VANGUARD PATELLA COMPONENTS by BIOMET MANUFACTURING, INC.

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valqus or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Device Description

Features of the Vanguard™ Patella Components are as follows:

1", true dome shape .
Grooves on the under surface ●
Single or 3-peg design
Available with or without an x-ray wire .
ArCom polvethvlene .

AI/ML Overview

The provided document is a 510(k) summary for the Vanguard™ Patella Components, a knee joint patellar component. It explicitly states:

"Clinical Testing: None provided"

This means that the submission does not include any clinical studies to demonstrate the device meets acceptance criteria. Therefore, most of the information requested in your prompt (such as acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) cannot be extracted from this document.

The basis for this device's acceptance is its substantial equivalence to legally marketed predicate devices (AGC® LP Patellar Button - K912245 and K921182) through non-clinical testing (engineering analysis).

Here's what can be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The underlying acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device, which was demonstrated via engineering analysis.
Reported Device Performance: Not reported in clinical terms as no clinical testing was performed. The device's performance is assumed to be equivalent to the predicate devices based on non-clinical engineering analysis.

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 was used.

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 clinical ground truth was established as no clinical testing was performed.

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

Not applicable. No clinical test set was used.

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. No clinical studies, including MRMC studies, were performed. This device is a medical implant, not an AI diagnostic tool.

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

Not applicable. This device is a medical implant, not an algorithm. No standalone performance testing in this context was performed.

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

Not applicable. No clinical ground truth was established as no clinical testing was performed. The "ground truth" for 510(k) clearance in this case was the established performance and safety of the predicate devices, against which the new device's engineering characteristics were compared.

8. The sample size for the training set

Not applicable. No training set was used as no clinical study or machine learning algorithm development was performed.

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

Not applicable. No training set was used.

Summary

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APR 2 2 2004

Image /page/0/Picture/1 description: The image shows two lines of text. The first line appears to contain the numbers "1.11", with the last "1" being slightly separated from the others. The second line contains the alphanumeric string "K040770", with each character clearly distinguishable.

Image /page/0/Picture/2 description: The image shows the word "BIOMET" in large, bold, black letters. Below the word "BIOMET" is the phrase "510(k) Summary" in a smaller font size. The text is black and the background is white.

Applicant/Sponsor:Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: Vanguard™ Patella Components

Common Name: Patellar Component

Classification Name: Knee joint patellofemorotibial, cemented, polymer/metal/ polymer, semi-constrained

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGC® LP Patellar Button - K912245 and K921182

Device Description: Features of the Vanguard™ Patella Components are as follows:

1", true dome shape .
Grooves on the under surface ●
Single or 3-peg design �
Available with or without an x-ray wire .
ArCom polvethvlene .

Intended Use: The intended use of the Vanguard™ Patella Components is replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus or posttraumatic deformity
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Summary of Technologies: The overall design, materials and processing of the Vanguard™ Patella Components are similar to the predicate device.

Non-Clinical Testing: Engineering analysis demonstrated equivalence between the Vanguard™ Patella Components and the predicate devices.

Clinical Testing: None provided

All trademarks are property of Biomet, Inc. MALING ADDRESS PO. BOX 587 Warsaw, IN 46581-0587

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K040770

Trade/Device Name: Vanguard™ Patella 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: March 24, 2004 Received: March 25, 2004

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious and have determined the device is substantially equivalent (for the indications forcroneed a o o and in sure) to legally marketed predicate devices marketed in interstate for associated in the 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. ate nos that have boom that do not require approval of a premarket approval application (PMA). and Cosmeter Prov, 100 (110) 1107 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 may or dayset to de 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 or any 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your your finding of substantial equivalence of your device to a legally prematicated predicated. The 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 If you attire 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 other general 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,

Miriam C. Provost

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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Indications for Use

510(k) Number (if known):

Device Name: Vanguard™ Patella Components

Indications For Use:

The Vanguard™ Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valqus or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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)

Muriam C. Provost

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

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510(k) Number_K640770

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.