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

Device Description

The purpose of this submission is to introduce a new EVOLUTION® Adaptive CS Tibial Insert that allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
. Tibial inserts manufactured from UHMWPE
. Available in 11 sizes, left and right
. Tibial insert thickness: 10 - 20mm
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

The provided text, a 510(k) summary for the EVOLUTION® MP Adaptive CS Insert, describes a medical device, specifically a tibial insert for a knee replacement system. It does not describe an AI/ML powered device, an imaging device, or anything that would involve performance metrics like sensitivity, specificity, or AUC, or a study with human readers or ground truth established by experts/pathology.

Instead, the "acceptance criteria" and "study" are related to mechanical and engineering performance to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested fields are not applicable to this type of device and study.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent indications for use to predicate devices	"The indications for use of the EVOLUTION® Adaptive CS Insert are identical to the previously cleared predicate devices."
Substantially equivalent design features and materials to predicate devices	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
Fundamental scientific technology unchanged from predicate devices	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."
Capable of withstanding expected in vivo loading without failure	"A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure." (Based on mechanical testing and engineering analyses)
Acceptable static stability	Evaluated via mechanical testing and engineering analyses
Acceptable contact area	Evaluated via mechanical testing and engineering analyses
Acceptable range of motion	Evaluated via mechanical testing and engineering analyses

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of typical clinical or AI/imaging studies. The "test set" here refers to the tested components of the device. The document mentions the insert is "Available in 11 sizes, left and right," implying these variations would be considered in testing.
Data Provenance: The testing was conducted internally by Wright Medical Technology, Inc. (manufacturer). It's an engineering and mechanical evaluation, not a clinical study involving human patients or existing medical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is an engineering/mechanical evaluation of a physical device, not an AI/imaging study requiring expert ground truth or diagnoses.

4. Adjudication Method for the Test Set

Not Applicable. No expert adjudication process like 2+1 or 3+1 is mentioned or relevant for this type of device testing. The "adjudication" is based on engineering principles and comparison to predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is not an AI/imaging device. No MRMC study involving human readers was conducted.

6. If a Standalone Study Was Done

Yes, in concept. The "study" (mechanical testing and engineering analyses) evaluates the device itself (the EVOLUTION® MP Adaptive CS Insert) in a standalone fashion to determine if it meets physical performance criteria and is substantially equivalent to predicate devices. It's not "standalone" in the AI sense of algorithm-only performance, but rather the device's inherent mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" here is the established mechanical performance characteristics and design parameters of the predicate devices, as well as the engineering specifications and test methods (e.g., for static stability, contact area, range of motion) that are deemed acceptable for such implants. The performance of the subject device is compared against these benchmarks.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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KI13325

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 Adaptive CS Insert.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	November 9, 2011
Contact Person:	Danielle MuellerRegulatory Affairs Specialist II
Proprietary Name:	EVOLUTION® MP Adaptive CS Insert
Common Name:	Tibial Insert
Classification Name and Reference:	21 CFR 888.3560 Knee joint PatellofemorotibialPolymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Class I21 CFR 888.3530 Knee joint FemorotibialMetal/Polymer Semi-Constrained Cemented Prosthesis Class II
Subject Product Code and Panel Code:	Orthopedics/87/ JWH, HRY
Predicate Devices:	EVOLUTION® MP Total Knee SystemADVANCE® Total Knee SystemAXIOM® Total Knee System510(k)s: K894334, K972626, K972770, K033890 K093552, K102380

DEVICE INFORMATION

A. Intended Use

The EVOLUTION® MP Adaptive CS Insert 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;
Correction of functional deformity; 3.
Revision procedures where other treatments or devices have failed; and treatment of fractures 4. that are unmanageable using other techniques.

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

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KN-3325

B. Device Description

. Tibial inserts manufactured from UHMWPE
. Available in 11 sizes, left and right
. Tibial insert thickness: 10 - 20mm

The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.

C. Substantial Equivalence Information

The indications for use of the EVOLUTION® Adaptive CS Insert 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® Adaptive CS Insert are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

p. 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

Wright Medical Technologies, Inc. % Ms. Danielle Mueller Regulatory Affairs Specialist II 5677 Airline Road Arlington Tenessee 38002

DEC - 9 2011

Re: K113325

Trade/Device Name: EVOLUTION® MP Adaptive CS Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: November 9, 2011 Received: November 10, 2011

Dear Ms. Mueller:

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

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Page 2 - Ms. Danielle Mueller

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,

ely yours,
for
N. Malkerson

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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KI13325

Indications for Use

510(k) Number (if known):

Device Name: EVOLUTION® MP Adaptive CS Insert

Indications For Use:

The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. 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.

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

Prescription Use × (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)

(Division Sign-Oft)
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K113325

Page 1 of _ 1

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.