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.

Device Description

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.

AI/ML Overview

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

Test	Acceptance Criteria/Standard	Reported Device Performance
Biocompatibility testing of Ti-6Al-4V alloy with bonded Titanium Nitride.	Meet ISO 10993-1 requirements.	"This test demonstrated that the material utilized by the subject femoral components meet ISO 10993-1 requirements. Therefore, there are no biocompatibility concerns."
Wear testing of the subject femoral components with Persona articular surfaces.	Equivalent to the predicate device Persona system (per ISO 14243-3).	"This test, completed per ISO 14243-3, demonstrated that the wear characteristics of the subject femoral components with Persona articular surfaces are equivalent to the predicate device Persona system."
Evaluation of Interactions with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment.	Safety and compatibility within the MRI environment, under previously defined conditions for the predicate device.	"This analysis demonstrated safety and compatibility of the Persona knee system within the MRI environment. Therefore, the Persona system can be used under the same MRI conditions previously defined for the predicate device system."

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

Zimmer, Incorporated Mr. Dan Williman Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K142787 Trade/Device Name: Zimmer® Persona® Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: September 25, 2014 Received: September 26, 2014

Dear Mr. Williman:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142787

Device Name

Zimmer® Persona® Personalized Knee System

Indications for Use (Describe)

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.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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574 267-6131

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Daniel J. WillimanProject Manager, Regulatory AffairsTelephone: 574-371-8065Fax: 574-372-4605
Date:	September 25, 2014
Trade Name:	Zimmer® Persona® The Personalized Knee System
Product Codes / Device:	MBH, OIY, JWH
Regulation / Description:	21 CFR § 888.3565 – Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis21 CFR § 888.3560 – Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis
Classification Panel:	Orthopedics/87
Predicate Device(s):	Persona™ Personalized Knee System (K113369, clearedMarch 27, 2012)NexGen Complete Knee Solution Legacy PosteriorStabilized (LPS)-Flex Fixed Bearing Tivanium Ti-6Al-4VAlloy Femoral Components, manufactured by Zimmer,Inc. (K062768, cleared October 13, 2006)Legion Primary Knee System, manufactured by Smith &Nephew, Inc., (K093746, cleared April 14, 2010)
Purpose and DeviceDescription:	The Persona Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurfacethe articulating surface of the femoral, tibial and patellarbones. With this submission, femoral components made

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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.

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.

Intended Use:

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Comparison to Predicate Device:	The proposed Persona Personalized Knee System femoralcomponents are similar or identical in intended use,materials, sterility, and performance characteristics to thepredicate devices. Testing described below was completedto demonstrate equivalence to the predicate devices.
Performance Data (Nonclinicaland/or Clinical):	Clinical Performance and Conclusions:
	Clinical Data and conclusions were not needed for thisdevice.
	Non-Clinical Performance and Conclusions:
	Performance testing and analyses were conducted on theproposed device per FDA's Class II Special ControlsGuidance Document: Knee Joint Patellofemorotibial andFemorotibial Metal/Polymer Porous-Coated UncementedProstheses and Establishing Safety and Compatibility ofPassive Implants in the Magnetic Resonance (MR)Environment, as well as the standards identified in the testdescriptions below.

Test	Results
Biocompatibility testing of Ti-6Al-4V allov with bonded Titanium	This test demonstrated that the material utilized by thesubject femoral components meet ISO 10993-1 requirements.
Nitride.	Therefore, there are no biocompatibility concerns.
Wear testing of the subject femoralcomponents with Persona articularsurfaces.	This test, completed per ISO 14243-3, demonstrated that thewear characteristics of the subject femoral components withPersona articular surfaces are equivalent to the predicatedevice Persona system.
Evaluation of Interactions with the	This analysis demonstrated safety and compatibility of the
Magnetic Fields in the Magnetic	Persona knee system within the MRI environment. Therefore,
Resonance Imaging (MRI)	the Persona system can be used under the same MRI
Environment	conditions previously defined for the predicate devicesystem.

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.