Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint confi guration, 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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augments are indicated for cemented use only.

Device Description

The purpose of this submission is to obtain clearance for the changes/proposed changes made to the Persona Revision Knee System femoral metaphyseal cones post their original 510(k) submission/clearance. The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.

AI/ML Overview

This FDA document is a 510(k) clearance letter for the Persona® Revision Knee System Femoral Metaphyseal Cones. It confirms that the device is substantially equivalent to a previously cleared predicate device.

The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way you've outlined for an AI/ML medical device. This is because the Persona Revision Knee System Femoral Metaphyseal Cones are a mechanical orthopedic implant, not an AI/ML imaging or diagnostic device.

For a mechanical device like this, "acceptance criteria" and "performance studies" are typically related to:

Biocompatibility: Ensuring the materials are safe for implantation.
Mechanical Testing: Verifying the strength, fatigue life, and wear characteristics of the implant components under simulated physiological loads. This often involves standardized tests (e.g., ISO standards) and sometimes finite element analysis (FEA).
Sterilization Validation: Confirming the chosen sterilization method is effective.
Design Verification and Validation: Ensuring the device meets its design specifications and user needs.

The provided text only briefly mentions that:

Finite Element Analysis (FEA) was used to predict peak stress under physiological loading. This is a common non-clinical method for evaluating the mechanical performance of orthopedic implants.

Therefore, I cannot populate your requested table and information points as they are designed for AI/ML device evaluations, and this document pertains to a traditional mechanical medical device.

Here's why each of your requested points cannot be answered from the provided text:

Table of acceptance criteria and reported device performance: Not applicable for an AI/ML device; for this mechanical device, specific mechanical test results and acceptance criteria are not detailed in this summary document.
Sample size for test set and data provenance: No test set of data (like images or patient records) for an algorithm is mentioned.
Number of experts and qualifications for ground truth: No ground truth established by experts for algorithmic performance is relevant here.
Adjudication method: Not applicable as there's no diagnostic output to adjudicate.
MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic tool.
Standalone performance: Not applicable, as there is no algorithm that performs independently.
Type of ground truth: Not applicable, as there's no diagnostic task involving ground truth.
Sample size for training set: Not applicable, as there is no AI algorithm to train.
How ground truth for training set was established: Not applicable.

Summary

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May 18, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer, Inc. Romil Sheth Regulatory Affairs Project Manager 1800 W. Center Street Warsaw. Indiana 46580

Re: K210829

Trade/Device Name: Persona® Revision Knee System Femoral Metaphyseal Cones Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: March 16, 2021 Received: March 19, 2021

Dear Romil Sheth:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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-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, Ph.D., R.A.C. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210829

Device Name

Persona Revision Knee System Femoral Metaphyseal Cones

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 confi guration, 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)
-------------------------------------------------	--

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.1800 W. Center StreetWarsaw, IN 46580Establishment Registration Number: 1822565
Contact Person:	Romil ShethRegulatory Affairs Project ManagerTelephone: (574-268-8196)Romil.Sheth@zimmerbiomet.com
Date:	March 16, 2021
Subject Device:	Trade Name: Persona® Revision Knee System FemoralMetaphyseal ConesClassification Name:• JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21CFR 888.3560 – Knee joint Patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis)• MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated,Polymer/Metal/Polymer (21 CFR 888.3565 – Kneejoint Patellofemorotibial metal/polymer porous-coatecuncemented prosthesis)
Predicate Device(s):	K181947 Persona Revision Zimmer, Inc.Knee System
Device Description:	The purpose of this submission is to obtain clearance forthe changes/proposed changes made to the PersonaRevision Knee System femoral metaphyseal cones posttheir original 510(k) submission/clearance

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The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.

Indications for Use:

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.

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

Intended Use: Same as the predicate device. o
Indications for Use: Same as the predicate device.
Geometry/Configurations/Sizes: Same as the 0 predicate device.
Material: Same as the predicate device.
Bone Interface Finish: Same as the predicate device. ●
o Fixation Method of Bone: Same as the predicate device.
o Sterility: Same as the predicate device.
Design Features: Similar to the predicate device. ●

Summary of Technological Characteristics:

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Summary of Performance Data (Nonclinical and/or Clinical)

Finite Element Analysis (FEA) was used to predict the peak stress under physiological loading for the subject Persona Revision Knee System femoral metaphyseal cones.

Substantial Equivalence Conclusion

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

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.