Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "TriGen Trochanteric Antegrade Nail." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a
new device.

Here's an analysis based on your requirements and the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Test Data: Withstand expected in vivo loading without failure.	Review of mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Substantial Equivalence: Similarities in indications for use, design features, operational principles, and material composition to predicate devices.	The substantial equivalence is based on its similarities to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942) in indications for use, design features, operational principles, and material composition.
Clinical Equivalence: (Implicitly, that clinical outcomes are comparable to predicate devices).	Not explicitly stated as a separate clinical study with new data. Equivalence is inferred from mechanical data and substantial equivalence to existing devices.

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

Sample Size: Not applicable. The document describes a 510(k) submission based on mechanical testing and substantial equivalence to predicate devices, not a clinical study with a "test set" of patients.
Data Provenance: Not applicable. The data primarily comes from mechanical test data and comparisons to existing predicate devices. No patient-specific data is mentioned, thus no country of origin or retrospective/prospective nature is indicated.

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

Number of Experts: Not applicable. As there was no clinical test set for this 510(k) submission, no ground truth was established by experts in this context. The "ground truth" for the submission is the regulatory determination of substantial equivalence based on engineering and design comparisons.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical test set or human interpretation was involved in the data presented in this summary.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. This is a premarket notification for a medical device (intramedullary nail), which typically relies on mechanical testing and substantial equivalence to existing devices rather than reader studies.
Effect Size of AI Improvement: Not applicable, as no AI component or reader study was performed.

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

Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical implant (intramedullary nail), not an algorithm or software.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" in this context is the mechanical equivalence to established devices, as determined by engineering tests, and the regulatory determination of substantial equivalence by the FDA based on design, materials, and intended use as compared to predicate devices. It is not pathology, outcomes data, or expert consensus from a clinical trial.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.

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

Ground Truth Establishment: Not applicable. No training set was used.

Summary

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MAR 2 3 2004

K040462
page 1 of 1

Date of Summary: February 20, 2004

Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Trochanteric Antegrade Nail

Contact Person and Address 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 Trochanteric Antegrade Nail Common Name: Intramedullary Nail

Device Classification Name

21 CFR 888.3020 Intramedullary fixation rod - Class II

Indications for Use

Mechanical and Clinical Data

A review of the mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The substantial equivalence of the TriGen Trochanteric Antegrade 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) and Intramedullary Nail System (K983942).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that consists of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

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

Re: K040462

Trade/Device Name: TriGen Trochanteric Antegrade Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 20, 2004 Received: March 8, 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 electronic 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 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.

Mark M. Milliman

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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TriGen Trochanteric Antegrade Nail Indications Statement

040462
page 1 of 1

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Mark N Milkeon

Restorative,

510(k) Number K040462

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.