Arthrex, Inc. Fiberwire™ suture consists of a family of varying length, needle type, and standard USP diameter sutures. They are made of long chain polyesters which are braided and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Arthrex Fiberwire™ USP suture family." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance as typically understood for AI/algorithm-based devices.

Therefore, the requested information elements related to AI algorithm performance (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's why and what information is available:

This 510(k) submission is for a physical medical device (sutures), not an AI/software as a medical device (SaMD). The regulatory pathway for this device, at the time of submission (2002), primarily involved demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing device characteristics, materials, intended use, and performance claims to those already approved.

Summary of available information based on the prompt's request:

A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not describe a study with specific acceptance criteria and a reported performance for an AI/algorithm. Instead, it asserts "substantial equivalence" based on similar features and intended use to predicate devices. The "performance" for a suture would typically relate to mechanical properties, biocompatibility, and sterility, which are not detailed in this summary but would have been part of the full 510(k) submission.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or data provenance related to an AI/algorithm's performance is mentioned.
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 for an algorithm is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for an algorithm's 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 type of study is relevant to AI/diagnostic imaging devices, not physical sutures.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth in the context of AI is not relevant here. The "truth" for this device's safety and effectiveness is established by its similarity to already approved devices and its compliance with relevant standards (though not explicitly stated in this summary).
The sample size for the training set:
- Not Applicable. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
- Not Applicable. No ground truth establishment method for a training set is described.

Key takeaway for this document:
The purpose of this 510(k) summary is to assert substantial equivalence of the "Arthrex Fiberwire™ USP suture family" to predicate devices based on common features and intended use in soft tissue approximation and ligation for orthopedic surgeries. It does not contain information about studies for an AI/algorithm-based device as requested.

Summary

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NOV 7 2002

510(k) Summary

K021434 510(k) Number: Ann Waterhouse, Requlatory Affairs Specialist Contact Person: Date Prepared: December 13, 2001

Trade/Proprietary Name: Arthrex Fiberwire™ USP suture family Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Arthrex K010673, Arthrex K012923, Grams American Predicate Devices: Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434.

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

Intended Use:

Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Description:

Substantial Equivalence:

The Arthrex, Inc. Fiberwire™ Family USP suture(s) are substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex suture 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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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 7 2002

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

Re: K021434

Trade/Device Name: Anthrex Fiberwire™ Family, USP Size Sutures Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 15, 2002 Received: August 16, 2002

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) 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 ( FR 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 – Ms. Ann Waterhouse

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" (21 CFR 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,

Miriam C. Provost
for G.M. Witte, Ph.D., M.D.

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): K021434

Device Name: Arthrex Fiberwire™Family, USP size sutures

Indications for Use:

Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Option Format 3-10-98)

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

110(k) Norther.

000024

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.