noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
inflammatory degenerative joint disease including rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is for cemented use only.

Device Description

The subject devices for this submission are all the predicate devices listed above, which consists of implant components used in knee arthroplasty. The only changes to the subject devices are updates to their labeling. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates. Testing is provided in this Traditional 510(k) that establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The basic design features are the following:

Metal Femoral component manufactured from cobalt chrome alloy ●
Femoral components available in porous and non porous versions
Tibial inserts manufactured from UHMWPE
Tibial bases manufactured from cobalt chrome alloy or titanium alloy ●
Tibial bases available in porous and non porous versions ●
All-poly patellae manufactured from UHMWPE
Metal portion of metal backed patellae manufactured from titanium allov .

AI/ML Overview

The provided text describes a 510(k) premarket notification for "MPO Total Knee Systems MR Labeling." This submission is solely for updating the labeling of existing total knee systems to include "MR Conditional" language and symbols, indicating their safety and compatibility in a magnetic resonance (MR) environment under specific conditions.

Therefore, the "device" in this context is not a new medical device whose performance is being evaluated in a clinical setting against acceptance criteria for diagnostic accuracy or treatment efficacy. Instead, the "device" is the existing knee implant system, and the study is focused on its MR compatibility, not its clinical performance or diagnostic capabilities.

Given this, the questions about acceptance criteria for device performance, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in their usual sense for a typical AI/diagnostic device submission.

However, I can extract information related to the MR compatibility testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Compatibility)

Since the standard format of diagnostic accuracy or treatment efficacy performance is not relevant here, the acceptance criteria are related to meeting specific MR safety standards. The document doesn't explicitly list a "table" of acceptance criteria but states that testing was conducted according to specific ASTM standards. The "performance" is that the devices met these standards to be deemed "MR Conditional."

Acceptance Criteria (based on standards)	Reported Device Performance (Conclusion)
Compliance with ASTM F2052-14 (Measurement of magnetically induced displacement force on passive implants)	The testing determined the effects of the MRI on the implants, and the effects of the implants on the image quality. The tests evaluated the worst case components and constructs for RF Heating, field interactions, and image artifacts. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling. (This implies satisfactory performance with respect to displacement force).
Compliance with ASTM F2119-7 (Evaluation of MR Image Artifacts from Passive Implants)	The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling. (This implies satisfactory performance with respect to image artifacts).
Compliance with ASTM F2503-13 (Marking Medical Devices... for Safety in the Magnetic Resonance Environment)	The submission is specifically for "MR Labeling" and "include MR Conditional language and symbols," indicating adherence to marking practices.
Compliance with ASTM F2182-11a (Measurement of Radio Frequency Induced Heating near Passive Implants)	The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling. (This implies satisfactory performance with respect to RF-induced heating).
General MR safety and compatibility recommendations from FDA Guidance (December 11, 2014)	The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling. (Overall compliance with guidance).

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

Sample Size: The document mentions "the worst case components and constructs" were evaluated for RF Heating, field interactions, and image artifacts. It does not provide a specific numerical sample size (e.g., number of individual implants tested). This is typical for bench testing where representative "worst-case" configurations are chosen rather than a large statistical sample of every single variation.
Data Provenance: The testing was non-clinical (bench testing) and performed to recognized ASTM standards and FDA guidance. The "country of origin of the data" is not explicitly stated, but it would have been conducted by the manufacturer or a contracted lab to meet US FDA requirements. It is a prospective test in the sense that it was specifically conducted for this submission.

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

Not Applicable. For MR compatibility bench testing, "ground truth" in the clinical diagnostic sense established by human experts is not relevant. The "ground truth" is determined by the physical measurements and observations made according to the defined test methods of the ASTM standards.

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

Not Applicable. Adjudication methods are for interpretation of clinical data or images, not for physical bench testing results. The results are objective measurements against specified thresholds in the standards.

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 is not an AI or diagnostic device. This is a knee implant system seeking MR conditional labeling. An MRMC study is not relevant.

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

No. This is not an algorithm or AI device.

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

Not Applicable. The "ground truth" for MR compatibility testing is the objective physical measurements and observations obtained by following validated test methods (e.g., temperature changes, deflection angles, artifact size) as defined by the ASTM standards.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. As there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

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

March 23, 2016

MicroPort Orthopedics, Incorporated Mr. Usman Rashid Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K152631 Trade/Device Name: MPO Total Knee Systems MR Labeling Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: HRY, JWH, MBH Dated: February 24, 2016 Received: February 26, 2016

Dear Mr. Rashid:

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 Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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" (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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152631

Device Name MPO Total Knee Systems MR Labeling

Indications for Use (Describe)

MPO Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
inflammatory degenerative joint disease including rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the MicroPort Orthopedics Total Knee systems in an MRI environment.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline RdArlington, TN 38002Phone: (866) 872-0211Fax: (855) 446-2247
Date:	March 15, 2016
Contact Person:	Usman RashidRegulatory Affairs Specialist
Proprietary Name of Modified Device:	MPO Total Knee Systems MR Labeling
Common Name:	MPO Total Knee Systems
Classification Name and Reference:	21 CFR 888.3565 Knee jointPatellofemorotibial Metal/Polymer Porous-Coated Uncemented ProsthesisClass II21 CFR 888.3560 Knee jointPatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented ProsthesisClass II21 CFR 888.3530 Knee joint FemorotibialMetal/Polymer Semi-ConstrainedCemented ProsthesisClass II
Subject Product Code and Panel Code:	Orthopedics/87/MBH, JWH, HRY
Predicate Devices:	EVOLUTION® Revision Stemmed Femur(K142550)EVOLUTION® MP CS/CR Porous Femur& EVOLUTION® Adaptive CS and PSInserts (K140735)

{4}------------------------------------------------

EVOLUTION® MP Adaptive PS Tibial Insert (K131679)

ADVANCE® TOTAL KNEE SYSTEM-PATELLA (K122218)

EVOLUTION® MP Adaptive CS Insert (K113325)

EVOLUTION® MP Total Knee System (K093552)

ADVANCE STATURE® Femoral Component (K063731)

ADVANCE® Spiked Porous Tibial Base (K063128)

ADVANCE® TOTAL KNEE SYSTEM (K061223)

ADVANCE® HA Coated Components (K043083)

ADVANCE® Double High Insert (K033890)

ADVANCE® Revision Product Line Extension (K990030)

ADVANCE® Modular Tibial Component (K973524)

ADVANCE® KNEE SYSTEM (K972626)

ADVANCE® TIBIAL COMPONENT (K960617)

ULTRACK TOTAL KNEE SYSTEM (K953439)

ORTHOLOC® ADVANTIM™ Tibial Base Component (K932858)

ORTHOLOC® ADVANTIM™ 5 Degree Tibial Stem (K930228)

SECOND GENERATION KNEE SYSTEM (K894334)

{5}------------------------------------------------

DEVICE INFORMATION

A. Intended Use

MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity:
1. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is for cemented use only.

B. Device Description

Metal Femoral component manufactured from cobalt chrome alloy ●
Femoral components available in porous and non porous versions
Tibial inserts manufactured from UHMWPE
Tibial bases manufactured from cobalt chrome alloy or titanium alloy ●
Tibial bases available in porous and non porous versions ●
All-poly patellae manufactured from UHMWPE
Metal portion of metal backed patellae manufactured from titanium allov .

C. Substantial Equivalence Information

Since this submission is only regarding device labelling change, the design features and materials of the subject devices are identical to those of the predicate devices. The indications for use are identical to the predicate devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{6}------------------------------------------------

D. Nonclinical Testing

Non clinical Testing was conducted to establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment according to the recommendations provided in the guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11, 2014. Testing was also conducted according to the following standards:

ASTM F2052-14. "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment";

ASTM F2119-7 "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants":

ASTM F2503-13 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment";

ASTM F2182-11a "Standard Test Method for Measurement of Radio Frequency Induced Heating near Passive Implants During Magnetic Resonance Imaging"

The tests determined the effects of the MRI on the implants, and the effects of the implants on the image quality. The tests evaluated the worst case components and constructs for RF Heating, field interactions, and image artifacts. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.

E. Clinical Testing

Clinical data was not provided for the subject devices.

F. Conclusion

All the information provided in this submission adequately supports the substantial equivalence of the labelling change.

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.