The ArthroCare Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

. Cysts
. Tumors
. Head, neck, and oral surgery
. Neck mass

The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.

Device Description

The ArthroCare Head and Neck Coblation Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific head and neck indications in otorhinolaryngology (ENT) procedures.

AI/ML Overview

This submission describes a medical device, the ArthroCare Head and Neck Coblation Wand, seeking 510(k) clearance based on substantial equivalence to a predicate device. As such, the concept of "acceptance criteria" and "device performance" as might be seen for a new AI/software-based device performing diagnostic tasks is not directly applicable in the same way.

Instead, the submission focuses on proving that the new device performs comparably to an existing, legally marketed predicate device. The "acceptance criteria" here are implicitly that the new device meets its design and performance specifications and functions comparably to the predicate device for its intended use. The "reported device performance" is the outcome of the bench and animal studies, confirming this comparability.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical electrosurgical device, the acceptance criteria are not presented in a quantitative table format suitable for diagnostic AI. Instead, the criteria are functional and comparative.

Acceptance Criterion (Implicit)	Reported Device Performance
Meets all design and performance specifications	"The Design Verification test results demonstrate that the Head and Neck Wand meets all design and performance specifications..."
Performs comparably to the predicate device (Gyrus Dissector Plasma Knife) for ablation, resection, coagulation, and hemostasis of soft tissue in ENT procedures.	"Bench testing was performed to evaluate the performance of the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. ... [The device] performs comparably to the predicate device.""A Pre-Clinical study was conducted in sheep to evaluate the tissue effects using the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. Based on the test results, the proposed device is substantially equivalent to the predicate."
No new questions of safety or effectiveness	"All testing conducted demonstrates that the ArthroCare Head and Neck Coblation Wand performs as intended when used in accordance with its labeling. The ArthroCare Head and Neck Coblation Wand is substantially equivalent to the predicate Gyrus Dissector Plasma Knife in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness."

The subsequent points (2-9) are very specific to studies involving data-driven algorithms (like AI/ML medical devices) and are generally not applicable to the 510(k) submission of a physical electrosurgical device like the ArthroCare Head and Neck Coblation Wand. The submission explicitly states "No clinical data are included in this submission," further indicating that these types of analyses were not performed. However, I will address them to clarify why they are not relevant in this context.

2. Sample size used for the test set and the data provenance

Not Applicable. This device is a physical electrosurgical tool. The "test sets" would refer to the samples and conditions used in bench and animal testing, not a dataset for an algorithm.
- Bench Testing: The submission mentions "Design Verification test results" but does not specify sample sizes for materials or number of tests.
- Animal Study: "A Pre-Clinical study was conducted in sheep." The number of animals used is not specified.
- Data Provenance: Not applicable in the context of data for an algorithm. The studies were conducted by the manufacturer (ArthroCare Corporation).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in this context typically refers to expert labels for diagnostic images or clinical outcomes for AI models. For a physical device, performance is measured against engineering specifications and direct observation of tissue effects by veterinary or surgical experts during animal studies (though not explicitly detailed here). The submission does not mention external experts establishing ground truth for testing.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labels for AI ground truth. This is not relevant for a physical device performance study.

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

No. An MRMC study is specific to evaluating diagnostic systems, especially with AI assistance. This submission does not involve AI, diagnostic tasks, or human readers.

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

Not Applicable. This is a physical electrosurgical device, not an algorithm.

7. The type of ground truth used

Not Applicable in the AI/ML sense. For bench testing, the "ground truth" would be the engineering specifications and expected physical properties or outcomes. For the animal study, the "ground truth" would be the observed tissue effects and their histopathological assessment by veterinary pathologists, compared between the device and the predicate. The submission states the animal study evaluated "tissue effects."

8. The sample size for the training set

Not Applicable. This device does not use an algorithm requiring a training set.

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

Not Applicable. This device does not use an algorithm requiring a training set or ground truth establishment in this manner.

Summary

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510(k) Summary

ArthroCare® Corporation Head and Neck Coblation® Wand

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

ﻟﻤﺴﻠﻤ

Submitter Name:	ArthroCare Corporation
Address	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Ashley J Dawson, PhDManager, Regulatory AffairsPhone: 512-358-5773Fax: 512-895-1489

Date Prepared: August 9, 2013

Device Name

Proprietary Name:	ArthroCare® Head and Neck Coblation® Wand
Common Name:	Head and Neck Coblation Wand
Classification Name:	Electrosurgical Device and Accessories
Device Class:	Class II
Product Code:	GEI
CFR Section:	21 CFR 878.4400

Predicate Device

Gyrus ACMI G3 Generator and Accessories-Dissector Plasma Knife

K080844 (August 13, 2009)

Description

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Intended Use/Indications For Use

The ArthroCare Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

. Cysts
. Tumors
. Head, neck, and oral surgery
. Neck mass

The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.

Performance Testing - Bench

Bench testing was performed to evaluate the performance of the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. The Design Verification test results demonstrate that the Head and Neck Wand meets all design and performance specifications and performs comparably to the predicate device.

Performance Testing - Animal

A Pre-Clinical study was conducted in sheep to evaluate the tissue effects using the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. Based on the test results, the proposed device is substantially equivalent to the predicate.

Performance Testing - Clinical

No clinical data are included in this submission.

Summary

All testing conducted demonstrates that the ArthroCare Head and Neck Coblation Wand performs as intended when used in accordance with its labeling. The ArthroCare Head and Neck Coblation Wand is substantially equivalent to the predicate Gyrus Dissector Plasma Knife in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness.

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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 abstract symbol that resembles a human figure with three wavy lines emanating from it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 9, 2013

Ashley J. Dawson, Ph.D. Manager, Regulatory Affairs ArthroCare Corporation 7000 West William Cannon Drive Austin, Texas 78735

Re: K131205

Trade/Device Name: ArthroCare® Head and Neck Coblation® Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 15, 2013 Received: July 16, 2013

Dear Dr. Dawson:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ashley J. Dawson, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical 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: ArthroCare® Head and Neck Coblation® Wand

Indications for Use:

The Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

. Cysts
Tumors
Head, neck, and oral surgery
Neck mass

The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-off) Division of Surgical Devices 510(k) Number

Page 1 of 1

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.