The Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal radius and other small bones.

Device Description

The Synthes Locking Distal Radius Plating System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal end of the radius.

AI/ML Overview

The provided text describes the regulatory clearance for the "Synthes Locking Distal Radius Plating System" and does not contain information about acceptance criteria for device performance or a study that proves the device meets those criteria, as it relates to performance metrics for an AI/ML device.

The document is a 510(k) premarket notification summary from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This process focuses on the safety and effectiveness profile relative to existing devices, and typically involves:

Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and indications for use.
Bench Testing: Mechanical, material, and sometimes biological (biocompatibility) tests to ensure the device meets engineering specifications and is safe for its intended use.
No Clinical Trials (often): For 510(k) clearances, extensive clinical trials proving novel clinical efficacy are often not required if substantial equivalence can be demonstrated through other means.

Therefore, I cannot extract the requested information based on the provided text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, data provenance, or number of experts.
Adjudication method.
MRMC comparative effectiveness study or human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

This is expected as the Synthes Locking Distal Radius Plating System is a surgical implant (a physical device), not an AI/ML-driven diagnostic or prognostic tool that would typically involve the types of performance studies and metrics requested.

Summary

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K012114

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SEP 2 8 2001

Summary of Safety and Effectiveness Information 3.

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes Locking Distal Radius Plating System
Device Classification(s)	Class II, §888.3030 - Plate, Fixation, BoneClass II, §888.3040 - Screw, Fixation, Bone
Predicate Device	- Synthes Distal Radius Plate System
Device Description	The Synthes Locking Distal Radius Plating System consists ofmachined metallic plates and screws that offer screw to plate lockingdesigned for various fracture modes of the distal end of the radius.
Indications	The Synthes Locking Distal Radius Plating System is intended forfixation of complex intra- and extra-articular fractures andosteotomies of the distal radius and other small bones.
Materials	Plates: Stainless Steel or TitaniumScrews: Titanium or Stainless Steel

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The seal is black and white.

SEP 2 8 2001

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew M. Hull, RAC Senior Regulatory Specialist Synthes, USA 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301

Re: K012114

Trade/Device Name: Synthes Locking Distal Radius Plating System Regulation Number: 888.3030, 888.3040 Regulation Name: Plate, fixation, bone Screw, fixation, bone Regulatory Class: II Product Code: HRS, HWC Dated: July 5, 2001 Received: July 6, 2001

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encreated) 7. the enactment date of the Medical Device Amendments, or to conniner of prior to 110) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter for (110) and the device, subject to the general controls provisions of the Act. The I ou may , and second 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 If your device 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 Orth 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, RAC

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 Ouvision 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,

sincerely yours,

Mark N. Melberse

Celia M. 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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K012114

Indications for Use Statement 2.

510(k) Number (if known):

KOLAI14 ______________________________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

Synthes Locking Distal Radius Plating System

The Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal radius and other small bones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)

signature

	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices

K012114
510(k) Number -

CONFIDENTIAL Synthes(USA) Synthes Locking Distal Radius Plating System 510(k)

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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.