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 OsseoTi 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 a new component to the Personalized Knee System, the component is the Persona Ti-Nidium PPS Femurs. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The 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 a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral 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 describes the regulatory clearance for the Persona Ti-Nidium PPS Femurs, a component of the Personalized Knee System, but it does not contain the specific details required to answer your questions about acceptance criteria and study design.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies with acceptance criteria in the way you've outlined for software or AI-driven medical devices.

Here's why the information you're asking for is not in the text:

Device Type: This submission is for an orthopedic implant (knee prosthesis components), not a diagnostic software or AI device. The regulatory pathway and what's typically reported in these summaries are different. Performance for orthopedic implants is usually evaluated through biomechanical testing, material characterization, and sometimes clinical follow-up for the overall system, rather than metrics like sensitivity, specificity, or AUC based on expert reads of images.
Focus of the Document: The document is primarily an FDA clearance letter and a 510(k) summary. It confirms the device's substantial equivalence to previously cleared predicate devices. It lists the types of non-clinical tests performed (e.g., fatigue, wear evaluation, material characterization) but does not provide the acceptance criteria for these tests or detailed results against those criteria. It states that "Clinical Testing Not Applicable," indicating that a clinical study with human subjects for efficacy was not required for this 510(k) clearance.

Therefore, I cannot provide the requested information from the given text. The text does not include:

A table of acceptance criteria and reported device performance (in the context of AI/software metrics).
Sample size used for a "test set" (as in expert-labeled data) or data provenance.
Number or qualifications of experts used to establish ground truth.
Adjudication method.
MRMC comparative effectiveness study or effect size.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

November 22, 2024

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

Re: K242543

Trade/Device Name: Personalized Knee System (Persona Ti-Nidium PPS Femurs) 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: August 26, 2024 Received: October 29, 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 (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,

Peter G. Allen -S

Digitally signed by Peter G. Allen -S Date: 2024.11.22 14:57:16 -05'00'

for: Lixin Liu 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242543

Device Name

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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21 CFR 807.92(a)(4)

21 CFR 807.92(a)(5)

510(k) #:	K242543		Prepared on:
Contact Details			21 CFR 807.92(a)(1)
Applicant Name	Zimmer, Inc.
Applicant Address	1800 W. Center Street Warsaw IN 46580 United States
Applicant Contact Telephone	(574) 371-0519
Applicant Contact	Dr. Gregory Foster
Applicant Contact Email	gregory.foster@zimmerbiomet.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
Common Name	Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Classification Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number	888.3565
Product Code(s)	MBH, JWH, OIY
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K221479	Persona the Personalized Knee System: Persona Porous Plasma		MBH
K193223	Persona the Personalized Knee System: Persona Ti-Nidium CRF		JWH

Device Description Summary

Intended Use/Indications for Use

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 patellectorny.
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

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of surgery.

When a Personalized Alignment approach is utilizated 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 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 OsseoTi Keel Tibia and the Persona OsseoTi 3-Peg Patella which are for uncemented use only. All other femoral, tibial basepate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Indications for Use Comparison

The indications are similar between the subject device, with the exception that the subject device indications mention an additional previously cleared component of the system.

Technological Comparison

The subject and predicate devices are both porous plasma sprayed (PPS) femoral components. The articulating geometry are equivalent between the predicate and the subject devices. The difference is that the predicate is manufactured with Co-Cr-Mo alloy with a Ti-6Al-4V PPS coating, while the subject device is manufactured with a Ti-6Al-4V PPS coating and undergoes the Ti-Nidium™ nitrogen surfacing hardening process.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Persona Ti-Nidium PPS anterior flange fatigue

Persona Ti-Nidium PPS posterior condyle fatigue -- three point bend

Persona Ti-Nidium PPS posterior condyle fatigue -cantilever Loading

Wear Evaluation of the Persona Ti-Nidium PPS femoral components coupled with Persona conventional bearings

Third Body wear and roughened femoral evaluation of the Persona Ti-Nidium PPS femoral components

Ti-Nidium treated porous plasma spray (PPS) plastic deformation, microstructural, metallurgical, and
chemical characterization

Evaluation of Ti-Nidium treated PPS product design verification requirements

Evaluation of Ti-Nidium treated PPS product requirements

Expanded in-vivo RF-induced heating simulations for the Persona Primary Knee System

Assessment of the Constraint, Range of Motion, and Contact Area/Stress of the Persona Ti-Nidium PPS Femurs

Clinical Testing Not Applicable

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

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.