The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Device Description

This Special 510(k) submission is a line extension to the T2 Nailing System to add a new style of Proximal Humeral Nail. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nail is intended for single use only.

AI/ML Overview

The provided text describes a Special 510(k) submission for a line extension to the T2 Nailing System, adding a new style of Proximal Humeral Nail. The submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The submission does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices. Instead, it relies on demonstrating comparable mechanical properties to a predicate device for a physical medical device.

Acceptance Criteria Category	Reported Device Performance
Mechanical Properties	"FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device."
Material Composition	"The material used to manufacture the line extension to the T2 Nail System is identical to that of the predicate."
Intended Use	The intended use for the T2 Proximal Humeral Nail is consistent with the predicate.

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

The text does not describe a test set or data provenance in the context of an AI/software device. The evaluation method mentioned is "FEA analysis and mechanical testing," which refers to engineering simulations and physical tests on the device itself, not data from patients or a clinical test set.

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 is not applicable to this submission. The "ground truth" here relates to the mechanical properties of the physical device, established through engineering standards and testing, not expert interpretation of medical images or clinical outcomes.

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

This is not applicable to this submission as there is no human-interpreted test set requiring adjudication.

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

This is not applicable. This submission is for a physical orthopedic implant (an intramedullary nail), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study is not relevant.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" in this context refers to the established mechanical properties and material composition of the predicate device, which are used as a benchmark for comparison. This is based on engineering specifications and prior performance of approved devices.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied for this physical device submission.

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

This is not applicable as there is no training set involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is an engineering and materials-based assessment rather than a clinical or AI performance study.

Study Type: Mechanical testing and Finite Element Analysis (FEA).
Objective: To demonstrate that the new T2 Proximal Humeral Nail line extension has "comparable mechanical properties" to its predicate device and is made of "identical" material.
Methodology:
- Material Comparison: Stated that the material used for the new device is "identical" to that of the predicate.
- Mechanical Property Comparison: Performed "FEA analysis and mechanical testing." While specific tests (e.g., bending, torsion, fatigue) are not detailed, these are standard methods for evaluating the structural integrity and performance of orthopedic implants.
Results: The FEA analysis and mechanical testing "demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device."
Conclusion: The device meets the acceptance criteria by demonstrating substantial equivalence in material and mechanical performance to a legally marketed predicate device. This approach is typical for line extensions of physical medical devices where the changes are limited and do not alter the fundamental scientific technology or intended use.

Summary

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K043404

Special 510(k)

DEC 27 2004

510(k) Summary of Safety and Effectiveness: T2 PHN Line Extension

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038

Date Summary Prepared:

December 10, 2004

Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Device Product Code:

T2 Proximal Humeral Nail Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR $888.3020 87 HSB

Description:

Intended Use:

Statement of Technological Comparison:

The material used to manufacture the line extension to the T2 Nail System is identical to that of the predicate. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device.

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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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K043404

Trade/Device Name: T2 Proximal Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 10, 2004 Received: December 10, 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. Vivian 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 (240) 276-0120. 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.

R. Mark N. Millherson

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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Indications for Use

510(k) Number (if known):

Device Name: T2 Proximal Humeral Nail

Indications for Use:

The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of The TE = = = limited to, non-unions, malunions, malalignments, pathological fractures, and impending minological fractures. Examples of specific indications according to AO classification include Paired B
Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Mulhern

Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K043404

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.