The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:

Fixation of small bone fragments, in long bone or small bone fractures .
Arthrodesis in hand and foot surgery .
Distal or proximal metatarsal or metacarpal osteotomies .
Mono or Bi-Cortical osteotomies in the foot or hand .
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
. Guide Wire in hip pinning procedures
Align and reduce long bone fractures .
For use with cerclage wire/cable in treating greater trochanter fractures ●

Device Description

The Arthrex K-Wire devices are made of stainless steel per ASTM F138. They are offered in several sizes and tip styles, sterile or non-sterile.

AI/ML Overview

This document is a 510(k) summary for the Arthrex K-Wire, which focuses on establishing substantial equivalence to previously marketed devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies for software, AI, or diagnostic devices, not a physical medical implant for which equivalence is being sought based on material and intended use.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. This document does not describe specific numerical acceptance criteria or performance metrics for the Arthrex K-Wire in the context of a study. The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to a predicate device, meaning it has the same intended use and similar technical characteristics, or can be demonstrated to be as safe and effective.

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

Not applicable / Cannot be provided. There is no "test set" in the context of a performance study described in this document. The submission relies on demonstrating substantial equivalence, not on a new performance study with human subjects or data.

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 / Cannot be provided. There is no "ground truth" or expert review in the context described because no performance study for diagnosis or classification is presented. The "ground truth" for substantial equivalence would be regulatory and scientific consensus on the safety and effectiveness of the predicate device, not expert labeling of data.

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

Not applicable / Cannot be provided. No adjudication method is relevant as there is no test set or expert disagreement to resolve.

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

Not applicable / Cannot be provided. This is a physical medical device (K-Wire), not an AI or diagnostic software. Therefore, an MRMC study is not relevant to its clearance process as described here.

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

Not applicable / Cannot be provided. This is not an algorithm or software device.

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

Not applicable / Cannot be provided (in the context of a performance study). The "truth" in this submission relies on the established safety and effectiveness of the predicate device and the materials used, as well as the device's conformance to recognized standards (e.g., ASTM F138 for stainless steel).

8. The sample size for the training set

Not applicable / Cannot be provided. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable / Cannot be provided. There is no "training set" or corresponding ground truth.

Summary of Information from the Document:

While the document doesn't fit the requested format for AI/diagnostic studies, it does provide the following key information about the device and its clearance:

Device Name: Arthrex K-Wire
Intended Use: Fixation of bone fractures, bone reconstructions, guide pins for other implants, and traction application.
Material: Stainless steel per ASTM F138.
Clearance Method: 510(k) substantial equivalence to a predicate device.
Basis for Equivalence: Same intended use, technical characteristics, or demonstrated to be as safe and effective as the predicate. Materials are well-characterized and used in predicate devices.
FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.

Summary

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NOV - 3 2005

510(k) Summary

K 052736

510(k) Number:
Company:	Arthrex, Inc.
Address:	1370 Creekside Blvd., Naples, FL 34108-1945
Telephone:	(239) 643-5553
Facsimile:	(239) 598-5508
Contact:	Ann Waterhouse, RAC
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	A milano, 1/ 3Allino

Trade Name:	Arthrex K-Wire
Common Name:	Pin
Classification:	Smooth or threaded metallic bone fixation fastener
Product Code:	HTY

Description:

The Arthrex K-Wire devices are made of stainless steel per ASTM F138. They are offered in several sizes and tip styles, sterile or non-sterile.

Indications for Use:

The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as quide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:

Fixation of small bone fragments, in long bone or small bone fractures .
Arthrodesis in hand and foot surgery .
Distal or proximal metatarsal or metacarpal osteotomies .
Mono or Bi-Cortical osteotomies in the foot or hand .
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
Guide Wire in hip pinning procedures .
Align and reduce long bone fractures .
For use with cerclage wire/cable in treating greater trochanter fractures ●

Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications for use. These indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2005

Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex. Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K052736

Trade/Device Name: Arthrex K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fastener Regulatory Class: II Product Code: HTY Dated: September 29, 2005 Received: September 30, 2005

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 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 - Ann Waterhouse, RAC

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/industry/support/index.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices 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:

Fixation of small bone fragments, in long bone or small bone fractures .
Arthrodesis in hand and foot surgery .
Distal or proximal metatarsal or metacarpal osteotomies .
Mono or Bi-Cortical osteotomies in the foot or hand .
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
. Guide Wire in hip pinning procedures
Align and reduce long bone fractures .
For use with cerclage wire/cable in treating greater trochanter fractures ●

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

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

510(k) Numbor K052736

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.