The truSculpt iD device is intended to generate heat within body tissues for the treatment of selected medical conditions, such as the relief of minor aches, pain, and muscle spasms; an increase in local circulation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlide roller is intended to provide temporary reduction in the appearance of cellulite.

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 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.

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

Device Description

The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, 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. The truGlide is a separate mechanical roller that can be used as a massager.

AI/ML Overview

The provided text describes the regulatory clearance of the Cutera truSculpt iD device, focusing on its substantial equivalence to predicate devices, rather than a clinical study establishing specific acceptance criteria for a new AI/performance claim.

Based on the available information, the truSculpt iD device is an electrosurgical cutting and coagulation device intended for:

Topical heating to elevate tissue temperature for relief of pain and muscle spasms and increase in local circulation.
Specifically, the 2MHz setting for the 40cm² handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

The "acceptance criteria" discussed in the document are primarily related to safety and technological equivalence compared to its predicate devices, rather than performance metrics of a novel clinical claim. The study mentioned is a technical performance study, not a clinical trial with specific performance endpoints for new indications.

Here's an breakdown based on the information provided, acknowledging its limitations regarding specific AI performance acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an equivalence submission for a traditional medical device, there aren't explicit clinical performance acceptance criteria in the typical sense of metrics like sensitivity, specificity, AUC as would be seen for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating substantially equivalent safety and effectiveness through technical characteristics and a limited performance study.

Acceptance Criterion Type (Implied)	Description / Reported Performance
Safety - Electrical & Mechanical	Criterion: Adheres to international standards for medical electrical equipment safety.
	Reported Performance: Compliance with IEC 60601-1/A1:2012, IEC 60601-2-2:2009, IEC 60601-1-6:2010/A1:2013, and IEC 60601-1-2:2014 demonstrated. This confirms the device meets general safety, specific safety for high-frequency surgical equipment, usability, and electromagnetic compatibility standards.
Safety - Biocompatibility	Criterion: Patient-contact materials are biocompatible.
	Reported Performance: Biocompatibility testing of patient-contact materials (Polyvinylidene fluoride (PVDF), liquid resin adhesive, silicone, hydrogel, stainless steel) according to ISO-10993-1:2018 demonstrated.
Safety - Skin Temperature Control	Criterion: Skin temperatures do not exceed a safe threshold (e.g., 45°C) during treatment, while maintaining therapeutic temperatures (40°-45°C).
	Reported Performance: Skin temperature testing on 3 human subjects demonstrated that skin temperatures do not exceed 45°C during treatment and that the device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin.
Software Verification & Validation	Criterion: Software functions correctly and safely.
	Reported Performance: Software Verification and Validation Testing completed. (No specific metrics provided, but implies successful completion.)
Technological Equivalence	Criterion: Device has equivalent technological characteristics and principles of operation to predicate devices, and any differences do not raise new safety or effectiveness questions.
	Reported Performance: Detailed comparison tables (provided in the source text) show equivalence in energy type, RF frequency, RF type, max RF power, temperature sensing, active control, and massage function. Differences were identified in patient contact materials and attachment methods for hands-free handpieces, but these were deemed not to raise new safety/effectiveness questions, supported by biocompatibility and skin temperature testing.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 3 human subjects for skin temperature testing.
Data Provenance: Not explicitly stated, but typically such performance/safety testing might be done in a single-center setting, likely in the country of manufacture or where the regulatory submission is made (USA, given the FDA context). It is a prospective performance/safety study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. For a technical performance study like skin temperature monitoring, the "ground truth" is measured by the device itself and validated against a calibrated external measurement system (e.g., a thermometer). Clinical "ground truth" from experts is not applicable here as it's not a diagnostic or treatment outcome study with expert interpretation.

4. Adjudication method for the test set

Not applicable as this was a technical performance/safety study (skin temperature measurement), not a clinical trial requiring adjudication of outcomes or expert review of images/diagnoses.

5. 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

No MRMC study was done. This device is a therapeutic energy-based device, not an AI-powered diagnostic or interpretative system that would involve human readers.

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

Not applicable. This is a traditional medical device, not an AI algorithm. The device has software for control, but its "performance" is its ability to deliver RF energy and monitor temperature, not to perform a diagnostic or interpretive task standalone or with human-in-the-loop.

7. The type of ground truth used

For the skin temperature testing, the ground truth would be direct physical measurement of skin temperature using a calibrated reference thermometer, compared against the device's internal temperature sensing and control.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in that context. The device's software is developed and validated through traditional software engineering processes.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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July 13, 2022

Cutera Inc. Mr. Amogh Kothare, M.S. VP Clinical and Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005

Re: K221407

Trade/Device Name: truSculpt iD Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: May 31, 2022 Received: June 2, 2022

Dear Mr. Kothare:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221407

Device Name truSculpt iD

Indications for Use (Describe)

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 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) 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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 BlvdBrisbane, CA 94005
Contact Person:	Mr. Amogh Kothare, MSVP Clinical and Regulatory Affairs3240 Bayshore BlvdBrisbane, CA 94005akothare@cutera.comm. (415) 690-6796o. (415) 657-5730f. (415) 715-3730
Preparation Date:	July 12, 2022
Device Trade Name:	truSculpt iD
Common Name:	Massager, Vacuum, Radio Frequency Induced Heat
Classification Name:	Electrosurgical cutting and coagulation device and accessoriesGEI, PBX, 21 CFR 878.4400
Primary PredicateDevice:	truSculpt RF Device (K172004)
SecondaryPredicate Device:	truSculpt RF Device; truSculpt; truSculpt 3D (K180709)
Intended Use:	The truSculpt iD device is intended to generate heat within bodytissues for the treatment of selected medical conditions, such as therelief of minor aches, pain, and muscle spasms; an increase in localcirculation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlideroller is intended to provide temporary reduction in the appearance ofcellulite.
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 indicatedfor reduction in circumference of the abdomen and non-invasivelipolysis (breakdown of fat) of the abdomen.The truSculpt massage device is intended to provide a temporaryreduction in the appearance of cellulite.
Device Description:	The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, 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. The truGlide is a separate mechanical roller that can be used as a massager.
Summary ofTechnologicalCharacteristics:	The truSculpt iD device has similar technological characteristics as the primary and secondary predicate devices. The truSculpt RF Device, truSculpt, truSculpt 3D, and truSculpt iD are all comprised of a console and RF applicators. The consoles for all devices consist of a mechanical enclosure, an RF generator, control electronics, a touchscreen user interface, and a control microprocessor.The shape and dimensions of the truSculpt iD RF handpieces are identical to those of the primary predicate device. The handpieces are now held in place by adhesive decals and a silicone belt, which are manufactured from biocompatible materials.The truSculpt iD device heats tissue through delivery of RF energy at 1 MHz and 2 MHz, which is identical to the primary and secondary predicate devices.
Performance Data:	IEC 60601-1/A1:2012 Medical Electrical Equipment – Part 1: General Requirements for Safety IEC 60601-2-2:2009 Medical Electrical Equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-1-6:2010/A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests Software Verification and Validation Testing Biocompatibility testing of patient-contact materials according to ISO-10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process Skin temperature testing on 3 human subjects to demonstrate the skin temperatures do not exceed 45°C during the course of the treatment
Clinical Data:	None

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Technical Comparison to Predicate Devices:

	truSculpt iD Device(current submission)	Primary Predicate DeviceCutera truSculpt RF Device(K172004)	Secondary Predicate DeviceCutera truSculpt RF Device(K180709)
Energy type	Radiofrequency	Radiofrequency	Radiofrequency
Massage	Yes	Yes	Yes
Temperature sensing	Yes	Yes	Yes
Temperature sensingactive control	Yes	Yes	Yes
Treatment activation	Control screen button or fingerswitch	Control screen button or fingerswitch	Fingerswitch
Area treated	Handheld: 16 and 40 cm²Hands-free: 40 to 240 cm²	Handheld: 16 and 40 cm²Hands-free: 40 to 240 cm²	Handheld: 16 and 40 cm²
Electrode shape	Square or Rectangle	Square or Rectangle	Square or Rectangle
RF frequency	1 MHz and 2 MHz	1 MHz and 2 MHz	1 MHz and 2 MHz
RF type	Bipolar/Monopolar	Bipolar/Monopolar	Bipolar/Monopolar
Max RF power	300 W	300 W	300 W
Patient contactmaterial	· Polyvinylidene fluoride (PVDF) forhandheld handpieces· Liquid resin adhesive for patientdecals (for hands-free handpieces)· Silicone for cummerbund (for hands-free handpieces)• Hydrogel for neutral electrode pads· Stainless steel for massage roller	· Polyethylene (3M Tegaderm) forhandheld and hands-freehandpieces• Hydrogel for neutral electrode pads· Stainless steel for massage roller	· Polyethylene (3M Tegaderm) forhandheld handpieces· Hydrogel for neutral electrode pads· Stainless steel for massage roller
Attachment of hands-free handpieces topatient	Adhesive patient decals andcummerbund	Cloth belt	Not Applicable

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The truSculpt iD device has equivalent technological characteristics and Conclusion: principles of operation as the primary and secondary predicate devices.

Performance data demonstrates that any differences between the truSculpt iD and its predicate devices do not raise new safety or effectiveness questions. Skin temperature testing on three subjects further demonstrates that the truSculpt iD device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin and that maximum skin temperatures do not exceed 45°C.

The truSculpt iD device is substantially equivalent to the predicate devices.

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.