Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning
Phase: NA
Conditions: Fat Necrosis, Muscle Stimulation
Sponsor: CynosureLutronic

 
 
 
 
 
 
CONFIDENTIAL 
 
 
 
Prospective Clinical Evaluation of the Safety and Efficacy 
of NON-INVASIVE Electronic Stimulation for 
Improvement of Muscle Strength and Toning, 
Circumferential Reduction of the Core and Extremities  
  
Sponsor: Lutronic, Inc. 
Funded by: Lutronic, Inc. 
 
  Date: September 8, 2021 
 
 
 
 
 
 
 
           Clinical Protocol Number: AFL19006 
                            
 
 
 
 
Version number: 2.0 
 
 
 
 

Electronic Stimulation for Strength and Muscle Toning 
 
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Sponsor Statement and Signature Page 
Company Name:  
 
Lutronic, Inc. 
Address: 
 
 
19 Fortune Drive 
Billerica, MA 01821 
Telephone: 
 
 
888-588-7644 
The investigation will be conducted in compliance with the clinical investigation plan (CIP), GCP, EN ISO 14155, the 
Declaration of Helsinki, and regulatory authority requirements. 
 
Lutronic, Inc. (hereinafter “Study Sponsor”) maintains responsibility for the ongoing safety of this clinical trial 
involving the evaluation of the Genius System.  Study Sponsor will promptly notify all investigators, the responsible 
IRB(s), and the regulatory authorities of any findings from ongoing trial monitoring activities that could adversely 
affect the safety of subjects, impact the conduct of the clinical study, or alter the IRB’s approval to continue the 
study, specifically within 5 working days of making an Unanticipated Adverse Device Effect (UADE) determination 
or 15 working days after first receiving notice of the UADE, within 10 days for Serious Adverse Event reports, and 
at least annually for routine reports.  In the event that participant safety could be directly affected by study results 
after the study has ended, Study Sponsor will notify all investigators of these results to enable investigators to 
consider informing participants as soon as possible or at least within one year of study closure.   
The following individuals are responsible for the content of the Clinical Investigational Plan: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Paul Cardarelli  
 
 
 
 
 
                Date 
Director, Clinical Research & Product Development 
 
 
Contact Information 
 
Protocol Number: 
 
AFL19006 
Sponsor: 
 
 
Lutronic Global 
 
 
 
 
19 Fortune Dr. 
 
 
 
 
Billerica, MA 01821 
 
 
Lutronic Contact Information: 
Paul Cardarelli 
 
 
 
 
Director, Clinical Research & Product Development 
 
 
 
 
Phone: 888-588-7644 
 
 
 
 
Email: pcardarelli@lutronic-usa.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Site Contact Information:  
Primary Investigator  
 
 
 
 
Omar A. Ibrahimi, M.D., Ph.D. 
19 Fortune Dr. 
 
 
 
 
Billerica, MA 01821 
Email: omar.ibrahimi@gmail.com 
Tel: (203) 428-4440 
Fax: (203)890-9449 
 
ANNE M. CHAPAS, M.D. 
Union Square Laser Dermatology 
19 Union Square West 
New York, NY 10003 
Phone: (212) 366-5400 
Fax: (212) 366-5461 
 
 
If you have any questions or complaints about your rights as a research subject, contact:  
Allendale IRB 
Telephone: (860)434-5872 
Fax: (860)434-5892 
rta1ali1@aol.com 
 
 
 
 
 
 
 
 
 
 
 
 

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Statement of Compliance 
I have thoroughly read and reviewed this clinical investigation plan (CIP) and hereby agree to participate in this 
clinical trial sponsored by Lutronic, Inc  I agree to conduct this investigation according to the requirements of the 
CIP provided by the Study Sponsor and in accordance with Good Clinical Practice (GCP) as required by EN ISO 
14155, the Declaration of Helsinki, Investigational Device Exemption (21 CFR Part 812), Protection of Human 
Subjects (45 CFR Part 46), and other applicable FDA regulations, and regulations of other relevant regulatory 
authorities and conditions imposed by the reviewing Institutional Review Board (IRB) or Ethics Committee (EC). I 
agree that no deviation from, or changes to the CIP will take place without prior agreement from the sponsor and 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. I agree to ensure that appropriate informed consent is obtained from 
all subjects prior to inclusion in this study.  I also agree to supervise all testing of the device involving human 
subjects, and to report to the Study Sponsor, within 24 hours, any adverse event that is serious, whether 
considered treatment-related or not.  I am aware that the Study Sponsor reserves the right to discontinue this 
investigation at any time. 
 
I understand that this investigation will be monitored by the Study Sponsor and/or a designee contracted or 
employed by the Study Sponsor. This monitoring will involve periodic inspection of my investigational site and 
ongoing review of the data that is submitted by me to the Study Sponsor. All study data will be scanned and 
uploaded within 1 week after the study visit. I am also aware that I may be inspected by a representative of the 
relevant regulatory authorities, including the United States Food and Drug Administration, to verify compliance 
with applicable regulations related to clinical research on human subjects. 
 
My current curriculum vitae and the curriculum vitae of physicians/licensed practitioners at this institution who 
will participate as co-investigators/sub-investigators in this study will be provided to the Study Sponsor. This 
curriculum vitae will include the extent and type of our relevant experience with pertinent dates and locations. All 
personnel involved in the conduct of this study have completed Human Subjects Protection Training. 
 
I certify that I have not been involved in an investigation that was terminated for non-compliance at the insistence 
of the Study Sponsor, the IRB or EC, or other regulatory authorities. I agree to provide the Study Sponsor sufficient, 
accurate financial disclosure information.  I also agree to update financial disclosure information if any relevant 
changes occur during the investigation and for one year following the completion of the study. 
 
I understand that this CIP and the trial results are confidential, and I agree not to disclose any such information to 
any person other than a representative of the Study Sponsor or the relevant competent authorities without the 
prior written consent of the Study Sponsor. 
Accepted by: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator Signature 
 
 
Principal Investigator Name 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-/Sub-Investigator Signature 
 
 
Co-/Sub-Investigator Name 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______ 
Co-/Sub-Investigator Signature 
 
 
Co-/Sub-Investigator Name 
 
 
Date 
 
 
 
 
 
 
 
 
 
 

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List of Abbreviations 
TERM 
DEFINITION 
TERM 
DEFINITION 
AE 
Adverse Event 
ICH E6 
 
International Conference on 
Harmonization Guidance for Industry, 
Good Clinical Practice: Consolidated 
Guidance  
ADE 
Adverse Device Effect 
ICMJE 
International Committee of Medical 
Journal Editors  
ANCOVA 
Analysis of Covariance 
IDE  
Investigational Device Exemption 
BMI 
Body Mass Index 
IFU 
Instructions for Use 
CFR 
Code of Federal Regulations 
ISO 
International Organization for 
Standardization 
CGAIS 
Clinician Global Aesthetic Improvement 
Scale 
IRB 
Institutional Review Board 
CIP 
Clinical Investigation Plan 
MOP 
Manual of Procedures 
CMP 
Clinical Monitoring Plan 
NRS 
Numeric Rating Scale for pain assessment 
CRF 
Case Report Form 
OHRP 
Office for Human Research Protections 
CRO 
Contract Research Organization 
PI 
Principal Investigator 
CV 
Curriculum Vitae 
PSQ 
Patient Satisfaction Questionnaire 
DCC 
Data Coordination Center 
QA 
Quality Assurance 
DSMB 
Data Safety Monitoring Board 
QC 
Quality Control 
EC 
Ethics Committee 
RF 
Radiofrequency 
eCRF 
Electronic Case Report Form 
Rhytidectomy 
Mini facelift 
ETE 
Expected Treatment Effect 
SAE 
Serious Adverse Event 
FDA 
Food and Drug Administration 
SAP 
Statistical Analysis Plan 
FDAAA 
Food and Drug Administration 
Amendments Act of 2007 
SADE 
Serious Adverse Device Effect 
GAIS 
Global Aesthetic Improvement Scale 
SGAIS 
Subject Global Aesthetic Improvement 
Scale 
GCP 
Good Clinical Practice 
SMC 
Safety Monitoring Committee 
GLP 
Good Laboratory Practice 
SOP 
Standard Operating Procedure 
GMP 
Good Manufacturing Practice 
UADE 
Unanticipated Adverse Device Effect 
HIPAA 
Health Information Portability and 
Accountability Act 
USA 
United States of America 
IB 
Investigator’s Brochure 
 
 
ICH 
International Committee on 
Harmonization 
 
 
 
 
 

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Protocol Synopsis 
Protocol Number: 
AFL19006 
Protocol Title: 
Prospective Clinical Evaluation of the Safety and Efficacy of NON-INVASIVE Electronic Stimulation 
for Improvement of Muscle Strength and Toning, Circumferential Reduction of the Core and 
Extremities  
Investigational Devices: 
The Accufit Electrical Muscle Stimulation device is an FDA cleared two-channel muscle 
stimulator that provides up to 8 electrodes with unique waveforms for muscle stimulation. 
Development Phase: 
Evaluation  
Study Objective: 
The objective of this clinical study is to assess the safety and efficacy of a novel electrical 
stimulation device for use in improving muscle strength and toning of the core and extremities. 
Brief Study Overview: 
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation 
system for Improvement of Muscle Strength and Toning, Circumferential Reduction of the Core 
and Extremities The study will enroll up to 60 subjects desiring and to improve muscle strength 
and tone and circumferential reduction in their core and extremities.  Each subject will receive 
up to 8 bi-weekly treatments over a 4-week period. Follow up visits planned for 30- and 90-days 
post treatment.  Measurement outcomes will be compared to baseline. 
Number of Sites 
Enrolling Participants: 
 Up to 6 sites 
Sample Size:  
The study will enroll up to 60 male and female subjects ≥ 18 years to 60 years of age who are 
seeking to improve muscle strength and tone in the extremities.  
Subject Population: 
Healthy, female and male adult subjects age 18 to 60 years who meet the inclusion/exclusion 
criteria.  
Inclusion Criteria:  
1. Able to read, understand and voluntarily provide written informed consent. 
2. Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved 
muscle strength and muscle toning in their core and extremities. 
3. Subject is determined to be physically fit and agrees to not making any major changes 
in their diet or lifestyle during the study. 
4. Able and willing to comply with the treatment/follow-up schedule and requirements. 
5. Women of child-bearing age are required to be using a reliable method of birth control 
at least 3 months prior to study enrollment and for the duration of the study as well as 
have a negative Urine Pregnancy test at baseline. 
 
Exclusion Criteria: 
1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in 
the last 6 months. 
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the 
treatment area in the past 12 months. 
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV 
infection) or use of immunosuppressive medications, 6 months prior to and during the 
study. 
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive 
bleeding. 
5. Having a history of skin cancer or any other cancer in the areas to be treated, including 
presence of malignant or premalignant pigmented lesions. 
6. Having a permanent implant in the treatment area such as metal plates or an injected 
chemical substance such as silicone in the treatment area. 
7. Suffering from significant skin conditions in the treatment area or inflammatory skin 
conditions including but not limited to open lacerations, abrasions, herpes sores, cold 
sores, active infections. 
8. Poor skin quality (severe laxity). 
9. Abdominal wall, muscular abnormality or hernia on physical examination. 
10. As per the investigator’s discretion, any physical or mental condition which may make it 
unsafe for the subject to participate.  

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11. Subjects unwilling or unable to adhere to all study requirements for treatment and 
follow-up. 
12. Investigator may exclude any subject at any time at his/her discretion. 
 
Primary Endpoint: 
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-
treatment baseline images when compared to post-treatment images taken at follow up visits. 
 
Secondary Endpoints: 
 
1. Global Aesthetic Improvement grading by Expert Clinician. 
2. Improvement of muscle strength as measured by a dynamometer at follow up visits 
compared to baseline measurements. 
3. Reduction in core circumference as measured by Seca Circumferential System at follow 
up visits compared to baseline measurement. 
4. To assess subject satisfaction using Satisfaction Survey at each follow up visit.  
 
Safety Endpoints: 
Subject’s assessment of discomfort as measured by a 0-10 numeric rating scale.  
Subjects experiencing a treatment-related adverse event (AE). 
Study Duration: 
The duration from when the study opens to enrollment for 12 months.  
Participant Duration: 
7 months 

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Table of Contents 
Sponsor Statement and Signature Page 
2 
Contact Information 
2 
Statement of Compliance 
4 
List of Abbreviations 
5 
Protocol Synopsis 
6 
1. 
KEY ROLES 
11 
1.1 
Internal Responsibilities 
11 
2. 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
11 
2.1 
Background Information 
11 
2.1.1 
Device Name and Indications for Use 
11 
2.1.2 
Mechanism of Actions 
11 
2.1.3 
Device Overview 
11 
2.2 
Rationale 
12 
2.3 
Potential Risks and Benefits 
12 
2.3.1 
Known Potential Risks 
12 
2.3.2 
Contraindications 
12 
2.3.3 
Known Potential Benefits 
12 
3. 
OBJECTIVES AND PURPOSE 
13 
3.1 
Study Objectives 
13 
3.2 
Study Endpoints 
13 
3.2.1 
Primary Endpoint 
13 
3.2.2 
Secondary Endpoints 
13 
4. 
STUDY DESIGN AND ENDPOINTS 
13 
4.1 
Description of the Study Design 
13 
4.2 
DURATION OF STUDY 
13 
5. 
SUBJECT ENROLLMENT AND WITHDRAWAL 
14 
5.1 
Participant Inclusion Criteria 
14 
5.1.1  
Informed Consent 
14 
5.1.2  
Pre-treatment Recruiting/Screening 
14 
5.1.2.1 
Screen Failures 
14 
5.1.3 
Inclusion Criteria 
14 
5.1.4 
Participant Exclusion Criteria 
15 
5.2 
Strategies for Recruitment and Retention 
15 
5.2.1 
Subject Payment 
16 
5.3  
Participant Withdrawal or Termination 
16 
5.4 
Premature Termination or Suspension of the Study or a Study Site 
16 

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6. 
STUDY PROCEDURES AND SCHEDULE 
16 
6.1 
Photography 
16 
6.2 
Study Schedule 
17 
6.2.1 STUDY SPECIFIC PROCEDURES 
17 
6.3 
LABORATORY EVALUATION 
17 
6.4 
Screening & Baseline Assessment (Visit 1) 
17 
6.5 
Study Treatment 
18 
6.5.1  
Subject Preparation for Study Treatment 
18 
6.5.2 
Study Treatment (Visits 1-12) 
18 
6.5.3 
Acute Responses 
19 
6.5.4 
Post- Care Instructions 
19 
6.5.5 
Schedule of Activities 
19 
6.5.6 
Safety Assessments 
20 
6.5.7 
Unscheduled Visit 
20 
6.6 
Study Treatment 
20 
6.6.1  
Subject Preparation for Study Treatment 
20 
6.6.2 
Study Treatment 
20 
6.6.3 
Acute Responses 
20 
6.6.4 
Post- Care 
20 
6.7 
Concomitant Medications 
20 
7. 
ASSESSMENT OF SAFETY 
21 
7.1 
Specifications of Safety Parameters 
21 
7.1.1 
Definition of an Expected Treatment Effect (ETE) and an Adverse Event (AE) 
21 
7.1.2 
Definition of Serious Adverse Event (SAE) 
21 
7.1.3 
Definition of Unanticipated Adverse Device Effects (Events) 
21 
7.2 
Classification of an Event 
22 
7.2.1 
Severity of Event 
22 
7.2.2 
Relationship to the Investigational Device 
22 
7.2.3 
Expectedness 
22 
7.3 
Time Period and Frequency for Event Assessment and Follow-up 
22 
7.4 
Reporting Procedures 
23 
7.4.1 
Adverse Event Reporting 
23 
7.4.2 
Serious Adverse Event Reporting 
23 
7.4.3 
Unanticipated Adverse Device Effect Reporting 
23 
7.4.4 
Reporting of Pregnancy 
23 
7.4.5 
Reporting of Deaths 
24 
8. 
CLINICAL MONITORING 
24 

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9. 
STATISTICAL ANALYSIS 
25 
9.1 
Statistical and Analytical Plans 
25 
9.2  
Analysis Datasets 
26 
9.3 
DESCRIPTION OF STATISTICAL METHODS 
26 
9.4 
SAFETY ANALYSES 
26 
9.6 
BASELINE DESCRIPTIVE STATISTICS 
27 
9.7 
Analysis of Primary Endpoints 
27 
9.8 
Analysis of Secondary Endpoints 
27 
10. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/ DOCUMENTS 
28 
11. 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
28 
11.1 
Ethical Standard 
28 
11.2 
Institutional Revthighiew Board 
28 
11.3 
Informed Consent Process 
29 
11.3.1 
Consent/Assent and Other Informational Documents Provided to Participants 
29 
11.3.2 
Consent Procedures and Documentation 
29 
11.4 
Participant and Data Confidentiality 
29 
12. 
DATA HANDLING AND RECORD KEEPING 
29 
12.1 
Data Collection and Management Responsibilities 
29 
12.2 
Investigator Records and Reports 
30 
12.2.1 
Investigator Records 
30 
12.2.2 
Investigator Reports 
30 
12.3 
Study Records Retention 
31 
12.4 
Protocol Deviations 
31 
12.5 
Publication and Data Sharing Policy 
32 
13. 
STUDY ADMINISTRATION 
32 
13.1 
 Study Investigators 
32 
13.2 
Amendment Policy 
32 
14. 
CONFLICT OF INTEREST POLICY 
33 
References 
34 
APPENDIX 
PROTOCOL REVISIONS LOG 
35 
 
 
 
 
 
 

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1. 
KEY ROLES 
Persons serving in key roles in the conduct or oversight of this clinical trial are listed in Table 1.1-1 below.  
1.1 
INTERNAL RESPONSIBILITIES  
TABLE 1: INTERNAL RESPONSIBILITIES 
Name 
Function 
Address 
Lutronic Aesthetics 
Sponsor 
19 Fortune Drive 
Billerica, MA 01821 
Phone: 888.588.7644 
Paul Cardarelli  
Clinical Research Director 
Phone: 888.588.7644 
Email: pcardarelli@lutronic-usa.com 
2. 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
2.1 
BACKGROUND INFORMATION 
In 1761 Luigi Galvani provided scientific evidence that current can activate muscle. Electrical Muscle 
Stimulation is known to assist in muscle contraction. 
 
2.1.1 Device Name and Indications for Use 
Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow 
through the muscles in order to activate the muscle.  The Accufit Electrical Muscle Stimulation device is 
an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms 
of interferential and biphasic for muscle stimulation.  The Accufit system is indicated for relaxation of 
muscles, muscle re-education, reduction of pain and increased local blood circulation.  
 
2.1.2 Mechanism of Actions 
Muscle stimulation technology has been around for many decades and has been shown to be safe and 
effective for a variety of clinical applications. The foundational basis for the technology revolves around 
electrical current flowing through the muscle can be used to activate the muscle. 
 
2.1.3 Device Overview 
 
FIGURE 1: SYSTEM SPECIFICATIONS  
 
Frequency 
Up to 4khz 
Output power 
Up to a 100mA 
Number of Electrodes 
8 electrodes with disposables contact pads 
Simulation 
Biphasic and Interferential Waveforms 
Pulse Repetition Rate 
Up to 200Hz 
Pulse Width 
Up to 290 us 
Handpieces/Delivery System 
Single use Hydrogel electrode Round or Square 

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2.2 
RATIONALE 
In accordance with the definition of “Significant Risk Device” provided in 21 CFR 812.3, the devices to be 
used in this study has been determined to be a Non-Significant Risk device based on the following: 
a) It is not an implant 
b) It is not purported or represented to be for use in supporting or sustaining human life and 
do not present a potential for serious risk to the health, safety or welfare of a subject 
c) It is not for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease or otherwise preventing impairment of human health 
d) Use of the device does not pose a serious risk to the health, safety, or welfare of a subject. 
 
2.3 
POTENTIAL RISKS AND BENEFITS 
2.3.1 Known Potential Risks 
Expected adverse events of the muscle Electrical stimulation treatment procedure include: 
• 
Transient tenderness 
• 
Erythema 
• 
Edema 
• 
Discomfort 
Other adverse events may include and include:  
• 
Localized tenderness 
• 
Skin burn  
• 
Hyperpigmentation 
• 
Hypopigmentation 
• 
Blister 
• 
Changes in skin laxity (rarely, skin contour irregularities, dimpling, and asymmetry).    
 
Risks will be mitigated by conducting this protocol with an investigator experienced in the therapeutic 
area of the clinical investigation.  The investigator will be trained by the sponsor on the use of the 
device.  The device design incorporates safety mechanisms which minimize risks.  Patients will also be 
rigorously screened prior to their enrollment and rigorously followed over the course of the study.  
 
2.3.2 Contraindications 
Do not use this device on the pectoral area or patients who have a cardiac pacemaker, implanted 
defibrillator or other implanted metallic or electronic device. Do not use this device on patients whose 
pain syndromes are undiagnosed. Avoid direct irradiation of the eyes. Do not treat locally over the 
endocrine glands. Do not treat ischemic tissues in individuals with vascular disease. 
 
2.3.3 Known Potential Benefits 
If the subject agrees to participate in this study, he/she will be contributing to the understanding of the 
safety and efficacy of the use of this investigational device for muscle toning.  This understanding may 
lead to optimization of the treatment with this device. 

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3. 
OBJECTIVES AND PURPOSE 
3.1 
STUDY OBJECTIVES 
The objective of this clinical study is to assess the safety and efficacy of using a non-invasive electrical 
stimulation system for circumferential reduction and improvement of muscle strength and muscle tone 
of the core and extremities.  
3.2 
STUDY ENDPOINTS 
3.2.1 
Primary Endpoint  
1. Photographic evaluation by an independent, blinded reviewer with correct identification of pre-
treatment baseline images when compared to post-treatment images taken at follow up visits 
(30 days, 90 days). Results will be reported as a % of the correctly identified post treatment 
photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post 
treatment photographs chosen by Blinded Reviewer will be calculated and used to determine 
efficacy. 
Bar, pie charts or graphs indicating percentages of the correctly identified post treatment 
photographs chosen by Blinded Reviewer may also be used to analyze efficacy. 
3.2.2 
Secondary Endpoints  
The secondary endpoints of this clinical trial include:  
1. Improvement in muscle strength of the treated extremity as measured by a dynamometer at 
follow up visits compared to baseline measurements. 
2. Reduction in circumference as measured by Seca Circumferential System at follow up visits 
compared to baseline measurement. 
3. To assess subject satisfaction using Satisfaction Survey at each follow up visit  
4. GAIS (Global Aesthetic Improvement Scale) by Expert Clinician. 
5. All statistical tests that will be two-sided. The level of statistical significance for effectiveness 
analyses is 5% (α = 0.05) for all tests of differences. Where appropriate, two-proportion z-test 
will be used to compare the subjects’ assessment of satisfaction at post-treatment visits.  
Analysis of Covariance (ANCOVA) may also be used where appropriate.  
4. 
STUDY DESIGN AND ENDPOINTS  
4.1 
DESCRIPTION OF STUDY 
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system 
for circumferential reduction and improvement in muscle strength and muscle tone of the core and 
extremities. The study will enroll up to 60 subjects desiring circumferential reduction and to improve 
muscle strength and muscle tone of their core and extremities.  Each subject will receive up to 8 bi-
weekly treatments over a 4-week period. Follow up visits planned for 30- and 90-days post treatment.  
Measurement outcomes will be compared to baseline.  
 
4.2 
DURATION OF STUDY 
This study is not expected to exceed 12 months in duration. 

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5. 
SUBJECT ENROLLMENT AND WITHDRAWAL 
5.1 
PARTICIPANT IMPROVEMENT CRITERIA 
The study population will consist of males and females aged 18 – 60 years of age who have chosen to 
participate in this clinical trial as evidenced by execution of the informed consent document.  
 
5.1.1  Informed Consent 
Written informed consent will be obtained from all subjects before any study-related procedures, 
including any pre-treatment screening procedures, are performed. Investigators, or delegated study 
personnel, may discuss the availability of the study and the possibility for entry with a potential subject 
without first obtaining consent. Informed consent must be obtained and documented prior to initiation 
of any procedures that are performed solely for the purpose of determining eligibility for research. 
 
Investigators have ethical and legal responsibilities to ensure that the protocol is clearly explained to 
each subject considered for enrollment in the study. Compliance with this requirement should be 
documented on a written Informed Consent Form approved by the reviewing IRB. Each Informed 
Consent Form will include the elements required by FDA regulations in 21 CFR Part 50. 
 
The IRB-approved Informed Consent Form will be signed by the study personnel obtaining consent. The 
subject will be given a copy of the signed Informed Consent Form. The investigative site will keep the 
original on file.  
 
5.1.2  Pre-treatment Recruiting/Screening 
Subjects will be recruited from the study site’s patient database or IRB approved advertisement and 
screened.  Study site personnel will explain the design and purpose of the study to potential study 
subjects. Subjects interested in participating will visit the study site where informed consent will be 
obtained.   
 
5.1.2.1 Screen Failures 
A screen failure subject is one from whom informed consent is obtained and is documented in writing 
(i.e., subject signs an Informed Consent Form), but who does not receive a test spot exposure visit 
because of failure to meet all the eligibility criteria. Screen failure subjects will be included in the total 
number of subjects enrolled (i.e., all subjects consented), but not counted towards the total subjects 
treated. 
 
5.1.3 Inclusion Criteria 
Subjects must meet all the following criteria for study enrollment: 
1. Able to read, understand and voluntarily provide written informed consent. 
2. Healthy male or female, ≥ 18 years to 60 years of age seeking treatment for circumferential 
reduction and improvement of muscle strength and muscle tone in the core and extremities. 
3. Subject is determined to be physically fit and agrees to not making any major changes in their 
diet or lifestyle during the study. 
4. Able and willing to comply with the treatment/follow-up schedule and requirements. 
5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 
months prior to study enrollment and for the duration of the study and have a negative Urine 
Pregnancy test at baseline. 

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5.1.4 Participant Exclusion Criteria 
Subjects will be excluded if they meet any of the following criteria: 
1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 
6 months. 
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area 
in the past 12 months. 
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) 
or use of immunosuppressive medications, 6 months prior to and during the study. 
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive 
bleeding. 
5. Having a history of skin cancer or any other cancer in the areas to be treated, including presence 
of malignant or premalignant pigmented lesions. 
6. Having a permanent implant in the treatment area such as metal plates or an injected chemical 
substance such as silicone in the treatment area. 
7. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions 
including but not limited to open lacerations, abrasions, herpes sores, cold sores, active 
infections. 
8. Poor skin quality (severe laxity). 
9. Abdominal wall, muscular abnormality or hernia on physical examination. 
10. As per the investigator’s discretion, any physical or mental condition which may make it unsafe 
for the subject to participate.  
11. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning 
booths, prior to 6 weeks and during the duration of the study.  
12. Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up 
13. Investigator may exclude any subject at any time at his/her discretion 
 
After subjects have provided informed consent and met the inclusion/exclusion criteria, the study 
procedures described in the following section will be performed.  
 
5.2  
STRATEGIES FOR RECRUITMENT AND RETENTION 
Subjects will be recruited from the site’s patient database and surrounding area. Site personnel should 
conduct/send reminder phone calls, emails, and/or text messages to remind subjects of upcoming 
appointments. The next appointment should be scheduled prior to the subject leaving the current 
appointment.  
 
All subjects who have signed an Informed Consent Form, except for screen failures, will be considered 
enrolled in the study. Subjects who complete the study duration will be considered to have completed 
the study. Any subject who does not return for a scheduled follow-up visit will be contacted at least 
twice by telephone to determine the cause for the missed visit and to try to get the subject scheduled 
for the follow-up. A new visit will be scheduled as soon as possible. All subjects should be followed until 
completing the study follow-up or until study discontinuation (withdrawal) for other reasons. The 
reason for study discontinuation should be documented for each subject. Subjects will be deemed “Lost-
to-Follow-up” if they have not returned within six weeks after the last follow-up target. For any subject 
lost to follow-up at least three attempts to contact the subject must be documented; the attempts must 
be two phone calls/emails and a registered letter. 
 

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5.2.1 Subject Payment 
Subjects will not be compensated for participation in this study. 
  
5.3  
PARTICIPANT WITHDRAWAL AND TERMINATION 
All subjects have the right to withdraw at any point during the study without prejudice. The investigator 
can discontinue any subject, at any time, if medically necessary. Subjects must be discontinued from the 
investigation by the investigator at any time for any of the following reasons: 
1. Withdrawal of informed consent. 
2. Pregnancy (no further study-related treatments will be performed; however, the follow-up visit 
will be completed if the study treatments has been completed and the subject will be followed 
to term, called after the pregnancy, childbirth, and/or pregnancy termination and queried for 
abnormalities or complications). 
3. Any AEs for which treatment continuation would constitute an unacceptably high risk for the 
subject. 
 
The reason for any subject’s withdrawal should be documented on the appropriate study-specific data 
form.   
5.4 
PREMATURE TERMINATION OR SUSPENSION OF THE STUDY OR STUDY SITE 
The study or study site can be prematurely terminated or suspended by the sponsor. Reasons for 
termination of the study or a study site may include, but are not limited to, the following: 
1. Subject enrollment is unsatisfactory. 
2. The risks and benefits of continuing the study have been reassessed, and the risks outweigh any 
potential benefits. 
3. The incidence of AEs constitutes a potential health hazard to the subjects. 
4. New scientific data do not justify a continuation of the study. 
5. The investigator or study site exhibit serious and/or persistent non-adherence to the protocol, 
the Declaration of Helsinki, EN ISO 14155, and/or applicable regulatory requirements. 
6. The sponsor decides to terminate the study at any time for any other reason. 
 
Furthermore, the study may be prematurely ended if the regulatory authority or the IRB has decided to 
terminate or suspend approval for the study, the study site, or the investigator. 
If the study is prematurely terminated or suspended for any reason, the investigator must inform the 
subjects and assure appropriate follow-up treatment. Within the timeframes noted in applicable 
regulations, the sponsor will promptly inform the investigators, study sites, the IRB, and regulatory 
authorities of the termination or suspension of the study, as well as provide reasons for the action. 
6. 
STUDY PROCEDURES AND SCHEDULE 
6.1 
PHOTOGRAPHY 
Standardized baseline and follow-up images will be taken as per specified Photography Procedure. 
A checklist is included in CRF to ensure “Standardized Images” are taken at specified visits.  
A series of standardized high-resolution digital photographs and/or video will be taken before and after 
treatment under controlled position and lighting conditions. Subjects will dress comfortably in loose 
garments and will be provided with disposable undergarments for photographs.  
 
Prior to Taking Photographs: 

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1. Jewelry Removed 
2. Disposable undergarments will be supplied 
 
While Taking Photographs 
1. Photographer will position subject for photographs  
LABORATORY EVALUATION 
After Taking Photographs (before subject leaves the office) 
1. Ensure all views have been taken 
2. Ensure all photographs are in focus  
3. Ensure lighting is consistent 
 
6.2 
STUDY SCHEDULE 
6.2.1 Study Specific Procedures 
The following procedures will be done as part of this study: 
1.  
Demographics (Visit 1) 
2.  
Medical/surgical history 
3.  
Concomitant medications 
4.  
Assessment of eligibility (inclusion/exclusion criteria) 
5.  
Urine pregnancy test for women of child-bearing potential (Visit 1 only) 
6.  
Adverse event reporting 
7.  
Photography (Pre-treatment, post-treatment and at follow up visits) 
8.  
Weight and circumferential measurements (Visit 1 and follow up visits only) 
9.  
Dynamometer measurements (Visit 1 and follow up visits only) 
10.  
Subject Satisfaction Survey (at follow up visits only) 
 
6.3 
LABORATORY EVALUATION 
Women of child-bearing potential will be asked to provide a urine sample for a urine pregnancy 
test to be performed according to local site standards. Urine pregnancy required within 24 hours 
of study intervention. A negative result must be available prior to administration of the 
treatment. 
 
A staff member will explain how the pregnancy test will be performed at the screening visit 
depending on which type of pregnancy test is available at the study center. Instructions will 
include: 
1. Hold the pregnancy test stick directly under your urine for 5-10 seconds. 
2. Alternatively, you may be asked to urinate into a specimen cup and dip the pregnancy test 
stick into the urine for 5-10 seconds. 
3. Results are typically available within 2-5 minutes, but some tests take as long as 10 minutes. 
4. A positive result indicating pregnancy will usually be a colored line or plus symbol in the result 
window. A negative result indicating no pregnancy will usually be absence of a colored line or a 
negative symbol. 
 
6.4 
SCREENING AND BASELINE (VISIT 1) 
The Principal Investigator or his/her designee will assess the subject eligibility for participation in the 
clinical study using the inclusion/exclusion criteria (Sections 5.1; 5.2). Subjects meeting the study criteria 
for enrollment will be asked to sign an informed consent document. The Principal Investigator or his/her 

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designee will obtain informed consent from the subject. All subjects must clearly indicate his/her 
understanding of the requirements and possible risks involved with study participation. Once subjects 
sign the informed consent document, they will be assigned a unique identifying number that will be 
composed of a two-digit site number and a three-digit subject number in sequence. This unique 
identifier will be used throughout the entire study and will be entered in the subject’s case report form 
(CRF). 
 
During the screening visit, the Principal Investigator or his/her designee will review the subjects 
medical/surgical history, demographic information, concomitant medication and examine the treatment 
area. Weight and circumferential measurements of the core and extremities. 
 
Women of child-bearing potential will be asked the date of their last menstrual cycle and required to 
provide a urine sample for a urine pregnancy test. A negative result is required within 24 hours of 
treatment for participation in study. The investigator will inquire about contraceptive use to confirm 
they meet the inclusion criteria. 
1. Obtain informed consent of potential participant verified by signature on study 
informed consent form. 
2. Verify all preliminary/screening inclusion/exclusion criteria are met. 
3. Document medical history.  
4. Obtain pregnancy screen (if applicable).  
5. Document concurrent medications. 
6. Obtain demographics. 
 
6.5 
STUDY TREATMENT 
6.5.1  Subject Preparation for Study Treatment 
The investigator, sub-investigator, or delegated clinician will first identify the skin areas to which 
treatment/exposure is to be performed. Treatment records will be maintained in accordance with this 
protocol. Skin in the treatment area should be clean. Subject will be instructed to avoid lotion or oil on 
the treatment area 24 hours prior to treatment.  
 
6.5.2 Study Treatment (Visits 1-8) 
All study treatments will be performed by the investigator, sub-investigator, or delegated clinician (i.e., 
study exposure clinician as designated by the principal investigator.)  The investigator will confirm that 
the subject continues to meet the inclusion criteria and none of the exclusion criteria prior to each study 
treatment. Concomitant medications will be reviewed. Specific treatment parameters will be 
determined by the Investigator and recorded on the case report forms.   
 
Each subject will receive up to 8 study treatments over a 4-week period.  Subjects return for a 30 day 
and 90-day post final treatment follow up visit.  
● Cleanse skin. 
● Obtain digital images. 
● Perform study treatment. 
● Obtain Numeric Pain Rating Scale score. 
● Assess for expected treatment effects (ETEs) and adverse events (AEs). 
 

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Subjects will be asked to return for follow up visits post-final treatment at 30 days and 90 days. At 1st 
and all follow up visits weight, dynamometer measurements, circumferential measurements, subject 
satisfaction survey, adverse events and photography will be completed and assessed.   
 
Subject discomfort during study treatment will be documented using a 0 (None) to 10 (Severe) numeric 
pain rating scale.  If the treatment becomes too uncomfortable for a subject, it will be discontinued, or 
the settings may be lowered to a more comfortable level.  Subjects may also request that treatment be 
discontinued at any time, for any reason. 
 
6.5.3 Acute Responses 
For all exposures, acute responses (e.g., erythema or edema) will be observed by the study exposure 
clinician and recorded after exposure. If any Serious Adverse Events (SAE) are noted, an SAE Form 
should be completed.  
 
6.5.4 Post- Care Instructions  
Following treatment subject may assume normal activities.  Hot baths, sauna and vigorous exercise 
should be avoided.  The subject should be reminded to not make any major changes in their diet or 
lifestyle during the study.  
 
6.5.5 
Schedule of Activities  
 
TABLE 1: SCHEDULE OF ACTIVITIES 
 
Screening 
Tx 1 
Tx 2 
Tx 3 
Tx 4 
Tx 5 
Tx 6 
Tx 7 
Tx 8 
FU 30 
day 
FU 90 
days 
Informed 
Consent 
x 
 
 
 
 
 
 
 
 
 
 
Pregnancy 
Verification 
x 
 
 
 
 
 
 
 
 
 
 
Concomitant 
Medications 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Medical History 
x 
 
 
 
 
 
 
 
 
 
 
Demographics 
x 
 
 
 
 
 
 
 
 
 
 
Weight 
x 
 
 
 
 
 
 
 
 
x 
x 
Dynamometer 
Measurements 
x 
 
 
 
 
 
 
 
 
x 
x 
Circumferential 
Measurements 
x 
 
 
 
 
 
 
 
 
x 
x 
Photography 
(pre- and - post 
treatment) 
 
x 
 
 
 
 
 
 
 
x 
x 
Subject 
Satisfaction 
 
 
 
 
 
 
 
 
 
x 
x 

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Pain Scale Rating  
 
x 
x 
x 
x 
x 
x 
x 
 
 
Adverse Events 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
6.5.6 Safety Assessments 
Assess for adverse events immediately post-treatments and at the follow-up visits. 
 
6.5.7 Unscheduled Visit 
Any unscheduled visit or examine should be documented in the subject’s medical record and adverse 
event form (if applicable) stating the reason for the visit and any actions taken. The Sponsor should be 
notified of the unscheduled visit. 
6.6 
STUDY TREATMENT 
This study involves up to 8 treatments to be conducted after obtaining informed consent, screening for 
inclusion/exclusion, complying with standardized photography requirements, and completing pregnancy 
tests, if applicable.  
 
6.6.1  Subject Preparation for Study Treatment 
The investigator, sub-investigator, or delegated clinician will first identify the skin areas to which 
treatment/exposure is to be performed. Treatment records will be maintained in accordance with this 
protocol. Skin in treatment area should be clean. No lotion or oil should be present on the area to be 
treated.  
 
6.6.2 Study Treatment 
All study treatments will be performed by the investigator, sub-investigator, or delegated clinician (i.e., 
study exposure clinician as designated by the principal investigator.)  
Specific treatment parameters will be determined by the Investigator and recorded on the case report 
forms.  Subject discomfort during study treatment will be documented using a 0 (None) to 10 (Severe) 
pain rating scale.  If the treatment becomes too uncomfortable for a subject, it will be discontinued, or 
the settings may be lowered to a more comfortable level.  Subjects may also request that treatment be 
discontinued at any time for any reason. 
 
6.6.3 Acute Responses 
For all exposures, acute responses (e.g., erythema or edema) will be observed by the study exposure 
clinician and recorded after exposure. If any Serious Adverse Events (SAE) are noted, an SAE Form 
should be completed.  
 
6.6.4 Post- Care Instructions 
Following treatment subject may assume normal activities.  Hot baths, sauna and vigorous exercise 
should be avoided.  The subject should be reminded to not make any major changes in their diet or 
lifestyle during the study.  
 
6.7 
CONCOMITANT MEDICATIONS 
All concomitant prescription medications taken during study participation will be recorded on the 
appropriate study-specific data form. For this protocol, a prescription medication is defined as a 
medication that can be prescribed only by a properly authorized/licensed clinician. Medications to be 

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reported on the data form and entered on the CRF are concomitant prescription medications, over-the-
counter medications and non-prescription medications. 
7. 
ASSESSMENT OF SAFETY 
7.1 
SPECIFICATIONS OF SAFETY PARAMETERS 
7.1.1 Definition of an Expected Treatment Effect (ETE) and an Adverse Event (AE) 
An expected treatment effect is defined as any typical treatment side-effect of the study devices of mild 
to moderate severity and lasting up to a typical maximum duration. An adverse event is defined as any 
new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled 
in the study, whether it is considered device-related by the investigator.  All ETEs and AEs will be 
collected during the conduct of this trial.   
 
7.1.2 Definition of Serious Adverse Event (SAE) 
Each adverse event should be assessed for its seriousness. The definition below should be used for this 
assessment. Please note that the term serious adverse event is not synonymous with a “severe” adverse 
event, which may be used to describe the intensity of an event experienced by the subject.  
An adverse event should be classified as serious if it meets any of the following criteria: 
a. 
Death 
Death was an outcome of the adverse event.  
b. 
Life-threatening 
The subject was at substantial risk of dying at the time of the adverse event or use or continued 
use of the device. 
c. 
Hospitalization (initial or prolonged) 
Admission to the hospital or prolongation of hospitalization was a result of the adverse event. 
d. 
Disability or Permanent Damage 
The adverse event resulted in a substantial disruption of a person's ability to conduct normal life 
functions, i.e., the adverse event resulted in a significant, persistent or permanent change, 
impairment, damage or disruption in the patient's body function/structure, physical 
activities and/or quality of life. 
e. 
Congenital Anomaly/Birth Defect 
Exposure to a medical product prior to conception or during pregnancy may have resulted in an 
adverse outcome in the child. 
f. 
Required Intervention to Prevent Permanent Impairment or Damage (Devices) 
Medical or surgical intervention was necessary to preclude permanent impairment of a body 
function, or prevent permanent damage to a body structure, either situation suspected to 
be due to the use of a medical product. 
g. 
Other Serious (Important Medical Events) 
The event does not fit the other outcomes, but the event may jeopardize the subject and may 
require medical or surgical intervention (treatment) to prevent one of the other outcomes. 
 
Non-serious adverse events are all events that do not meet the criteria for a “serious” adverse event. 
 
7.1.3 Definition of Unanticipated Adverse Device Effects (Events) 
An unanticipated adverse device effect is defined as “any serious adverse effect on health or safety, or 
any life-threatening problem, or death caused by, or associated with, a device; if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the investigational plan, 

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or application (including supplementary application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.” 
 
7.2 
CLASSIFICATION OF AN EVENT 
7.2.1 Severity of Event 
Each adverse event should be assessed for its severity, or the intensity of an event experienced by the 
subject, using the following classifications: 
1 = Mild 
Discomfort noticed, but no disruption to daily activity 
2 = Moderate Discomfort sufficient to reduce or affect normal daily activity 
3 = Severe 
Inability to work or perform normal daily activity 
 
7.2.2 Relationship to the Investigational Device 
The investigator should assess the relationship of the adverse event to the investigational device. The 
relationship should be assessed using the categories presented in Table 2. 
 
TABLE 2: RELATIONSHIP BETWEEN ADVERSE EVENTS AND INVESTIGATIONAL DEVICE 
Definite 
Definite relationship exists between the device/procedure and an adverse 
event 
Probably Related 
A reasonable causal relationship between the device/procedure and an 
adverse event is more likely than not. 
Possibly Related 
A reasonable relationship exists between the device/procedure and an adverse 
event, but the causal relationship is unclear or lacking. 
Not Likely Related 
A temporal relationship exists between the device/procedure and an adverse 
event, but there is no reasonable causal relationship. For example, the adverse 
event occurs in a time frame, which makes a causal relationship to device 
treatment improbable. 
Unrelated 
No relationship between treatment with the device/procedure and the 
adverse event exists. 
 
7.2.3 Expectedness 
Reported events will be categorized as Expected Treatment Effects if the event meets the definition of 
any typical treatment side-effect of study devices of mild to moderate severity and lasting up to a typical 
maximum duration. 
 
7.3 
TIME PERIOD AND FREQUENCY FOR EVENT FOLLOW UP AND ASSESSMENT 
The occurrence of an AE or SAE may come to the attention of study personnel during a study visit or 
upon review by a study monitor. All ETEs and AEs will be captured on the appropriate data form. 
Information to be collected includes event description, date of onset, clinician’s assessment of 
seriousness and severity, relationship to study device/treatment (assessed only by those with the 
training and authority to decide), actions taken, and date of event resolution. All AEs occurring while on 
study must be documented appropriately regardless of relationship. All ETEs/AEs assessed as “not yet 
resolved” must continue to be followed via telephone contact, email or clinic visit every 7 days or sooner 
as per the physician’s direction until event resolution or stabilization or tissue resection. 
   
A pre-existing condition should not be reported as an adverse event unless there has been a substantial 
increase in severity or frequency of the problem that has not been attributed to natural history. 
 

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Changes in the severity of an event will be documented to allow for a determination if the event should 
be re-categorized from an ETE to AE.   
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation or 
until tissue is resected. At each study visit, the investigator will inquire about the occurrence of 
ETEs/AEs/SAEs since the last visit. Events will be followed for outcome information until resolution or 
stabilization or tissue is resected. 
 
7.4 
REPORTING PROCEDURES 
7.4.1 Adverse Event Reporting 
Any new medical problem, or an exacerbation of an existing condition, reported from the time the 
informed consent form is signed must be followed until the last study visit after the last study 
treatment/exposure or until event resolution.   
AEs will not be followed up after the final study visit as tissue will be resected at the abdominoplasty 
visit. AEs related to the abdominoplasty are outside the scope of this study and will not be reported. 
 
7.4.2 Serious Adverse Event Reporting 
Serious adverse events must be reported to the Sponsor as soon as possible, preferably within 24 
hours but in no event later than 72 hours. Any AE considered serious by the PI or Sub-investigator or 
which meets the definition of an SAE included in Section 7.1.2, Definition of Serious Adverse Event 
must be documented on an SAE data form. 
 
The Sponsor will conduct an investigation. If the Sponsor determines that the investigation presents an 
unreasonable risk to subjects, all investigations or parts of the investigation presenting that risk will be 
terminated as soon as possible. The investigator must report serious adverse events to the reviewing IRB 
according to the IRB regulations at the study site. 
 
7.4.3 Unanticipated Adverse Device Effect Reporting 
If an unanticipated adverse device effect occurs, the study investigator shall complete the appropriate 
study-specific data form and submit to the study sponsor and to the reviewing IRB as soon as possible, 
but in no event later than 10 working days after the investigator first learns of the effect. The study 
sponsor contact information is provided in Section 1, Key Roles. The study sponsor is responsible for 
conducting an evaluation of an unanticipated adverse device effect and shall report the results of such 
evaluation to FDA and to all reviewing IRBs and participating investigators within 10 working days after 
the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional 
reports concerning the effect as FDA requests. 
 
7.4.4 Reporting of Pregnancy 
Each pregnancy that starts during the subject’s study participation must be reported by the investigator 
to the Sponsor within 24 hours of learning of its occurrence. Pregnancies and pregnancy follow-up 
should be reported on an Adverse Event form. Pregnancy follow-up should describe the outcome of the 
pregnancy, including any voluntary or spontaneous discontinuation; details of the birth; the presence or 
absence of any congenital abnormalities, birth defects, maternal or newborn complications, and their 
relation to the device or treatment/exposure. Each pregnancy must be reported as a non-serious AE if 
the subject has received at least one study treatment/exposure.  The following criteria should be 
followed: 

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a. If a subject becomes pregnant after the Baseline visit and all study treatments/test spot 
exposure have been completed, the subject should continue to be followed for the duration 
of the pregnancy. 
b. If a subject becomes pregnant after the Baseline visit but before any study treatments/test 
spot exposures, the subject should be exited from the study. 
c. If a subject becomes pregnant after the Baseline visit but before all study treatments/test 
spot exposures have been completed, additional study treatments/test spot exposures 
should be discontinued, and the subject should continue to be followed for the duration of 
the pregnancy. 
 
7.4.5 Reporting of Deaths 
The investigator must notify the Sponsor as soon as possible, preferably within 24 hours but in no event 
later than 48 hours, of learning of a subject’s death, regardless of whether the death is related or 
unrelated to the investigational device. The investigator should attempt to determine, as conclusively as 
possible, whether the death is related to the device. The cause of death and the investigator’s discussion 
regarding whether the death was device-related should be described in a written report. The 
investigator mush report death to the reviewing IRB according to the IRB regulations at the study site. 
8. 
CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 
the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirement(s). 
1. Monitoring for this study will be performed by the Sponsor or Sponsor contract monitor. 
2. Clinical study site and data monitoring will be conducted via both centralized and on-site 
monitoring. 
a. Centralized data monitoring will focus primarily on: 
i. Ongoing, real-time review of clinical data supporting safety, and primary and 
secondary study-defined endpoints, specifically: 
1. Tracking the occurrence of adverse events and expected treatment 
effects. 
ii. Ongoing, real-time review of clinical data as entered on Case Report Forms 
(CRF):  
1. Initial study consent was obtained for all enrolled subjects;  
2. Eligibility for study participation of all enrolled subjects;  
3. Verification of protocol compliance and data completeness. 
iii. Ongoing, real-time evaluation of data trends to identify outliers, unexpected 
trends, or holes in data collection; 
iv. Ongoing, real-time evaluation of study photographs. 
b. Centralized monitoring requires timely data entry and timely uploading of completed 
CRFs to the study HIPAA compliant cloud-based system, e.g., no later than 7 working 
days after a study visit has occurred. 
c. On- site monitoring visits will include: 
i. Review of primary/secondary endpoint data source documents; 
ii. Confirmation that subject randomization is being completed appropriately (if 
applicable); 
iii. Confirmation that study blinding is maintained (if applicable); 

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iv. Confirmation of appropriate execution of the PGAIS, SGAIS, PSQ, or other study-
specific scales; 
v. Note any other study-specific study design items requiring on-site confirmation. 
d. General on-site monitoring tasks will include: 
i. Review of study conduct and progress at each investigative site, e.g., protocol 
compliance, subject recruitment, etc.; 
ii. Confirmation that written informed consent was obtained and documented at 
the time of screening, using an appropriate version of an IRB-approved ICF, and 
subject eligibility is confirmed.  
iii. Confirmation that all expected treatment effects, adverse events and/or 
protocol deviations noted in site records are appropriately documented on 
study specific CRFs.  
iv. Identification and resolution of any device performance issues; 
v. Review of the investigator’s study records, study management documents and 
subject informed consent documents.  
vi. Confirmation that all investigative site personnel with study-related 
responsibilities are adequately trained and that the applicable training records 
are maintained in the Site Regulatory Binder.  
vii. Confirmation that study-related responsibilities of site personnel are 
appropriately documented on the Delegation of Responsibility Log and the log is 
maintained in the Site Regulatory Binder. 
viii. Reconciliation of the Device Disposition Log against device inventory and 
confirmation that study devices are kept in a secure location.  
ix. Confirmation that required regulatory documents are present in the Site 
Regulatory Binder and are current and correct.  
x. Ensure that all findings, conclusions and any actions taken to correct 
deficiencies noted during an on-site monitoring visit are documented in a site 
monitoring report.  
e. On-site monitoring frequency 
i. An on-site monitoring visit will be completed at each study site at least one time 
during this clinical trial. 
ii. The frequency of site monitoring visits may be adjusted based on a number of 
factors, including but not limited to:  
1. Duration of the study; 
2. Number of subjects enrolled; 
3. Number of investigators/sites;  
4. Complexity of the study; 
5. The level of the study site’s experience in conducting and overseeing 
clinical trials;  
6. The quality of the data documented on study-specific data forms and 
entered into the study database; 
7. Number of outstanding issues from previous visits. 
9. STATISTICAL ANALYSIS 
9.1 
STATISTICAL AND ANALYTICAL PLANS 
The primary analysis of efficacy will be based on the evaluable treated subjects, hence, only those 
subjects who received complete study treatments and follow up visits will be included in the analysis.  

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9.2  
ANALYSIS DATASETS 
The following analysis sets will be defined for the statistical analysis of this investigation:  
 
Safety Evaluation Set (SES)  
Subset of all subjects who received the investigational treatment.  
 
Full Analysis Set (FAS)  
Subset of subjects in SES that received complete treatments have primary effectiveness data available.    
 
Per Protocol Set (PPS)  
Subset of all subjects who received complete treatments and have completed the study without major 
protocol deviations. 
 
9.3 
DESCRIPTION OF STATISTIC METHODS 
Endpoints will be summarized using descriptive statistics including mean score, standard deviation, 
standard error and range. Frequency and percentage of subjects within each category will be presented 
for categorical data. If applicable, Wilcox t-test may be used to determine if two sets of data are 
significantly different from one another. If p-value is below the level of statistical significance for 
effectiveness analyses (α = 0.05) for all tests of differences, then the null hypothesis is rejected in favor 
of the alternative hypothesis. Rejection of null hypotheses will establish that: 
o The two-sided 95% confidence interval for the difference between the means excludes 
zero. 
o  The two means are statistically significantly different at the 5% level (P <0.05) two-
sided. 
Upon rejection of null hypotheses, further statistical test tools such as, Confidence Interval, and/or One-
way ANOVA and/or descriptive statistical tools may be used to determine the performance of the 
treatment. 
 
9.4 
SAFETY ANALYSES  
The safety analysis will be done by analyzing spontaneous reports of adverse events (AE), as well as 
analysis of immediate response reports by the principal investigator from his/her 
observation/examination of the treated area. Appropriate Medical Dictionary for Regulatory Activities 
(MedDRA) code will be used to describe all spontaneously reported events or other study related 
adverse events. 
Summaries of spontaneously reported or other study related adverse events will be presented as: 
o Number (%) of subjects with any AE 
o  Number (%) of subjects with any serious adverse events (SAE) 
o  Number (%) of subjects permanently withdrawn from treatment due to AE 
 
Summaries of analysis of immediate response reports by the principal investigator examination 
will be displayed on a bar or pie chart and/or a table as; 
a. The overall frequency of subjects with each event (pain during treatment, hemorrhage, 
burn, erythema, edema, purpura, etc.). 
b. Frequency of subjects with specific severity/intensity for each event using a 5-
pointscale: 1=none; 2=trace; 3=moderate; 4=marked; 5=severe. 

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c. The overall proportion of subjects observed with marked or severe intensity of any 
event will be calculated and compared to those with none, trace or moderate 
severity/intensity. 
 
9.6 
BASELINE DESCRIPTIVE STATISTICS 
Subjects’ baseline demographics will be compared using descriptive statistics such as mean score, 
standard deviation, standard error and range. Data will be displayed in tables or graphical presentation. 
 
9.7 
ANALYSIS OF PRIMARY ENDPOINTS 
The following will be considered for the analysis of primary endpoints: 
The results of each Blinded Reviewer’s evaluation of photographs taken at 1 month and 3 months 
compared to baseline will be analyzed, and the results will be reported as a % of the correctly identified 
post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly 
identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to 
determine 
 
Bar, pie charts or graphs indicating percentages of the correctly identified post treatment photographs 
chosen by Blinded Reviewer may also be used to analyses efficacy. 
 
The % of the correctly identified post treatment photographs chosen by Blinded Reviewer of all subjects 
who received all treatments with the investigational device and for whom all valid post-baseline 
assessment was obtained will be analyzed for these primary endpoints. Multiple imputation method or 
modelling of available data may be used for missing data as appropriate. 
 
9.8 
ANALYSIS OF SECONDARY ENDPOINTS 
For the analysis of changes in muscle tone and muscle strength, circumference of the extremities and 
subjects’ assessment of satisfaction with the treatment secondary endpoints, the following analysis will 
be considered: 
 
Summary tables of changes in measurements of muscle tone and strength, circumference and subjects’ 
assessment of satisfaction at 1 and 3 months post last treatment as compared to baseline will be 
displayed as mean difference, standard deviation and standard error. 
 
Bar charts, pie chart, graphs or any other descriptive statistical displays indicating scores, percentages 
and/or proportions of changes in circumference and subjects’ assessment of satisfaction at 1 month and 
3-month post-treatment as compared to baseline will be used where applicable to analyze efficacy. 
 
All statistical tests that will be two-sided. The level of statistical significance for effectiveness analyses is 
5% (α = 0.05) for all tests of differences. Where appropriate, two-proportion z-test will be used to 
compare the differences between changes in abdominal circumference and subjects’ assessment of 
satisfaction at1 month and 3 months post last treatment as compared to baseline. 
 
Analysis of Covariance (ANCOVA) may also be used where appropriate. Change in abdominal 
circumference and subjects’ assessment of satisfaction assessments at twelve weeks post-treatment as 
compared to baseline of all subjects who received all treatments with the investigational device and for 
whom have all valid post-baseline assessment was obtained will be analyzed for these secondary 

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endpoints. Multiple imputation method or modelling of available data may be used for missing data as 
appropriate. 
10. SOURCE DOCUMENTS AND ACCESS TO SOURCE DOCUMENTS 
Source documents are defined as the results of original observations and activities of a clinical 
investigation. Source documents will include, but are not limited to, study-specific data forms, progress 
notes, electronic data, computer printouts, screening logs, and recorded data from automated 
instruments. All source documents pertaining to this study will be maintained by the investigators and 
made available for inspection by authorized persons. 
 
Following written SOPs, the clinical study monitors will verify that the clinical trial is conducted, and data 
are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements. 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
11. ETHICS/PROTECTION OF HUMAN SUBJECTS 
11.1 ETHICAL STANDARD 
This clinical study will be conducted in accordance with the Protection of Human Subjects Regulations, 
including Subpart B Informed Consent of Human Subjects (21 CFR Part 50); the Institutional Review 
Board Regulations (21 CFR Part 56); the Financial Disclosure by Clinical Investigators Regulations (21 CFR 
Part 54); and the Investigational Device Exemptions Regulations (21 CRF Part 812), and the ICH E6. 
 
11.2 INSTITUTIONAL REVIEW BOARD 
Prior to initiation of any study procedures, the protocol, informed consent, and recruitment materials, 
and all participant materials will be submitted to a duly constituted IRB for view and approval. In 
addition, any amendments to the protocol or Informed Consent Form will be reviewed and approved by 
the IRB. The Sponsor must receive a letter documenting IRB approval at the clinical site prior to the 
initiation of the study. 
The investigator is responsible for providing the appropriate reports to its reviewing IRB during the 
clinical study. These reports will include: 
1. Informing the IRB of the study progress periodically as required, but at least annually; 
2. Reporting any unanticipated adverse device effects within 10 working days of first learning of 
the event; 
3. Reporting any deviations from the clinical protocol to protect the life or well-being of a subject 
in the case of an emergency within five working days after the emergency occurred; 
4. Reporting the use of the device without obtaining informed consent from a subject within five 
working days of the event; and  
5. Providing any other reports requested by the IRB. 
 
The IRB must be notified of study completion within 30 days of the final visit of the last subject and 
should be provided with a summary of the results of the study by the investigator. 
 

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11.3 INFORMED CONSENT PROCESS 
11.3.1 Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study device, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study product.  
 
11.3.2 Consent Procedures and Documentation 
Informed consent will be obtained from all subjects prior to study participation. Informed consent is a 
process that is initiated prior to the individual’s agreeing to participate in the study and continues 
throughout the individual’s study participation. Extensive discussion of risks and possible benefits of 
participation will be provided to each participant. Consent forms will be IRB-approved, and the 
participant will be asked to read and review the document. The investigator, or investigator-delegated 
study personnel, will explain the research study to the participant and answer any questions that may 
arise. All participants will receive a verbal explanation in terms suited to their comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research participants. 
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participants should have the opportunity to discuss the study with their surrogates 
or think about it prior to agreeing to participate. The participant will sign the informed consent 
document prior to any procedures being done specifically for the study. The participants may withdraw 
consent at any time throughout the course of the trial. A copy of the informed consent document will be 
given to the participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
 
11.4 PARTICIPANT AND DATA CONFIDENTIALITY  
All information generated in this study must be considered highly confidential and must not be disclosed 
to any persons not directly concerned with the study without prior written permission from the 
Sponsor. Authorized regulatory officials and Sponsor personnel (or its representatives) will be allowed 
full access to inspect the records. All investigational devices and/or other materials collected will be 
used solely in accordance with this protocol, unless otherwise agreed to in writing by the Sponsor.  
Subjects should be identified only by initials and unique subject numbers on study-specific data forms. If 
necessary, their full names may be made known to a regulatory agency or other authorized officials. 
12. 
DATA HANDLING AND RECORD KEEPING 
12.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported.    
 
During each subject’s visit to the clinic, study data will be documented by study personnel on study-
specific data forms (CRFs). In addition, study personnel will record progress notes to document all 
significant observations, and any contact with a subject by telephone or other means that provides 
significant clinical information will also be documented in the progress notes as described above. 
For transmission to the Sponsor, information from the study progress notes and other source 
documents will be promptly transcribed to study-specific data forms (CRFs). In this clinical trial, study-

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specific data forms (CRFs) may also serve as source documents. Transcription of study data onto study-
specific data forms should be completed and uploaded within 7 days of the study visit. 
Copies of the CRF serving as source documents must be maintained for each participant enrolled in the 
study. Data reported in the CRF derived from source documents should be consistent with the source 
documents or the discrepancies should be explained and captured in a progress note and maintained in 
the participant’s official study record. 
 
Any changes to information in the study progress notes, other source documents, and data forms will be 
initialed and dated in ink on the day the change is made by a site study staff member authorized to 
make the change. Changes will be made by striking a single line through erroneous data, and clearly 
entering the correct data. If the reason for the change is not apparent, a brief explanation for the 
change will be written in the source documentation by the clinician. 
 
12.2 INVESTIGATOR RECORDS AND REPORTS 
12.2.1 Investigator Records  
 
Prior to participation in the investigation, the investigator must provide the following documentation to 
the Sponsor:  
o Investigator Agreement, signed by the investigator, which lists any physicians who will be 
involved in conducting the investigation under the direction of the primary investigator; 
o A copy of the principal investigator’s, sub-investigator’s, other delegated study clinicians’ 
curriculum vitae; 
o A letter signed by the chairperson of the IRB overseeing the conduct of this study indicating that 
the IRB has reviewed and approved this investigational plan; and 
o A copy of the IRB-approved Informed Consent Form. 
During the study, investigators are required to maintain on file the following accurate, complete, 
and current records relating to this study as described in 21 CFR §812.140. A summary of these 
records is listed below: 
o All correspondence and required reports, which pertain to the study. 
o Records of receipt, use, or disposition of study devices, including the type and quantity of 
devices; the dates of receipt; the serial numbers; the names of all persons who received, used or 
disposed of each device; and why and how many units of the device have been returned to the 
Sponsor, repaired, or otherwise disposed. 
o Records of each subject’s case history and exposure to the device. 
o Signed and dated consent forms. 
o Relevant observations, including records concerning adverse events, condition of each subject 
upon entering and results of diagnostic tests. 
o Study-specific data forms and corrections to the forms. 
o Protocol and amendments. 
o Subject recruiting materials. 
o Investigator curriculum vitae. 
 
12.2.2 Investigator Reports 
Investigators are required to prepare and submit to the Sponsor the following complete, accurate, and 
timely reports on this investigation when are required. These reports, which are listed below, are 
required by 21 CFR §812.150; additional reports may be requested by the Sponsor: 
o The investigator will notify the Sponsor of a subject death occurring during the investigation, as 
soon as possible, preferably within 24 hours of learning of the subject’s death, but in no event 

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later than 48 hours. The investigator will notify the reviewing IRB of a subject death as specified 
by the IRB. 
o The investigator will notify the Sponsor of any unanticipated adverse device effects within 48 
hours after learning of the effect. The investigator will notify its reviewing IRB of any 
unanticipated adverse device effects, as soon as possible, but no later than 10 working days 
after learning of the effect. 
o The investigator will notify the Sponsor of the withdrawal of IRB approval, as soon as possible, 
but no later than five working days after learning of the withdrawal. 
o The investigator will provide current progress reports to the Sponsor and reviewing IRB at 
regular intervals and at least on an annual basis. 
o The investigator will notify the Sponsor and reviewing IRB of any deviation from the 
investigational plan to protect the life and physical well-being of a subject in an emergency, as 
soon as possible, but no later than five working days after the emergency occurred. 
o The investigator will notify the Sponsor and reviewing IRB that an informed consent was not 
obtained from a subject, as soon as possible, but no later than five working days after such an 
occurrence. 
o The investigator will provide a final summary report to the Sponsor and reviewing IRB within 
three months after termination or completion of the study. 
o The investigator will provide any other information upon the request of an IRB, FDA, or the 
Sponsor. 
 
12.3 STUDY RETENTION RECORDS 
The investigator is responsible for retaining the necessary records, including a copy of the protocol, 
device labeling, study-specific data forms, medical records, original reports of test results, all study-
related correspondence, a record of written informed consent, and any other documents pertaining to 
the conduct of this study. 
FDA regulations require all investigators participating in investigational device studies to maintain 
detailed clinical records during the investigation and for a period of at least two years after the latter of 
the following two dates: 
1. The date on which the investigation is terminated or complete; or 
2. The date the records are no longer required for purposes of supporting a premarket approval 
application. 
The investigator must not dispose of any records relevant to this study without either: 
1. Obtaining written permission from the Sponsor; or 
2. Providing an opportunity for the Sponsor to collect such records. 
 
The investigator shall take responsibility for maintaining adequate and accurate electronic or hard copy 
source documents of all observations and data generated during this study. Such documentation is 
subject to inspection by the Sponsor and the FDA. 
 
12.4 PROTOCOL DEVIATIONS 
This study should be conducted as described in this protocol, except for an emergency in which the 
protection, safety, and well-being of a subject requires a protocol deviation, based on the judgment of 
the investigator (or a responsible, appropriately trained professional designated by the investigator). If 
the deviation from the protocol is necessary to protect the physical well-being of a subject in an 

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emergency, such protocol deviations must be reported to the Sponsor and the reviewing IRB as soon as 
possible, but no later than five working days after the emergency occurred.  
In the event of a significant deviation from the protocol due to an accident or mistake, the investigator 
or designee must contact the Sponsor at the earliest possible time by telephone to discuss the deviation 
and its impact on the study and subject continuation in the study. These discussions will be documented 
by the investigator and the Sponsor and reviewed by the monitor. 
 
12.5 PUBLICATION AND DATA SHARING POLICY 
The data produced by this Lutronic‐sponsored study is the sole property of Lutronic.  Thereby, 
abstracts, publications and presentations of this data must be pre‐approved by Lutronic in writing (e‐
mail approval is acceptable).  The Sponsor must also be provided with the opportunity to review all 
investigator‐prepared abstracts, publications or presentations.  A period of thirty (30) days for 
presentational materials and abstracts and forty‐five (45) days for manuscripts will be required for 
review and comment by Sponsor’s Clinical Research Department. These requirements acknowledge 
Sponsor's responsibility to evaluate such publications for their accuracy, to ascertain whether 
Confidential Information is being inappropriately released, to provide the Principal Investigator with 
information which may not yet have been available to him/her, and to provide input from co‐authors 
regarding content and conclusions of the publication or presentation.    If requested in writing by the 
Sponsor, the Institution will withhold publication to protect the potential patentability of any invention 
described therein and/or made available to fulfill regulatory requirements. Notwithstanding the 
foregoing, Institution agrees that if the Study is part of a multi‐center study, the first publication of the 
results of the Study shall be made in conjunction with the results from the investigators at the other 
study centers as a multi‐center publication. 
13. STUDY ADMINISTRATION  
13.1  STUDY INVESTIGATORS 
All investigators will be experienced with aesthetic treatments using a variety of accepted clinical 
modalities. 
 
13.2 AMENDMENT POLICY 
The investigator will not make any changes to this protocol without prior written consent from the 
Sponsor and subsequent approval by the IRB, except if the deviation from the protocol is necessary to 
protect the life and physical well-being of a subject in an emergency. Such protocol deviations must be 
reported to the Sponsor and the reviewing IRB as soon as possible, but no later than five working days 
after the emergency occurred. 
 Any permanent change to the protocol, whether it is an overall change or a change for specific study 
center(s), must be handled as a protocol amendment. Any amendment to the protocol that appears 
indicated as the study progresses will be fully discussed by the investigator(s) and the Sponsor. If 
agreement is reached regarding the need for an amendment, the Sponsor will write it. The written 
amendment must be submitted to the chairman of the IRB identified with this responsibility. Except for 
“administrative amendments”, investigators must await IRB approval of protocol amendments before 
implementing the change(s). Administrative amendments are defined to have no effect on the validity of 
the data or information resulting from the completion of the approved protocol, or the relationship of 
likely patient risk to benefit relied upon to approve the protocol; the scientific soundness of the 
investigational plan or protocol; and the right, safety or welfare of the human subjects involved in the 
investigation. 

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When, in judgment of the chairman of the IRB, the investigators and/or the Sponsor, the amendment to 
the protocol substantially alters the study design and/or increases the potential risk to the subject, the 
currently approved written Informed Consent Form will require similar modification. In such cases, 
repeat informed consent will be obtained from subjects enrolled in the study before continued 
participation. 
14. CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the trial.  
 
 
 
 

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References 
 

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APPENDIX PROTOCOL REVISIONS LOG 
VERSION 
DATE 
SIGNIFICANT REVISIONS 
V1.0 
6/25/2020 
Initial Release 
V2.0 
9/8/2021 
Expand to include extremities, strength measurements, investigators