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 Personalized 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 Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona Osseo Ti Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Device Description

The purpose of this submission is to add compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system.

The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

AI/ML Overview

The provided text is a 510(k) summary for the "Persona the Personalized Knee System." It details the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the added compatibility of the Persona OsseoTi 3-Peg Patella with Posterior Stabilized (PS) femoral components.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an algorithm or AI performance. The tests mentioned are non-clinical durability tests for mechanical components of a knee prosthesis, performed according to ISO standards. These are physical tests, not studies evaluating software or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device being described.

Here's what can be extracted based on the provided text, while acknowledging that the primary request is not fully addressable due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

Since the device is a knee prosthesis and not an AI/software device, the "acceptance criteria" and "reported device performance" are related to mechanical durability rather than algorithmic accuracy. The document states that durability testing was performed "per ISO 14243-5." This ISO standard would inherently define the acceptance criteria (e.g., number of cycles without failure, wear rates within limits). However, the specific quantitative acceptance criteria and the detailed qualitative or quantitative performance results (e.g., actual wear rates, exact number of cycles completed by the device in the test without failure) are not reported in this summary. It only states that the tests were done.

Acceptance Criteria (Inferred from ISO 14243-5)	Reported Device Performance
Durability as per ISO 14243-5	Tested as per ISO 14243-5 (specific results not detailed in this summary)

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

Sample Size for Test Set: Not applicable in the context of an AI/software test set. For the mechanical durability tests, the "sample size" would refer to the number of prostheses tested. This is not explicitly stated in the provided text.
Data Provenance: Not applicable in the context of clinical data for AI. These are non-clinical mechanical tests, likely performed in a lab setting by the manufacturer (Zimmer, Inc., based in Warsaw, Indiana, USA).

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 experts interpreting data, is relevant for AI/software evaluations. For mechanical durability testing, the "ground truth" is determined by the physical outcome of the test (e.g., whether a component fractured, or wear measurements). This doesn't involve human experts establishing a ground truth in the interpretative sense.

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

Not applicable. Adjudication methods are used to resolve disagreements among multiple human readers/experts in AI/software evaluations. This is a non-clinical mechanical test.

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:

No. This document does not mention any MRMC study. The device is a physical knee prosthesis, not an AI or software product intended to assist human readers.

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

No. This is not an algorithm.

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

Not applicable in the AI/software sense. For mechanical tests, the "ground truth" is the physical measurement or observation of the component's state after rigorous testing (e.g., did it fail, what was the wear rate).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a premarket notification for a physical medical device (knee prosthesis) and its mechanical testing. It does not pertain to an AI/software device, therefore, almost all the specific questions about acceptance criteria and studies for AI performance cannot be answered from this text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

October 29, 2024

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

Re: K243247

Trade/Device Name: Persona the Personalized Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY Dated: October 11, 2024 Received: October 11, 2024

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory

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assistance/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,

Lixin Liu -S

Lixin Liu, PhD 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) K243247

Device Name

Persona® the 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 Personalized 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Gregory FosterRegulatory Affairs PrincipalTelephone: (574) 371-0519Fax: fax (574) 377-3718Gregory.foster@zimmerbiomet.com
Date:	October 28, 2024
Subject Device:	Trade Name: Persona® the Personalized Knee System
	Common Name: Knee Prosthesis
Classification Name:	Classification Name:
	MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis)JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,Cemented, Polymer/Metal/Polymer (21 CFR 888.3560 Knee jointpatellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis)OIY- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,Cemented, Polymer + Additive/Metal/Polymer + Additive (21CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis

Predicate/Reference Device(s):

PrimaryPredicate	K240299	Zimmer®Persona® thePersonalized KneeSystem: PersonaOsseoTi 3-PegPatella	Zimmer, Inc.
ReferenceDevice	K031462	NexGen® PrimaryPorous Patella	Zimmer, Inc.

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Device Description:	The purpose of this submission is to add compatibility of the PersonaOsseoTi 3-Peg Patella to the Persona® the Personalized Knee SystemPosterior Stabilized (PS) femoral components. The addition of thiscompatibility does not change the intended use or fundamental scientifictechnology of the device system.
	The Persona® the Personalized Knee System is a semiconstrainedmodular knee prosthesis designed to resurface the articulating surface ofthe femoral, tibial, and patella bones. With this submission compatibilityof the Persona OsseoTi 3-Peg patella components will be added to thePersona PS femoral components of the knee system. These patellacomponents articulate against femoral component as part of a total kneesystem. These patellar components come in a variety of sizes to matchthe needs of a patient's anatomy when performing total knee arthroplasty.These components are provided sterile and single use.
Indications for Use:	When a mechanical alignment approach is utilized, this device isindicated 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 ispatellofemoral erosion, dysfunction or prior patellectomy.- Moderate valgus, varus, or flexion deformities.- The salvage of previously failed surgical attempts or for a knee in whichsatisfactory stability in flexion cannot be obtained at the time of surgery.
	When a Personalized Alignment approach is utilized, this device isindicated 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 Personalized Alignment (PA) surgical technique may only be usedwith Persona cemented and uncemented CR femoral components,Persona CR, Ultra Congruent (UC), and Medial Congruent (MC)articular surface components, the Persona Cemented Stemmed tibialcomponents without a stem extension, and the Persona OsseoTi KeelTibia and Cemented Keel Tibia.
	Porous coated components may be used cemented or uncemented(biological fixation), except for the Persona OsseoTi Keel Tibia and thePersona OsseoTi 3-peg Patella which are for uncemented use only. Allother femoral, tibial baseplate and all-polyethylene (UHMWPE andVEHXPE) patella components are indicated for cemented use only.

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Indications for Use Comparison: The indications for Use are identical between the predicate and the subject device. The subject and predicate devices are identical metal-backed porous Technological Comparison: patella resurfacing prostheses, with a direct compression molded UHMWPE articulating surface. The articulating geometry are identical between the predicate and the subject devices. The difference is that the predicate is only compatible with the CR femoral variants of the Persona the Personalized Knee System, while the subject device is compatible with both the PS and CR variants of the femoral components.

Non-Clinical and/or Clinical Tests (Summary & Conclusions):

Non-Clinical Tests:

Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg . Patella with Size 9 PS Femur
. Durability Testing, per ISO 14243-5, Persona OsseoTi 3-Peg Patella with Size 12 PS Femur
Durability Performance of the NexGen TM Patella per ISO . 14243-5
Durability Testing, per ISO 14243-5, 35 mm NexGen TM Patella . with SZ 12 PS Femur

Clinical Tests:

None provided

The proposed device has the same intended use as the predicate(s). The proposed device has identical technological characteristics to the predicate(s), and the information provided herein demonstrates that:

· any differences do not raise different questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate device(s).

Substantial Equivalence Conclusion:

Based on the information contained within this submission, it is concluded that the Persona® the Personalized Knee System are substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.