The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.

AI/ML Overview

The provided text is a 510(k) summary for the truSculpt device. It focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety standards. It explicitly states "Results of Clinical Study: None", which means the document does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that data is not present in the provided document.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: No clinical acceptance criteria or performance metrics are reported.
Sample sized used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical performance is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set.
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 not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical efficacy data is presented.
The sample size for the training set: Not applicable as no machine learning model or training set is discussed.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Establishing substantial equivalence to a predicate device (Cutera truSculpt RF Device K122389).
Listing safety requirements (IEC 60601-1-2).
Software verification and validation testing (truSculpt Software Verification and Validation Testing Report (V0005 rN)).
Comparing technological features with the predicate device.

The "Results of Clinical Study: None" statement is key here, indicating that this submission does not include data from a clinical efficacy study.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2014

Cutera Incorporated Dr. Bradley Renton Vice President of Regulatory and Medical Affairs 3240 Bayshore Boulevard Brisbane, California 94005

Re: K133739

Trade/Device Name: truSculpt Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: June 6, 2014 Received: June 9, 2014

Dear Dr. Renton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

510(k) Number (if known): K133739

Device Name: _ truSculpt

Indications for Use:

The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(K) Summary

This 510(K) Summary of safety and effectiveness for the truSculpt RF device is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Cutera, Inc.
Address:	3240 Bayshore Blvd., Brisbane, CA 94005
Contact Person:	Bradley Renton
Telephone:	415-657-5568 – phone
Fax:	415-715-3568 - fax
Email:	brenton@cutera.com
Preparation Date:	June 6, 2014
Device Trade Name:	truSculpt
Common Name:	Massager, Vacuum, Radio Frequency Induced Heat
Classification Name:	Electrosurgical cutting and coagulation device andaccessories, PBX, 21 CFR 878-4400
Legally Marketed PredicateDevice:	Cutera truSculpt RF Device (K122389)
Device Description:	The truSculpt device consists of a console, one or more RFhandpieces that connect to the console with an umbilicalcable, and a truGlide massage roller. All system functionsare controlled through the console. The handpieces deliverRF energy to generate a heating profile that produces amoderate temperature rise in the subcutaneous tissue, whilemonitoring epidermal temperature. In addition, there is aseparate mechanical roller that can be used as a massager.
Intended Use:	The truSculpt is intended to generate heat within bodytissues for the treatment of selected medical conditions,such as the relief of minor aches and pain, muscle spasms,and an increase in local circulation. It is also intended toprovide temporary reduction in the appearance of cellulite.
Specific Indications:	The truSculpt RF energy is intended to provide topicalheating for the purpose of elevating tissue temperature forthe treatment of selected medical conditions such as relief opain, muscle spasms, and increase in local circulation.The truSculpt massage device is intended to provide atemporary reduction in the appearance of cellulite.

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Attachment 5 510(K) Summary

Requirements for Safety

IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility

truSculpt Software Verification and Validation Testing Report (V0005 rN)

Results of Clinical Study: None

Summary of Technological See table below Characteristics:

Conclusion:

Cutera believes that the requested changes are substantially equivalent to the predicate device and do not raise any new issues of safety or effectiveness.

Feature/Parameter	Current	Cutera truSculpt RF Device (K122389)
Infrared light	No	Yes (optional); up to 20 W max, 700 – 2000 nm
Massage	Yes – as a separate handpiece	Yes – as a separate handpiece
Vacuum (suction)	No	Yes
Temperature sensing	Yes	Yes
Temperature sensingactive control	Yes	Yes
Treatment activation	Fingerswitch	Footswitch
Area treated	16 – 40 cm²	16 – 40 cm²
Electrode shape	Square or Rectangle	Square
RF frequency	300kHz – 50 MHz	300kHz – 50 MHz
RF type	Bipolar / Monopolar	Bipolar / Monopolar
Max RF power	300 W	300 W
Duty cycle	0 – 100%	0 – 100%
Patient contactmaterial	Polyethylene (3M Tegaderm) and 316 SS	Polyethylene (3M Tegaderm) and 316 SS

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.