The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire™ Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.

Device Description

Arthrex, Inc. FiberTape™ Family consists is a ribbon-like suture consisting of FiberWire components along with several needle types for specific surgical uses. r locatified of long chain polyesters which are braided and sterilized froos taps se. They are available in dyed and non-dyed varieties, with or without needles.

AI/ML Overview

I am sorry, but I cannot provide information on acceptance criteria and study data for the device described in the provided text. The document is a 510(k) summary and related FDA correspondence from 2004 for the Arthrex FiberTape™ Family. This type of document is primarily focused on demonstrating "substantial equivalence" to existing legally marketed devices, rather than presenting detailed performance studies with acceptance criteria in the manner you've outlined for AI/ML devices.

Specifically, the document focuses on:

Intended Use and Description: Describing what the product is and what it's for.
Substantial Equivalence: Comparing the new device to existing predicate devices (other sutures) to argue that it is equally safe and effective.
Regulatory Classification and Limitations: FDA's confirmation of the device's classification and any specific warnings or limitations required for its labeling (e.g., "The safety and effectiveness of this device for use as an artificial ligament or tendon has not been established.").

This document does not contain the kind of detailed performance study data, acceptance criteria, sample sizes for test sets, expert consensus, ground truth establishment, or specific metrics (like sensitivity, specificity, or effect sizes for human reader improvement with AI assistance) that you are requesting. Those types of studies and details are more characteristic of submissions for complex diagnostic devices, particularly those involving AI or algorithms, which require extensive validation of their performance against a defined ground truth.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text, as this information is not present within this 510(k) submission.

Summary

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JAN 1 4 2004

Kφ32245

510(k) Summary

510(k) Number:
Contact Person:	Ann Waterhouse, Regulatory Affairs Specialist
Date Prepared:	July, 2003
Trade/Proprietary Name:	Arthrex FiberTape™ Family
Product Code:	GAT
Classification Name:	Suture, Non-absorbable, Synthetic, Polyester
Predicate Devices:	Arthrex K010673, Arthrex K012923, Arthrex K021434Johnson & Johnson K012124, and Ethicon Endo-Surgery Mersilene Tape

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Intended Use:

The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.

Description:

Substantial Equivalence:

The Arthrex, Inc. FiberTape™ Family is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex suture tape and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K032245

Tradc/Device Name: Arthrex FiberTape™ Family Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture Regulatory Class: II Product Code: GAT Dated: October 14, 2003 Received: October 16, 2003

Dear Ms. Waterhouse:

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). You may, thereforc, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the provisions of the requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this 1 ho Other of Doctor an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling following the indications for use:

The safety and effectivencss of this device for use as an artificial ligament or tendon has not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2 - Ms. Ann Waterhouse

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he I Dri mining of basification for your device and permits your device to proceed to the ucerted in a clussillearen to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is etablined 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 1 toase of a rised a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I vitated and 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 form in the qualisy by visions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-__ Also, at ree (21 the regulation entitled, "Misbranding by reference to premarket notification" (21 PICR 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,

Daniel G. Schultz, M.D. Director 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:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Millhuser

estorative

Page 1 of 1

K03 2245

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.