InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.

Device Description

Intramedullary Nail and Accessories

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "TriGen InterTAN" intramedullary nail. For medical devices undergoing 510(k) clearance, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device, rather than performance against pre-defined numerical thresholds or the kind of study typically associated with AI/software devices.

This document focuses on the mechanical and clinical data supporting substantial equivalence, not a standalone performance study as would be seen for an AI diagnostic.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices in Indications for Use, design features, operational principles, and material composition.	"A review of the mechanical test data indicated that the TriGen InterTAN nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of this 510(k) submission for a physical orthopedic implant. The "test" here refers to mechanical testing, not a clinical trial with a patient sample.
Data Provenance: The mechanical test data would be generated in a lab setting, likely in the US, by Smith & Nephew, Inc. This is not patient data, so "retrospective or prospective" does not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. The "ground truth" for mechanical testing is based on engineering specifications and physical measurements, not expert consensus on diagnostic images.
Qualifications of Experts: The data would have been reviewed by engineers and potentially clinicians to interpret mechanical test results in the context of clinical relevance, but the text doesn't specify these individuals or their qualifications.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of human readers, often with and without AI assistance, which is not applicable to a physical orthopedic implant like the TriGen InterTAN nail.

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

Standalone Performance: No, a standalone performance study was not done. This concept is applicable to AI algorithms, not a physical medical device. The "standalone" performance here refers to the mechanical integrity of the nail itself.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for demonstrating the equivalence of the TriGen InterTAN nail is primarily based on mechanical test data demonstrating its ability to withstand "expected in vivo loading without failure," compared to established performance of predicate devices. This is an engineering standard, not clinical pathology, expert consensus, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this device.

Summary

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K040212

FEB 2, 0 2004

Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen InterTAN

Contact Person and Address

Date of Summary: January 29, 2004

Kim Kelly Project Manager, Regulatory/Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566

Name of Device: TriGen InterTAN Common Name: Intramedullary Nail and Accessories

Device Classification Name

21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II

Indications for Use

Mechanical and Clinical Data

A review of the mechanical test data indicated that the TriGen InterTAN nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivoloading without failure.

Substantial Equivalence Information

The substantial equivalence of the TriGen InterTAN nail is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780).

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Ms. Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K040212

Trade/Device Name: TriGen InterTAN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II

Product Code: JDS Dated: January 29, 2004 Received: January 30, 2004

Dear Ms. Kelly:

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim Kelly

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marufacturers, 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,

/ Mark N. Millbern

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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Hoala

TriGen InterTAN Indications Statement

L. Merle N. Milkesen

Division Division of General, Restorative, and Neurological Devices

040212 510(k) Number

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _ OR

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.