Painful and disabled knee joint resulting from osteoarthritis, and/or traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
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 biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.

Regenerex components are intended only for uncemented biologic fixation application.

The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Device Description

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

AI/ML Overview

This document is a 510(k) premarket notification for Biomet Knee Joint Replacement Prostheses, primarily focusing on its MR Labeling. It establishes substantial equivalence to previously cleared predicate devices. The document highlights MR safety testing as the basis for this equivalence. There is no study provided that establishes acceptance criteria for clinical performance or any AI/algorithm-related performance. The document is a regulatory submission for a medical device (knee prostheses), not an AI/ML-driven device, and thus the requested information regarding AI performance will not be found.

However, based on the provided text, I can extract information related to the device's MR safety and the context of the submission.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present:

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

Since this is a submission related to MR Labeling for a physical knee implant, and not a disease detection algorithm, typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The "performance" in this context relates to MR safety.

Acceptance Criteria (Implied for MR Conditional Labeling)	Reported Device Performance (Summary of MR Testing)
Device is MR Conditional per ASTM F2503-13	MR Conditional label established.
RF heating within acceptable limits (ASTM F2182-11a)	Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status.
Image distortion within acceptable limits (ASTM F2119-07)	Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status.
Magnetically Induced Displacement Force within acceptable limits (ASTM 2052-14)	Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status.
No specific pyrogenicity reported for individual tests	Products determined to be nonpyrogenic.
CEM43 analysis performed	Testing performed; no specific details, but supports MR Conditional status.

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

Sample Size for Test Set: Not applicable in the context of this document. The "tests" refer to non-clinical laboratory MR safety tests on the implants themselves, not a clinical study on patients.
Data Provenance: Not specified, but likely laboratory testing conducted by or for the manufacturer (Biomet, Inc., located in Warsaw, Indiana, USA). These are non-clinical, in-vitro tests, not patient data.

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. Ground truth in this context would be adherence to ASTM standards for MR safety testing. The "experts" would be the engineers and technicians performing and interpreting the results of the physical MR tests. Their qualifications are not specified but would be implicit in their roles as testers and regulatory affairs personnel.

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

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The assessment is based on physical measurements against established technical standards (ASTM).

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. This document does not describe an AI/ML-driven device or an MRMC study.

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

No. This document does not describe an AI/ML-driven device. It concerns physical knee joint prostheses and their MR safety labeling.

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

The "ground truth" for the non-clinical tests is defined by established engineering and medical device standards, specifically ASTM standards (F2503-13, F2182-11a, F2119-07, ASTM 2052-14) for MR safety and principles of nonpyrogenicity. It is a technical, objective ground truth based on physical measurements and compliance with industry standards.

8. The sample size for the training set

Not applicable. This document is not describing an AI/ML model for which a training set would be required.

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

Not applicable. No AI/ML model or training set is involved.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.

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

Biomet, Inc Jason Heckaman Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581

saw, Indiana

Re: K171054 Trade/Device Name: Biomet Knee Joint Replacement Prostheses 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, HRY, MBV, MBH, OIY Dated: June 26, 2017 Received: June 27, 2017

July 28, 2017

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 (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171054

Device Name

Biomet Knee Joint Replacement Prostheses

Indications for Use (Describe)

Painful and disabled knee joint resulting from osteoarthritis, and/or traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
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.

Regenerex components are intended only for uncemented biologic fixation application.

The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Biomet Knee Joint Replacement Prostheses MR Labeling 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: 3003506715
Contact Person:	Jason HeckamanManager, Regulatory AffairsTelephone: (574-371-8313)
Date:	July 27, 2017
Subject Device:	Trade Name: Biomet Knee Joint ReplacementProstheses MR LabelingCommon Name: Knee Prosthesis
	Classification Name:JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer(21 CFR 888.3560)HRY- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer (21 CFR888.3530)MBV - Prosthesis, Knee, Patello/Femorotibial,Semi-Constrained, UHMWPE, Pegged, Cemented,Polymer/Metal/Polymer (21 CFR 888.3560)MBH - Prosthesis, Knee, Patello/Femorotibial,Semi-Constrained, Uncemented, Porous, Coated,Polymer/Metal/Polymer (21 CFR 888.3565)OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer +Additive/Metal/Polymer + Additive (21 CFR888 3560)

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Predicate Device(s):

Manufacturer: Biomet, Inc.

K912245	AGC Revision Knee Prosthesis
K915132	MCK (Maximum Congruent Knee) Knee System
K921182	Ultra High Molecular Weight PolyethyleneComponent
K960856	Konstruct Patellar Component
K993159	Maxim Knee System
K010212	Offset Tibial Tray
K033489	AGC Total Knee System, Ascent Total Knee System, Maxim Complete Knee System, MaximAccel Knee System
K040770	Vanguard Patella Components
K042757	Vanguard SSK Knee System
K060525	Vanguard Removable Molded Poly Tibia
K080204	Vanguard Knee System Titanium FemoralComponents
K080361	Regenerex Tibial Components
K083782	Regenerex Patella Components
K102125	Patient-Specific Vanguard Femoral Components
K110362	Vanguard Asymmetrical Patellar Component
K113550	Vanguard Complete Knee System
K121149	Vanguard SSK 360 Revision Knee System
K140902	E1 Series A Patellae, Standard 3-Peg, E1 Series A Patellae, Thin 3-Peg, E-1 Series A Patellae,Asymmetrical, 3-Peg
K142933	Biomet Tibial Trays

Summary of Technological Characteristics:

design features or dimensions, packaging or sterilization. The subject devices are intended for use in total knee arthroplasty.

Indications for Use: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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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) devices and all-polyethylene patellar components are indicated for cemented application only.

Regenerex components are intended only for uncemented biologic fixation application.

The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests:

Biomet has performed non-clinical Magnetic ● Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
- RF heating- ASTM F2182-11a O
- o Image Distortion- ASTM F2119-07
- Magnetically Induced Displacement Force - O ASTM 2052-14
- o CEM43 analysis
Testing has been performed to establish product nonpyrogenicity.

. Clinical Tests:

Clinical data was not provided for the subject devices.

Substantial Equivalence Conclusion:

Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the

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passive implants in a magnetic resonance (MR) environment. The subject devices are substantially equivalent to the legally marketed predicated 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.