The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.

Device Description

Intramedullary Nail

AI/ML Overview

The provided document describes the "TriGen Straight Humeral Nail System" by Smith & Nephew, Inc. However, it does not contain information about acceptance criteria for a device's performance that is typically measured against specific metrics (e.g., sensitivity, specificity, accuracy) nor does it detail a study proving the device meets such criteria.

Instead, the document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices.

Here's how the information provided relates to your request:

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

No specific acceptance criteria or performance metrics (like sensitivity, specificity, or accuracy) are provided in the document for the TriGen Straight Humeral Nail System.
The document states: "A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." This is a general statement about mechanical equivalence and capability, not a set of quantitative acceptance criteria or detailed performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "mechanical test data," but it does not specify the sample size used for these tests, the type of data (e.g., patient data, in vitro data), or its provenance.

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)

This information is not applicable or provided in the context of this 510(k) submission. The evaluation is based on mechanical testing and comparison to predicates, not a clinical study involving expert interpretation of data or images.

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

This information is not applicable or provided.

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

No MRMC study was performed or is mentioned. This device is an intramedullary nail, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Not applicable. This is a medical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would implicitly be engineering standards and successful in vivo performance of the predicate devices. However, this is not explicitly defined as "ground truth" in the document.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

Summary based on the provided text:

The TriGen Straight Humeral Nail System received FDA clearance based on its substantial equivalence to previously marketed predicate devices (Smith & Nephew's Titanium Nail System K981529, Smith & Nephew's Intramedullary Nail System K983942, and Acumed's Polarus nails K951740).

The primary evidence for equivalence cited is:

Similarities in indications for use.
Similar design features, operational principles, and material composition.
Mechanical test data indicating it is "equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

The document does not provide detailed quantitative performance metrics or the specifics of the mechanical testing (e.g., sample sizes, exact nature of tests, pass/fail criteria). It relies on a general statement of equivalence based on those tests.

Summary

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OCT - 1 2003

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Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Straight Humeral Nail System

Contact Person and Address

Date of Summary: September 2, 2003

Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153

Name of Device: TriGen Straight Humeral Nail System 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 Straight Humeral Nail System 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 Straight Humeral Nail System 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), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K951740).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 1 2003

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116

Re: K032722

Trade/Device Name: TriGen Straight Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Inrtramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2003 Received: September 4, 2003

Dear Ms. Akil:

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. Janet Johnson Akil

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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K03a7a2

TriGen Straight Humeral Nail System Indications Statement

Marli N. Mellema

Restorative and Neuro 510(k) Number -

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.