CR) femoral components to the Persona Personalized Knee System." This is a hardware modification, not an AI/ML software submission.
Basis for Substantial Equivalence: It's based on "Intended Use: Identical to predicates," "Indications for Use: Identical to predicate," "Materials: Similar to predicates," "Design Features: Identical to predicate," and "Sterilization: Identical to predicate." These are general device characteristics, not performance metrics for an intelligent system.

However, I can extract the non-clinical tests performed, which serve as the "proof" for the modified hardware component, albeit not in the context of AI/ML performance acceptance criteria.

Here's a breakdown of what can be inferred or directly stated from the provided document, even if it doesn't align with an AI/ML device's typical performance study criteria:

Acceptance Criteria and Study for Persona® Personalized Knee System (Hardware Modification):

Based on the provided FDA 510(k) summary, the device is a knee prosthesis, and the submission is for the addition of new components (Ti-Nidium cruciate retaining (CR) femoral components). The regulatory pathway chosen is substantial equivalence to existing predicate devices. This means that instead of defining novel performance acceptance criteria for a new type of device or AI/ML algorithm, the manufacturer needed to demonstrate that the modified device is as safe and effective as existing legally marketed devices, primarily through non-clinical (bench) testing.

The "acceptance criteria" here are implied by the successful completion of these non-clinical tests to demonstrate that the new component does not negatively impact the established safety and efficacy of the overall system when compared to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Test Type)	Reported Device Performance (Summary)
Mechanical Durability/Integrity:	"Performance data and analyses demonstrate that: any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." (General conclusion)
- Intercondylar (IC) notch deformation (Internal test method)	Not explicitly detailed, but presumably met internal standards to ensure structural integrity and prevent deformation.
- Posterior condyle fatigue (Internal test method)	Not explicitly detailed, but presumably met internal standards to ensure resistance to repeated stress.
Biocompatibility/Wear Performance:
- Ti-Nidium femoral induced wear of ultra-high molecular weight polyethylene (UHMWPE) articular surfaces (per ISO 14243-3)	Not explicitly detailed, but the test was performed to assess adverse wear effects. Conclusion implies acceptable wear.
- Assessment of wear due to 3rd body particles during articulation	Not explicitly detailed, but the test was performed to assess resilience to wear in the presence of contaminants. Conclusion implies acceptable wear.
Imaging Compatibility:
- Evaluation of the Persona Ti-Nidium Femur Components in the Magnetic Resonance Imaging (MRI) Environment	Not explicitly detailed, but presumably showed acceptable MRI compatibility (e.g., minimal artifact).
Sterility/Endotoxin Levels:
- Bacterial Endotoxin Test (BET) per ANSI/AAMI ST 72:2011, demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests	Met the specified limit of ≤20 EU/Device.

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

Sample Size: Not specified in the document. For bench testing, sample sizes are typically determined by statistical power calculations or industry standards for the specific test (e.g., n=3 or n=5 for certain mechanical tests, or a larger number for wear tests).
Data Provenance: The tests are "Non-Clinical Tests," meaning they were performed in a lab setting (benchtop testing), likely by the manufacturer (Zimmer, Inc.). There is no mention of country of origin for data as it's not patient data.
Retrospective or Prospective: Not applicable, as this refers to patient data collection.

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

Not Applicable: This type of information (experts establishing ground truth) is relevant for studies involving qualitative assessments, diagnostic accuracy, or clinical endpoints adjudicated by medical professionals (e.g., radiologists, pathologists). For a knee prosthesis hardware modification, the "ground truth" is established by adherence to engineering specifications, material properties, and performance against established mechanical or sterility standards as measured by laboratory equipment.

4. Adjudication Method for the Test Set

Not Applicable: Similar to point 3, adjudication methods are used to resolve disagreements among human reviewers (e.g., in reading medical images). Bench test results are quantitative measurements, not subject to human adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No: The document explicitly states: "Clinical data was not deemed necessary for the subject device." Therefore, no MRMC study (which involves human readers/clinicians) was conducted or provided for this submission. The effect size of human readers improving with AI assistance is not relevant here as the device is a hardware implant, not an AI system.

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

Not Applicable: This device is a physical knee prosthesis, not an algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: The "ground truth" for non-clinical tests is based on established engineering and materials science principles and validated test methods (e.g., ISO standards, internal validated methods). For example, a fatigue test's "ground truth" is whether the component fractured after a certain number of cycles, compared to a predefined acceptance limit. For the Bacterial Endotoxin Test, the ground truth is the measured Endotoxin Units per device staying below a specified limit.

8. The Sample Size for the Training Set

Not Applicable: This refers to machine learning models. The Persona® Personalized Knee System is a medical device hardware.

9. How the Ground Truth for the Training Set was Established

Not Applicable: This refers to machine learning models.

In summary, the provided document is a 510(k) clearance letter for a hardware modification to a knee prosthesis. The regulatory path chosen (510(k) based on substantial equivalence) and the type of data presented (non-clinical bench testing) are entirely different from the robust clinical and AI/ML performance studies that would require the detailed information you requested about acceptance criteria, human experts, and large datasets for training and testing AI algorithms.

Summary

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January 24, 2020

FDA U.S. FOOD & DRUG
ADMINISTRATION

Zimmer, Inc Gregory Foster Regulatory Affairs Specialist 1800 W. Center Street Warsaw, Indiana 46580

Re: K193223

Trade/Device Name: Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: November 21, 2019 Received: November 22, 2019

Dear Gregory Foster:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193223

Device Name

Persona® Personalized Knee System

Indications for Use (Describe)

When a mechanical alignment approach is utilized, 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.

When a kinematic alignment approach is utilized, 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.
Moderate valgus, varus, or flexion deformities.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Persona® Personalized Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Gregory FosterSpecialist, Regulatory AffairsTelephone: 574-371-0519Fax: 574-372-4710
Date:	20-Jan-2020
Subject Device:	Trade Name: Persona® Personalized Knee SystemCommon Name: Knee Prosthesis
	Classification Name:
	JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)OIY - Prosthesis, Knee, Patellofemorotibial Semi-Constrained, Cemented, Polymer +Additive/Metal/Polymer + Additive (21 CFR 888.3560)
Predicate Device(s):
	K113369 Zimmer® Persona™ Knee System Zimmer, Inc.
	K062768 NexGen® Complete Knee Solution LegacyⓇ Posterior Stabilized Flex Fixed Bearing and Tivanium® Ti-6Al-4V Alloy Femoral Zimmer, Inc.
	K172524 ZimmerⓇ PersonaⓇ The Personalized Knee System Zimmer, Inc.

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Purpose and Device Description:

The purpose of this submission is for the addition of the Ti-Nidium cruciate retaining (CR) femoral components to the Persona Personalized Knee System. These modifications do not change the intended use or fundamental scientific technology of the device.

Intended Use and Indications for Use:

When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disabilitv 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.

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When a kinematic alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polvarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Moderate valgus, varus, or flexion deformities.

The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components. Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to predicates. ●
Indications for Use: Identical to predicate.
Materials: Similar to predicates. ●
Design Features: Identical to predicate
Sterilization: Identical to predicate.

Summarv of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

Intercondylar (IC) notch deformation testing per O an internal test method.
Posterior condyle fatigue testing per an internal o test method.
Ti-Nidium femoral induced wear of ultra-high O molecular weight polyethylene (UHMWPE) articular surfaces testing per ISO 14243-3.
Assessment of wear due to 3rd body particles O during articulation.

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o Evaluation of the Persona Ti-Nidium Femur Components in the Magnetic Resonance Imaging (MRI) Environment.
Bacterial Endotoxin Test (BET) per ANSI/AAMI o ST 72:2011as part of cleaning validation demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
. Clinical Tests:
- o Clinical data was not deemed necessary for the subject device.

Substantial Equivalence Conclusion

The subject device has the same intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate that:

any differences do not raise new questions of safety ● and effectiveness; and
. the proposed device is at least as safe and effective as the legally marketed predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.