The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for use in a range of surgical procedures. The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.

Device Description

The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for a range of surgical repairs. The electrodes are sold sterile, single use in a pouch/pouch configuration.

AI/ML Overview

This 510(k) premarket notification for the Arthrex OPES Electrodes and Accessories is a submission for a Class II electrosurgical cutting and coagulation device. The submission declares substantial equivalence to predicate devices.

Substantial equivalence claims are based on demonstrating that the new device has the same intended use and technical characteristics as a predicate device, or if it has different technological characteristics, that it can be demonstrated to be as safe and effective as the predicate device.

Crucially, this type of submission (510(k) for substantial equivalence) typically does not include new clinical study data or performance metrics against specific acceptance criteria in the way a PMA (Premarket Approval) application would for novel devices. Instead, it relies on demonstrating that the device is similar enough to already marketed devices that new studies are not required to prove safety and effectiveness.

Therefore, many of the requested elements for a study proving device acceptance criteria will not be present in this document.

Here's an analysis based on the provided text:

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

This document describes a substantial equivalence claim for a Class II medical device (electrosurgical cutting and coagulation device). There is no table of acceptance criteria and reported device performance within this 510(k) summary. Substantial equivalence claims are primarily based on comparing the new device's design, materials, intended use, and performance to a legally marketed predicate device, rather than establishing and meeting novel acceptance criteria through a new clinical study. The assertion given is: "The difference between the Arthrex product line and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness. Furthermore, the device and accessories are well characterized and have been used in surgical applications with similar indications. The devices, as designed, are as safe and effective as predicate devices."

Regarding a study that proves the device meets the acceptance criteria:

Based on the information provided, no new clinical or comparative effectiveness study is presented in this 510(k) summary to establish or prove performance against specific acceptance criteria. The basis for clearance is substantial equivalence to predicate devices. This means that Arthrex asserted that their device is as safe and effective as a device already on the market without needing to conduct a new comprehensive study with novel acceptance criteria.

Therefore, the following points associated with a new clinical study are not applicable or cannot be extracted from this 510(k) summary:

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

Not applicable. No specific new test set or associated data provenance is described in this substantial equivalence submission.

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. No new test set or ground truth establishment by experts is detailed for this substantial equivalence submission.

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

Not applicable. No new test set or adjudication method is described.

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. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, and there is no mention of an MRMC or AI component.

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

Not applicable. This device is an electrosurgical tool, not an algorithm.

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

Not applicable. No new ground truth data is presented for a novel study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device(s).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that would require a training set.

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

Not applicable. (See point 8)

Summary

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KO23986

DEC 1 7 2002

510(k) Summary

510(k) Number:
Company:	Arthrex, Inc.
Address:	2885 S. Horseshoe Dr., Naples, FL 34104
Telephone:	(239) 643-5553
Facsimile:	(239) 430-3494
Contact:	Ann Waterhouse
Trade Name:	Arthrex OPES Electrodes and Accessories

Product Code: GEI

Common Name: High Frequency Devices and Accessories

Description:

Indications for Use:

The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.

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. The difference between the Arthrex product line and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness. Furthermore, the device and accessories are well characterized and have been used in surgical applications with similar indications. The devices, as designed, are as safe and effective as predicate devices.

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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 depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The profiles are positioned within a circular frame. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

DEC 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TUV Product Service · Mark Job . 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K023986

Trade/Device Name: Arthrex Opes Electrodes and Accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2002 Received: December 2, 2002

Dear Mr. Job:

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

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Page 2 -- Mr. Mark Job

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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. 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K023986 510(k) Number (if known):

Device Name: Arthrex OPES Electrodes and Accessories

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Option Format 3-10-98)

Prescription use

Clara Wells

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

510(k) Number _K023986

Revised page 6

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.