The Afghan External Fixator and its components are intended to be used in adolescents (12-21 years) and adults for securing small bone fractures and bone fragments on non-long bones including: patella and olecranon.

Components in the Afghan External Fixator are for single use only.

Device Description

Subject of this premarket notification is the Afghan External Fixator. The Afghan External Fixator is a unilateral external fixation system that offers specially designed components used in the management of small bone fractures. System components include male and female struts (or frame) and nuts made from stainless steel material. Like the predicate devices listed below, the subject components are used in conjunction with Kirschner wires to provide a device customized to meet specific patient needs.

AI/ML Overview

The provided text describes a medical device submission (K092002 for the Afghan External Fixator) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets specific acceptance criteria through a clinical study or comprehensive performance testing against predefined metrics.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document because it is not a performance study report.

This 510(k) summary primarily addresses:

Device Description: The Afghan External Fixator is a unilateral external fixation system for small bone fractures.
Intended Use: For adolescents (12-21 years) and adults to secure small bone fragments on non-long bones (patella and olecranon).
Technological Characteristics: Similar to predicate devices in materials and characteristics.
Substantial Equivalence: Based on similarities in design features and indications for use with identified predicate devices (Osteo Kirschner Wires, Smith & Nephew Kirschner Wires, Smith & Nephew External Fixation System Unilateral & Multilateral Fixators and Accessories).

There is no mention of:

Specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, mechanical strength thresholds).
A formal study to prove the device meets such criteria.
Sample sizes for a test set or training set.
Expert involvement for ground truth establishment.
Adjudication methods.
MRMC studies or AI performance.
Standalone algorithm performance.
Types of ground truth (pathology, outcomes data, etc.).

In summary, the provided document is not a study report demonstrating acceptance criteria; it is a regulatory submission for substantial equivalence.

Summary

{0}------------------------------------------------

K092002

510(k) Summary of Safety and Effectiveness Afghan External Fixator

Submitted By:	Smith & Nephew, Inc.,Orthopaedic Division1450 Brooks RoadMemphis, TN 38116	DEC 10 2009
Date:	July 1, 2009
Contact Person:	Laura Sejnowski, Regulatory Affairs SpecialistTel: (901) 399-5349 Fax: (901) 398-5146
Proprietary Name:	Afghan External Fixator
Common Name:	External Fixation System
Classification Name and Reference:	21 CFR 888.3030, smooth or threaded metallic bonefixation fastener, Class II
Device Classification for Predicate Devices:	21 CFR 888.3030, smooth or threaded metallic bonefixation fastener, Class II
Device Product Code and Panel Code:	Panel: Orthopedics / 87Product Code: KTT

Device Description:

Intended Use:

The Afghan External Fixator and its components are intended to be used in adolescents (12-21 years) and adults for securing small bone fragments on non-long bones including: patella and olecranon.

Technological Characteristics:

The Afghan External Fixator is similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics.

Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features and overall indications for use.

. Osteo Kirschner Wires - K971962
. Smith & Nephew Kirschner Wires - Preamendment
Smith & Nephew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and . Accessories - K994143

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DEC 1 0 2009

Smith & Nephew, Inc. c/o Ms. Laura Sejnowski Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K092002

Trade/Device Name: Afghan External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: December 3, 2009 Received: December 4, 2009

Dear Ms. Sejnowski:

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

{2}------------------------------------------------

Page 2 – Ms. Laura Sejnowski

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/CDRHOffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jondur

Image /page/2/Picture/7 description: The image shows a signature in cursive. The signature appears to be written in black ink on a white background. The signature is stylized and difficult to read, but it appears to start with the letter 'J'. The signature is the only element in the image.

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

Enclosure

{3}------------------------------------------------

Premarket Notification Indications for Use Statement

510(k) Number (if known): K092002

Device Name: Afghan External Fixator

Indications for Use:

Components in the Afghan External Fixator are for single use only.

Prescription Use __ X (Part 21 CFR 801.109)

AND/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)

Anita for mxn
(Division Sign-Off)

ivision of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092002

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.