The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions 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 vecomes of 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 of 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

Not Found

AI/ML Overview

The provided text describes the EBI® OptiLock® Periarticular Plating System, a metallic bone fixation device, and its 510(k) submission. However, it does not include detailed acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial or a deep learning AI validation study would. Instead, this document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and engineering rationales.

Here's an analysis of the provided information in the context of your request:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for this device appear to be primarily based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, as per the FDA 510(k) process. The study conducted to meet these criteria was mechanical testing and engineering rationales.

Here's how to break down the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness: As safe and effective as predicate devices for the stated indications for use.	Mechanical testing demonstrated that the Modified System conforms to its design specifications. Engineering Rationales were provided to justify not performing further testing on additional sizes.
Design Specifications Conformance: The device meets its internal design requirements.	Mechanical testing confirmed conformance to design specifications.
No New Issues of Safety or Effectiveness: Technological differences from predicate devices do not introduce new safety or effectiveness concerns.	Performance data and Engineering Analyses demonstrated that the Modified System is as safe and effective as its predicate devices, implying no new issues.

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

This information is not explicitly stated in the provided document. The study described is mechanical testing, which typically uses a sample of the manufactured devices or components. The document does not specify the number of units tested. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of mechanical testing.

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

This information is not applicable to this type of submission. Mechanical testing relies on engineering standards, specifications, and physical measurements, rather than expert interpretation of medical data or images to establish a "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are objective measurements against defined specifications, not subjective interpretations requiring adjudication.

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

This information is not applicable. This submission is for a medical device (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

This information is not applicable. As mentioned above, this is a physical medical device, not a software algorithm.

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

The "ground truth" for the mechanical testing would be the established engineering specifications, material properties, and biomechanical requirements for internal fixation devices. These are typically derived from industry standards, scientific literature, and internal design requirements.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical testing for a physical device.

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

This information is not applicable. There is no "training set" in this context.

Summary of the Kolo1098 Submission:

The Kolo1098 submission for the EBI® OptiLock® Periarticular Plating System primarily relies on demonstrating substantial equivalence to a previously marketed predicate device (EBI® Pertiarticular Plating System). The "study" that proves this substantial equivalence is comprised of:

Mechanical Testing: Performed to show that the Modified System conforms to its design specifications.
Engineering Rationales: Provided to explain why further testing on all additional sizes of the Modified System components was not deemed necessary.

The FDA's review concluded that "Performance data and Engineering Analyses demonstrate that the Modified System is as safe and effective as its predicate devices," thus achieving substantial equivalence and permitting the device to be marketed. This type of regulatory submission does not involve clinical trials or AI performance evaluations as would be expected for a diagnostic or AI-driven device.

Summary

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Kolo1098

510(k) SUMMARY

MAY 2 4 2006

EBI, L.P.'s

EBI® OptiLock® Periarticular Plating System

SUBMITTER:	EBI, L.P.
ADDRESS:	100 Interpace ParkwayParsippany, NJ 07054
PHONE:	(973) 299-9300
FAX:	(973) 257-0232
CONTACT PERSON:	Jennifer P. Harakal
DATE PREPARED:	April 18, 2006
TRADE NAME:	EBI® OptiLock® Periarticular Plating System
COMMON NAME:	Internal Fixation Device
CLASSIFICATION NAME:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories, Smooth or threaded metallicbone fixation fastener, 21 CFR 888.3030, 21 CFR 888.3040
CLASSIFICATION #:	Class II
PREDICATE DEVICES:	EBI® Pertiarticular Plating System

INTENDED/INDICATIONS FOR USE:

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

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of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.

TECHNOLOGICAL CHARACTERISTICS:

Performance Data

Mechanical testing of the Modified System was conducted which demonstrates that the Modified System conforms to its design specifications. Additionally, Engineering Rationales were written to demonstrate why further testing on the additional sizes of the Modified System components was not required to establish substantial equivalence.

Substantial Equivalence

The Modified System is as safe and effective as its predicate devices with respect to intended use, indications for use, technological characteristics and principles of operation. The technological differences between the Modified System and its predicate devices do not raise any new issues of safety or effectiveness. Performance data and Engineering Analyses demonstrate that the Modified System is as safe and effective as its predicate devices. As such, the Modified System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three legs and the text "DEPARTMENT OF HEALTH AND" arranged in a semi-circle above the eagle. The text is in all caps and is black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

EBI, L.P. % Ms. Jennifer P. Harakal 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K061098

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: II Product Code: HRS, HWC Dated: April 18, 2006 Received: April 19, 2006

Dear Ms. Harakal:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Jennifer P. Harakal

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Herbert Lomarino

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K001098

Device Name: EBI® OptiLock® Periarticular Plating System

Indications for Use:

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

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

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 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-Off Division of General. Restorative. and Neurological Devices

Page 1 of 1

510(k) Number

115

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.