The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.

Device Description

The AccENT Head and Neck Electrosurgery System is comprised of three components: the AccENT Wand, the AccENT Cable, and an electrosurgical generator called the Controller. The Cable connects the Controller to the Wand. The Wand is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm. The Wand offset and distal tip angles range from 0 to 90 degrees. The AccENT wand shaft is configured as straight or offset to allow for better access to the treatment area. The distal tip is configured with multi-electrodes. The Wand is supplied sterile and intended for single patient use. The 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 AccENT Head and Neck 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

The provided text is a 510(k) Premarket Notification for the ArthroCare AccENT Head and Neck Electrosurgery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and detailed performance metrics as would be typical for a novel device or software.

Therefore, many of the requested elements for describing an acceptance criteria study are not present in this document. The submission relies on demonstrating that the new device has "technological characteristics...the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems." In other words, its acceptance is based on its similarity to already cleared devices, implying similar performance.

Here's an analysis based on the information available:

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

This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices, implying that the performance is expected to be similar to already-cleared devices for ablation and coagulation. No specific performance metrics or acceptance criteria are listed.

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

This information is not provided. As this is a 510(k) submission based on substantial equivalence, there is no mention of a specific test set or clinical study conducted to establish performance in the way implied by this question.

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)

This information is not provided. No specific test set with ground truth established by experts is mentioned.

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

This information is not provided.

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

This information is not provided. This device is an electrosurgical system, not an AI-powered diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not provided. This device is an electrosurgical system, not an algorithm. Its operation involves direct use by a surgeon.

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

This information is not provided. No specific ground truth establishment is described, as the submission focuses on substantial equivalence to existing devices.

8. The sample size for the training set

This information is not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

This information is not provided.

Summary of Device Acceptance Criteria (Implied by Substantial Equivalence):

While no explicit acceptance criteria are stated for a study of the AccENT Head and Neck Electrosurgery System, the 510(k) submission process itself implies the following:

Acceptance Criteria (Implied): The device must be "substantially equivalent" to legally marketed predicate devices in terms of intended use, technological characteristics (design, materials, principle of operation, product specifications), and safety and effectiveness.
Study Proving Acceptance (Implied): The submission is the "study" proving acceptance. It demonstrates this by:
- Identifying Predicate Devices: Listing several predicate electrosurgical and surgical systems (ArthroCare Arthroscopic Electrosurgery System, Valleylab Force 2 Electrosurgical Generator, etc.).
- Detailing Device Description: Explaining the components (Wand, Cable, Controller), its bipolar nature, and how it operates.
- Stating Intended Use: Clearly defining its use for ablation and coagulation of soft tissue in otolaryngological surgery.
- Comparing Technological Characteristics: Explicitly stating that the "technological characteristics of the AccENT Head and Neck Electrosurgery System are the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization."

In essence, the "proof" for this 510(k) submission is the argument that the AccENT system is fundamentally the same as devices already on the market and has no new questions of safety or effectiveness.

Summary

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ArthroCare Corporation Sunnyvale, California Premarket Notification

510(k) Summary X.

JAN - 9 1998

Name of Device A.

Trade name:	AccENT Head and Neck Electrosurgery System
Common name:	Electrosurgical Unit and Accessories
Classification name:	Electrosurgical Cutting and Coagulation Device(21 CFR 878.4400)

Predicate devices B.

Device	Premarket Notification
ArthroCare Arthroscopic Electrosurgery System	K943450, 03/10/95
ArthroCare Arthroscopic Electrosurgery System 980(Model 2000)	K963123, 10/08/96
ArthroCare Dental Electrosurgery System	K962445, 07/30/96
ArthroCare General Dermatology ElectrosurgerySystem	K964849, 04/14/97
Stryker Hummer II MicroDebrider System	K952681, 07/20/95
Valleylab Force 2 Electrosurgical Generator	K921884, 12/92
Coherent Medical Versapulse Laser System	K914136
Sharplan CO2 Surgical Laser	K933362

Device description C.

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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.

D. Intended use

The AccENT Head and Neck Electrosurgery System is intended for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.

Technological characteristics E.

The technological characteristics of the AccENT Head and Neck Electrosurgery System are the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems. 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 AccENT Head and Neck Electrosurgery System is substantially equivalent to devices currently marketed in the United States.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

Mr. Mark Smutka Director, Regulatory Affairs and Quality Assurance Arthrocare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086

Re: K973478

Trade Name: AccENT Head & Neck Electrosurgery System Regulatory Class: II Product Code: GEI Dated: December 11, 1997 Received: December 15, 1997

Dear Mr. Smutka:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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

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Page 2 - Mr. Smutka

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

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

Enclosure

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ArthroCare Corporation Sunnyvale, California Premarket Notification

Indications Statement

AccENT Head and Neck Electrosurgery System Device Name:

510(k) Number: K973478

Indications for use:

The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number L973478

X Prescription Use (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.