The ENTec Plasma Wands are 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 ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.

AI/ML Overview

This document is a 510(k) summary for the ArthroCare ENTec® Plasma Wands™, submitted to the FDA for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific device performance from a study, sample sizes, expert involvement, and ground truth methodologies is not explicitly available within the provided text. The document is a regulatory submission for premarket clearance, not a clinical study report.

Here's an attempt to answer the questions based only on the provided text, while also clearly stating what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on:

Indications for use (which are essentially the same as the predicate devices).
Materials incorporated.
Product specifications.
Energy requirements.

No specific quantitative acceptance criteria (e.g., minimum ablation rate, maximum tissue damage at a certain power) or a study reporting detailed device performance against such criteria are presented. The core argument is that the device is similar enough to already approved devices.

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

This information is not provided in the 510(k) summary. Given that it's a 510(k) for substantial equivalence and not a clinical trial report, there's no mention of a "test set" in the context of clinical performance data. The evaluation was likely based on bench testing, comparison of specifications, and a review of existing clinical data for the predicate devices.

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

This information is not provided. There is no mention of a "test set" requiring expert ground truth in this document.

4. Adjudication method for the test set

This information is not provided. There is no mention of a "test set" or an adjudication method.

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 tool, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI performance evaluation is irrelevant and not applicable here.

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

This information is not provided. This is an electrosurgical device, not an algorithm, so a standalone algorithm performance study is not applicable.

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

This information is not provided. No specific "ground truth" (in the context of clinical outcomes or diagnostic accuracy) is discussed as this is a 510(k) for an electrosurgical device based on substantial equivalence. The "ground truth" for the submission is that the predicate devices are safe and effective, and the new device is substantially equivalent to them.

8. The sample size for the training set

This information is not provided. As this is a medical device and not an AI/ML algorithm being developed, the concept of a "training set" in the context of machine learning is not applicable here.

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

This information is not provided. As explained above, the concept of a "training set" for AI/ML is not relevant to this 510(k) submission for an electrosurgical device.

Summary

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ArthroCare
CORPORATION

MAR 2 8 2002

510(k) Summary ArthroCare Corporation ENTec® Plasma Wands™

KO14290

General Information

Manufacturer:

ArthroCare, Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

2951580

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

Date Prcpared:

Device Description

Trade Namc:

ENTcc® Plasma Wands™M

December xx, 2001

Generic/Common Name:

Classification Name:

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

Electrosurgical Device and Accessories

Predicate Devices

Predicate Devices
ENTec Coblator™ Plasma Surgery System	K973478, K000036,K000778, and K011279
Somnus Somnoplasty System	K982717
Ethicon PowerStar Bipolar Scissors	K981361
Ellman Surgitron IEC II	K001253
Lumenis VersaPulse PowerSuite Holmium(Ho:YAG) and Dual Wavelength(Ho:YAG/Nd:YAC) Surgical Lasers	K011703
Medtronic Xomed Monopolar EnergizedBlade	K002987

680 Vaqueros Avenue • Sunnyvale, CA 94085 • (408) 736-0224 • Fax: (408) 736-0226

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Intended Use

The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

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

Product Description

The ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.

Substantial Equivalence

In establishing substantial equivalence to the predicate devices, ArthroCare evaluated the indications for use, materials incorporated, product specifications, and energy requirements of those systems. The expansion of the indications to include specific ENT procedures does not raise any new issues of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol in the center, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

MAR 2 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Re: K014290

Trade/Device Name: ENTec® Plasma Wands™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 27, 2001 Received: December 28, 2001

Dear Mr. Prothro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to 114) 2011-01-11 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, alors, and controls 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 (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 or any I vith 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 - Mr. Bruce Prothro

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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

for Celia M. Witten, Ph.D., M.D.
Director 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

ENTec® Plasma Wands™ Device Name: K 014290 510(k) Number:

Indications for Use:

The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy .
Cysts 요
Head, Neck, Oral, and Sinus Surgery 체
속 Mastoidectomy
Myringotomy with Effective Hemorrhage Control 예
Nasal Airway Obstruction by Reduction of Hypertrophic 트 Nasal Turbinates
Nasopharyngeal/Laryngeal indications including u Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
Neck Mass 때
Papilloma Keloids 의
Submucosal Palatal Shrinkage 1
Submucosal Tissue Shrinkage 속
Tonsillectomy
Traditional Uvulopalatoplasty (RAUP)
Tumors
Tissue in the Uvula/Soft Palate for the Treatment of Snoring

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801 109)	X OR	Over-the-Counter Use

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K014290

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.