Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Thermage ThermaCool TC System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity, or specific performance metrics) that the Thermage ThermaCool TC System had to meet. Instead, the submission relies on the concept of substantial equivalence to predicate devices. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device has "substantially equivalent" technological characteristics and intended use to previously cleared devices.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (Thermage ThermaCool IIA System, ThermaCool II System, ThermaCool System) in terms of:	"The technological characteristics of the Thermage ThermaCool TC System are substantially equivalent to those of the Thermage ThermaCool IIA System, ThermaCool II System, and ThermaCool System."
- Design	(Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim)
- Principle of operation	(Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim)
- Materials	(Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim)
- Intended use (Dermatologic and General Surgical procedures for electrocoagulation and hemostasis)	"The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis." (Matches the stated intended use)

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic performance. The submission relies on establishing substantial equivalence through a comparison of technological characteristics and intended use with predicate devices. Therefore, there is no mention of a specific sample size for a test set, nor is there information about data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no described clinical study with a "test set" or diagnostic performance evaluation, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Since no test set or diagnostic performance study is described, there is no information about an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The submission focuses on substantial equivalence rather than comparative effectiveness with human readers.

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

This device is an electrosurgical unit, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The submission focuses on the safety and effectiveness of the medical device itself through substantial equivalence.

7. The Type of Ground Truth Used

Given that this is a 510(k) submission for an electrosurgical unit based on substantial equivalence, the "ground truth" is effectively derived from the established safety and effectiveness of the predicate devices. There is no mention of pathology, outcomes data, or expert consensus in the context of demonstrating this device's performance against a specific "ground truth" for a diagnostic task.

8. The Sample Size for the Training Set

This submission is for a medical device (electrosurgical unit), not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/machine learning device, the concept of establishing "ground truth for a training set" is not applicable.

Summary

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JAN 2 9 2002

K013639

510(k) Safety Summary 14.0

Name of Device A.

Trade Name:	Thermage ThermaCool TC System (Model TC)
Common Name:	Electrosurgical Unit and Accessories
Classification Name:	Device, Electrosurgical Cutting and Coagulation andAccessories (21 CFR 878.4400)
Contact Person:	Pamela M. Buckman, RN, MSSr. Director of Regulatory/Clinical Affairs

Predicate Devices B.

ThermaCool TC System (including coolant canister and footswitch:

Device	Premarket Notification
Thermage ThermaCool IIA System	K013034, Cleared 10/4/01
Thermage ThermaCool II System	K003183, Cleared 12/8/00
Thermage-ThermaCool System	K000944, Cleared 7/19/00

Other ThermaCool TC System Accessories (return pad, coupling fluid and skin marking paper):

Accessory	Predicate	Premarket Notification
Return Pad	Nikomed ElectrosurgicalGrounding Pad	K000079, Cleared 2/4/00
Coupling Fluid	Cadwell Lectron II	K933804, Cleared 3/22/94
Skin MarkingPaper	Skin Marker	Class I, Exempt (878.4660)

Device Description C.

The Thermage ThermaCool TC System consists of the following components:

RF Generator .
Coolant Control Center ●
Coolant Canister .
Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
Accessory cables and tubing ●
Optional footswitch component .
Accessories: coupling fluid, return pad and skin marking paper .

The Handpiece Assembly and Coolant Control Center connect to the RF Generator.

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Indicated Use D.

The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Technical characteristics E.

The technological characteristics of the Thermage ThermaCool TC System are substantially equivalent to those of the Thermage ThermaCool IIA System, ThermaCool II System, and ThermaCool System.

F. Summary

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool TC System is substantially equivalent to devices currently cleared for marketing in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

JAN 2 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela M. Buckman, RN, MS Sr. Director of Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721

Re: K013639

Trade Name: Thermage Thermacool TC System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2002 Received: November 5, 2001

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Buckman

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxeming your antial equivalence of your device to a legally premarket nothication: "The PDF micing of casification 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 II you desire specific au rio for you avitro diagnostic devices), please contact the Office of additionally 21 CT F Fatt 607.10 for questions on the promotion and advertising of Compliance at (301) 594 1057. Thenker Compliance at (301) 594-4639. Also, please note the your device, prodo combranding by reference to premarket notification™ (21CFR Part 807.97). It general information on your responsibilities under the Act may be obtained from the Other general information on your respectional 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,

/ Mark n Millan

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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510(k) NUMBER (IF KNOWN):

Thermage ThermaCool TC System (Model TC)

INDICATIONS FOR USE:

DEVICE NAME:

The Thermage ThermaCool TC System (Model TC) is indicated for use in Dermatologic The Thermage Thematoon To 65 electrocoagulation and hemostasis.

K013639

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use

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

Thermage ThermaCool TC System 510(k)
510(k) Number. K013639

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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.