The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

Device Description

The ArthroCare Electrosurgery System is a bipolar, high frequency electrosurgical System designed for use in general surgical procedures where ablation and resection of soft tissue and coagulation of blood vessels is desired. The System consists of three components: an electrosugical generator called the Controller, the reusable Cable, and the disposable Wand. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to connect the Controller to the Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.

AI/ML Overview

This document is a 510(k) summary for a medical device modification, not a study report. It states that the device's substantial equivalence is based on the fact that modifications to the ArthroCare Electrosurgery System's Wands "are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." Therefore, it does not contain specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria in the way a clinical or performance study would.

Instead, the submission for K992972 is a Special 510(k) for modifications to an already cleared device (K971532). It claims substantial equivalence to the predicate device because the technology, principle of operation, and intended use remain the same.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted directly from this document.

Here's what can be gathered, addressing your points where possible:

A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission asserts that the modifications do not significantly affect safety or efficacy, implying that the modified device's performance is still within the acceptable range of the original cleared device. No new performance metrics or acceptance criteria are defined or reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. This document does not describe a performance or clinical study with a test set.
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/Not provided. This document does not describe a performance or clinical study requiring ground truth establishment by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. This document does not describe a performance or clinical study with a test set.
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 electrosurgery system, not an AI-assisted diagnostic tool leveraging human readers. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgery system and does not involve an algorithm for standalone performance evaluation in the described context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. As there is no described performance study, there is no ground truth data. The submission relies on demonstrating that modifications do not change the fundamental safety and efficacy established for the predicate device.
The sample size for the training set:
Not applicable/Not provided. This document does not describe a performance study involving a training set.
How the ground truth for the training set was established:
Not applicable/Not provided. As there is no training set described, there is no ground truth established for it.

Summary

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K992972

Special 510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare® Electrosurgery System

Manufacturer:

ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94086-2916

Establishment Registration Number:

Contact Person:

Betty M. Johnson Manager, Regulatory Affairs

September 2, 1999

Device and Accessories (21 CFR 878.4400)

2951580

Date Prepared:

Device Description

Classification Name:

Trade Name:

Generic/Common Name:

Predicate Devices

ArthroCare Electrosurgery System

ArthroCare® Electrosurgery System

Electrosurgical Cutting and Coagulation

Electrosurgical Device and Accessories

K971532; cleared on July 23, 1997

Intended Use

The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

Product Description

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is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.

Substantial Equivalence

The ArthroCare Electrosurgery System was previously cleared under K971532, on July 23, 1997 for the following indications: soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures. This special 510(k) proposes modifications in materials, performance specifications, and labeling for the ArthroCare Electrosurgery System. The proposed modifications are only applicable to the Wand components of the System. The technology, principle of operation and the intended use of the entire System remain the same as in the original cleared 510(k). The modified Wands have the following similarities to the ArthroCare Electrosurgery System Wand which was previously cleared in K971532:

. the same indications for use
the same operating principle .
incorporate the same basic Wand design .
. packaged and sterilized using the same materials and processes

Summary of Safety and Effectiveness

The ArthroCare Electrosurgery System modified Wands, described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in materials, performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.

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Image /page/2/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 symbol that resembles an abstract human figure or a caduceus, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Ms. Betty M. Johnson Manager, Regulatory Affairs Arthrocare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086-2916

Re: K992972

Trade Name: ArthroCare® Electrosurgery System Regulatory Class: II Product Code: GEI Dated: September 2, 1999 Received: September 3, 1999

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Betty M. Johnson

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Indications Statement

Device Name: 510(k) Number: ArthroCare® Electrosurgery System Koo Zaar

Indications for use:

The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

[Signature]

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992972

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-the-Counter Use
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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.