The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.

Device Description

The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to provide surgeons with bone plates that are capable of using locking screws for better stability and non-locking screws for compression. Threaded slots are also available for non-locking screws to hold the plate to the bone while adjusting the plate along the length of the bone. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.

AI/ML Overview

The provided text is a 510(k) summary for the EBI® OptiLock Upper Extremity Plating System, an internal fixation device. This type of submission focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through clinical studies with acceptance criteria in the way a diagnostic AI/ML device submission would.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document. This is because the device is a mechanical surgical implant, not a diagnostic imaging or AI algorithm, and its approval pathway does not typically require the types of performance studies listed in the prompt.

Here's how to interpret the provided document in the context of your questions:

Acceptance Criteria and Reported Device Performance: This document does not describe performance criteria or reported performance results in the way a diagnostic device would (e.g., sensitivity, specificity thresholds). For an internal fixation device like this, acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices regarding intended use, materials, and function. This is typically supported by engineering testing (e.g., mechanical strength, fatigue testing, biocompatibility) rather than clinical performance metrics in humans. These engineering tests would have their own internal acceptance criteria, but they are not detailed in this 510(k) summary.
Study Proving Device Meets Acceptance Criteria: The "study" here is the 510(k) submission itself, where the manufacturer provides information and data to demonstrate substantial equivalence to predicate devices. This involves comparing the technological characteristics of the new device to existing, legally marketed devices.

Let's address the specific points you requested, noting where information is not applicable or provided:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics in this summary. The overarching acceptance criterion for the 510(k) process is "substantial equivalence" to predicate devices in intended use, materials, and function.
- Reported Device Performance: Not reported in clinical performance terms. The document asserts that "There are no significant differences between the EBI® OptiLock Upper Extremity Plating System and other currently marketed internal fixation systems. It is substantially equivalent to the predicate devices in regard to intended use, materials, and function." This implies that the device performs equivalently to the predicates, based on engineering data, but no specific performance numbers are given.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This submission does not involve clinical "test sets" in the context of diagnostic performance evaluation.
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. Ground truth for diagnostic performance is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) 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. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device lies in established engineering standards (e.g., ASTM standards for materials) and the performance characteristics of the predicate devices. The claim of substantial equivalence is the cornerstone, supported by comparison of design, materials, and intended use.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
How the ground truth for the training set was established: Not applicable.

In summary: The K0624994 submission for the EBI® OptiLock Upper Extremity Plating System is a product of traditional medical device regulation focused on mechanical and material equivalence to existing devices, not on the performance criteria or study methodologies typically associated with diagnostic AI/ML products.

Summary

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K0624994

OCT 1.9 2006

510(k) Summary

This 510(k) Summary for the EBI® OptiLock Upper Extremity Plating System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

1.	Submitter:	EBI, L.P.
2.	Submission Prepared by:	Amy-Ahlam ChaibiRegulatory Affairs Specialist
3.	Contact Person:	Debra Bing100 Interpace ParkwayParsippany, NJ 07054Phone: (973) 299-9300, ext. 3964

Date prepared: August 18, 2006

4. Proprietary Name:	EBI® OptiLock Upper Extremity Plating System
Common Name:	Internal Fixation Device
Classification Names:	Smooth or Threaded Metallic BoneFixation Fastener, 21 CFR 888.3040Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030

5. Predicate or legally marketed devices that are substantially equivalent:

Synthes Small Fragment Dynamic Compression Locking (DCL) System 0 (K000684)
Synthes LCP Proximal Humerus Plate (K011815) o
Synthes LCP Proximal Humerus Plate, Long (K041860) ם
D Synthes 3.5 mm LCP Distal Humerus System (K033995)
C Synthes 3.5 mm Cortex Screws (K043185)

6. Description of the device:

The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to

provide surgeons with bone plates that are capable of using locking screws for better

stability and non-locking screws for compression. Threaded slots are also available for

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non-locking screws to hold the plate to the bone while adjusting the plate along the length of the bone. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.

7. Intended Use:

The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.

The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.

8. Materials:

The EBI® OptiLock Upper Extremity Plating System is manufactured from Stainless Steel as per ASTM F621-02, ASTM F138-03 and ASTM F139-03, and Titanium as per ASTM F136 and F620.

9. Comparison of the technological characteristics of the device to predicate

devices: There are no significant differences between the EBI® OptiLock Upper Extremity Plating System and other currently marketed internal fixation systems. It is substantially equivalent* to the predicate devices in regard to intended use, materials. and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, L.P. % Ms. Amy Ahlam Chaibi Regulatory Affairs Director 100 Interface Parkway Parsippany, New Jersey 07054

OCT 1 9 2006

Re: K062494

Trade/Device Name: EBI® OptiLock Upper Extremity Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Pedicle screw spinal system Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 21, 2006 Received: August 25, 2006

Dear Ms. Chaibi:

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 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. Amy Ahlam Chaibi

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Pen Cult

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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STATEMENT OF INDICATIONS FOR USE

Page __ 1 __ of __ 1

510(k) Number (if known): _____________________________

Device Name: EBI® OptiLock Upper Extremity Plating System

Indications For Use:

The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.

The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

(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

510(k) Number K062447

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.