1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.
  The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.

Device Description

The Unicondylar Femoral Components are designed for use with tibial components of the Genesis I Knee System. The Unicondylar Femoral Components are metal alloy devices processed via a proprietary oxidation process.

AI/ML Overview

This document is a 510(k) summary for the Smith & Nephew, Inc. Unicondylar Femoral Components, a Class II medical device (Knee joint femorotibial metal/polymer/non-constrained cemented prosthesis).

The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, sensitivity, specificity, or other statistical measures.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is very similar to devices already legally marketed in terms of design, indications, and material composition.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions related to sample size, ground truth, expert opinions, or MRMC studies, as these types of studies were not presented in this 510(k) submission.

Here's a breakdown of what the document does state regarding "proof" of the device's suitability:

1. A table of acceptance criteria and the reported device performance:

Not applicable. The document does not provide a table with acceptance criteria or reported device performance in the manner typically seen for new diagnostic algorithms or complex clinical outcome studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No clinical test set data is provided. The submission relies on mechanical testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set adjudication is described.

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. This device is a physical implant (femoral component for knee surgery), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. No ground truth for a clinical study is provided. The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is described.

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

Not applicable. No training set ground truth establishment is described.

Summary of the provided information related to device performance and safety:

The document states:

Mechanical Data: "A review of the mechanical test data indicated that the Unicondylar Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Substantial Equivalence: The primary method of demonstrating safety and effectiveness is through substantial equivalence. "The substantial equivalence of the Unicondylar Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components distributed by Smith & Nephew, Inc."

In essence, the "study" proving the device meets "acceptance criteria" is the demonstration of substantial equivalence to previously approved devices, supported by mechanical testing that confirms the device's ability to withstand in vivo loading. No clinical trials or performance studies with human subjects are detailed in this 510(k) summary.

Summary

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Kososol pge 11

Summary of Safety and Effectiveness Smith & Nephew, Inc. Unicondylar Femoral Components

FEB 2 5 2003

Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (991) 399-6566

Device Description

Device Classification Name

21 CFR 888.3520 Knee joint femorotibial metal/polymer/non-constrained cemented prosthesis - Class II

Indications for Use

The Unicondylar Femoral Components are indicated for restoring either compartment of a knee that has been affected by the following:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.

The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.

Mechanical and Clinical Data

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

Substantial Equivalence Information

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

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

Re: K030301 Trade/Device Name: Unicondylar Femoral Component Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 28, 2003 Received: January 29, 2003

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.

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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), 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) you may obtain. 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,

Mark N Milkman

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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K0}030/

Unicondylar Femoral Components Indications Statement

The Unicondylar Femoral Components are indicated for restoring either compartment of a knee that has been affected by the following:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.

The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.

O Mark N. Milherson

Division
Division
and
K03030

(k) Number

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR (Per 21 CFR 801.109)

Over-The Counter Use No

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.