Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r and "alsublished one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of possible of possible of failure of previous joint replacement procedure.

The device is a single use implant intended for implantation with bone cement.

Device Description

The Maxim® Accel (Vanguard™) PS+ Bearing is intended to replace the articular portions of the knee joint. The system is posterior stabilized (PS) that limits axial and varus/valgus rotation.

AI/ML Overview

This document is a 510(k) summary for the Maxim® Accel (Vanguard™) PS+ Bearings, a knee implant device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study for an AI/ML device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

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

Not provided. This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria from a clinical trial.
The "Non-Clinical Testing" section states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a general statement, not a table of criteria and performance.

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

Not applicable / Not provided. Since no clinical testing was performed or reported as a basis for substantial equivalence, there is no clinical "test set" in the context of human data. The testing mentioned is "non-clinical laboratory testing."

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 / Not provided. This information pertains to studies where human expert consensus is used to establish ground truth for evaluating a device's performance, typically in diagnostic or prognostic AI/ML applications. This is not reported for this medical device submission.

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

Not applicable / Not provided. As no clinical test set using human data and requiring ground truth adjudication is mentioned, this information is not relevant to this document.

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

No, an MRMC study was NOT done. This type of study is relevant for evaluating the impact of AI on human performance, often in diagnostic imaging. This submission deals with a physical implant, not an AI/ML diagnostic tool.

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

Not applicable. This question pertains to the performance of an algorithm without human intervention, again typically for AI/ML devices. This submission concerns a physical knee implant.

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

Not applicable / Not provided for clinical ground truth. For the "Non-Clinical Testing," the "ground truth" would be the engineering specifications and performance benchmarks for mechanical equivalence. The document states "The results indicated that the device was functional within its intended use," implying it met engineering and functional requirements compared to the predicate.

8. The sample size for the training set

Not applicable / Not provided. The concept of a "training set" applies to machine learning models, which are not involved in this 510(k) submission for a physical knee implant.

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

Not applicable / Not provided. Similar to point 8, this question is for AI/ML device development and is not relevant to this document.

In summary: The provided document is a 510(k) summary for a knee implant, which demonstrates substantial equivalence primarily through non-clinical laboratory testing. It does not contain the kind of clinical study data, acceptance criteria, or ground truth establishment details requested, which are typically found in submissions for diagnostic devices, especially those utilizing AI/ML. The basis for clearance is the demonstration that the modified device (Maxim® Accel (Vanguard™) PS+ Bearings) is as safe and effective as the previously cleared predicate device (Maxim® Accel Knee System - K023546) through non-clinical testing.

Summary

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Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are all capitalized and outlined in black, with the interior of the letters being white. The overall design is simple and bold, making the word easily readable.

510(k) Summary

Sponsor:	Biomet Manufacturing, Corp.P.O. Box 587Warsaw, IN 46581-0587
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Tracy J. Bickel Contact Person: Regulatory Associate Biomet Manufacturing Corp. (574) 267-6639

Maxim® Accel (Vanguard™) PS+ Bearings Proprietary Name:

Knee bearing (insert) Common Name:

Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560)

Substantially Equivalent Devices: Maxim® Accel Knee System - K023546

Device Description: The Maxim® Accel (Vanguard™) PS+ Bearing is intended to replace the articular portions of the knee joint. The system is posterior stabilized (PS) that limits axial and varus/valgus rotation.

Intended Use:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint 3. replacement procedure.

The device is a single use implant intended for implantation with bone cement.

Summary of Technologies: The posterior stabilized bearing features have been modified from its Sunmal y or rechnologies: The postoalgus restraint. The Maxim® Accel (Vanguard™) PS+ onginal sattle to eno warrans, design, sizing, and indications are similar and/or identical to the predicate device. This submission modifies the posterior stabilized bearing features.

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.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

피

FAX 574 267.8157

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Tracy J. Bickel, RAC Regulatory Associate Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K041046

Trade/Device Name: Maxim® Accel (Vanguard") PS+ Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: ET OF Resorted comented prosthesis Regulatory Class: II Product Code: JWH Dated: April 21, 2004 Received: April 22, 2004

Dear Ms Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your beceined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to they 2011a) 2011ance with the provisions of the Federal Food, Drug, devices that have been recise and require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, increasers, misions of the Act include requirements for annual registration, listing of general controls profice, 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 If your device 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 complics with other requirements of the Act than a Dederal statutes and regulations administered by other Federal agencies. You must or uny 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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Page 2 - Tracy J. Bickel, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your e FDA finding of substantial equivalence of your device to a legally premaince noticated wice 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 If you desire specific darioliance 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,

Mark A. Melkerson, Ph.D., M.D.

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: Maxim® Accel (Vanguard™) PS+ Bearings

Indications For Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r and "alsublished one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of possible of possible of failure of previous joint replacement procedure.

The device is a single use implant intended for implantation with bone cement.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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 Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K041046

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.