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.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application.

The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.

Device Description

The Vanguard 360 Revision Knee System is a total knee replacement system intended for use in primary or revision total knee joint arthroplasty. The system is comprised of a series of femoral and tibial components (bearings and trays) designed to work in conjunction with patella components and optional auxiliary components, including stem extensions, offset adaptors, and tibial and femoral augments. This submission includes a modification to the screw hole location in the 57.5mm Vanguard 360 Posterior Femoral Augments and a subcomponent design and material change in the Vanguard 360 Bowed Stem Extension Trials.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet Vanguard 360 Revision Knee System. This type of submission is for medical devices seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

As such, the document does not describe a study that validates the device against acceptance criteria in the manner typically associated with AI/ML diagnostic or prognostic devices. Instead, it focuses on demonstrating that the modifications to the existing device (Vanguard 360 Revision Knee System) are substantially equivalent to the predicate device and do not introduce new risks.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the performance data presented to support substantial equivalence for the modifications to the device itself.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a mechanical device modification, the "acceptance criteria" are generally related to demonstrating mechanical equivalency and safety, not diagnostic performance. The document doesn't explicitly state numerical acceptance criteria in a detailed table as one would expect for an AI diagnostic. Instead, it refers to "Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device."

Criterion Type	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Mechanical Integrity	Demonstrate that the modified components maintain equivalent mechanical properties and fit as the predicate device, ensuring safety and effectiveness.	57.5mm Posterior Femoral Augments:- Tolerance Analysis Report: Submitted and reviewed (implies meeting design tolerances).- Fit Evaluation: Submitted and reviewed (implies proper fit with existing components).Bowed Stem Trials:- Pull Force Comparison: Data was generated and submitted (implies comparable mechanical strength, specifically pull-out resistance, to the existing trials, suggesting the 416 SST cylindrical pin does not compromise structural integrity).
Material Equivalence	Ensure that new materials or modified components maintain biocompatibility and structural integrity.	For augments: "There are no changes to the augment materials..."For bowed stem trials: "materials of the stem, barrel, and shaft are unchanged (Ti-6Al-4V and 17-4PH SST)." The new subcomponent is 416 SST, which is a known and accepted material in medical devices.
Functional Equivalence	Demonstrate the modification does not alter the intended function or clinical performance.	"The subject augments have similar technological characteristics as the predicate.""The subject bowed stem extension trials also have similar characteristics as the existing trials." The screw hole location change and pin change are considered minor and not affecting overall function in a way that would require new clinical data.
Safety and Effectiveness	The modified device must be at least as safe and effective as the legally marketed predicate device, with no new risks of safety or efficacy introduced.	"Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device.""Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy."

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. This document describes non-clinical testing of mechanical components (tolerance analysis, fit evaluation, pull force comparison) for demonstrating substantial equivalence. These are laboratory-based tests of physical parts, not clinical trials or AI algorithm performance tests with patient data. No "test set" of patient data is mentioned.

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. As no clinical "test set" or ground truth based on expert review is used, this information is not relevant to this submission. The "ground truth" here is the engineering specifications and performance of the predicate device against which the modified components are compared.

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

Not Applicable. No expert adjudication of clinical data occurred.

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 is a medical device for knee arthroplasty, not an AI diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This device is a mechanical knee replacement system, not an algorithm.

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

For the non-clinical tests, the "ground truth" or reference is established through engineering specifications, material science principles, and comparison to the performance characteristics of the legally marketed predicate device. For instance, the "pull force comparison" implies a standard mechanical test with a measurable outcome compared against a known baseline for the predicate.

8. The sample size for the training set:

Not Applicable. This device did not involve AI/ML development, so there is no training set of data.

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

Not Applicable. No training set was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2015

Biomet, Incorporated Mr. Jason Heckaman Regulatory Affairs Project Manager 56 East Bell Drive Warsaw, Indiana 46581

Re: K143192

Trade/Device Name: Vanguard 360 Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBV Dated: January 13, 2015 Received: January 14, 2015

Dear Mr. Heckaman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Jason Heckaman

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K143192

Device Name: Vanguard 360 Revision Knee System

INDICATIONS FOR USE:

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.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Prescription Use |X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Vanguard 360 Revision Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Jason HeckamanProject Manager, Regulatory AffairsPhone: 574-371-3707Fax: 574-372-1683
Date:	November 5, 2014
Subject Device:	Trade Name: Vanguard 360 Revision Knee SystemCommon Name: Knee ProsthesisClassification Name:• JWH – prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR §888.3560)• MBV–prosthesis, knee, patellofemorotibial, semi-constrained, UHMWPE. Pegged.cemented, polymer/metal/polymer (21 CFR

Legally marketed devices to which substantial equivalence is claimed:

888.3560)

K093293 Vanguard 360 Revision Knee System ●

Device Description

Intended Use and Indications for Use

The subject devices are intended for use in total knee arthroplasty.

Indications for use are as follows:

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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.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Summary of Technological Characteristics

The subject changes include a change in the screw hole location in the subject augments and a change to incorporate a 416 SST cylindrical pin subcomponent in the subject trials.

The subject augments have similar technological characteristics as the predicate. There are no changes to the augment materials, shape, sizes, thicknesses, method of attachment to the femoral components, sterilization method, or shelf life.

The subject bowed stem extension trials also have similar characteristics as the existing trials. There are no changes to the shape or sizes available and the materials of the stem, barrel, and shaft are unchanged (Ti-6Al-4V and 17-4PH SST). Like the existing trials, the subject stem trials will be provided nonsterile.

Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- Tolerance Analysis Report Vanguard 360 57.5mm Posterior Femoral Augments o
- o Vanguard 360 57.5mm Posterior Femoral Augments Fit Evaluation
- Pull Force Comparison Bowed Stem Trials o
Clinical Tests ●
- o Clinical data was not required to establish substantial equivalence between the subject and predicate devices.

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Substantial Equivalence Conclusion

Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.

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.