The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding.
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 comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or as a loop electrode. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The ArthroCare Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ArthroCare Electrosurgery System. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance metrics.

Instead, a 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device already legally marketed in the US, rather than proving performance against specific quantitative acceptance criteria through a standalone study with performance metrics like sensitivity, specificity, etc.

Here's why the requested information cannot be fully provided from this document:

Nature of the submission: This is a 510(k) for an electrosurgical system. These submissions primarily focus on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.
Medical Device vs. AI/Software: The questions provided are highly tailored for AI/Software-as-a-Medical-Device (SaMD) or diagnostic devices where performance metrics (e.g., sensitivity, specificity, AUC) are key. This document describes a physical electrosurgical system, which is broadly different. The document explicitly states "There is no software utilized in the operation of the Controller."
Focus on Equivalence: The document repeatedly emphasizes "substantial equivalence" and states "The technological characteristics of the ArthroCare Electrosurgery System are identical to those of the predicate ArthroCare devices, as well as the devices distributed by other manufacturers. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization."

Therefore, I cannot populate the table or answer most of the questions as they are not applicable to the type of information presented in this 510(k) for an electrosurgical system.

However, I can extract the following relevant details from the provided text:

Device Name: ArthroCare Electrosurgery System
Intended Use: "The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding." (Section D) and "The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures." (Indications Statement)
Predicate Devices: K943450, K955531, K961069, K962445, K963123, K964849 (all ArthroCare systems) and K800617, K850668 (Conmed Hyfrecator).
Key Technological Feature: Bipolar operation with an integral return electrode on the shaft, eliminating the need for a separate return pad and preventing energy penetration through the patient's body (unlike monopolar devices).
Lack of Software: "There is no software utilized in the operation of the Controller."

Regarding your specific questions:

A table of acceptance criteria and the reported device performance: This document does not provide such a table. Performance against specific quantitative acceptance criteria is not typically required for a 510(k) submission where substantial equivalence to a predicate device is established based on technological characteristics and intended use.
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 type of data is associated with clinical studies or performance studies, which are not detailed here as the submission relies on substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment is relevant for diagnostic performance studies, not for a 510(k) of an electrosurgical device based on technological equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
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. The device is an electrosurgical system, not an AI-assisted diagnostic tool. There's no AI involved ("no software utilized").
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The submission is based on substantial equivalence, not performance against an established ground truth.
The sample size for the training set: Not applicable. No machine learning training set is involved.
How the ground truth for the training set was established: Not applicable. No machine learning training set is involved.

Summary

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

ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

JUL 2 3 1997

X. 510(k) Summary

971532

Name of Device A.

gar general de la provinsi de la provinsi de la provinsi de la provincia de la provincia de la provincia de la provincia de la provincia de la provincia de la provincia de l'

Trade name:	ArthroCare Electrosurgery System
Common name:	Electrosurgical System
Classificationname:	Electrosurgical Cutting and Coagulation Device andAccessories(21 CFR 878.4400)

B. Predicate devices

Device	PremarketNotification
ArthroCare Arthroscopic Electrosurgery System 970	K943450, 03/10/95
ArthroCare Bipolar Loop Electrosurgery System	K955531, 02/21/96
ArthroCare Urologic Multi-electrode ElectrosurgerySystem	K961069, 05/28/96
ArthroCare Dental Wand System	K962445, 07/30/96
ArthroCare Electrosurgery System 980	K963123, 10/08/96
ArthroCare General Dermatology ElectrosurgerySystem	K964849, 04/14/97
Conmed Hyfrecator	K800617, 05/02/80K850668, 05/20/85

C. Device description

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

ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

frequency electronic instrument. There is no software utilized in the operation of the Controller.

The ArthroCare Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

D. Intended use

The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding.

E. Technological characteristics

The technological characteristics of the ArthroCare Electrosurgery System are identical to those of the predicate ArthroCare devices, as well as the devices distributed by other manufacturers. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization.

F. Summary

By virtue of design, materials, function and intended use, the ArthroCare Electrosurgery System is substantially equivalent to devices currently marketed in the United States.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures or forms that are interconnected and flowing upwards, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl L. Shea Director-Regulatory and Clinical Affairs ArthroCare Corporation . . . . . . . . . . . . . . 595 North Pastoria Avenue Sunnyvale. California 94086

JUL 2 3 1997

Re: K971532

Trade Name: ArthroCare Electrosurgery System Regulatory Class: II Product Code: GEI Dated: April 25, 1997 Received: April 28, 1997

Dear Ms. Shea:

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 requirements , as set forth in the Quality System Regulation (OS) 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.

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

Page 2 - Ms. Cheryl L. Shea

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,

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

Enclosure

{4}------------------------------------------------

ArthroCare Corporation Sunnyvale, California Premarket Notification April 25, 1997

Indications Statement

Device Name: ArthroCare Electrosurgery System 510(k) Number: ---------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tion (OBE)

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

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.