The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy
Cysts
Head, Neck, Oral, and Sinus Surgery
Mastoidectomy
Myringotomy with Effective Hemorrhage Control
Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
Neck Mass
Papilloma Keloids
Submucosal Palatal Shrinkage
Submucosal Tissue Shrinkage
Tonsillectomy
Traditional Uvulopalatoplasty (RAUP)
Tumors
Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Device Description

The ArthroCare ENT Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

AI/ML Overview

This document is a 510(k) summary for the ArthroCare ENT Coblator Surgery System, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device after modifications to performance and dimensional specifications, and labeling.

Therefore, the document does not contain the kind of detailed study information (like acceptance criteria, sample sizes, expert qualifications, or MRMC studies) that would typically be found in a clinical trial report or a comprehensive validation study for a new, non-substantially equivalent device.

Here's why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable / Not provided. The document states that the "proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System." This implies that the device is expected to meet the existing performance and safety standards established for the predicate device (K021364), rather than defining new, explicit acceptance criteria and then presenting new performance data against them. The phrase "performance specifications" refers to the device's technical characteristics, not clinical performance metrics.

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

Not applicable / Not provided. This document is a 510(k) submission, not a new clinical study report. It relies on the substantial equivalence to a previously cleared device (K021364) for safety and effectiveness. There is no mention of a new "test set" in the context of clinical or performance data to prove efficacy for the modified device.

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

Not applicable / Not provided. As no new test set or clinical study is described, this information is not present.

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

Not applicable / Not provided. No specific test set with ground truth is mentioned.

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 / Not provided. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Such a study would not be relevant.

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

Not applicable / Not provided. This is not an AI algorithm.

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

Not applicable / Not provided. No clinical ground truth data is presented for this 510(k) submission. The safety and effectiveness are based on substantial equivalence to the predicate device.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/machine learning device; thus, there is no "training set."

9. How the ground truth for the training set was established:
* Not applicable / Not provided. As there is no training set, this information is not relevant.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, rather than a report on a new clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present. The core claim is that the modifications "do not significantly affect the safety or efficacy of the System" compared to the predicate, K021364.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized "A" with a swooping line underneath, followed by the text "rthroCare" in a clean, sans-serif font. Below "rthroCare" is the word "CORPORATION" in smaller, all-caps letters.

FEB 0 3 2003

510(k) Summary 030108 ArthroCare Corporation ArthroCare ENT Coblator Surgery System

General Information

Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 (408) 736-0224 Phone Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs Date Prepared: January 10, 2003 Device Description Trade Name: ArthroCare ENT Coblator Surgery System Generic/Common Name: Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (21 CFR 878.4400) Predicate Devices ENTec® Plasma Wands K021364

Product Description

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Intended Uses

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

파 Adenoidectomy
Cysts
Head, Neck, Oral, and Sinus Surgery
트 Mastoidectomy
Myringotomy with Effective Hemorrhage Control
파 Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
트 Neck Mass
Papilloma Keloids
트 Submucosal Palatal Shrinkage
트 Submucosal Tissue Shrinkage
Tonsillectomy
l Traditional Uvulopalatoplasty (RAUP)
I Tumors
Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications. dimensional specifications, and labeling for the ArthroCare ENT Coblator Plasma Surgery System, which was previously cleared in K021364 on May 30, 2002. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare ENT Coblator Surgery System remain the same as in the predicate cleared 510(k).

Summary of Safety and Effectiveness

The modified ArthroCare ENT Coblator Surgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Arthocare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936

Re: K030108

Trade/Device Name: Arthrocare ENT Coblator Surgery System Regulation Number: 878:4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2003 Received: January 13, 2003

Dear Ms. Defiesta-Ng:

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.

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 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.

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Page 2 - Ms. Valerie Defiesta-Ng

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. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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Indications for Use Statement

ArthroCare ENT Coblator Surgery System Device Name:

KO30108 510(k) Number:

Indications for Use:

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy l
트 Cysts
Head, Neck, Oral, and Sinus Surgery .
트 Mastoidectomy
Myringotomy with Effective Hemorrhage Control 트
I Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
트 Neck Mass
트 Papilloma Keloids
트 Submucosal Palatal Shrinkage
발 Submucosal Tissue Shrinkage
이 Tonsillectomy
이 Traditional Uvulopalatoplasty (RAUP)
해 Tumors
Tissue in the Uvula/Soft Palate for the Treatment of 트 Snoring

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

Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

Miriam C. Provost

Ivision Sign-Off) Ivision of General, Restorative and Neurological Devices

Number K630/08

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.