The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.

Device Description

The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cynosure SculpSure device, specifically seeking clearance for the treatment of the submental area. It contains information about the device's
description, indications for use, and a summary of clinical and non-clinical tests conducted to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of pre-defined acceptance criteria with corresponding performance metrics. Instead, it describes performance outcomes that were achieved. However, based on the narrative, we can infer the implied acceptance criteria from the reported results.

Metric/Criteria (Inferred)	Acceptance Criteria (Implied)	Reported Device Performance
Efficacy: Blind Evaluation of Photos	High percentage of post-treatment photos identifiable by blind evaluators (indicating visible change).	93% (51/55) of post-treatment photographs were identifiable by blind evaluators.
Efficacy: Fat Reduction (Ultrasound)	Demonstrable and statistically significant reduction in adipose tissue thickness via ultrasound.	15.2% (1.785mm) normalized fat reduction at 12 weeks post-final treatment was shown by ultrasound imaging.
Efficacy: Patient Satisfaction	High patient satisfaction rate with the treatment.	100% (55/55 subjects) satisfaction rate reported at 12 weeks post-final treatment follow-up visit using a 6-point Likert scale.
Safety: Adverse Events	Side effects should be transient, and the majority should be mild or moderate in nature, with no significant difference across BMI groups.	All reported adverse events (swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters), except for one, were transient, and the majority were mild or moderate in nature. No significant difference in safety (or efficacy) between BMI < 30 and BMI >= 30 groups.
Software Verification & Validation	Software performs as intended.	Software verification and validation was performed, and it was demonstrated that the software performs as intended.
Power Output Consistency	Power output meets specification.	Testing confirmed that the power output meets specification.
Electromagnetic Compatibility (EMC) & Electrical Safety	Device meets relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).	Results confirmed the device meets the standards.
Biocompatibility	Patient-contacting materials are biocompatible per ISO 10993-1.	All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.
Submental Mask Beam Uniformity	Submental mask provides beam uniformity within +/- 15% specification.	Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification.

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

Sample Size for Clinical Test Set: 57 subjects were enrolled in the study for the submental area.
- 23 subjects had a BMI < 30.
- 34 subjects had a BMI >= 30.
- 5 patients received 1 treatment, the rest received 2 treatments.
- Efficacy analysis performed on 55 subjects (implied that 2 subjects were lost to follow-up or excluded from efficacy analysis, as 51/55 and 55/55 are reported).
- Safety analysis performed on all 57 subjects.
Data Provenance: The study was a "prospective, controlled study" conducted at "3 study centers." The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it is highly likely the study was conducted in the United States, but this is not explicitly stated.

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

Number of Experts: The document states "On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs." The exact number of individual blind evaluators is not specified.
Qualifications of Experts: The qualifications of these "blind evaluators" are not provided in the document.

4. Adjudication Method for the Test Set

For the blind evaluation of photographs, the document only states "blind evaluation of pre- and post- final treatment (12 week) photographs." No specific adjudication method (e.g., 2+1, 3+1) is mentioned. It's unclear if multiple evaluators independently rated and then their results were averaged or if consensus was reached, or if there was a primary and secondary read.

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

This document describes a clinical study for a medical device (laser system) for fat reduction, not a diagnostic AI system that assists human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted for this device. The efficacy endpoints were direct measurements (fat reduction, patient satisfaction) and blind photo evaluation, not diagnostic accuracy requiring human reader interaction with AI.

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

This question is not applicable to the SculpSure device as it is a physical medical device (a laser system), not an algorithm or AI software for diagnostic purposes. Its performance is measured directly by its physical effect on the body, not as a standalone software output.

7. The Type of Ground Truth Used

The ground truth for the efficacy endpoints in this study was established using a combination of:

Expert Consensus/Blind Evaluation: Implicitly, the ability of "blind evaluators" (human experts) to correctly identify post-treatment photographs served as a form of ground truth for visible changes.
Objective Measurement: Percentage change in adipose tissue thickness from baseline, measured through ultrasound imaging, provided an objective, quantifiable ground truth for fat reduction.
Patient-Reported Outcomes: Patient satisfaction measured via a 6-point Likert scale represents a subjective but crucial ground truth from the patient's perspective.
Observed Clinical Outcomes: For safety, the reporting and assessment of adverse events observed during visits forms the ground truth for safety.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device's performance, not to train an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 57 subjects were part of the clinical test set (or study cohort) to assess the device's efficacy and safety.

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

This question is not applicable as there was no AI training set involved in this device submission.

Summary

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

September 26, 2017

Cynosure, Inc. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886

Re: K171992

Trade/Device Name: SculpSure Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: June 30, 2017 Received: July 3, 2017

Dear Amy Tannenbaum:

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 Actinclude 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 device-

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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 (DICE) 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 (DICE) 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.

Sincerelv.

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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) Kpending

Device Name SculpSure™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for SculpSure Laser System

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a)(1) Submitter Information
Applicant	Cynosure, Inc.
Address	5 Carlisle RoadWestford, MA 01886
Phone Number	(978) 256-4200
Fax Number	(978) 256-6556
Establishment RegistrationNumber	1222993
Contact Person	Amy Tannenbaum
Preparation Date	June 30, 2017
807.92(a)(2) Name of Device
Trade or Proprietary Name	SculpSure
Common or Usual Name	Laser
Classification Name	Laser for disruption of adipocyte cells for aesthetic use
Classification Panel	General & Plastic Surgery
Regulation	21 CFR 878.5400
Regulatory Class	II
Product Code(s)	PKT
807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed
Predicate Devices	Cynosure SculpSure K171111, Zeltiq Coolsculpting K162050The predicate devices have not been subject to a design-relatedrecall
807.92(a)(4) Device Description
The Cynosure SculpSure is a diode laser system. The maincomponents of SculpSure are a console and four applicators thatdeliver the laser energy to the patient. Electrically efficientsemiconductors generate optical radiation (1060 nm) which isused to deliver laser energy to subcutaneous tissue layers.
807.92(a)(5) Intended Use of the Device
The SculpSure laser system is intended for non-invasive lipolysisof the abdomen, flanks, back, and thighs in individuals with aBody Mass Index (BMI) of 30 or less. In addition, the device isintended for non-invasive lipolysis of the submental area inindividuals with a Body Mass Index (BMI) of 43 or less. Thedevice is intended to affect the appearance of visible fat bulges in

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the abdomen, flanks, back, thighs, and submental area.
807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to thePredicate
	Proposed SculpSureLaser System	Cynosure SculpSureLaser System	Zeltiq CoolsculptingDevice
510(k) Number	KPending	K171111	K162050
Manufacturer	Cynosure, Inc.	Cynosure, Inc.	Zeltiq Aesthetics, Inc.
Lipolysis Method	Heat-assisted	Heat-assisted	Cold-assisted
Device Type	Diode Laser	Diode Laser	N/A
Wavelength	1060 ±20 nm(infrared)	1060 ±20 nm(infrared)	N/A
Spot Size	4 x 6 cm2 on each ofthe Applicator heads(up to four applicatorsper body treatment)14.28 cm2 (oneapplicator head andframe used forSubmental treatment)	4 x 6 cm2 on each ofthe Applicator heads(up to four applicatorsper treatment)	4.5 x 7 cm2 (2x)approximate
Pulse Width (laserON time)	CW	CW	N/A
Power Density	Up to 1.4 W/cm2(body)Up to 2.35 W/cm2(submental)	Up to 1.4 W/cm2	N/A
Attachment topatient	Belt (body treatment)Headgear and straps(submental treatment)	Belt (body treatmentonly)	Belt
Voltage	200-240V~, SinglePhase	200-240V~, SinglePhase	N/A
Current	20A	20A	N/A

Software verification and validation was performed, and it was demonstrated that the software performs as intended. Testing confirmed that the power output meets specification. Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible. Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification.

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807.92(b)(2) Clinical tests submitted

A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of Cynosure SculpSure laser for the non-invasive fat reduction of the submental area. The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the three studies. 57 subjects were enrolled in the study. 23 of the subjects had a BMI of less than 30, and 34 subjects had a BMI of 30 or higher. Each subject received up to 2 treatments with SculpSure at the submental area. There were 5 patients that received 1 treatment, and the rest received 2 treatment effectiveness was assessed through blind evaluation of pre- and post- final treatment (12 week) photographs; percentage change in the adipose tissue thickness from baseline to 12 week follow up measured through ultrasound imaging; and patient satisfaction measured at the 12 week post- final treatment follow up visit through 6 point Likert scale. On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs; ultrasound imaging at 12 week post follow up visit showed 15.2% (1.785mm) normalized fat reduction and patient satisfaction survey at 12 week post follow up visit showed 100% (55/55 subjects) satisfaction rate. All subjects that were treated in the study (N=57) were included in the safety analysis and adverse events were assessed at all visits. The side effects that were reported were swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters. All events, except for one, were transient and the majority were mild or moderate in nature. There was no significant difference between the safety and efficacy results of the subjects that had a BMI below 30 as compared to the safety and efficacy results of the subjects that had a BMI of 30 or above. The study concluded that the SculpSure is safe and effective for non-invasive fat reduction at the submental area.

807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted

Cynosure believes that SculpSure is substantially equivalent to its predicate devices with same intended use and similar technological characteristics. The non-clinical data for SculpSure supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the SculpSure should perform as intended in the specified use conditions. Additionally, the successful clinical performance of SculpSure as documented in clinical study demonstrate that the SculpSure has a safety and effectiveness profile that is similar to its predicate devices. Therefore, Cynosure is requesting clearance for treatment of the submental area.

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.