Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for: 1) Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent. The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Genesis Knee System, the Genesis II Knee System, and the Profix Knee System (tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs).

Device Description

There have been no changes in indications for use, design, or material property changes to any Geness, Genesis II, or Profix Knee System UHMWPE components that will be sterilized using the VHP® process. The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization Genesis Knee System, Genesis II Knee System, and Profix Knee System components (tibial articular inserts, all polyethylene tibial bases, patellar, and flex-lok pegs) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.

AI/ML Overview

Acceptance Criteria and Study for Smith & Nephew UHMWPE Components Sterilization

This document describes the acceptance criteria and the study that demonstrates the Smith & Nephew UHMWPE Components of the Genesis, Genesis II, and Profix Knee Systems meet these criteria after being sterilized with the VHP® Sterilization Process.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the VHP® sterilization process is its ability to achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶ for the UHMWPE components.

Acceptance Criteria	Reported Device Performance
Microbicidal effectiveness of vaporized hydrogen peroxide.	Test results demonstrated the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants. (Implies microbicidal effectiveness).
No detrimental effects of the VHP sterilization cycle on UHMWPE materials and product packaging.	The effects of the VHP sterilization cycle on UHMWPE materials in which the product is packaged were evaluated and found acceptable (Implies no detrimental effects).
Process validation to demonstrate effectiveness and reproducibility, resulting in a SAL of at least 10⁻⁶.	Process validation efforts demonstrated that the VHP® sterilization process is effective and reproducible, resulting in a SAL of at least 10⁻⁶. The VHP sterilization process was also demonstrated to be safe, reproducible, predictable, and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek Mylar pouches.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for the "numerous tests" conducted. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the context of validating the sterilization process. The ground truth for sterilization is typically established through recognized microbiological methods and standards, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., medical image interpretation) where multiple readers might have differing opinions. For sterilization validation, the results are generally objective and based on established laboratory protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for validating a sterilization process.

6. Standalone Performance (Algorithm Only)

This study focuses on the standalone performance of the VHP® sterilization process itself, without human intervention during the sterilization cycle. The performance metrics reported directly reflect the capabilities of the process to achieve sterility. The statement, "Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10," confirms its standalone capability.

7. Type of Ground Truth Used

The ground truth used for this study is based on microbiological efficacy testing and sterility assurance level (SAL) determination. This involves standardized methods to challenge the sterilization process with known microbial loads and evaluate its ability to eliminate them to a specified probability (10⁻⁶ in this case). This is an objective, science-based ground truth.

8. Sample Size for Training Set

Not applicable. This is not a study involving machine learning or AI where a "training set" would be used. The "training" for the VHP® sterilization process refers to the development and optimization of the sterilization cycle parameters, which is a process engineering activity rather than an AI training process.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no "training set" in the AI sense for this type of study. The development of the VHP® sterilization process and its parameters would have relied on iterative testing and validation using microbiological indicators and standard sterility testing protocols to ensure efficacy and reproducibility. These protocols establish the "ground truth" for effective sterilization parameters.

Summary

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MAR 1 5 2002 K0127

Orthopaedic Division

Smith & Nephew, Inc.
1450 Brooks Rd., Memphis, TN 38116 U.S.A.
901-396-2121, For information: 1-800-821-5700
For orders and order inquiries: 1-800-238-7538

Smith+Nephew

510(k) Summary of Safety and Effectiveness

Submitter's name:	Smith & Nephew, Inc., Orthopaedic Division
Submitter's address:	1450 Brooks Road, Memphis, TN 38116
Submitter's telephone number:	Direct phone: 901-399-6487 or FAX: 901-398-5146
Contact person:	David Henley, Senior Clinical/Regulatory Affairs Specialist
Date summary prepared:	March 15, 2002
Trade or proprietary device name:	UHMWPE Components of the Genesis, the Genesis II, and theProfix Knee Systems Sterilized with the VHP® SterilizationProcess
Common or usual name:	Genesis, Genesis II, and Profix Knee System UHMWPEComponents
Classification name:	21 CFR 888.3560, knee joint patellofemorotibialpolymer/metal/polymer, semi-constrained cemented prosthesis

Substantially Equivalent Legally Marketed Devices

The Genesis Knee System Smith & Nephew, Inc. .
The Genesis II Knee System Smith & Nephew, Inc. .
The Profix Knee System Smith & Nephew, Inc. �

Device Description

The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization Genesis Knee System, Genesis II Knee System, and Profix Knee System components (tibial articular inserts, all polyethylene tibial bases, patellar, and flex-lok pegs) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.

VHPGenPro510kSumS&E

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Device Intended Use

Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for:

Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent.

KOID + +

2012

The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Genesis Knee System, the Genesis II Knee System, and the Profix Knee System (tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs).

Technological Characteristics

The VHP sterilization process is similar to the predicate sterilization processes listed above. Both of these predicate sterilization processes are intended to terminally sterilize orthopaedic implants/medical devices to a Sterility Assurance Level (SAL) of 10 . When compared to the VHP process, the predicate processes also have similar technological characteristics.

Performance Characteristics

The Orthopaedic Division of Smith & Nephew, Inc. has conducted numerous tests as supporting evidence that the VHP® sterilization process is qualified for sterilization of all UHMWPE orthopaedic implants in the Genesis, Genesis II, and Profix Knee Systems by demonstrating the following:

Microbicidal effectiveness of the vaporized hydrogen peroxide .
The effects of the VHP sterilization cycle on UHMWPE materials in which the . product is packaged
Process validation efforts to demonstrate that the VHP® sterilization process is effective and . reproducible resulting in a SAL of at least 100

Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10 . The VHP sterilization process was also demonstrated to be safe, reproducible, predictable and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek Mylar pouches.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Orthopedic Division Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K012778

Trade/Device Name: UHMWPE Components of the Genesis II, and the Profix Knee Systems 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 Dated: December 14, 2001 Received: December 17, 2001

Dear Mr. Henley:

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 for associated in 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dr. I has haatutes 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); good manufacturing practice requirements as set forth in the 0017; adoning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Mark N Milkunas

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications Enclosure

510(k) Number (if known): Kol2778

Device Name: UHMWPE Components of the Genesis, Genesis II, and Profix Knee Systems Sterilized with the VHP® Sterilization Process

Indications for Use:

Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for:

Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligaments) are absent or incompetent.

The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the following product systems:

. Genesis Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellac, and flex-lok pegs)
Genesis II Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok ● pegs)
. Profix Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I. Mach A Milken

Division of General, Restorative and No ological Devices

510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use
(Optional Format 1-2-96)

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.