The EVOLVE® EPS ORTHOLOC™ System consists of plates manufactured per ASTM F138 or F139 and screws manufactured per ASTM F138 or F2229. The plates are precontoured with compression slots and locking screw holes. The screws will be available in both locking and non-locking designs.

AI/ML Overview

The provided text is a 510(k) summary for a bone plate system (EVOLVE® EPS ORTHOLOC™ System). This type of submission focuses on demonstrating substantial equivalence to a predicate device for mechanical devices, not on proving clinical efficacy or diagnostic accuracy through studies involving AI or human readers.

Therefore, the input document does not contain the information requested regarding acceptance criteria related to device performance in an AI or diagnostic context, nor does it describe a study that would demonstrate such performance.

Specifically, the following requested information cannot be extracted from this document:

A table of acceptance criteria and the reported device performance: This document does not define performance metrics in the way that would apply to a diagnostic AI device (e.g., sensitivity, specificity). It focuses on mechanical properties demonstrated by substantial equivalence to predicate devices and materials testing.
Sample size used for the test set and the data provenance: No test set involving patient data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic test set is described.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable as there is no mention of an AI algorithm or training data.
How the ground truth for the training set was established: Not applicable.

The document states: "The safety and effectiveness of the EVOLVE® EPS ORTHOLOC™ System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k)." This refers to engineering analyses and comparisons to existing devices, not clinical studies in the context of AI or diagnostics.

Summary

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K100146 (1/1)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

FEB - 2 2010

ﺮﻳﺐ ﻓﻲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® EPS ORTHOLOCTM System.

Submitted By:	Wright Medical Technology, Inc.
Date:	January 11, 2010
Contact Person:	Kelsey Lee
	Regulatory Affairs Specialist
Proprietary Name:	EVOLVE® EPS ORTHOLOC TM
Common Name:	Bone Plate System
Classification Name and Reference:	21 CFR 888.3030 - Plate, Fixation, Bone- Class II
Device Product Code and Panel Code:	Orthopedics/87/HRS

DEVICE INFORMATION

A. INTENDED USE

The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features of the EVOLVE® EPS ORTHOLOC™ System are substantially equivalent to the design features of the predicates identified in this 510(k) submission. The safety and effectiveness of the EVOLVE® EPS ORTHOLOC™ System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 · Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. % Ms. Kelsey Lee Regulatory Affairs Specialist · 5677 Airline Road Arlington, Tennessee 38002

FEB - 2 2010

Re: K100146

Trade/Device Name: Evolve® EPS ORTHOLOC™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: January 11, 2010 Received: January 19, 2010

Dear Ms. Lee:

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kelsey Lee

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbara Muchmo

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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Indications for Use

510(k) Number (if known): K100|46

Device Name: EVOLVE® EPS ORTHOLOC™ System

Indications For Use:

The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.

Prescription Use XXX (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)

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Sonita for mxn
(Patient Signat

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100146

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.