The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including:

Abscesses
Aponeurotic Repair
Basal Cell Carcinoma
Biopsy
Blepharoplasty
Cosmetic Repairs
Cysts
Epithelioma
Keratosis
Mammaplasty
Nevi (Moles)
Oculoplastic Procedures
Panniculectomy
Papilloma Keloids
Pedicle Flap
Rhytidectomy
Development of Skin Flaps
Skin Tags
Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows
Verrucae (Warts)

Device Description

The Visage Wands are bipolar, high frequency electrosurgical devices designed for general dermatological, cosmetic, plastic, and reconstructive procedures.

AI/ML Overview

This 510(k) summary for the ArthroCare Visage® Wands does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a modern regulatory submission for AI/ML-based medical devices.

The document is for an electrosurgical device cleared in 2002, which is a different class of device with different regulatory requirements and evaluation methods compared to AI/ML diagnostic tools.

Here's why the requested information cannot be extracted from the provided text:

Device Type: The Visage® Wands are an electrosurgical device for cutting, coagulation, and ablation, not an AI/ML diagnostic or predictive tool. Performance is typically assessed through engineering tests, biocompatibility, sterilization validation, and often animal or cadaver studies, rather than clinical studies with human readers or AI algorithms.
Regulatory Era: This submission dates back to 2002. Regulatory expectations for clinical evidence, especially for demonstrating performance against specific numerical acceptance criteria, have evolved significantly since then. For electrosurgical devices, the focus was often on substantial equivalence to predicate devices based on intended use, materials, product specifications, and energy requirements, supported by bench testing and sometimes preclinical animal studies.
Nature of "Performance Testing": The document states, "performance testing has been completed to demonstrate the safe and effective use of the Visage Wands in the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels." This "performance testing" refers to general engineering and safety tests (e.g., power output, safety features, material compatibility) rather than a clinical study with detailed statistical analysis, sample sizes, and ground truth establishment in the way AI/ML devices are evaluated.
Lack of AI/ML Component: There is no mention of any AI or machine learning component in this device. Therefore, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "training set," or "test set" as understood in AI/ML validation are not applicable.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details for an AI/ML device based on this document.

The document primarily focuses on:

Intended Use and Indications: Clearly defining what the device is for and the specific procedures it can be used in.
Substantial Equivalence: Comparing the device to legally marketed predicate devices to demonstrate that it is as safe and effective.
Regulatory Classification: Identifying the relevant CFR section and product code.

If you were to search for similar information for an AI/ML device, you would need a 510(k) summary or an FDA Decision Summary that explicitly details the clinical performance study, often found in sections describing "Non-Clinical Data" (for bench/software testing) and "Clinical Data" (for human studies).

Summary

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ArthroCare
CORPORATION

510(k) Summary

MAY 0 2 2002

ArthroCare Corporation Visage® Wands

K020408

2951580

(408) 736-0224

Bruce Prothro

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Phone:

Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

February 6, 2002

Visage® Wands

Electrosurgical Device and Accessories

Vice President, Regulatory Affairs, Quality

Assurance, and Clinical Research

Classification Name:

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

Predicate Devices

ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System Coherent Ultrapulse CO2 Laser Ellman Surgitron IEC Ethicon PowerStar Bipolar Scissors MedArt Uni-Laser 450P CO2 Laser System & Accessories

K001302 K003624 K963339 K980177 K981361 K991297

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Product Description

The Visage Wands are bipolar, high frequency electrosurgical devices designed for general dermatological, cosmetic, plastic, and reconstructive procedures.

Intended Use

The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including:

트 Abscesses
트 Aponeurotic Repair
로 Basal Cell Carcinoma
트 Biopsy
Blepharoplasty
Cosmetic Repairs
트 Cysts
Epithelioma 트
Keratosis
Mammaplasty
하 Nevi (Moles)
Oculoplastic Procedures 트
메 Panniculectomy
Papilloma Keloids 트
Pedicle Flap 에
트 Rhytidectomy
Development of Skin Flaps 프
Skin Tags 트
. Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows
. Verrucae (Warts)

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. Additionally, performance testing has been completed to demonstrate the safe and effective use of the Visage Wands in the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels. The expansion of the indications to include specific general dermatological, cosmetic, plastic, and reconstructive procedures does not raise any new issues of safety or efficacy.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with lines extending above them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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: K020408

Trade/Device Name: Visage® Wands Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 6, 2002 Received: February 7, 2002

Dear Mr. Prothro:

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. 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 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 - 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 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

Device Name: 510(k) Number:

Visage® Wands K02Q408_

Indications for Use:

The Visage Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general dermatology, cosmetic, plastic, and reconstructive surgery including:

Abscesses 을
Aponeurotic Repair 글
프 Basal Cell Carcinoma
트 Biopsy
해 Blepharoplasty
트 Cosmetic Repairs
Cysts
Epithelioma
트 Keratosis
Mammaplasty 이
Nevi (Moles)
Oculoplastic Procedures
Panniculectomy
Papilloma Keloids
Pedicle Flap
Rhytidectomy
Development of Skin Flaps
Skin Tags
Skin Resurfacing for Treatment of Wrinkles, Rhytides, and Furrows
Verrucae (Warts)

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

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

Muriam C. Provost

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

510(k) Number K020408

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.