TITANIUM TOGGLE BUTTON(S) by BIOMET MANUFACTURING, INC.

The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets through which multiple loops of suture are threaded. There are two types of Toggle Buttons, the standard toggle button with two eyelets and the NS toggle button with one larger eyelet only. The suture loops provide a means to attach the soft tissue grafts to the toggle buttons. The loops are attached to the toggle button by putting the loops through the eyelet(s). This device is used to anchor the suture loops to bone.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Titanium Toggle Button(s)". This submission is for a physical medical device, not a software algorithm or an AI-powered diagnostic tool. Therefore, the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets in AI, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through material similarity, intended use, size comparisons, and non-clinical mechanical testing.

Here's a breakdown of the relevant information from the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Pull-out strength at least equivalent to predicate devices	The Titanium Toggle Button(s) has a greater pull-out strength than that of the predicate devices.

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

Sample Size: Not specified for the mechanical testing.
Data Provenance: Not specified (implied to be internal laboratory testing).

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 applicable. Ground truth for mechanical testing is based on physical measurements and engineering standards, not expert interpretation.

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

Not applicable. Mechanical testing data is objective.

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. This is a physical device, not an AI diagnostic tool.

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

No. This is a physical device.

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

For the mechanical testing, the "ground truth" would be the objective measurements of pull-out strength according to established engineering standards or test protocols.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Additional Information from the Document:

Clinical Testing: None provided as a basis for substantial equivalence. The submission relies solely on non-clinical (mechanical) testing and comparison to predicate devices.
Summary of Technologies: "The titanium Toggle Buttons are similar to or identical to predicate devices in terms of material, intended use, and size."

Summary

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FEB 1 3 2004

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K033838
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510(k) Summary

Applicant/Sponsor: Arthrotek, Inc.

Tracy J. Bickel Contact Person: Requiatory Associate

Proprietary Name: Titanium Toggle Button(s)

Common Name: Soft Tissue Anchor

Classification Name: Fastener, fixation, nondegradable, soft tissue (888.3040)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Cruciate Ligament Button (K813581): Biomet, Inc. .
Pre-Threaded EndoButton (K984550): Smith and Nephew, Inc. .
Endobutton Continuous Loop (K980155): Smith and Nephew, Inc. .

Device Description: The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets through which multiple loops of suture are threaded. There are two types of Toggle Buttons, the standard toggle button with two eyelets and the NS toggle button with one larger eyelet only. The suture loops provide a means to attach the soft tissue grafts to the toggle buttons. The loops are attached to the toggle button by putting the loops through the eyelet(s). This device is used to anchor the suture loops to bone.

Indications for Use: Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Summary of Technologies: The titanium Toggle Buttons are similar to or identical to predicate devices in terms of material, intended use, and size.

Non-Clinical Testing: Mechanical testing was utilized to determine that the Titanium Toggle Button(s) has a greater pull-out strength than that of the predicate devices.

Clinical Testing: None provided as a basis for substantial equivalence.

SHIPPING ADDRESS MAILING ADDRESS 56 E. Bell Drive PO Box 587 Warsaw, IN 46582 Warsaw, IN 46581-0587 ドヘン

()Firich 574.267.6639

F- Mau. biomet@biome1.com

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Ms. Tracy J. Bickel Regulatory Associate Biomet Manufacturing Corporation 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K033838

Trade/Device Name: Titanium Toggle Button(s) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 8, 2003 Received: December 10, 2003

Dear Ms. Bickel:

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 CI·R 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Tracy J. Bickel

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.

l Mark N. Milliman

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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510(k) Number (if known): Device Name: Titanium Toggle Button(s) Indications for Use:

Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

(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 (Per 21 CFR 801 (Optional Format 1-2-96) - 37-Division : Division of General, Restorative, and Neurologic 510(k) Nu 3

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.