The DeRoyal non-sterile locking compression plate system is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.

Device Description

The DeRoyal Non-Sterile Locking Compression Plate System consists of disposable locking plates and screws in either stainless steel or titanium. The plates have alternating holes to accept either cortical, malleolar, shaft, cancellous or locking screws.

AI/ML Overview

The provided text describes a 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.

Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable based on the information provided in this 510(k) summary. A 510(k) summary typically references bench testing and comparison to predicate devices, not clinical effectiveness studies with explicit acceptance criteria for device performance as a standalone system.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The 510(k) summary evaluates "substantial equivalence" to a predicate device, not against specific, pre-defined performance acceptance criteria in a clinical or standalone study. The primary "performance" reported is that the device is "substantially equivalent" to the predicate.

2. 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 document does not present data from a clinical test set in the way described. Substantial equivalence is typically demonstrated through design, material, and mechanical property comparisons to a predicate device, often leveraging existing data on the predicate.

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. There is no mention of experts establishing ground truth for a test set in this 510(k) summary.

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

Not Applicable. No test set or adjudication method is 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 document describes a surgical implant, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

Not Applicable. This is a physical medical device (surgical plate), not an algorithm or software. Standalone performance as described is not applicable.

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

Not Applicable. No explicit ground truth is mentioned. The submission relies on establishing equivalence to a legally marketed predicate device. This implies that the predicate device's established safety and effectiveness serve as the "ground truth" to which the new device is compared in terms of design, materials, and intended use.

8. The sample size for the training set:

Not Applicable. There is no mention of a "training set" in the context of this device. This is not an AI or machine learning device.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary based on available information:

The 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System aims to demonstrate substantial equivalence to predicate devices (Synthes Locking Compression Plates and Synthes Locking Screws). This process primarily involves comparing the new device's design, materials (stainless steel or titanium), manufacturing processes, and intended use to those of the predicate devices. The "study" mentioned, implicitly, is the submission of information that "supports substantial equivalence." This is a regulatory pathway that relies on comparison to existing, legally marketed devices, rather than de novo clinical trials with acceptance criteria for a novel device.

Summary

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A092317

Page 1 of 1

510(k) Summary

NOV - 2 2009

SPONSOR:

DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849

System

HRS

DEVICE NAME:

CLASSIFICATION NAME:

Class II, 21CFR888.3030 - Single/multiple component metallic bone fixation appliances and accessories.

DeRoyal Non-Sterile Locking Compression Plate

PRODUCT CODE:

PREDICATE DEVICE:

Synthes Locking Compression Plates (LCP) Synthes Locking Screws

DEVICE DESCRIPTION:

INTENDED USE: The DeRoyal Non-Sterile Locking Compression Plate System is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.

SUBSTANTIAL

EQUIVALENCE: Information presented supports substantial equivalence.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

NOV 0 2 2009

DeRoyal Industries, Inc. % Ms. Gracie Greenway Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849

Re: K092317

Trade Name: DeRoyal Locking Compression Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: HRS, HWC Dated: July 27, 2009

Received: August 4, 2009

Dear Ms. Greenway:

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

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Page 2 - Ms. Gracie Greenway

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.

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark N. Milliman

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:

9231

Device Name: DeRoyal Industries, Inc. Locking Compression Plate System

Prescription Use __ X (Per 21CFR 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millerson

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

510(k) Number

KO92317

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.