The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities. Components in the Smith & Nephew Rail System are for single use only.

Device Description

Subject of this premarket notification is the Smith & Nephew Rail System. The Smith & Nephew Rail System Subject of the promation notified offers specially designed components used in the management of Is a unlateral extential inxanon system that enoric openally, orthopedic surgery. System lower extremly bone fraction and rooms, distraction/compression devices and associated accessories components include fail Sognions, pir dainter, al. Like the predicate devices listed below, the subject made lion and minute and components that can be used with the rail segments (or frame) to provide a device customized to meet specific patient needs.

AI/ML Overview

This document, K090926b, is a 510(k) summary for the Smith & Nephew Rail System, an external fixation system used in orthopedic surgery. The purpose of this document is to establish substantial equivalence to previously marketed devices.

This submission does not contain information on acceptance criteria or a study proving the device meets acceptance criteria related to device performance in the way a diagnostic AI would be evaluated (e.g., sensitivity, specificity).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to the regulatory process for medical devices in the United States, specifically the 510(k) pathway.

The "acceptance criteria" for this device are satisfied by demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. This means the device's technological characteristics, intended use, and performance are sufficiently similar to those already approved by the FDA, such that it can be considered equally safe and effective.

The "study that proves the device meets the acceptance criteria" in this case is the 510(k) submission itself, which presents a detailed comparison of the new device to its predicate devices.

Here's an breakdown of why the requested information about acceptance criteria and performance studies in the context of AI/diagnostic devices isn't present in this 510(k) summary, and what information is provided:

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

Acceptance Criteria (for this 510(k) submission): Substantial equivalence to identified predicate devices regarding design features, materials, and overall indications for use.
Reported Device Performance: The document implicitly states performance is equivalent to the predicate devices. No specific quantitative performance metrics (like sensitivity, specificity, accuracy) are provided because this is a mechanical medical device, not a diagnostic or AI algorithm. The performance is assessed through comparing technological characteristics and intended use.

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 information is not relevant for a mechanical external fixation system being submitted through a 510(k) pathway. There are no "test sets" or "data provenance" in the sense of patient data for evaluating a diagnostic algorithm. The "test" is the comparison to predicate devices, and the "data" is the engineering specifications and intended use.

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. See point 2. There's no "ground truth" to establish in this context because it's not a diagnostic device. The ground truth, if anything, is the established safety and efficacy of the predicate devices.

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

Not applicable. See point 2. No adjudication method for a test set is relevant here. The "adjudication" is performed by the FDA reviewers assessing the substantial equivalence claim.

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 device is an external fixation system, not an AI or diagnostic tool. MRMC studies evaluate the performance of diagnostic aids, which is outside the scope of this submission.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

Not applicable. As noted earlier, there's no "ground truth" in the way it's used for diagnostic algorithms. The closest equivalent would be the established clinical performance and safety history of the predicate devices, which serve as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve training data or algorithms.

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

Not applicable. This device does not involve training data or algorithms.

Summary of the 510(k) Submission's Approach to "Meeting Acceptance Criteria":

The Smith & Nephew Rail System demonstrates "acceptance" by establishing substantial equivalence to existing, legally marketed predicate devices. This involves comparing:

Intended Use: The indications for use match or are very similar to the predicate devices (fracture fixation, deformity correction, limb lengthening, etc., in adult and pediatric patients).
Technological Characteristics: The device shares similar design features, materials, and overall technological characteristics with the predicate devices.

Predicate Devices Identified:

Smith & Nephew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories - K994143
Taylor Spatial Frame External Fixation System K970748
Heidelberg External Fixator K970751
Jet-X Bar System Clamps, Bar and Posts MR Conditional K072212
Hex-Fix Field External Fixator K953397

The "study" proving the device meets the acceptance criteria is the documentation provided in the 510(k) submission itself, which articulates these similarities and justifies the claim of substantial equivalence to the FDA. The FDA's issuance of the substantial equivalence letter (pages 1-3) confirms their agreement with this assessment.

Summary

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

K090926b (pg. 1 of 1)

510(k) Summary of Safety and Effectiveness Smith & Nephew Rail System

Submitted By:	Smith & Nephew, Inc.,Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	March 30, 2009
	JUN - 8 2009
Contact Person:	Laura Sejnowski, Regulatory Affairs SpecialistTel: (901) 399-5349 Fax: (901) 398-5146
Proprietary Name:	Smith & Nephew Rail System
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:

Device Description.
Subject of this premarket notification is the Smith & Nephew Rail System. The Smith & Nephew Rail System Subject of the promation notified offers specially designed components used in the management of Is a unlateral extential inxanon system that enoric openally, orthopedic surgery. System lower extremly bone fraction and rooms, distraction/compression devices and associated accessories components include fail Sognions, pir dainter, al. Like the predicate devices listed below, the subject made lion and minute and components that can be used with the rail segments (or frame) to provide a device customized to meet specific patient needs.

Intended Use:

meetided boo.
The Smith & Nephew Rail System and components are intended to be used on adult or pediatric patients as The Smith and are intended to be used for fracture fixation (open and closed); fractures and disease which required and are intended to ontractures or loss of range of motion and fractures requiring distraction; generally may round in joint outling, infected fractures or non-unions; and correction of long bone podualitires. The Smith & Nephew Rail System and its components are for single use only.

Technological Characteristics:

Technological online of the recomments similar to legally marketed devices listed below in that they share rine online a nople from Ran of each of the 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.

Smith & Neohew External Fixation System Unilateral (Linear) & Multilateral (Circular) Fixators and . Accessories - K994143
Taylor Spatial Frame External Fixation System K970748 .
Heidelberg External Fixator K970751 .
Jet-X Bar System Clamps, Bar and Posts MR Conditional K072212 .
Hex-Fix Field External Fixator K953397 ●

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes, resembling birds in flight, arranged in a diagonal line.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2009

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

Re: K090926

Trade/Device Name: Smith & Nephew Rail System

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: March 30, 2009 Received: April 2, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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

Page 2 - Ms. Laura Sejnowski

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

Sincerely yours,

Barbara Buchun

Mark N. Melkerson Director

Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Kogo926

Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: Smith & Nephew Rail System

Indications for Use:

Components in the Smith & Nephew Rail System are for single use only.

Prescription Use × (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)

Aibara Smelld for

ion of Surgical, Orthopedic,

510(k) Number K090226

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.