Partial replacement of the articulating surfaces of the knee when only one side of the Joint is anceced due to the compartmental primary degenerative or posttraumatic arthritis, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.

Device Description

The tibial component consists of ArCom®, ultrahigh molecular weight polyethylene (UHMWPE) bearings in right and left medial/lateral allocations.

AI/ML Overview

The provided document, K042093, is a 510(k) summary for the Biomet Manufacturing, Corp.'s Vanguard M™ Series Unicondylar Tibial Bearings. This document outlines the device description, indications for use, and a summary of non-clinical testing. However, it explicitly states that no clinical testing was provided as a basis for substantial equivalence. Therefore, the information requested regarding acceptance criteria based on clinical studies, sample sizes, expert qualifications, and ground truth establishment for a study cannot be provided from this document.

From the provided document, the following can be extracted related to non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Device to be functional within its intended use.	"The results indicated that the device was functional within its intended use."

2. Sample Size and Data Provenance (for any testing done):

Sample Size: Not specified for non-clinical testing.
Data Provenance: Not applicable as no clinical data was used for substantial equivalence. Non-clinical testing was performed in a laboratory setting by the manufacturer.

3. Number of Experts and Qualifications (for establishing ground truth):

Not applicable. No clinical study with expert ground truth establishment was conducted or submitted for substantial equivalence.

4. Adjudication Method:

Not applicable.

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

No MRMC comparative effectiveness study was mentioned or performed.

6. Standalone (Algorithm Only) Performance Study:

Not applicable as this is a medical device (tibial bearing) and not an algorithmic/AI device.

7. Type of Ground Truth Used:

Not applicable as no clinical study or ground truth establishment based on clinical data was performed. For non-clinical testing, the "ground truth" would be engineering specifications and functional benchmarks.

8. Sample Size for the Training Set:

Not applicable as no clinical study or AI algorithm requiring a training set was performed.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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K042093

NOV -1 2004

510(k) Summary

Biomet Manufacturing, Corp. Sponsor: P.O. Box 587 Warsaw, IN 46581-0587

Tracy Bickel Johnson, RAC Contact Person: Regulatory Associate Biomet Manufacturing Corp. (574) 267-6639
Proprietary Name: Vanguard M™ Series Unicondylar Tibial Bearings

Common Name: Molded Unicondylar Tibial Bearing

Classification Name: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.3530)

Substantially Equivalent Devices: Fixed Bearing Uni Component (K021621); Repicci III™ Substantially Equivalent Devices Bovielink® Endo-Model™ Sled Uni-Knee (K954186).

Device Description: The tibial component consists of ArCom®, ultrahigh molecular weight Device Description: "The tiblar component consists of a concr-Mo base and central keel. They polychylence (OH) NVP2) proth right and left medial/lateral allocations.

Indications for Use: Partial replacement of the articulating surfaces of the knee when only Inforcations for ose. Furtur replacement of the compartmental primary degenerative on postone side of the Joint is anceced due to the bomparative or plateau fractures, deformity or revision of previous arthroplasty.

This device is intended to be used with bone cement.

Summary of Technologies: The Vanguard M™ Series Unicondylar Tibial Bearings are to be used Sunmal y of Technologics: The Vangabra . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . with previously cleared blomet i children with an update to the indications for use thicklesses were added to the carent System and Marings are similar and/or identical to the statement. "The vangual of material, function, indications, and labeling.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial Norit-Cithical Testing Nort ciffical laboratory Essang
equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an emblem featuring a stylized caduceus, a symbol often associated with healthcare. The caduceus has three strands and a serpent winding around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2004

Tracy Bickel Johnson, RAC Regulatory Associate 56 East Bell Drive Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K042093

Trade/Device Name: Vanguard M™ Series Unicondylar Tibial Bearings Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: August 2, 2004 Received: August 3, 2004

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 76 the enactment date of the Medical Device Amendments, or to connisted pror to rizey 2011-07-12, in accordance with the provisions of the Federal Food, Drug, de neces mat have been require approval of a premarket approval application (PMA). and Cosmeter Fee (110) that the device, subject to the general controls provisions of the Act. The I ou mayy areres, and servisions 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 rr your de ree to such additional controls. Existing major regulations affecting your device can may or bacyer to 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 r hat 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 or car) I 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

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Page 2 – Tracy Bickel Johnson, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with acation. 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 in you attire of Compliance at (240) 276-0120. 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 other Economics, 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. Melkers

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Vanguard M™ Series Unicondylar Tibial Bearings

Indications For Use:

Partial replacement of the articulating surfaces of the knee when only one side of r artial replacement of the compartmental primary degenerative or postthe John 15 anceed aus to anse, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

This device is intended to be used with bone cement.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative. and Neurological Devices ેને 2013 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.