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. Adolescent TAN is for single use only.

Device Description

Intramedullary Nail

AI/ML Overview

This submission describes a medical device, the TriGen Adolescent TAN (an intramedullary nail), and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding a test set, ground truth, or training set as typically seen for AI/ML-based devices.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance (no criteria or performance metrics are mentioned beyond mechanical equivalence).
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
Standalone (algorithm only) performance study.
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How the ground truth for the training set was established.

Based on the provided text, the device's acceptance is based on its substantial equivalence to predicate devices, supported by a review of mechanical test data.

Here's what can be extracted:

Acceptance Criteria and Device Performance (as inferred from the document):

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical equivalence to currently used clinically devices.	"The TriGen Adolescent TAN is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
Similarities in indications for use, design, operational principles, and material composition to predicate devices.	Stated to be "substantially equivalent" to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942) based on these similarities.

Study Information:

Type of Study: Mechanical test data review and comparison to predicate devices. This is not a clinical study involving human patients or an AI/ML algorithm.
Data Provenance: Not applicable as it's a mechanical test and comparison to predicate devices, not data from a test set of cases.
Ground Truth: The "ground truth" in this context refers to the established mechanical performance of existing, clinically used devices and the design/material properties of the predicate devices.
Sample Sizes: Not applicable in the context of clinical test or training sets for AI. The "sample" would be the tested device itself and the predicate devices for comparison.
Experts: Not explicitly stated as "experts for ground truth," but the evaluation was conducted by the FDA and the manufacturer, implying qualified personnel.

Summary of Device Acceptance:

The TriGen Adolescent TAN received 510(k) clearance based on a finding of substantial equivalence to existing, legally marketed predicate devices. This determination was primarily supported by:

Mechanical Test Data: A review indicated the device performs equivalently to existing clinical devices and can withstand expected in-vivo loading without failure.
Comparison to Predicate Devices: The device's indications for use, design features, operational principles, and material composition were found to be similar to Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942).

Summary

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Kc40929
page 1 of 1

MAY 2 5 2004

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

Date of Summary: April 8, 2004

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 Adolescent TAN 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 Adolescent TAN 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 Adolescent TAN 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 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" arranged around the perimeter. Inside the circle is a stylized representation of three wavy lines, which symbolize the human services aspect of the department's mission.

Public Health Service

MAY 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040929

Trade/Device Name: TriGen Adolescent TAN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HSB Dated: April 8, 2004 Reccived: April 9, 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 10 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 docs 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 yours,

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 Adolescent TAN Indications Statement

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 Millhuser

neral, Restorative, and Neurological Devices

510(k) Numbar ._

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

OR 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.