LONG LENGTH DYAX NAIL by HOWMEDICA OSTEONICS CORP.

The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

Device Description

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

The predicate Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures' occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The predicate design is cannulated, with a medial/lateral and anterior/posterior curve.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Long Length Dyax Nail System." This is a line extension to an existing device (Long Length Gamma® Nail System). The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does NOT contain information about acceptance criteria, detailed performance data, or a specific study designed to prove the device meets acceptance criteria as would be found in a clinical trial or performance study report.

The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove effectiveness or safety through a new clinical effectiveness study. Substantial equivalence is often established through technological comparison, material comparison, and sometimes mechanical testing, rather than human expert-based performance evaluations like those described in your request.

Therefore, most of the information requested cannot be extracted from this specific document. However, I can confirm what is available:

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

Not Available. The document does not provide a table of acceptance criteria or reported device performance data in the context of human-expert evaluation, clinical outcomes, or AI performance metrics. It focuses on device description and substantial equivalence.

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

Not Available. This information pertains to a study involving a test set, which is not described in this 510(k) summary.

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)

Not Available. This information pertains to a study involving human experts, which is not described in this 510(k) summary.

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

Not Available. This information pertains to a study involving adjudicated ground truth, which is not described in this 510(k) summary.

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

Not Applicable/Not Available. The device is an intramedullary nail for fracture fixation, not an AI or imaging diagnostic device that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The document does not mention any such study.

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

Not Applicable/Not Available. This question relates to AI algorithm performance. The device is a physical surgical implant, not an algorithm.

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

Not Applicable/Not Available. This question relates to a study that would establish ground truth for performance evaluation of a diagnostic or predictive device. No such study or ground truth is discussed for this intramedullary nail. The "truth" for this device's efficacy would be clinical outcomes (e.g., successful fracture healing), but such outcomes data are not presented in this 510(k) summary, which is focused on substantial equivalence.

8. The sample size for the training set

Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.

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

Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.

What the document does provide in relation to "proof" or "study":

The document states that the new device (Long Length Dyax Nail System) is a "line extension" and demonstrates "substantial equivalence" to a "predicate Long Length Gamma® Nail System" through:

Technological Comparison: The primary "study" implicitly referenced is a comparison of materials and design.
- Predicate device material: Stainless steel.
- Subject device material: Titanium alloy.
- Design changes: Proximal diameter, distal screw hole diameters, distal hole configuration, and additional nail lengths.
Intended Use Comparison: "There is no change in intended use for the modified device when compared to the previously cleared product."
Compatibility: The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible.

Essentially, the "study" proving the device meets its acceptance criteria (which is "substantial equivalence" for a 510(k)) is a documented comparison of its features and materials to those of a previously cleared device, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria. Mechanical testing would typically be performed as part of demonstrating substantial equivalence for an orthopedic implant, but the details of such testing (e.g., fatigue strength, bending rigidity) are not included in this summary.

Summary

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KD13468

Special 510(k) Summary of Safety and Effectiveness: NOV 1 6 2001 Line Extension to the Long Length Gamma® Nail System

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Contact Person:	Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:	October 17, 2001

Device Identification

Proprietary Name:	Long Length Dyax Nail (formerly the Long Length Gamma® Nail System)
Common Name:	Intramedullary Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020

There is no change in intended use for the modified device when compared to the previously cleared product. The subject Long Length Dyax Nails are substantially equivalent to the existing design of Long Length Gamma® Nails which were determined substantially equivalent via the 510(k) process.

1 Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Karen Ariemma Regulatory Affairs Department Howmedica Osteonics 59 Route 17 Allendale, New Jersey 07401

Re: K013468

Trade/Device Name: Howmedica Long Length Dyax Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2001 Received: October 18, 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 (OS) 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. Karen Ariemma

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.

Mark N. Millerson

elia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 6 2001

510(k) Number (if known): K. 0| 34/6 8

Device Name: Long Length Dyax Nail System (line extension to the Long Length Gamma® Nail System)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

K 013468

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark M Milliken

Division Sign-Off Division of General. Restorative and Neurological Devices

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.