The provided text is a 510(k) Premarket Notification for the "ThermaCool TC System." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical or AI performance study would.

The document states:

"There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
"However, voluntary standards such as in-house Standard Operating Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device."

Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as a regulatory submission demonstrating equivalence, not a detailed performance study with acceptance criteria.

To answer your specific questions based on the provided document:

A table of acceptance criteria and the reported device performance:
- Not available in the provided text.
- The document implies that "voluntary standards such as in-house Standard Operating Procedures" are used, but no specific performance metrics or acceptance criteria are listed.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text. This document does not describe a clinical test set or data.
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):
- Not applicable. This document does not describe a study involving expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. This device is an electrosurgical system, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electrosurgical system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable.
The sample size for the training set:
- Not applicable.
How the ground truth for the training set was established:
- Not applicable.

Summary

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031046

510(k) Premarket Notification

Summary of Safety and Effectiveness Information

ThermaCool TC SYSTEM APRIL 1, 2003

ThermaCool TC System Device Name:

RF Unit, coagulator Common Name(s):

Classification Name: Electrosurgical cutting and coagulation device and accessories

Establishment Name & Registration Number:

Thermage Name: Number: 2954746

Classification:

Title 21, Code of Federal Regulations,

$ 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.

ProCode: 79GEI

Equivalent Device(s): The modified ThermaCool TC System claims substantial equivalence to the ThermaCool TC System K013639 and K021402.

Description of the Device:

The device as described in the above referenced Premarket Notifications has been modified to include a modified Treatment Tip.

Applicant / Sponsor Name / Address:

Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax

Contact Person:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Havward, CA 94545-3721 510.782.2286 telephone 510.723.3348 fax

Submission Correspondent:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510. 723.3348 fax

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031046 4/2

Manufacturing Facility:

At the present time, this ThermaCool TC System component is manufactured by Thermage Inc. in accordance with defined Thermage specifications.

Performance Standards:

There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories. However, voluntary standards such as in-house Standard Operating Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, with three curved lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

MAY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, R.N., M.S. Senior Director, Clinical/Regulatory Affairs Thermage 4058 Point Eden Way Hayward, California 94545

Re: K031046

Trade/Device Name: ThermaCool TC System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 1, 2003 Received: May 8, 2003

Dear Ms. Buckman:

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 - Ms. Pamela M. Buckman, R.N., M.S.

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. 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) you may obtain. 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 vours.

Mark N Wilkerson

Celia 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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DEVICE NAME: ThermaCool TC System

INDICATIONS FOR USE:

The ThermaCool TC System is indicated for use in

. Non-invasive treatment of periorbital rhytids and wrinkles
. Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Mark N. Wilkinson

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

510(k) Number K031046

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

ThermaCool510.doc

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.