TROCHANTERIC DYAX NAIL SYSTEM by HOWMEDICA OSTEONICS CORP.

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Trochanteric Gamma® Nail System. The subject device, named the Trochanteric Dyax Nail System, is a line extension of the Trochanteric Gamma® Nail System. The predicate Trochanteric Gamma® Nail System is fabricated from stainless steel. The subject Trochanteric Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter and changing the distal screw hole diameter and configuration. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Trochanteric Dyax Nail.

AI/ML Overview

This 510(k) submission (K013524) describes a line extension of an existing medical device, the Trochanteric Gamma® Nail System. The new device, the Trochanteric Dyax Nail System, is a modification of the predicate device, primarily in the material used (titanium alloy instead of stainless steel) and minor design changes to the proximal diameter and distal screw hole configuration.

Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel AI system. The information requested in your prompt (AI-specific details like sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of device submission, which is for an orthopedic implant.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: For a line extension of an orthopedic implant, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must have the same intended use, similar technological characteristics, and raise no new questions of safety or effectiveness. The specific criteria typically involve showing that the material change and design modifications do not negatively impact the device's mechanical properties, biocompatibility, and clinical performance when compared to the predicate. This is often established through mechanical testing, material characterization, and biocompatibility testing.
Reported Device Performance: The document does not provide a table of performance metrics in the way one would for an AI device. Instead, the "performance" is implicitly demonstrated by the FDA's finding of substantial equivalence. The summary states: "The subject Trochanteric Dyax Nails are substantially equivalent to the existing design of Trochanteric Gammas Nails which were determined substantially equivalent via the 510(k) process." This statement serves as the "report" that the device meets the criteria for market clearance. Mechanical testing data (fatigue, torsion, bending, etc.) would have been submitted to the FDA to support this claim, but those specific results are not included in this public summary.

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

Not Applicable (N/A) for an AI test set. This is an orthopedic implant. The "test set" would refer to mechanical test specimens, not patient data in the context of AI. The document does not specify the number of mechanical test specimens.
Data Provenance: N/A for AI. For an orthopedic implant, data provenance would relate to the source of materials, manufacturing processes, and potentially, clinical experience with the predicate device (though not a formal "data set" in the AI sense).

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

N/A. Ground truth in the context of AI refers to expert-labeled data. For a mechanical device, performance is evaluated through engineering tests, not expert consensus on images or other data. The "ground truth" would be the measured physical properties and performance under simulated loads.

4. Adjudication Method for the Test Set:

N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in AI studies. For a mechanical device, test results are typically analyzed against predefined engineering specifications.

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:

N/A. This is a core component of AI device evaluation and is not relevant to a line extension for an orthopedic implant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

N/A. This applies to AI algorithms. The Trochanteric Dyax Nail is a physical implant.

7. The Type of Ground Truth Used:

N/A (for AI ground truth). For this device, the "ground truth" for demonstrating substantial equivalence would be:
- Mechanical Test Results: Data from physical tests (e.g., fatigue, static bending, torsional strength) demonstrating that the titanium alloy nail performs comparably or better than the stainless steel predicate.
- Material Characterization: Chemical composition and physical properties of the titanium alloy.
- Biocompatibility Testing: Ensuring the new material is safe for implantation.
- Clinical History of Predicate: The established safety and effectiveness of the existing Trochanteric Gamma® Nail provides the basis for comparison.

8. The Sample Size for the Training Set:

N/A. There is no "training set" for an orthopedic implant.

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

N/A. There is no "training set" for an orthopedic implant.

In summary, the provided document is a 510(k) premarket notification for an orthopedic implant line extension, not an AI device. Therefore, the questions related to AI-specific evaluation methodologies are not applicable. The "study" that proves the device meets acceptance criteria in this context refers to the manufacturing, laboratory testing (mechanical, biocompatibility), and regulatory review process that leads to a substantial equivalence determination by the FDA.

Summary

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510(k) Premarket Notification

K013524

Special 510(k) Summary of Safety and Effectiveness:

NOV 1 4 2001 Line Extension to the Trochanteric Gamma® Nail System

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Karen AriemmaRegulatory Affairs Specialist
Date of Summary Preparation:	October 22, 2001
Device Identification
Proprietary Name:	Trochanteric Dyax Nail System (formerly theTrochanteric Gamma® Nail System)
Common Name:	Intramedullary Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020

The predicate Trochanteric Gamma® Nails an intramedullary rod intended to be used for stabilizing various types of intertrochanteric fractures of the proximal femur. There is no change in intended use for the modified device when compared to the previously cleared product. The subject Trochanteric Dyax Nails are substantially equivalent to the existing design of Trochanteric Gammas Nails which were determined substantially equivalent via the 510(k) process.

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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 and Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is enclosed within a circular border, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2001

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K013524

Trade/Device Name: Trochanteric Dyax Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 22, 2001 Received: October 23, 2001

Dear Ms. Ariemma:

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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

fo Mark N. Milkman

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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K013524

NOV 1 4 2001

Page 1 of 1

510(k) Number (if known): Kol 3524

Device Name: Trochanteric Dyax Nails (line extension to the Trochanteric Gamma® Nail)

Indications For Use:

The device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use A

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N Millkerson

(Division Sign-Off) Division of General, Festorative and Neurological Devices K013524

510(k) Number _

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.