The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

Device Description

The Total Knee Femoral Components are designed for use with tibial and patellar components of the Genesis II or Profix Total Knee Systems. The Total Knee Femoral Components are metal alloy devices processed via a proprietary oxidation process.

AI/ML Overview

The provided document, K022010, describes the Total Knee Femoral Components from Smith & Nephew, Inc. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

Instead, this document is a 510(k) premarket notification for a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is related to:

Mechanical and Clinical Data: A general statement about mechanical testing indicating equivalence to existing devices and ability to withstand in vivo loading.
Wear Claims: A specific marketing claim about wear reduction based on in-vitro simulator testing, but it explicitly states "The results of in-vitro tests have not been shown to correlate with clinical wear mechanisms." This wear test has its own methodology, but it's not framed as "acceptance criteria" for a primary performance standard in the way an AI device would be evaluated.
Substantial Equivalence: The primary method for gaining market clearance through comparison to existing, legally marketed devices.

Therefore, many of the requested categories for an AI-based device's acceptance criteria and study cannot be directly addressed from this document because it's not evaluating an AI device in that manner.

However, I can extract the closest analogous information where possible and explicitly state when the requested information is not available or not applicable based on the document's content.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (or Analogous Performance Claim)	Reported Device Performance (from In-Vitro Wear Test)
85% reduction in aggregate wear rate compared to CoCr femoral components	Total Knee Femoral Components: 0.69 ± 0.52 mm³/million cycles
	Cobalt Chrome (CoCr) Femoral Components: 4.68 ± 2.30 mm³/million cycles
Capable of withstanding expected in vivo loading without failure	"The Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." (General statement, no specific metric provided.)
Substantial Equivalence to predicate devices	Similarities in design features, overall indications, and material composition to existing Genesis II and Profix Total Knee Systems.

2. Sample Size Used for the Test Set and Data Provenance

This information is primarily available for the in-vitro wear test:

Sample Size for Wear Test: n=3 per test condition (for the aggregate wear rates computed).
Data Provenance: In-vitro testing in a multi-axial knee joint simulator using specific device components and bovine calf serum. This is a controlled laboratory environment, not human data.
- Country of Origin: Not specified for the in-vitro lab where testing was performed, but the manufacturer is based in Memphis, TN, USA.
- Retrospective or Prospective: Not applicable for in-vitro simulator testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: For the mechanical and wear testing of this traditional device, "ground truth" as established by human experts for an AI system is not relevant. The wear rates are derived from direct physical measurements in a simulator.

4. Adjudication Method for the Test Set

Not Applicable: No human adjudication is described for the in-vitro wear test. The measurements are taken directly from the simulator outputs.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No: This is not an AI device, so an MRMC study comparing human readers with and without AI assistance was not performed or described.

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

Not Applicable: This is not an AI algorithm; therefore, a standalone performance assessment of an algorithm was not done. The "standalone" performance here refers to the device's inherent mechanical properties and wear characteristics.

7. The Type of Ground Truth Used

For Wear Claims: Direct physical measurement of material loss (wear debris) from in-vitro simulator testing.
For Mechanical Equivalence: Mechanical test data (details not provided beyond a general statement).
For Substantial Equivalence: Comparison of device design features, indications, and material composition to predicate devices. This relies on engineering specifications and regulatory definitions rather than expert consensus, pathology, or outcomes data in the AI sense.

8. The Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of an AI algorithm for this traditional medical device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no training set, this question is not applicable.

Summary

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AUG 1 9 2002

Kodd2010
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Summary of Safety and Effectiveness Smith & Nephew, Inc. Total Knee Femoral Component

Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566

Device Description

Device Classification Name

21 CFR 888.3560 Knee joint patellofemorotibial metal/polymer/metal semi-constrained cemented prosthesis - Class II

Indications for Use

Mechanical and Clinical Data

A review of the mechanical test data indicated that the Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

Wear Claims

The following marketing claim will be made for the Total Knee Femoral Components:

" {Total Knee Femoral Components} offer an 85% reduction in aggregate wear rate as compared to cobalt chrome (CoCr) femoral components (0.69 + 0.52 mm3/million cycles vs. 4.68 ± 2.30 mm /million cycles). Testing was performed in a multi-axial knee joint simulator for a minimum of 6 million cycles per individual test using size 5 Genesis II femoral components as an articulating counterface, size 5 Genesis II UHMWPE tibial inserts, and Hyclone bovine calf serum as a lubricant. UHMWPE tibial inserts were sterilized via ethylene oxide. For each test condition the aggregate wear rates were computed as the slope of the line fit through the averaged data (n=3) after the initial

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wear-in period of 1.94 million cycles (1.e., 1.94 -- 6.13 million cycles). The results of invitro tests have not been shown to correlate with clinical wear mechanisms."

Substantial Equivalence Information

The substantial equivalence of the Total Knee Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components of the Genesis II and Profix Total Knee Systems distributed by Smith & Nephew, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim P. Kelly, M.S. Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K022010 Trade/Device Name: Total Knee Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: July 22, 2002 Received: July 23, 20002

Dear Ms. Kelly:

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.

AUG 1 9 2002

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Page 2 - Ms. Kim P. Kelly

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 vours.

Sincerely yours,

Mark A. Melkus

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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K022010
page 1 of 1

Total Knee Femoral Components Indications Statement

The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic athritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

Mark N. Millhiser

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO22010 510(k) Number _

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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.