Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
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.
The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

Device Description

Genesis II Porous Plus HA Knee System Components contain an HA coating on the porous coated areas of the devices. These porous plus HA components are designed for use with existing knee components contained within the Genesis II Total Knee System.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew Genesis II Knee System, specifically the Porous Plus HA Knee System Components. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance levels in the way a clinical trial for a new drug or an AI-powered diagnostic device might.

Therefore, many of the details requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission for a medical device that demonstrates substantial equivalence based on material and design similarity, and existing predicate devices.

Here's a breakdown based on the information available in the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Intended Use: The device is intended for specific knee conditions including Rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement, or total knee replacement. The posterior stabilized system is for primary and revision surgery when cruciate ligaments are incompetent but collateral ligaments are intact.	The Genesis II Porous Plus HA Knee System Components are affirmed to be for "use with existing knee components contained within the Genesis II Total Knee System" and have the same Indications For Use as the predicate devices.
Substantial Equivalence: The device should be substantially equivalent to legally marketed predicate devices.	The Genesis II Porous Plus HA Knee System Components are deemed "substantially equivalent" to the Smith & Nephew Genesis II Knee System for Uncemented Applications (K030612), Smith & Nephew Synergy HA on Porous Hip Stems (K002996), and Smith & Nephew Echelon Porous Plus HA Hip Stems (K023302).
Design and Materials: The device's design and materials should be comparable to the predicate devices.	The document states, "The intended use, designs, and materials of the Genesis II Total Knee System are substantially equivalent to the predicate components found in the original Genesis II System submissions previously cleared by FDA."
Applicable FDA Guidance Compliance: The device should meet the requirements of applicable FDA guidance documents.	"Summary report results indicate that the subject devices meet the requirements of the applicable FDA guidance documents." (Specific guidance documents and the "summary report" details are not provided in this excerpt).

2. Sample sized used for the test set and the data provenance:

Not Applicable. This submission is for establishing substantial equivalence based on material and design comparisons to predicate devices, not a clinical study with a test set of patient data. The "test set" in this context would refer to material and mechanical testing data, which is not detailed in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This type of information is generally relevant for AI/ML device submissions where expert annotation is used to create a ground truth for diagnostic accuracy. Given this is a knee implant, the "ground truth" would relate to material properties, mechanical performance, and biocompatibility, typically evaluated through engineering tests, not expert clinical interpretation of data.

4. Adjudication method for the test set:

Not Applicable. As per the above, there isn't a traditional "test set" requiring clinical adjudication.

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. MRMC studies are specific to diagnostic devices, especially those involving human interpretation of medical images, and are not relevant for a knee implant 510(k) submission.

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

Not Applicable. This is a hardware device (a knee implant), not an algorithm or software device.

7. The type of ground truth used:

For this type of device, the "ground truth" for demonstrating substantial equivalence would primarily be objective engineering performance data (e.g., mechanical strength, wear characteristics, biocompatibility of materials, fixation properties) as tested against recognized standards and compared to the predicate devices, along with clinical history and performance of the predicate devices. The provided text mentions "summary report results" indicating compliance with FDA guidance, which would encompass such engineering data.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that uses a "training set."

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

Not Applicable. No training set exists for this type of device.

In summary: The K032683 submission for the Genesis II Porous Plus HA Knee System components relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics (design, materials, HA coating on porous areas), and meets applicable FDA guidance documents, implying that relevant engineering and biocompatibility tests were performed and their results deemed acceptable by the FDA in relation to the predicate devices. The document does not describe a clinical study in the typical sense with patient sample sizes, expert-adjudicated ground truth, or AI performance metrics.

Summary

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K032683

510(K) SUMMARY SMITH & NEPHEW GENESIS II KNEE SYSTEM

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:

1450 Brooks Road, Memphis, TN 38116 901-399-5153 Janet Johnson Akil August 28, 2003 Genesis II Total Knee System Total Knee Prosthesis Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Class II Orthopedics/87

Smith & Nephew, Inc., Orthopaedic Division

DEVICE CLASS: PANEL CODE:

DEVICE INFORMATION:

A. INTENDED USE:

The Genesis II Total Knee System is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
1. 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.

The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

DEVICE DESCRIPTION: B.

SUBSTANTIAL EQUIVALENCE INFORMATION: ﺰ

Genesis II Porous Plus HA Knee System Components are substantially equivalent to the Smith & Nephew Genesis II Knee System for Uncemented Applications (K030612), Smith & Nephew Synergy HA on Porous Hip Stems (K002996), and Smith & Nephew Echelon Porous Plus HA Hip Stems (K023302).

D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, designs, and materials of the Genesis II Total Knee System are substantially equivalent to the predicate components found in the original Genesis II System submissions previously cleared by FDA. Summary report results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, TN 38116

Re: K032683

Trade/Device Name: Genesis II Porous Plus HA Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBH Dated: August 28, 2003 Received: August 29, 2003

Dear Ms. Akil:

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.

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 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Janet Johnson Akil

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark McMillan

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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K032683

510(k) Number (if known):

Device Name: Genesis II Knee System

Indications For Use:

The Genesis II Total Knee System is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. 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.

The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Division of General, Restorative and Neurological I 510(k) Number

Indications Statement - Porous Plus HA Knee Components GII.doc

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.