The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. Indications include: 1. Treatment of patients who are not candidates for total knee arthroplasty. 2. Irretrievably failed total knee arthroplasty. 3. Limb salvage in oncology surgery. 4. Trauma. 5. Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice. These devices are intended for cemented use only.

Device Description

The Modular Arthrodesis Nail is a multi-component device designed to provide arthrodesis fixation of the knee. The device has a central locking collar that connects fernoral and tibial adapter segments. The adapter segments are available in two resection lengths (1 cm or 3 cm), each with two body styles (standard or elliptical). All components of the Modular Arthrodesis Nail are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F-136.

AI/ML Overview

The provided text is a 510(k) Summary for the Biomet Manufacturing Corp.'s Modular Arthrodesis Nail. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing. Crucially, it explicitly states that clinical testing was not required for this device to support substantial equivalence.

Therefore, the document does not contain information regarding acceptance criteria, or the details of a study (clinical or standalone AI performance) proving the device meets acceptance criteria.

The 510(k) process in this case relies on demonstrating substantial equivalence to already legally marketed devices through other means (like mechanical testing and material similarity), rather than proving efficacy or performance through clinical trials or specific acceptance criteria.

To answer your request, if this were documentation of an AI/ML device, the following would need to be present but are explicitly absent for this device:

The following information is NOT available in the provided document:

Table of acceptance criteria and the reported device performance: No acceptance criteria or performance metrics are detailed, as no clinical study was conducted.
Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as no clinical or performance study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical or performance study was conducted.
Adjudication method for the test set: Not applicable as no clinical or performance study was conducted.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
The type of ground truth used: Not applicable as no clinical or performance study was conducted.
The sample size for the training set: Not applicable as the "device" is a physical medical implant, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable as the "device" is a physical medical implant, not an AI/ML algorithm.

Summary of Relevant Information from the Provided Text:

Device Name: Modular Arthrodesis Nail
Manufacturer: Biomet Manufacturing Corp.
Basis for Substantial Equivalence: Similar intended use, functional characteristics (rigid fixation), and material (Ti-6Al-4V titanium alloy) as predicate devices.
Non-Clinical Testing: "Mechanical testing indicated that the Modular Arthrodesis Nails are substantially equivalent to the predicate devices for the uses indicated."
Clinical Testing: "Clinical testing was not required for these components to support substantial equivalence."

Conclusion Regarding Your Request:

The provided 510(k) summary explicitly states that clinical testing was not required for the Modular Arthrodesis Nail to establish substantial equivalence. Therefore, there are no acceptance criteria, study details, or performance data of the type you are asking for (which are typically associated with clinical trials or AI/ML performance studies) within this document. The device's approval was based on non-clinical mechanical testing and comparison to predicate devices, not on a human clinical study or an AI/ML performance study with specific ground truth and expert adjudication.

Summary

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042409 :12

DEC - 2 2004

Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are all capitalized and outlined in black, with the interior of the letters being white. The "O" in the middle is a perfect circle, and the "E" and "T" have a unique, geometric design.

510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (574) 267-6639 ext. 1568FAX: (574) 372-1683
Proprietary Name:	Modular Arthrodesis Nail
Common Name:	Titanium Intramedullary Rod
Classification Name:	Rod, Fixation, Intramedullary and Accessories (21 CFR §888.302)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Wichita® Fusion Nail - Howmedica Inc. (K993603) Titanium Intramedullary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howmedica Inc. (K020384) Orthopedic Salvage System - Biomet Inc. (K002757)

Device Description:

Intended Use:

The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knce.

Indications include:

1. Treatment of patients who are not candidates for total knee arthroplasty.
Irretrievably failed total knee arthroplasty 2.
1. Limb salvage in oncology surgery,

MAILING ADDRESS PO. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive W:nisaw, IN 46582

대

OFFICE 574.267.6639

FAX 574.267.81.37

E MAIL biomet@bionet.com

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1. Trauma
1. Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice.

These devices are intended for cemented use only.

Summary of Technologies: The Modular Arthrodesis Nail has the same intended use (arthrodesis), the same functional characteristics (rigid fixation) as the predicate devices, and is made of the same titanium alloy material as the predicate Titanium Intramedullary Nails and Orthopedic Salvage System (OSS) components used with the Modular Arthrodesis Nail.

Non-Clinical Testing: Mechanical testing indicated that the Modular Arthrodesis Nails are substantially equivalent to the predicate devices for the uses indicated.

Clinical Testing: Clinical testing was not required for these components to support substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2004

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell DR. P.O. Box 587 Warsaw, IN 46581

Re: K042409

Trade/Device Name: Modular Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2004 Received: September 3, 2004

Dear Mr. Baker:

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 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 - Mr. Gary Baker

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,

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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Page 1 of 1

Statement of Indications For Use

510(k) Number (IF KNOWN): Koy2489

Device Name: Modular Arthrodesis Nail

Indications for Use:

The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

Indications include:

Treatment of patients who are not candidates for total knee arthroplasty l .
Irretrievably failed total knee arthroplasty 2.
Limb salvage in oncology surgery 3.
Trauma 4.
Any other condition where there is little soft tissue or bony tissue available for 5. support, and arthrodesis is the treatment of choice.

These devices are intended for cemented use only.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evanuation (ODE)

lellin Wht
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number C042405

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.