The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone and nonunions and malunions.

The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions for the medial proximal tibia and tibial shaft.

The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Device Description

This submission is being made for sterile packaging of plates and screws that comprise the OptiLock Periarticular Plating System.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (EBI OptiLock Periarticular Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the indications for use. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing with a defined dataset, ground truth, or expert review.

Therefore, I cannot populate the requested table and sections based on the provided text. The document states:

"The technological characteristics of the OptiLock Periarticular Plating System are the same as, or similar to the predicate devices."
"The OptiLock Periarticular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics and principles of operation and do not present any new issues of safety or effectiveness."

This indicates that the submission relies on the similarity of its design and intended use to previously cleared devices, rather than presenting a performance study with acceptance criteria.

Response:

Based on the provided 510(k) Summary for the EBI OptiLock Periarticular Plating System, there is no information regarding specific acceptance criteria or a study that proves the device meets such criteria in terms of analytical or clinical performance.

The document is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices based on intended use, indications, technological characteristics, and principles of operation. It does not present data from a performance study with a test set, ground truth, or expert review.

Therefore, the requested information cannot be extracted from this document, and the table and sections below cannot be filled.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (e.g., Performance Threshold, Statistical Metric)	Reported Device Performance
Not provided in the document	Not provided in the document

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable, no performance study data provided.
Data Provenance: Not applicable, no performance study data provided.

3. 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, no ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, no test set or adjudication method described.

5. 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, this is a medical device for internal fixation (plates and screws), not an AI/software device. No MRMC study was performed or described.

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

Not applicable, this is a medical device for internal fixation (plates and screws), not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, no ground truth for a performance study is described.

8. The sample size for the training set

Not applicable, this is a physical medical device, not a software/AI device that requires a training set.

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

Not applicable, this is a physical medical device.

Summary

{0}------------------------------------------------

510(k) Summary

AUG 0 5 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Submitter/Manufacturer:	Biomet Trauma100 Interpace ParkwayParsippany, NJ 07054
Establishment RegistrationNumber:	2242816
Contact:	Shikha GolaRegulatory Affairs SpecialistBiomet Trauma100 Interpace ParkwayParsippany, NJ 070654Tel.: 973-299-9300Fax: 973-257-0232E-mail: shikha.gola@ebimed.com
Date Prepared:Trade/Proprietary Name:	June 29, 2009EBI OptiLock Periarticular Plating System
Common/Usual Name:	Internal Fixation Device
Classification Name:	Single/MultipleComponentMetallicBoneFixationAppliances and Accessories, Smooth or threaded metallicbone fixation fastener, 21CFR 888.3030, 21 CFR 888.3040
Device Classification:	HRS, Plate, Fixation, BoneHWC, Screw, Fixation, BoneClass II
Legally Marketed DeviceInformation:	Cleared through K061098 on May 24, 2006 and K042237 onSeptember 16, 2004.
Device Description	This submission is being made for sterile packaging of platesand screws that comprise the OptiLock Periarticular PlatingSystem.
Summary of Technologies:	The technological characteristics of the OptiLockPeriarticular Plating System are the same as, or similar to thepredicate devices.

Page 1 of 2

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Indications for Use:

The EBI OptiLock Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.

Substantial Equivalence:

The OptiLock Periarticular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics and principles of operation and do not present any new issues of safety or effectiveness.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three parallel lines forming the body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

AUG 0 5 2009

Biomet Trauma % Ms. Shikha Gola Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K092078

Trade/Device Name: EBI OptiLock Periarticular Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 8, 2009 Received: July 9, 2009

Dear Ms. Gola:

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.

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 (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.

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Page 2 - Ms. Shikha Gola

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For
Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

Indications for Use

092078

510(k) Number (if known): K092078

Device Name: EBI OptiLock Periarticular Plating System

Indications for Use:

The EBI OptiLock Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f Environmental (PDE)

(Division Sign-Off) for MCM

Division of Surgical, Orthopedic, and Restorative Devices

Page 16

510(k) Number K092078

Deg

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.