The Arthrex Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.
The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.

Device Description

Arthrex Fiberwire® and FiberTape™ sutures of varying lengths, diameters, and needle types are made of long chain polyesters, braided with nylon or silk, and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

AI/ML Overview

It appears there might be a misunderstanding of the provided document. The text is a 510(k) summary for a medical device (Arthrex FiberWire® Family sutures) submitted to the FDA.

This type of document primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than presenting a study with acceptance criteria and device performance results in the way a diagnostic or AI-driven device might.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert adjudication is not applicable to this 510(k) summary for a surgical suture.

Here's why and what information can be extracted:

Substantial Equivalence: For devices like sutures, the FDA's 510(k) process typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar materials, design, intended use, and performance characteristics, rather than extensive clinical studies with specific performance metrics and acceptance criteria as one might see for an AI algorithm or a diagnostic test.

Let's address the points of your prompt based on the provided text, indicating where information is not available or not applicable:

A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not present quantitative acceptance criteria or detailed performance results for the suture in the way a diagnostic device would. The core claim is "substantial equivalence" to predicate devices. There are no reported numerical performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of an AI or diagnostic study described here. The evaluation is based on comparing the new suture's characteristics to those of predicate sutures.
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. No "ground truth" establishment by experts in this manner is described. The assessment is a regulatory review by the FDA based on the information provided by the manufacturer.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is described.
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. This is a surgical suture, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (suture), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for a suture's safety and effectiveness is primarily established through its materials, manufacturing processes, and comparison to devices with a known safe and effective history (predicate devices) as determined by regulatory bodies. There isn't a specific "ground truth" derived from clinical outcomes or expert consensus described as part of a formal study in this document.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI or machine learning device.
How the ground truth for the training set was established:
- Not Applicable. As there's no training set, there's no ground truth for it.

In summary, the provided 510(k) summary is for a physical medical product (surgical suture) and therefore does not contain the types of information requested that are typically associated with performance studies for diagnostic devices or AI algorithms. The primary "study" implicitly referenced is the comparison to predicate devices to establish substantial equivalence.

Summary

{0}------------------------------------------------

AUG - 5 2004

510(k) Summary

510(k) Number:	K041589
Contact Person:	Ann Waterhouse, Regulatory Affairs Specialist
Sponsor:	Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108
Date Prepared:	June 2004

Trade/Proprietary Name:	Arthrex FiberWire® Family
Product Code:	GAT, GAP, GAW
Classification Name:	Suture, Non-absorbable, Synthetic, Polyester and Silk
Predicate Devices:	Arthrex K021434, Johnson & Johnson K012124,AuroLab K024091

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 Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.

Description:

Technical Differences in Regards to Predicate Devices:

The Arthrex FiberWire Family is made up of several sutures which have similar or identical material make up. The difference in the predicate K021434 Arthrex FiberWire Family of sutures, when compared to the subject of this submission. consists of a marker thread of silk instead of nylon.

Substantial Equivalence:

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

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Ms. Ann Waterhouse Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K041589

Trade/Device Name: Arthrex FiberWire Regulation Number: 21 CFR 878.5000 Regulation Number: 21 CFX 876:5000
Regulation Name: Non-absorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: June 10, 2004 Received: June 11, 2004

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 5 Iv(c) prematially equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the encrosule for tegally mancess profits | Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the charactering and the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the previous of the Act . (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, inerelore, market the devree, babyer to the go
general controls provisions of the Act include requirements for annual registration adjus and general controls provisions of the free networks. I prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is Classifica (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional ochaoist. Extoking and to 898. In addition, FDA may be found in the Oous of reasts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a basedin.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination and Journer Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements) not 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

{2}------------------------------------------------

Page 2 - Ms. Ann Waterhouse

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematice notification. The 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 If you desire spocitie aarrosis - J 01) 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 other general 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,

Miriam C. Provost

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

{3}------------------------------------------------

Page 1 of 1

510(k) Number (if known): КоЧ / 589

Device Name: Arthrex FiberWire™

Indications for Use:

The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.

AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K041589

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.