non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
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™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The EVOLUTION™ Unicondylar Knee System is for cemented use only.

Device Description

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

Femoral components manufactured from Cobalt Chrome Alloy
Femoral component sizes 1 5, Resurfacing- or Resection-based .
Tibial inserts manufactured from UHMWPE
Tibial insert: Universal, sizes 1 - 5
Tibial insert: Conforming, sizes 1 5, left and right .
Tibial component thickness: 8, 9, 10, 11, 12mm
Tibial bases manufactured from Titanium Alloy
Tibial base sizes 1 – 5, left and right
All-poly tibial components manufactured from UHMWPE
All-poly Universal: sizes 1 - 5, left and right
All-poly Conforming: sizes 1 - 5, left and right
All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "EVOLUTION™ Unicondylar Knee System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the document does not contain information about explicit acceptance criteria and a study designed to prove the device meets those criteria in the way envisioned by the posed questions (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance).

Instead, the "study" demonstrating the device's acceptability is based on showing equivalence to existing devices through mechanical testing and engineering analyses, along with a comparison of design features and materials.

Here's a breakdown based on the provided text, addressing the questions where applicable and explaining why certain information is not present:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate devices.	"The EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices"
Capability of withstanding expected in vivo loading without failure.	"capable of withstanding expected in vivo loading without failure"
Safety and effectiveness supported by substantial equivalence.	"The safety and effectiveness of the EVOLUTION™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
Indications for use identical to previously cleared predicate devices.	"The indications for use of the EVOLUTION™ Unicondylar Knee System are identical to the previously cleared predicate devices."
Design features and materials substantially equivalent 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 relative to predicate devices.	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."

Note: The "acceptance criteria" here are implied by the 510(k) process, which is about demonstrating substantial equivalence, not setting and meeting novel performance thresholds. The "reported device performance" directly addresses these equivalence claims.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable/not provided because the submission relies on mechanical testing, engineering analyses, and comparison to predicate devices, not a clinical "test set" of patients with discrete performance metrics.
- The "study" here is primarily a comparison document and technical report, not a clinical trial.
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):
- This information is not applicable/not provided. Ground truth in the context of a clinical test set is not relevant for this type of submission. The "ground truth" for demonstrating equivalence largely lies in technical specifications, material properties, and mechanical test results, assessed by engineers and regulatory bodies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. There was no clinical "test set" requiring adjudication.
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:
- This information is not applicable/not provided. This is a medical device (knee implant) submission, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable/not provided. Not an AI or software device. Performance is assessed through mechanical testing and equivalence, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as well as accepted engineering principles, material science standards, and mechanical testing results. The submission argues that because the new device's design, materials, and mechanical performance are equivalent to these established devices, it also shares their safety and effectiveness profile.
The sample size for the training set:
- This information is not applicable/not provided. There is no "training set" in the context of an implantable medical device submission based on substantial equivalence.
How the ground truth for the training set was established:
- This information is not applicable/not provided. See point 8.

Summary

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K100973

AUG 1 0 2010

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™ Unicondylar Knee System.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	August 2, 2010
Contact Person:	Danielle MuellerRegulatory Affairs Specialist II
Proprietary Name:	EVOLUTION™ Unicondylar Knee System
Common Name:	Unicondylar Knee System
Classification Name and Reference:	21 CFR 888.3530 Knee joint FemorotibialMetal/Polymer Semi-Constrained CementedProsthesis Class II21 CFR 888.3520 Knee joint FemorotibialMetal/Polymer Non-Constrained CementedProsthesis Class II
Subject Product Code and Panel Code:	Orthopedics/87/ HRY, HSX
Predicate Devices:	ADVANTIM® Unicondylar Knee SystemADVANCE® Unicondylar Knee SystemADVANCE® Ultra-Congruent Tibial InsertEVOLUTION™ MP Total Knee System510(k)s: K881779, K012591, K014171, K030193,K972770, K093552

DEVICE INFORMATION#### A. Intended Use

The EVOLUTION™ Unicondylar 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
1. correction of functional deformity;

... . . . . .

revision procedures where other treatments or devices have failed: and treatment of fractures 3. that are unmanageable using other techniques.

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The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.

The EVOLUTION™ Unicondylar Knee System is for cemented use only.

B. Device Description

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

. Femoral components manufactured from Cobalt Chrome Alloy
Femoral component sizes 1 5, Resurfacing- or Resection-based .
. Tibial inserts manufactured from UHMWPE
. Tibial insert: Universal, sizes 1 - 5
Tibial insert: Conforming, sizes 1 5, left and right .
. Tibial component thickness: 8, 9, 10, 11, 12mm
. Tibial bases manufactured from Titanium Alloy
Tibial base sizes 1 – 5, left and right
. All-poly tibial components manufactured from UHMWPE
. All-poly Universal: sizes 1 - 5, left and right
. All-poly Conforming: sizes 1 - 5, left and right
. All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm

The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

C. Substantial Equivalence Information

The indications for use of the EVOLUTION™ Unicondylar 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™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 5677 Airline Road Arlington, Tennessee 38002

Allo 1 0 2010

Re: K100973

Trade/Device Name: EVOLUTION Unicondylar Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, HSX Dated: July 15, 2010 Received: July 16, 2010

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. Iisting 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

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Page 2 - Ms. Danielle Mueller

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,

Clabare Buchus

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

Enclosure

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K100973

Indications for Use

510(k) Number (if known):

AUG 1 0 2010

Device Name: EVOLUTION™ Unicondylar Knee System

Indications For Use:

The EVOLUTION™ Unicondylar 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. 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™ Unicondylar Knee System is 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)

Sonuta for mxm

Page 1 of __1

Surgical, Orthopedic, ivision o and Restorative Devices

510(k) Number K100973

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.