Non-inflammatory 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.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

Device Description

The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below:

Manufactured from Cobalt Chrome Alloy
Coated with Titanium Niobium Nitride
Sizes 1-8, left and right

AI/ML Overview

This document is a 510(k) Premarket Notification for the EVOLUTION® NitrX™ Medial-Pivot Knee. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing an independent study to prove the device meets acceptance criteria as would be done for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable in this context.

Here's why and what information is available:

Device Type: The EVOLUTION® NitrX™ Medial-Pivot Knee is a physical orthopedic implant (knee prosthesis), not an AI/software medical device. The "acceptance criteria" for such a device are typically met through demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness information.
Study Focus: The submission is a "Traditional 510(k)" which aims to show the new device is as safe and effective as an already cleared device. This is done through nonclinical testing (e.g., biocompatibility, mechanical testing) and comparison to predicate devices, rather than clinical efficacy studies against specific performance metrics for diagnostic or prognostic tasks.
Clinical Testing: The document explicitly states: "Clinical data was not provided for the subject devices." This further confirms that a prospective clinical study with human readers and ground truth, as implicitly requested by your prompt's structure, was not conducted or submitted for this specific device clearance.

Available Information from the document, rephrased to fit the prompt's categories where possible but noting the lack of direct applicability:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for 510(k) clearance): Substantial equivalence to predicate device(s) regarding indications for use, technological characteristics, and safety and effectiveness.
- Reported Device Performance:
  - Nonclinical Testing Performed on Subject Device: Biocompatibility evaluation/testing, Tibial baseplate component fatigue testing, Wear analysis (Mode 1 and aggressive Mode 3), Morphological analysis, Metal ion analysis.
  - Nonclinical Predicate Test Results Used to Support Subject Device: Range of motion analysis, Stability/Constraint, Contact area/stress, MR Assessments (Field Interactions, Torque, Displacement, RF Heating), Gravimetric Analysis, Bioburden Testing.
  - (Specific quantitative performance values for these tests are not provided in this summary document.)
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the context of mechanical and material testing for an implant. The "samples" would be the manufactured device components subjected to various engineering tests. No test set of patient data is described.
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 for an AI/software device involving human interpretation is not relevant for this orthopedic implant. The "ground truth" for mechanical testing would be established by industry standards, engineering principles, and validated test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a concept used for human reader studies, not for mechanical device testing.
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 MRMC study was done (not applicable for this device type).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical testing, the "ground truth" implicitly relies on established engineering principles, material science standards, and accepted testing methodologies (e.g., ISO standards for wear testing, biocompatibility standards).
The sample size for the training set:
- Not applicable. There is no AI model or training set for this physical implant.
How the ground truth for the training set was established:
- Not applicable. There is no AI model or training set for this physical implant.

In summary, this document is a regulatory submission for a physical medical device (a knee implant) cleared via the 510(k) pathway, which fundamentally differs from the type of device (e.g., AI/ML-based software) that would involve the specific "acceptance criteria" and "study" details requested in your prompt regarding human reader performance or algorithm-specific metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

May 16, 2019

MicroPort Orthopedics, Inc. Ryan Ross Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K182251

Trade/Device Name: EVOLUTION® NitrX™ Medial-Pivot Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 17, 2018 Received: August 20, 2018

Dear Ryan Ross:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Raquel Peat, PhD, MPH, USPHS FOR Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182251

Device Name EVOLUTION® NitrX™ Medial-Pivot Knee

Indications for Use (Describe)

The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease: including osteoarthritis, 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.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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EVOLUTION® NitrX™ Medial-Pivot Knee Traditional 510(k)

Image /page/3/Picture/3 description: The image is a logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath.

MicroPort Orthop Arlington, TN ortho.microport.com

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, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® NitrX™ Medial-Pivot Knee.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Rd, Arlington TN, 38002Phone: 866-872-0211Fax: 855-446-2247
Date:	May 16, 2019
Contact Person:	Ryan RossManager, Regulatory Affairs
Proprietary Name:	EVOLUTION® NitrX™ Medial-Pivot Knee
Common Name:	Cemented Tibial BaseCemented Femur
Classification Name and Reference:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesisClass II
Subject Product Code and Panel Code:	Orthopedics/87/JWH
Predicate Device:	EVOLUTION® Medial Pivot Total Knee System (K093552,K102380)
Reference Device:	Foundation® Knee System with TiNbN Coating, Foundation® PSKnee System with TiNbN Coating, 3DKnee™ System with TiNbNCoating (K122239)
Reference Device:	EVOLUTION® Knee Systems - MR Labeling (K180317)

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Image /page/4/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. Below that is the text "Full Function, Faster" in blue.

DEVICE INFORMATIC

A. Intended Use

The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

1. Inflammatory degenerative joint disease, including rheumatoid arthritis;
1. Correction of functional deformity

Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

B. Device Description

. Manufactured from Cobalt Chrome Alloy
Coated with Titanium Niobium Nitride ●
Sizes 1-8, left and right ●

C. Substantial Equivalence Information

The design features and materials of the subject devices are substantially equivalent to those of the predicate/reference devices. The indications for use are identical to the predicate device. The fundamental scientific technology of the modified devices has not changed relative to the predicate device. 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.

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Image /page/5/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle with a red star in the center. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in blue.

D. Nonclinical Testing

Nonclinical testing performed on the subject devices included:

Biocompatibility evaluation/testing
. Tibial baseplate component fatigue testing
Wear analysis (Mode 1 and aggressive Mode 3)
Morphological analysis ●
. Metal ion analysis

Additionally, nonclinical predicate test results were used to support the subject due to equivalencies between devices. Predicate testing included:

Range of motion analysis
Stability/Constraint
Contact area/stress ●
MR Assessments- Field Interactions, Torque, Displacement, RF Heating ●
Gravimetric Analysis ●
Bioburden Testing

E. Clinical Testing

Clinical data was not provided for the subject devices.

F. Conclusion

The indications for use and fundamental scientific technology of the subject devices are identical to the predicate devices. Design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of EVOLUTION® NitrX™ Medial-Pivot Knee.

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.