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™ MP Total Knee System is for cemented use only.

Device Description

The design features of the EVOLUTION™ MP Total Knee System are summarized below:

Femoral components manufactured from Cobalt Chrome Alloy
Femoral component sizes 1 8, left and right
Intended to be used with currently available patella components
Tibial inserts manufactured from UHMWPE
Tibial insert sizes 1 8, left and right
Tibial insert thickness: 10, 12, 14, 17, 20, 24mm
Tibial bases manufactured from Cobalt Chrome Alloy
Tibial base sizes 1 8, left and right
Asymmetric

AI/ML Overview

This document is a 510(k) summary for a medical device called the "EVOLUTION™ MP Total Knee System". It describes the device's intended use, features, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the typical sense (e.g., accuracy, sensitivity, specificity, or specific mechanical test results with defined pass/fail thresholds). This document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific criteria.

The core of the submission revolves around the assertion that:

"The indications for use of the EVOLUTION™ MP Total Knee System are identical to the previously cleared predicate devices."
"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."
"The safety and effectiveness of the EVOLUTION™ MP Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

Therefore, instead of a table of acceptance criteria, the "acceptance" granted by the FDA is a determination of substantial equivalence to existing predicate devices. The "reported device performance" is implicitly considered to be equivalent to that of the predicate devices.

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

The provided document does not describe a specific clinical or performance test set with a sample size. The substantial equivalence claim is based on comparing the device's design, materials, and intended use to predicate devices, which likely involved a review of existing data and specifications rather than new testing on a specific "test set" of patients or samples. The document does not mention data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the document does not describe a performance study with a test set requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable as the document does not describe a performance study with a test set requiring adjudication.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

This information is not applicable. The device is a total knee system (an implant), not typically subjected to MRMC studies (which are common for diagnostic imaging AI). The submission focuses on device design and material equivalence.

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

This information is not applicable. This device is a physical knee implant, not an algorithm.

7. The type of ground truth used:

This information is not applicable as the document does not describe a performance study relevant to establishing ground truth for a diagnostic or AI device.

8. The sample size for the training set:

This information is not applicable. The device is a physical knee implant; thus, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a total knee system seeking market clearance based on substantial equivalence to predicate devices, not through a conventional performance study with explicit acceptance criteria, test sets, or efficacy data in the typical sense of AI/diagnostic device submissions.

Summary

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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™ MP Total Knee System.

Submitted By:	Wright Medical Technology, Inc.
Date:	November 16, 2009
Contact Person:	Ryan RossRegulatory Affairs Specialist II
Proprietary Name:	EVOLUTION™ MP Total Knee System
Common Name:	Total Knee System
Classification Name and Reference:	21 CFR 888.3560 Knee joint PatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis Class II
	21 CFR 888.3530 Knee joint FemorotibialMetal/Polymer Semi-Constrained CementedProsthesis Class II

Subject Product Code and Panel Code:

Orthopedics/87/ JWH, HRY

Device Information

A. Intended Use

The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
inflammatory degenerative joint disease including rheumatoid arthritis; 2.
correction of functional deformity; 3.
1. revision procedures where other treatments or devices have failed; and
treatment of fractures that are unmanageable using other techniques. 5.

The EVOLUTION™ MP Total Knee System is for cemented use only.

Page 1 of 2

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X093552

B. Device Description

The design features of the EVOLUTION™ MP Total Knee System are summarized below:

. Femoral components manufactured from Cobalt Chrome Alloy
Femoral component sizes 1 8, left and right ●
Intended to be used with currently available patella components
. Tibial inserts manufactured from UHMWPE
Tibial insert sizes 1 8, left and right ●
Tibial insert thickness: 10, 12, 14, 17, 20, 24mm .
Tibial bases manufactured from Cobalt Chrome Alloy .
Tibial base sizes 1 8, left and right .
. Asymmetric

C. Substantial Equivalence Information

The indications for use of the EVOLUTION™ MP Total Knee System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the EVOLUTION™ MP Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Page 2 of 2

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Image /page/2/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 an abstract image of a bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR - 4 2010

Wright Medical Technology, Inc. % Mr. Ryan Ross Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K093552

Trade/Device Name: EVOLUTION™ MP Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH, HRY Dated: March 3, 2010 Received: March 4, 2010

Dear Mr. 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. 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.

.....

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Page 2 - Mr. Ryan Ross

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 Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Каввава Василир

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

Enclosure

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K093552

Indications for Use

510(k) Number (if known):

Device Name: EVOLUTION™ MP Total Knee System

Indications For Use:

The EVOLUTION™ MP Total Knee System is 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
1. treatment of fractures that are unmanageable using other techniques.

EVOLUTION™ MP Total Knee System non-porous components are for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Qustur for mxm

(Division Sign-9 Division of Surgical, Orthopedic, and Restorative Devices

Page I of Illia

510(k) Number K093552

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.