The Synthes 3.5 mm Broad LC-DCP Plate is of a Limited Contact - Dynamic Compression Plate (LC-DCP) design. The plates are 4.2 mm thick, 13.5 mm wide, and available in lengths from 90 mm (7 holes) to 285 mm (22 holes).

AI/ML Overview

The provided document, K020872, is a 510(k) premarket notification for the "Synthes 3.5 mm Broad LC-DCP Plates," which are bone fixation plates. The FDA's review in this document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than requiring performance studies with acceptance criteria to demonstrate safety and effectiveness for a novel medical device.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not present:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Information about a standalone (algorithm only) performance study.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence and does not detail the technical performance testing typically associated with the type of acceptance criteria mentioned in the prompt.

Summary

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JUN 12 2002

020872
page 1 of 1

3. Summary of Safety and Effectiveness Information

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes 3.5 mm Broad LC-DCP Plates
Device Classification(s)	Class II, §888.3030 - Plate, Fixation, Bone
Substantial Equivalence	Documentation was provided which demonstrated the Synthes 3.5 mmBroad LC-DCP Plates to be substantially equivalent to another legallymarketed device.
Device Description	The Synthes 3.5 mm Broad LC-DCP Plate is of a Limited Contact -Dynamic Compression Plate (LC-DCP) design. The plates are 4.2 mmthick, 13.5 mm wide, and available in lengths from 90 mm (7 holes) to285 mm (22 holes).
Indications	The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on thediaphysis of the long bones (i.e., humerus, ulna, and tibia).
Material	Stainless Steel

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2002

Mr. Matthew M. Hull Senior Regulatory Affairs Specialist Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301

Re: K020872

Trade Name: Synthes 3.5 mm Broad LC-DCP Plates Regulatory Number: 888.3030 Regulatory Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 14, 2002 Received: March 18, 2002

Dear Mr. Hull:

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. Iisting 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 -- Mr. Matthew M. Hull

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

h. Mark M. Mcllwraith

Celia Witten, Ph.D., M.D. 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 2.

510(k) Number (if known):

Device Name:

Indications for Use:

020872

Synthes 3.5 mm Broad LC-DCP Plates

The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on the diaphysis of the long bones (i.e., humerus, ulna, and tibia).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Mahlon N Milburn

sion of General. Restorative and Neurological Devices

510(k) Number -

CONFIDENTIAL Synthes(USA) Synthes 3.5 mm Broad LC-DCP Plates 510(k)

000004

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.