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 and muscle spasms and increase in local circulation.
Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for temporary reduction in circumference of the abdomen.
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 TruSculpt device from Cutera, Inc. (K162512) underwent a clinical study to demonstrate its safety and effectiveness for temporary circumferential reduction of the abdomen and flank regions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Efficacy Primary Endpoint:
Statistically significant difference in circumferential measurement between Sham and Treatment groups at 12 weeks post-treatment.	Subjects in the Treatment group demonstrated a statistically significant reduction in circumference of 1.9 cm (Fisher's exact test, two-tailed, p<0.0001) of the treated flanks and abdomen, as compared to the Sham group, at 12 weeks following treatments.
Efficacy Secondary Endpoints:
Subject assessment of improvement at 12 weeks post-treatment.	Improvement was reported by 98% of subjects in the Treatment group.
Subject satisfaction level at 12 weeks post-treatment.	Subjects in the Treatment group were satisfied (54%) and highly satisfied (30%) with their treatment outcome.
Subject discomfort and pain levels during treatment.	No treatments were discontinued due to patient discomfort. The median pain score for the Treatment group was 6 on a 0 - 10 scale, with a range of pain scores from 4 – 8.
Safety Endpoint:
Incidence and severity of adverse device effects during the study period, including subject pain level at follow-up visits.	As expected, all Treatment group subjects experienced erythema (redness) and edema (swelling), and 9 (20%) subjects experienced palpable lumps. Additionally, soreness was observed in 40 (87%) subjects. All adverse effects resolved without intervention. No serious adverse events were noted.
Responder Rate (≥ 1 cm reduction)	35 (76%) subjects in the Treatment group were considered treatment responders. The difference in responder rates between the Treatment and Sham groups was statistically significant (p < 0.0001).

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

Sample Size for Test Set: 70 subjects were enrolled in the clinical study. 47 subjects were in the Treatment group and 23 subjects were in the Sham group. 69 subjects completed the study (1 subject was lost to follow-up from the treatment group).
Data Provenance: The study was a "single-center" study. The document does not specify the country of origin of the data, but it is a
FDA submission for a US company ("Cutera, Inc. 3240 Bayshore Blvd. Brisbane, California 94005"), implying the study was likely conducted in the US. The study design was prospective and controlled.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth. The primary efficacy endpoint was based on "difference in circumferential measurement," which suggests objective measurements rather than expert consensus on images. The secondary endpoints involved "subject assessment of improvement and satisfaction," which relies on patient self-reporting.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the nature of the measurements (circumferential reduction and patient-reported outcomes), a formal adjudication process by external experts would likely not be applicable in the same way it would be for image-based diagnostic studies.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the device's standalone clinical effectiveness compared to a sham control, not on human readers' performance with and without AI assistance.

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

Yes, the clinical study performed was a standalone study for the device. The study evaluated the direct effect of the truSculpt RF device's application on subjects, without human-in-the-loop performance involving an AI algorithm interpreting data for a human. It assessed the outcome of the device's treatment directly.

7. The Type of Ground Truth Used

The ground truth for the primary efficacy endpoint was objective physical measurement: "circumferential measurement" taken at baseline and at follow-up visits. For secondary endpoints, the ground truth was patient-reported outcomes (subject assessment of improvement, satisfaction level, and discomfort/pain levels). Safety endpoints utilized observation of adverse events and subject pain reporting.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of an AI/algorithm. The clinical study described is for the device's performance itself and does not involve machine learning model training.

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

As no training set for an AI/algorithm is described, this question is not applicable.

Summary

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

December 9, 2016

Cutera, Inc. Bradley Renton, Ph.D. Vice President, Regulatory and Medical Affairs, & Compliance Officer 3240 Bayshore Blvd. Brisbane, California 94005

Re: K162512

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, GEI Dated: September 7, 2016 Received: September 8, 2016

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 of medical devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely, Jennifer R. Stevenson -A For 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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Indications for Use

510(k) Number (if known) K162512

Device Name truSculpt

Indications for Use (Describe)

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

Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for temporary reduction in circumference of the abdomen.

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

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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 - phone415-715-3568 - faxbrenton@cutera.com
Preparation Date:	December 6, 2016
Device Trade Name:	truSculpt
Common Name:	Massager, Vacuum, Radio Frequency Induced Heat
Classification Name:	Electrosurgical cutting and coagulation device and accessories, PBX,21 CFR 878.4400
Legally MarketedPredicate Devices:	Cutera truSculpt RF Device (K133739)BTL XP1000 RF (K143559)Syneron Transcend (K120510)
Device Description:	The truSculpt device consists of a console, one or more RF handpiecesthat connect to the console with an umbilical cable, and a truGlidemassage roller. All system functions are controlled through the console.The handpieces deliver RF energy to generate a heating profile thatproduces a moderate temperature rise in the subcutaneous tissue,while monitoring epidermal temperature. In addition, there is a separatemechanical roller that can be used as a massager.
Intended Use:	The truSculpt is intended to generate heat within body tissues for thetreatment of selected medical conditions, such as the relief of minoraches, pain, and muscle spasms; an increase in local circulation; andtemporary reduction in circumference of the abdomen. It is alsointended to provide temporary reduction in the appearance of cellulite.
Indications for Use:	The truSculpt RF energy is intended to provide topical heating for thepurpose of elevating tissue temperature for the treatment of selectedmedical conditions, such as relief of pain and muscle spasms andincrease in local circulation.Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated fortemporary reduction in circumference of the abdomen.The truSculpt massage device is intended to provide a temporaryreduction in the appearance of cellulite.
Non ClinicalPerformance Data:	The truSculpt was successfully tested to the following standards inentirety and there were no exceptions:IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety (Edition 3.0, 2005 + CORR. 1:2006 + CORR.2:2007)IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: GeneralRequirements for Safety - Collateral Standard: ElectromagneticCompatibility (Edition 3, 2007)truSculpt Software Verification and Validation Testing Report:This document describes the specific tests that were used to verify andvalidate the software used in the truSculpt system. Testing includedverification of correct Startup/Flash Screens, Operating Screens andscreen selection; Software Version confirmation; Checksum verification;clearing of log files; Frequency verification for all handpieces andoperating modes; correct function of displays and indicators; correctfunction of controls, buttons, and inputs; temperature limits; treatmentcountdown indicator; calibrated delivery; screen data accuracy; dateand time entry; data pop-up screens; error conditions; induced faultconditions; Shot and Error log capture and printing; and anomalies, ifany, encountered during testing. No anomalies were encounteredduring testing.
SubstantialEquivalenceComparison:	The truSculpt RF device that is the subject of this submission has thesame indications for use as the previously cleared truSculpt RF device,with the exception of the addition of a new indication for use that isidentical to the cleared indication for use for the BTL XP1000 RF andSyneron Transcend.For the requested indication for use, the subject device usesradiofrequency energy, which is the same energy type used by the BTLXP1000 RF, and Syneron Transcend; uses temperature sensing, whichis the same as the BTL XP1000 RF and Syneron Transcend; treats anarea of 40 cm², which is in between the areas treated for the BTLXP1000 RF (201 cm²) and the Syneron Transcend (1.3, 7.5, and 12.5cm²); and uses a RF frequency of 2 MHz, which is between the 1 MHzoperating frequency of the Syneron Transcend and the 27.12 MHzoperating frequency of the BTL XP1000 RF. See Table 5A - TechnicalSpecification Comparison below.To ensure the technology differences between the subject device andthe predicate devices for the same indication for use did not raise anynew questions of safety or efficacy a clinical trial was conducted.
Clinical PerformanceData:	An IRB-approved single-center, controlled, randomized, pivotal studywas conducted to evaluate the safety and efficacy of treatment with theCutera truSculpt RF device for circumferential reduction in theabdominal and flank regions using the 2 MHz frequency. Seventysubjects were enrolled and treated in this study, with 47 subjects in the
Study Design	Prospective, randomized, controlled, single-center study
Sample Size	70 subjects enrolled (47 in Treatment group and 23 in Sham group)
Main Criteria for Inclusion	Male or female, 24 to 60 years of age (inclusive); Fitzpatrick Skin Type I – VI; has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region; has a Body Mass Index (BMI) ≥ 20 and ≤ 30
Follow-up Intervals	4 and 12 weeks post-treatment
Endpoints
	PrimaryDifference in circumferential measurement relatedto Sham and Treatment groups at 12 weeks post- treatment
	Secondary Subject assessment of improvement at 12 weeks post-treatment Subject satisfaction level at 12 weeks post-treatment Subject discomfort and pain levels during treatment
	SafetyIncidence and severity of adverse device effectsduring the study period, including subject painlevel at follow-up visits
SummaryResults	Efficacy Subjects in the Treatment group demonstrateda statistically significant reduction incircumference of 1.9 cm (Fisher's exact test, two-tailed, p<0.0001) of the treated flanks and abdomen, as compared to the Sham group, at 12 weeks following treatments. Subjects in the Treatment group were satisfied (54%) and highly satisfied (30%) with their treatment outcome, and improvement was reported by 98% subjects. No treatments were discontinued due to patient discomfort. The median pain score for the Treatment group was 6 on a 0 - 10 scale, with a range of pain scores from 4 – 8.
	SafetyAs expected, all Treatment group subjects experienced erythema (redness) and edema (swelling), and 9 (20%) subjects experienced palpable lumps. Additionally, soreness was observed in 40 (87%) subjects. All adverse effects resolved without intervention. No serious adverse events noted.

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Attachment 5 510(K) Summary

Treatment group and 23 subjects in the Sham group. Sixty-nine subjects completed the study with 1 subject lost to follow-up from the treatment group. Subjects received 1 treatment with the Cutera truSculpt RF device. Subjects were followed at 4 and 12 weeks posttreatment.

Standardized photographs were taken at baseline and at 4 and 12 weeks post-treatment. Efficacy was assessed through measurement of circumference at baseline and at 4 and 12 weeks post-treatment, as well as through subject assessment of improvement and satisfaction. Safety was evaluated through assessment of the incidence and severity of adverse effects, including subject pain level at the follow-ups.

At 12 weeks post-treatment, subjects in the Treatment group demonstrated an average circumferential reduction of 1.9 ± 0.1 cm. Subjects in the Sham group demonstrated an average circumferential reduction of 0 ± 0.1 cm. The difference in circumferential reduction between the Treatment and the Sham groups was 1.9 cm and was found to be statistically significant (p < 0.0001). Thirty-five (76%) subjects in the Treatment group were considered treatment responders (demonstrating 1 cm or greater reduction in circumferential reduction) at the 12-week follow-up visit. Four (17%) subjects in the Sham group were considered treatment responders (demonstrating 1 cm or greater reduction in circumferential reduction) at the 12-week follow-up visit. The difference in responder rates between the Treatment and Sham groups was also found to be statistically significant (p < 0.0001).

All subjects tolerated treatment with no treatments needing to be discontinued due to patient discomfort. The median pain score for the Treatment group was 6 on a 0 - 10 scale, with a range of pain scores from 4 - 8. As expected, all Treatment group subjects experienced erythema (redness) and edema (swelling), and 9 (20%) subjects experienced palpable lumps. Additionally, soreness was observed in 40 (87%) Treatment group subjects. All adverse effects resolved without intervention. No serious adverse events were noted.

The study design and results are summarized in the table below.

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Attachment 5 510(K) Summary

In conclusion, treatment using the Cutera truSculpt RF device was found to be safe and effective for temporary circumferential reduction, with no serious adverse effects.

Cutera believes that the truSculpt RF device is substantially equivalent Conclusion: to the predicate devices for the requested indication for use and, based on the clinical data presented, any technical differences do not raise new questions of safety or effectiveness.

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Section 5 510(K) Summary

Table 5A - Technical Specification Comparison

	Cutera truSculpt RF Device(current submission)	Cutera truSculpt RF Device(K133739)	BTL XP1000 RF(K143559)	Syneron Transcend(K120510)
Energy Type	Radiofrequency	Radiofrequency	Radiofrequency	Radiofrequency + Infrared
Massage	Yes	Yes	No	Yes
Vacuum (suction)	No	No	No	Yes
Temperature sensing	Yes	Yes	Yes	Yes
Temperature sensingactive control	Yes	Yes	Yes	Yes
Treatment activation	Fingerswitch	Fingerswitch	Fingerswitch	Fingerswitch
Area treated	16, 25, and 40 cm²	16 - 40 cm²	201 cm²	1.3, 7.5, and 12.5 cm²
Electrode shape	Square or Rectangle	Square or Rectangle	Rectangle	Rectangle
RF frequency	1 MHz and 2 MHz	300 KHz - 50 MHz	27.12 MHz (±400 kHz)	1 MHz
RF type	Bipolar / Monopolar	Bipolar / Monopolar	Bipolar	Bipolar
Max RF power	300 W	300 W	200 W	150 W
Patient contact material	Polyethylene(3M Tegaderm) and 316 SS	Polyethylene(3M Tegaderm) and 316 SS	Unknown	Unknown

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.