Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
Failure of previous joint replacement procedure.
Correction of varus/valgus or post-traumatic deformity.
Correction or revision of unsuccessful osteotomy, or arthrodesis.
. Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device. .
. The device is a single-use device intended for use with bone cement.

Device Description

The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.

AI/ML Overview

The provided 510(k) summary for the Biomet Vanguard™ Knee System Titanium Femoral Components does not describe acceptance criteria or a study proving the device meets them in the context of typical AI/software device evaluation metrics (e.g., sensitivity, specificity, AUC).

Instead, this document is a premarket notification for a medical device (a knee implant) that emphasizes "substantial equivalence" to predicate devices. The "testing" mentioned refers to non-clinical laboratory testing to ensure the device is functional for its intended use, rather than a clinical trial or performance study against specific acceptance criteria in the manner of AI/imaging diagnostics.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional within intended use (implied)	"The results indicated that the device was functional within its intended use." (K080204, pg 2/2)
Maintain same indications for use as predicate devices	Same indications for use as predicate devices. (K080204, pg 1/2)
Same design technology as predicate devices	Same design technology as predicate devices. (K080204, pg 1/2)
Safe and effective for patients with metal sensitivity	Device designed for use in patients with metal sensitivity. (K080204, pg 1/2)

Missing: Specific quantitative performance metrics (e.g., wear rates, mechanical strength thresholds, clinical outcomes) and numerical results demonstrating compliance with those thresholds. The document states "Non-clinical laboratory testing was performed to determine substantial equivalence," but does not detail the specific tests, their acceptance criteria, or the explicit results.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable/Not provided. The document refers to "non-clinical laboratory testing," which would typically involve physical samples of the device undergoing mechanical or material tests, not a "test set" of patient data.
Data Provenance: Not applicable/Not provided.

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

Not applicable. No "ground truth" established by experts in the context of diagnostic performance is mentioned. The assessment is based on non-clinical engineering and material science evaluations.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is not mentioned as it is typically relevant for diagnostic imaging devices or algorithms where human interpretation is involved.

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

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

7. The type of ground truth used

The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications and biocompatibility requirements. This would be established by standard engineering and material science testing methods (e.g., ASTM standards), not by expert consensus, pathology, or outcomes data in the way typically associated with AI/diagnostic devices.

8. The sample size for the training set

Not applicable. There is no training set for this type of physical medical device.

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

Not applicable.

Summary of what the document focuses on instead:

The core of this 510(k) submission is to demonstrate substantial equivalence to already legally marketed predicate devices. This means the manufacturer shows that the new device has the same intended use, indications for use, and technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

The primary "study" mentioned is non-clinical laboratory testing to ensure the device is functional.
Clinical testing was explicitly not provided as a basis for substantial equivalence. This is a common aspect of 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparisons to predicate devices.
The key finding stated is that "The results indicated that the device was functional within its intended use." This is the broad "acceptance criterion" that the non-clinical testing aimed to meet.

Summary

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K080204 (pg 1/2)

Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with the letters connected. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.

MAR 2 0 2008

510(k) Summary

Preparation Date:	23 January, 2008
Applicant/Sponsor:	Biomet Manufacturing Corporation
Contact Person:	Gary Baker, MS RAC
Proprietary Name:	Vanguard TM Knee System Titanium Femoral Components
Common Name:	Titanium femoral knee components
Classification Name:	Knee joint, patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis (21 CFR § 888.3560)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Biomet Titanium Femoral Component -- K981996 (Biomet Inc.) Maxim Accel Knee System - K023546 (Biomet Inc.) Vanguard " SSK Knee System - K042757 (Biomet Inc.)

Device Description: The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.

Indications for Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
1. Failure of previous joint replacement procedure.
1. Correction of varus/valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, or arthrodesis.
· Device designed for use in patients with metal sensitivity.
· Standard surgical and rehabilitative procedures are indicated with this device.
· The device is a single-use device intended for use with bone cement.

Summary of Technologies: The Vanguard™ Knee System Titanium Femoral Components have the same indications for use and the same design technology as the predicate devices.

Mailing Address P.O. Box 587 Warsaw. IN 46581-058 Toll Free: 800-348-9500 Office: 574.267.6639 ain Fax: 574.267.8137 www.biomet.com

Shipping Address 66 East Bell Drive Varsaw IN 46587

Section 5 - Page 1

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KOBOZOY (pg 2/2)

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial 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/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 three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet, Inc. % Mr. Gary Baker 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581

MAR 2 0 2008

Re: K080204 Trade/Device Name: Vanguard™ Knee System Titanium Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH Dated: January 23, 2008 Received: January 28, 2008

Dear Mr. Baker:

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 - Mr. Gary Baker

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark N. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO80204 (pg 1/1)

SECTION 4 - INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Page 1 of 1

Device Name: Vanguard™ Knee System Titanium Femoral Components

Indications for Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
1. Failure of previous joint replacement procedure.
1. Correction of varus/valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, or arthrodesis.
- . Device designed for use in patients with metal sensitivity.
- Standard surgical and rehabilitative procedures are indicated with this device. .
- . The device is a single-use device intended for use with bone cement.

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (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)

Souther
(Division Sign-Off)

ช้ Division of General, Restorative, and Neurological Devices

510(k) Number K080204

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.