An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift
Phase: NA
Conditions: Skin Laxity
Sponsor: ThermiGen, LLC

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 1 of 51 
 
CLINICAL PROTOCOL 
AN OPEN-LABEL, SINGLE-CENTER, SINGLE-TREATMENT, SAFETY AND 
EFFECTIVENESS EVALUATION OF PERCUTANEOUS RADIOFREQUENCY 
IN ACHIEVING SUBMENTAL LIFT  
 
Investigational Device Name (if 
applicable): 
ThermiRF  
Regulatory Clearance No.:  
K130689 
Protocol Number: 
Thermi_0005 
Sponsor: 
ThermiGen, LLC 
Version and Date: 
Final - 10 MAY 2016 
 
 
 
This document contains privileged and confidential information belonging to the Sponsor.  Except as 
otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold the information 
contained herein in confidence and not copy or disclose it to others (except where required by applicable 
law) or use it for unauthorized purposes.  In the event information is disclosed to others, as required by 
applicable law, they must be informed that the information is privileged and confidential and may not be 
further disclosed by them.  These restrictions on disclosures will apply equally to all future information 
supplied to you that is indicated as privileged and confidential.  You agree that no unpublished information 
contained herein will be published or disclosed without the prior written approval of Sponsor.  In the event 
of any actual or suspected breach of this obligation, Sponsor must be promptly notified. 

Investigational Device:  ThermiRF
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 2 of 51 
  
INTERNAL PROTOCOL APPROVAL FORM 
 
Protocol Effective Date: 10 May 2016 
 
Protocol No.: 
Thermi_0005 
Protocol Title: 
An Open-Label, Single-Center, Single-Treatment, Safety and 
Effectiveness Evaluation of Percutaneous Radiofrequency in 
Achieving Submental Lift    
 
 
 The above reference protocol was authored, reviewed and approved by the THERMI 
approving committee listed below.  
 
Changes to the approved protocol will require issuance of an amendment /amended 
protocol and separate approval of such amendment. 
 
SPONSOR 
REPRESENTATIVE 
(Name and Title) 
FUNCTION 
SIGNATURE OF APPROVAL 
DATE 
Claudia Jennings 
Consultant Clinical 
 Author 
 
 
Kevin O’Brien 
President  
Reviewer & Approver 
 
 
Toni Fournier 
VP Commercialization 
Reviewer & Approver 
 
 
Sam Dickson 
Consultant Statistician 
Reviewer & Approver 
 
 
Carrie Eddings 
Regulatory Manager 
Reviewer & Approver 
 
 
 
 
 
 
 
10-May-2016

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 3 of 51 
INVESTIGATOR SIGNATURE OF AGREEMENT 
 
The signature below constitutes the investigator agreement to conduct the study in 
accordance to the stipulations and guidelines set forth in the protocol, including all 
statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable United States Food and Drug Administration (FDA), the 
applicable Code of Federal Regulations (CFR), and International Conference on 
Harmonization (ICH).   
 
 
 
Principal 
Investigator Name 
 
 
Dr. Barry DiBernardo 
Signature 
 
 
                           
Date:________ 
Sub-Investigator 
Name 
 
Dr. Maria DelVecchio 
Signature 
       
 
                                 
                                                         Date:________ 
Sub-Investigator 
Name 
 
Signature 
         
 
                             
                                                         Date:________ 
 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 4 of 51 
TABLE OF CONTENTS 
1. 
ETHICS .............................................................................................. 8 
1.1. 
Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC) ................................................................................................... 8 
1.2. 
Ethical Conduct of the Study .............................................................. 8 
1.3. 
Subject Information and Consent ....................................................... 8 
2. 
INVESTIGATORS AND STUDY ADMINISTRATIVE 
STRUCTURE ..................................................................................... 9 
3. 
INTRODUCTION ............................................................................ 10 
3.1. 
Background and Rationale ................................................................ 10 
3.2. 
Regulatory Status .............................................................................. 11 
4. 
STUDY OBJECTIVES .................................................................... 12 
4.1. 
Primary Objective/Endpoint ............................................................. 12 
4.2. 
Secondary Objective/Endpoint ......................................................... 12 
4.3. 
Exploratory Endpoint ........................................................................ 12 
5. 
OUTCOMES MEASURE ................................................................ 13 
5.1. 
Primary Outcomes measure .............................................................. 13 
5.2. 
Secondary Outcomes Measure ......................................................... 13 
6. 
INVESTIGATIONAL PLAN ........................................................... 14 
6.1. 
Overall Study Design and Plan ......................................................... 14 
6.2. 
Discussion of the Study Design and Subject Selection .................... 14 
6.3. 
Selection of Study Population .......................................................... 15 
6.3.1 
Inclusion Criteria .............................................................................. 15 
6.3.2 
Exclusion Criteria ............................................................................. 15 
7. 
TREATMENTS ................................................................................ 17 
7.1. 
Treatment Administration ................................................................. 17 
7.2. 
Modification of Study Intervention/Investigational Product for a 
Subject .............................................................................................. 17 
7.3. 
Identity of Investigational Device and Supplies ............................... 17 
7.3.1 
Single Use Procedure Kits ................................................................ 17 
7.3.2 
Other Supplies .................................................................................. 18 
7.4. 
Investigational Device Storage and Accountability ......................... 18 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
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7.5. 
Blinding ............................................................................................ 18 
7.6. 
Blinded Rater Reliability Assessment .............................................. 19 
7.7. 
Expected / Unexpected Risk ............................................................. 19 
7.8. 
Prior and Concomitant Medications and Therapies .......................... 20 
7.8.1 
Permitted ........................................................................................... 20 
8. 
STUDY PROCEDURES .................................................................. 21 
8.1. 
VISIT 1 (Screening) - (Day 1) .......................................................... 21 
8.2. 
VISIT 2 (Treatment) ......................................................................... 22 
8.3. 
Visit 3 (Day 30) - (± 7 to 14 days) .................................................... 23 
8.4. 
VISITS  4 (Days  60) - (± 7 to 14 days) ........................................... 23 
8.5. 
VISIT 5 and 6 Follow-Up (Days  90 and 180  “EOS”) - (± 7 to 14 
days) .................................................................................................. 24 
8.6. 
Subject Withdrawal and Early Termination ..................................... 24 
8.6.1 
Protocol Deviations .......................................................................... 24 
8.6.2 
Status Classification .......................................................................... 24 
9. 
ASSESSMENTS............................................................................... 25 
9.1. 
Clinical Evaluations .......................................................................... 25 
9.2. 
Effectiveness Assessments ............................................................... 26 
9.3. 
Assessment of Safety ........................................................................ 26 
10. 
ADVERSE EVENT REPORTING .................................................. 27 
10.1. 
Introduction ....................................................................................... 27 
10.2. 
Reporting Period ............................................................................... 27 
10.3. 
Definition of an Adverse Event ........................................................ 27 
10.4. 
Serious Adverse Events .................................................................... 28 
10.5. 
Severity Assessment ......................................................................... 28 
10.6. 
Causality Assessment ....................................................................... 29 
11. 
STATISTICAL METHODS AND DETERMINATION OF 
SAMPLE SIZE ................................................................................. 30 
11.1. 
Study Hypothesis .............................................................................. 30 
11.2. 
Sample Size Determination .............................................................. 30 
11.3. 
Analysis Populations ........................................................................ 30 
11.4. 
Demographics and Baseline Characteristics ..................................... 31 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 6 of 51 
11.5. 
Analyses ............................................................................................ 31 
11.5.1 
Primary Effectiveness Analysis ........................................................ 31 
11.5.2 
Secondary Effectiveness Analyses ................................................... 31 
11.5.3 
Interim Analysis ................................................................................ 32 
11.5.4 
Safety Analysis ................................................................................. 32 
11.6. 
Statistical Analysis Plan ................................................................... 32 
12. 
QUALITY CONTROL AND QUALITY ASSURANCE ............... 33 
13. 
ADMINISTRATIVE REQUIREMENTS ........................................ 34 
13.1. 
Protocol Amendments and Administrative Changes ........................ 34 
13.2. 
Data Handling and Record Keeping ................................................. 34 
13.3. 
Case Report Forms / Electronic Data Record ................................... 34 
13.4. 
Record Retention .............................................................................. 35 
14. 
SPONSOR DISCONTINUATION CRITERIA ............................... 36 
15. 
PUBLICATION OF STUDY RESULTS ......................................... 37 
16. 
REFERENCES ................................................................................. 38 
APPENDIX 1 SCHEDULE OF EVALUATIONS ........................................... 39 
APPENDIX 2 PHYSICIAN GLOBAL AESTHETIC IMPROVEMENT 
SCALE (P-GAIS) ............................................................................. 40 
APPENDIX 3 SUBJECT- GLOBAL AESTHETIC IMPROVEMENT SCALE 
(S-GAIS) ........................................................................................... 41 
APPENDIX 4 PHYSICIAN- GLOBAL SATISFACTION QUESTIONNAIRE 
(P-GSQ) OF THE NECK ................................................................. 42 
APPENDIX 5 SUBJECT- GLOBAL SATISFACTION QUESTIONNAIRE (S-
GSQ) OF THE NECK ...................................................................... 43 
APPENDIX 6 CUTOMETER BROCHURE .................................................... 44 
APPENDIX 7 NUMERICAL RATING SCALE.............................................. 45 
APPENDIX 8 APPLICATION OF NON-SIGNIFICANT RISK..................... 46 
APPENDIX 9 THERMI_RF USER MANUAL 4002-01 REV C.PDF (1MB) 50 
APPENDIX 10 BLINDED RATER VALIDATION GUIDELINES ............... 51 
 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 7 of 51 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation/ 
Term* 
Definition 
AE 
Adverse event 
CIB 
Clinical Investigator Brochure 
CRF 
Case report form 
eCRF 
Electronic Case Report Form 
EOS 
End of study 
ESP 
External service provider 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF/ICD 
Informed consent form/Informed consent document 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
ID 
Investigational Device 
IRB 
Institutional Review Board 
ITT 
Intent-To-Treat 
NSR 
Non-Significant Risk 
P-GAIS 
Physician Global Aesthetic Improvement Scale 
P-GSQ 
Physician Global Satisfaction Questionnaire 
PI 
Principal Investigator 
PPP 
Per Protocol Population 
PRA 
Percutaneous Radiofrequency Ablation 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious adverse event 
S-GAIS 
Subject Global Aesthetic Improvement Scale 
S-GSQ 
Subject Global Satisfaction Questionnaire 
TM 
Trademark 
MeDRA 
Medical Dictionary for Regulatory Activities 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 8 of 51 
1. 
ETHICS 
1.1. 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study 
protocol, protocol amendments, informed consent forms, and other relevant documents, 
e.g., recruitment materials, if applicable, from the IRB/IEC.  All correspondence with the 
IRB/IEC should be retained in the Investigator File (Site Master File).  Copies of 
IRB/IEC approvals should be forwarded to the Sponsor. 
The only circumstance in which a protocol amendment may be initiated prior to IRB/IEC 
approval is where the change is necessary to eliminate apparent immediate hazards to the 
subjects.  In that event, the investigator must notify the IRB/IEC and the Sponsor in 
writing within 5 working days after the implementation. 
1.2. 
Ethical Conduct of the Study 
The study will be performed in accordance with the protocol, International Conference on 
Harmonization Good Clinical Practice guidelines (ICH E6) and applicable local 
regulatory requirements and laws. 
1.3. 
Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject 
names on any forms, reports, publications, or in any other disclosures. In case of data 
transfer, Sponsor will maintain high standards of confidentiality and protection of subject 
personal data. 
The informed consent form must be agreed to by the Sponsor and the IRB/IEC and must 
be in compliance with ICH GCP, local regulatory requirements, and legal requirements. 
The investigator must ensure that each study subject, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the study and possible 
risks associated with participation.  The investigator, or a person designated by the 
investigator, will obtain written informed consent from each subject or the subject's 
legally acceptable representative before any study-specific activity is performed.  The 
informed consent form used in this study, and any changes made during the course of the 
study, must be prospectively approved by both the IRB/IEC and the Sponsor before use.  
The investigator will retain the original of each subject's signed consent form. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 9 of 51 
2. 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
Details on the administrative structure of the study (e.g., investigator, coordinating, 
steering committee, administration, monitoring and evaluation committees, institutions, 
statistician, central laboratory facilities, external service provider (ESP or CRO), or 
clinical study supply management) will be maintained in the Sponsor’s Study Master File 
throughout the study for inclusion in the clinical study report.  

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 10 of 51 
3. 
INTRODUCTION 
3.1. 
Background and Rationale 
 
Biochemical changes in dermal connective tissue lies at the foundation of skin laxity, 
often leading to the inevitable “Aging Face Syndrome.” The appearance of a young and 
well defined neck is deemed to have cervicomental angle of 90 ° – 105 °, a good tone, a 
well-defined mandibular border, no accumulation of fat in the submental area, and no 
evidence of platysma bands [1].  
 
In the course of aging, the neck serves as an indicator for the loss of collagen and elastin 
causing excessive skin laxity, an increase in submental fat and loose jowls along the 
mandibular border.  A 2014 American Society for Dermatologic Surgery consumer 
survey found 68 percent of respondents were concerned about excess fat under the chin 
and neck. Data were obtained through a blind online survey conducted in April 2014 
through the web-based Contribute service. The survey received 8,315 responses. 
 
Laxity of submental area is therefore, a common cosmetic complaint of the aging 
population. As the “baby boomer” generation reaches later life, aesthetic surgical medical 
interventions are becoming increasingly sought after by patients to aid and improve the 
cosmetic profile of these persons. 
 
Thermi plans to evaluate the safety and effectiveness of ThermiRF™ radiofrequency in 
the treatment of submental skin laxity using.  The planned treatment uses targeted 
temperature controlled RF to achieve lifting in subjects with mild to moderate severity 
defined as normal muscle and mild to moderate skin laxity and mild to moderate fat on 
the submental area.  Additionally biomechanical changes of the skin will be evaluated 
using the Cutomer® which may be evident as a result of the  ThermiRF treatment [6]. 
The ThermiRF system uses radiofrequency to apply heat to target areas using 
electrocoagulation; this is a percutaneous minimally -invasive technique. 
 
ThermiRF Device 
 
The ThermiRF device is a minimally invasive radiofrequency solution, and an established 
therapeutic modality for the treatment of nerve tissue ablation and electrocoagulation. 
The use of radiofrequency in aesthetics is well published. [2-4]. the temperature 
controlled radiofrequency is less-invasive and provides a better safety profile (reduced 
risk) when compared to surgery, other more invasive treatments and non-temperature 
controlled energy devices.  The ThermiRF device delivers a controlled thermal endpoint 
as a result of its proprietary software algorithm and feedback loop that consistently 
measures the tissue temperature at the tip of the treatment RF electrode.   
 
As the electric current permeates a tissue layer, ions found within that layer, deliver or 
carry the current. This, in turn, increases the kinetic activity of the ions. Increased ion 
kinetics and oscillations engenders resistive tissue thermogenesis.  

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 11 of 51 
 
Thermogenesis is calculable via the Specific Absorption Rate (SAR) equation, which 
assesses local electrical conductivity and magnitude of local electric current density 
generated around the electrode (Equation 1). 
 
The electric field strength generated is capable of heating tissue in close proximity to the 
electrode. Thermal conduction attenuates the heating of tissue as you move further from 
the electrode. With proper controls, generating the ideal thermal endpoint will occur very 
close to the electrode, thereby affecting only the intended target tissue area (Figure 1). 
 
Figure 1: Distribution of RF-induced heat 
 
 
Regulation of tissue temperature derives from power control. Power (P) is equal to the 
voltage multiplied by the current; the Power is delivered via the radiofrequency electrode. 
Depending on the tissue impedance, the power will need further adjustment, ensuring the 
proper voltage/current is delivered to satisfy the tissue impedance. Finally, thermal 
sensors – thermocouples – integrated within the radiofrequency electrode to allow for 
accurate measurement of tissue temperature and the system will adjust power to maintain 
the physician selected therapeutic temperature. With these proper controls in place, 
selective thermogenesis serves as a viable treatment for numerous medical conditions. 
 
The generation of heat is enough to promote tissue necrosis within a defined area. 
Accordingly, percutaneous radiofrequency can be administered for destruction of 
terminal fibers, which in turn, contracts tissue. Overall, percutaneous radiofrequency 
administers energy in a highly selective manner to induce the desired clinical outcome; 
“lift” achieved through tissue contracture and tightening.  
 
3.2. 
Regulatory Status 
 
The ThermiRF® Device is classified by the FDA/IEC as a Class 2 radiofrequency device. 
The device used in this study was cleared by the Food and Drug Administration (FDA) 
for dermatological and general surgical procedures for electrocoagulation and hemostasis 
[K130689]. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 12 of 51 
4. 
STUDY OBJECTIVES 
4.1. 
Primary Objective/Endpoint 
 
 
x Improvement in overall lift of the submental area at Day 90, as determined by: 
 
o Quantitative assessment based on 3D photography 
4.2. 
Secondary Objective/Endpoint 
 
x Overall aesthetic improvement of the submental area and jawline definition at 
Days 90 and 180 evaluated by the investigator and subject, using the following 
subjective assessment: 
 
o Qualitative assessment based on 2D photography performed by blinded 
panel   
o Physician - Global Aesthetic Improvement Scale Scores (P-GAIS)  
o Subject – Global Aesthetic Improvement Scale Scores (S-GAIS)  
o Physician - Global Satisfaction Questionnaire (P-GSQ)  
o Subject - Global Satisfaction Questionnaire (S-GSQ)  
 
Each individual endpoint will be based on study subject population response for each 
individual endpoint. 
x Safety will be evaluated using the following measures: 
 
o Numerical Rating Scale (NRS) a 10-point pain scale 
o Self-reported and observed adverse event 
 
4.3. 
Exploratory Endpoint 
 
o Elasticity measurement at Days 90 and 180. 
 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 13 of 51 
5. 
 
OUTCOMES MEASURE 
5.1. 
Primary Outcomes measure 
 
Overall tissue lift at the submental area as determined by quantitative assessment at 
Day 90 compared to baseline based on 3D photography. 
5.2. 
Secondary Outcomes Measure 
 
Overall improvement in submental area as determined by qualitative assessment at 
Day 90 compared to baseline based on 2D photography and subjective questionnaire. 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 14 of 51 
6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design and Plan  
 
This is an open-label, single-center, single-treatment prospective evaluation of the 
ThermiRF device in the treatment of submental skin laxity.   The purpose of this 
prospective study is to determine the effectiveness and safety of the ThermiRF device in 
achieving overall submental lift. 
In this study, “Lift” is defined as a ≥ 20 mm2 lift of the submental area after the 
ThermiRF treatment. 
A total of 70 male and female healthy volunteers between the age of 35 and 65 will be 
considered for this study.  Subjects who sign the informed consent form and meet all 
entry criteria will be enrolled in this study and will be assigned a unique number/code to 
preserve confidentiality. 
A total of six study visits are planned as described below: 
x Visit 1: Screening visit  – (Day 1) 
x Visit 2: Single Treatment visit  
x Visit 3: Day 30 safety assessment (± 7 to 14 days) 
x Visit 4: Day 60 safety and Image capture for validation exercise (± 7 to 14 days) 
x Visit 5: Day 90 safety and effectiveness follow-up visit (± 7 to 14 days) 
x Visit 6: Day 180 safety and effectiveness follow-up visit - (± 7 to 14 days) 
Photo images (2D and 3D) will be collected at Visits 1, Visit 4 (on first 30 subjects only), 
and at Visits 5 and 6 using a standard camera (2D) and the Vectra XT system (3D).  The 
purpose of the photos are to quantitatively and qualitative evaluate treatment 
effectiveness using objective and subjective assessments to measure physical changes to 
the skin’s microstructure and aesthetic skin features over time. 
A skin elasticity assessment using the Cutomer® will be collected at Visits 1 (screening), 
5 (Day 90) and 6 (Day 180) to assess if any biomechanical changes of the skin occurred 
as a result of the ThermiRF treatment. 
Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point 
scale, and adverse events reports (observed or reported). 
The overall study duration is approximately 12 months (i.e., 5-6 month recruitment 
period and 6 month study visits).   
6.2. 
Discussion of the Study Design and Subject Selection 
 
The study design represents a prospective evaluation of the ThermiRF system effectiveness 
in the treatment of submental laxity through electrocoagulation and neocollagenesis 
towards achieving Lift.  Submental laxity is a common occurrence of the aging population 
affecting not only the submental area near the upper part of the neck but also the jawline.  
For the purposes of this study, subjects between the ages of 35 and 65 years old, are likely 
to show architectural changes of aging on the submental area, with a clearly noticeable 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 15 of 51 
“mild to moderate” severity defined as having “normal” muscle, “mild to moderate” skin 
laxity and “mild to moderate” fat.  Subject’s skin laxity severity will be confirmed by the 
investigator at the screening visit to ensure appropriateness in subject selection. In an effort 
to eliminate variance across the group and with respect to treatment response, each subject 
will serve as his/her own control  
 
The application of RF treatment on this category of subjects is “superficial” in nature 
with no adjuvant therapies needed.  It is anticipated the benefits will be “lift” of the 
treated (submental) area following a minimally invasive approach resulting in less 
adverse outcomes such as swelling, bruising, and pain. 
6.3. 
Selection of Study Population 
The following eligibility criteria are designed to select subjects for whom protocol 
requirements are considered appropriate.  All relevant medical and non-medical 
conditions should be taken into consideration when deciding whether this protocol is 
suitable for a particular subject. 
6.3.1 
Inclusion Criteria 
x Male or female between the age of 35 and 65 inclusive; 
x Mild to Moderate Skin Laxity Severity on the submental area defined as: “normal” 
muscle, “mild to moderate” skin laxity and “mild to moderate” fat; 
x Desire to improve jawline definitions and/or submental skin lift 
x Body mass index (BMI) ≤30; 
x Females of childbearing potential who are sexually active must be willing to use an 
approved method of birth control during study participation. 
x Cooperative, reliable, and able to read and comprehend English; 
x Able to read, understand, sign and date the informed consent document (English 
only); 
x Able and willing to comply with the schedule visit(s) and study requirements. 
6.3.2 
Exclusion Criteria 
Subjects presenting with any of the following will not be included in the study: 
x Excessive subcutaneous fat on the submental area 
x Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other 
analgesics, anti-inflammatory products, or any products including herbals and 
supplements that could interfere with the clinical assessments of this study (other than 
drugs used for anesthesia); 
x History of cosmetic treatments on the face and neck including but not limited to: facial 
skin tightening procedures within the past year, injectable fillers of any type, Botox on 
the lower face, ablative resurfacing laser treatment, none ablative, rejuvenative laser or 
light treatment within the past six months, deep facial peels, dermabrasion, face lift, 
neck lift, blepharoplasty or brow lift, contour threads or other. 
x History or current injury to the Head and Neck. 
x Severe solar elastosis 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
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x Clinically significant facial wounds, lesions or acute infections including cystic acne, 
dermatitis, lupus or other immunodeficiency affecting the dermis 
x Presence of metal stents or facial implants 
x Pregnant or planning pregnancy prior to the end of study participation 
x Current or past history of smoking 
x History or current diagnosis of cancer of any type 
x History 
of 
uncontrolled 
cardiovascular 
disease(i.e. 
myocardial 
infarction, 
hypertension, hypercholesterolemia, peripheral vascular disease, other) 
x Known hypersensitivity to local anesthetic medications 
x History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or 
anticipated treatment with prescription anticoagulants 
x Possesses a surgically implanted electronic device (i.e. pacemaker) 
x History of AIDs/HIV 
x Serious 
mental health illness such as dementia or schizophrenia; psychiatric 
hospitalization in the past two years 
x Developmental disability or cognitive impairment that would  preclude adequate 
comprehension of the informed consent form and/or ability to follow study subject 
requirement and/or record the necessary study measurements 
x A family member of the investigator or an employee of the investigator. 
x Participation in any other investigational study within 30 days prior to consent; 
In addition to the above restrictions, subject selection must be consistent with all the 
warnings, precautions, and contraindications associated with the ThermiRF procedures.   
The investigator will thoroughly familiarize him or herself with the approved labeling or 
manual of operations for the ID and devices used in this study. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 17 of 51 
7. 
TREATMENTS 
7.1. 
Treatment Administration 
The single ThermiRF treatment to the neck (right/left) will be administered by the 
investigator in accordance with the protocol requirements, and with adherence to Good 
Clinical Practices (GCP) and standard of practice for surgical procedures.   
Only study subjects who signed the informed consent and meet all entry criteria, will be 
enrolled and treated. 
7.2. 
Modification of Study Intervention/Investigational Product for a Subject 
 
The output dosage is pre-determined based on the ThermiRF software algorithm.  
Therefore, no adjustments are planned nor anticipated. 
7.3. 
Identity of Investigational Device and Supplies  
ThermiRF is an FDA cleared device.  The device is provided as a system and it includes a 
rectangular unit consisting of a front and rear panels, and single-use procedure kits. The 
system is designed to precisely deliver RF energy to target tissue. The system 
continuously monitors tissue temperature for patient safety using temperature controlled 
technology.    
7.3.1 
Single Use Procedure Kits 
The investigator will be provided with single use procedure kits to be dispensed as one 
kit per study participant.  The single used procedure kit consist of: 
 
 
DESCRIPTION OF PROCEDURE KIT 
MODEL/ID 
DESCRIPTION 
S-1510-B-18 
RF Disposable Cannula 15 CM length, 18 gauge, 10mm exposed tip 
RFDE-15 
Disposable 15 CM RF Electrode 
RF-DGP-S 
RF Disposable Grounding Pad  
 
The RF Cannula and RF Electrode are sterile products and are individually packaged 
under sterile conditions and labeled with the commercially available label (Figure 2). 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 18 of 51 
Figure 2: Primary Label Sample  
 
 
For the purposes of this study, a secondary label will be applied to separate the study 
supplies, from the commercial product (Figure 3).   
Figure 3: Secondary Label Sample 
THERMI_0005 
“FOR INVESTIGATIONAL USE ONLY” 
7.3.2 
Other Supplies 
The investigator will be permitted to use the following: 
x Urine Pregnancy Test Kits: Commercially available/marketed urine pregnancy test 
kits and anesthesia of his/her choice. 
x Cutometer® MPA 580: Commercially available standard device used to measure 
elasticity and other biomechanical parameters of the skin. 
 
x Vectra XT System: a handheld 3D imaging system that delivers precision optics for 
high-resolution 3D images to measure contouring and area differences. 
 
7.4. 
Investigational Device Storage and Accountability  
The investigator must maintain adequate records documenting the receipt, use, loss, or 
other disposition of the ID(s).  All study related supplies must be stored in a secured area 
or locked location and shall be accessible to the investigator or designee responsible for 
the conduct of this study.   Used materials will be discarded by the investigator while 
unused materials will be returned to the sponsor at the conclusion of the study. 
7.5. 
Blinding 
  
This study is open-label however, photo images collected during the study will be 
evaluated qualitative by a panel of three qualified raters whom will be blinded (i.e., will 
not know) to the date and time when the photo images were collected.  Each rater will 
evaluate the images independent of each other and will provide their respective photo 
image qualitative assessment for analysis. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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7.6. 
Blinded Rater Reliability Assessment 
 
Prior to the completion of the study, the panel of raters will undergo a validation process 
as defined by the sponsor using photo images collected at Day 60.  The method used to 
evaluate and validate the reliability of the blinded panel (Appendix 10), will follow the 
approach taken by Kim, et al. [5], where a range of possible outcomes can be detected 
from “no improvement” to “some improvement” to “significant improvement” at the 
specified time point.  The approach implemented by Kim, et. al., is deemed consistent 
with ICH guidelines for validation of analytical procedures. 
7.7. 
Expected / Unexpected Risk 
The anticipated risks and/or discomforts associated with the procedure are described 
below: 
General Statement: 
The device has risk of burns or fire, and therefore, cannot be used near conductive 
materials such as metal bed parts, inner-spring mattress, etc. 
 
A disposable grounding pad is used to ground/neutralize the electrical current.   Subjects 
undergoing radiofrequency treatment will be kept away from contact with metal parts 
which are grounded or which have appreciable capacitance to earth.  
 
The device cannot be used in subjects with a pacemaker, implantable defibrillators, or 
monitoring equipment. 
Risk Associate with the PRD Procedure 
Known risks associated with the use of ThermiRF include:  
x Erythema 
x Edema 
x Electric shock: operator risk only: mitigated through electrical safety testing. 
x Postoperative pain and edema that resolved within three days 
x Second-degree burn treatment 
x Treatment induced ulcers and fistulas 
 
Although no immediate risks are anticipated, all aspects of this clinical 
investigation will be conducted under the direct supervision and oversight of the 
investigator and designated study staff.  Adverse events whether spontaneous, or 
self-reported, will be collected and analyzed. 
 
Other Risk 
Surgical shock, pulmonary complications, irregular surface area.  Proper pre and post 
treatment safety precautions will reduce the risk of these complications.  

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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Any unexpected or unforeseen complications will be managed by the investigator 
throughout the conduct of the study.  Unforeseen or unexpected side effects not listed 
above will be reported to the sponsor and regulatory representatives (IRB) as they occur. 
7.8. 
Prior and Concomitant Medications and Therapies 
7.8.1 
Permitted 
Subjects will be allowed to continue with their usual necessary medical therapies, with no 
medically unnecessary changes in their diet or overall lifestyle. If medical conditions 
exist at the start of the study that require drug therapy during the study, those conditions 
and any concomitant medications prescribed should be recorded in the subject’s source 
documents and the appropriate section of the CRF. 
Subjects must abstain from exclusionary procedures/medications/therapies as listed under 
the Exclusion Criteria for the duration of the study. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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8. 
STUDY PROCEDURES 
Study procedures as described in this section are depicted in the schedule of evaluations 
(Appendix 1). 
8.1. 
VISIT 1 (Screening) - (Day 1) 
  
Subjects who signed the informed consent at Visit 1 will have the following assessments 
performed: 
x Inclusion and exclusion criteria 
x Medical and Medication History  
x Demographic and baseline characteristics 
x Brief physical exam and Medical Clearance 
x Vitals including height and weight 
x Photography (2D and 3D) 
x Confirmation of “Skin Laxity Severity” by the investigator 
x Elasticity measurement 
Subjects who meet all  required entry criteria will be enrolled in the study, and will be a 
subject ID starting with “0116” and continuing in sequential order until enrollment is met 
(i.e., 7016).  The first two digits represent the subject number and the last two digits 
represent the year when the study is initiated.   
 
Enrolled subjects will be scheduled for Visit 2 promptly after Visit 1. A prescription slip 
for an antibiotic and an analgesic medication will be dispensed at the discretion of the 
investigator with instructions as follow: 
INSTRUCTION 
“Begin taking the antibiotics the day before the procedure at Visit 2, and continue taking 
as prescribed until the dose regimen is completed.  The analgesic should be brought to 
the research site at which time, the first dose will be taken” 
 
“Make arrangements to have a legal representative drive to and from the research site.” 
   
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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8.2. 
VISIT 2 (Treatment)  
 
Upon arrival, subjects will have the following assessments performed: 
 
x Verify conformance with eligibility criteria 
x Urine pregnancy test (must be performed prior to treatment at V1 or V2) 
 
Provided the subject conforms to all entry criteria, the subject will be prepared for surgery 
and the visit will proceed as follow: 
 
The subjects will be placed in a sitting or supine position.  Using a surgical pen or marker 
the investigator will outline the treatment area and the area will be anesthetized using 
tumescent solution containing lidocaine and epinephrine.  Sufficient time will be allowed 
for the anesthesia to take effect prior to the surgical procedure 
 
Up to three small incisions measuring approximately 2 mm in length will be made to the 
right and left of the jaw line below the ear lobe, and below the chin.  Each incisions will 
act as the point of entry for the investigational device probe.  
 
The depth of penetration is approximately 2 mm below the dermis.  The affected area of 
the neck will be infused with standard tumescent Hunstad formula (50-100cc).  The 
investigator will proceed with the treatment by inserting the electrode to the distal portion 
of the first pass.  Once in position, and the electrode temperature will be brought to the 
“procedure set temperature” in accordance with the suggested temperature ranges below 
(Figure 4).  
 
Figure 4: Suggested Temperature Ranges 
 
 
The investigator will begin to slowly withdraw the electrode to ensure the temperature 
achieves the level of the set temp.    

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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The pass is repeated in a “fanning” manner to ensure treatment of the entire neck area is 
achieved (Figure 5). 
Figure 5: Treatment Passes 
 
 
 
 
 
      
 
 
 
 
 
The surface of the skin must reach a temperature between 45-470C.   
At the conclusion of the treatment, hypoallergenic tape may be applied and the use of a 
neck garment required in support of tissue repair post treatment.  The duration of garment 
use is approximately 3-5 days or as directed by the investigator. 
Subjects will be sent home and will be instructed on the following: 
“Do not drive, engage in physical exercise or operate heavy machinery the day of the 
procedure at Visit 2 and for approximately 14 to 21 days for physical exercise including 
heavy lifting.” 
8.3. 
Visit 3 (Day 30) - (± 7 to 14 days) 
   
The following assessments will be performed: 
 
x NRS 
x AE and ConMed assessment  
8.4. 
VISITS  4 (Days  60) - (± 7 to 14 days) 
This visit applies to the first 30 subjects enrolled in the study. During this visit, the 
following assessments will be performed: 
x NRS 
x Photography (2D and 3D) 
x Questionnaires  
o P-GAIS (Appendix 2) 
o S-GAIS (Appendix 3) 
o P-GSQ (Appendix 4) 
o S-GSQ (Appendix 5) 
x AE and ConMed assessment  
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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8.5. 
VISIT 5 and 6 Follow-Up (Days  90 and 180  “EOS”) - (± 7 to 14 days) 
 
During these follow-up visits, the following assessments will be performed: 
 
x NRS 
x Photography (2D and 3D) 
x Elasticity measurement 
x Questionnaires  
o S-GAIS 
o P-GAIS 
o SGSQ 
o PGSQ  
x AE and ConMed assessment  
8.6. 
Subject Withdrawal and Early Termination 
Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or Sponsor for safety, 
behavioral, or administrative reasons.  Every effort should be made to document subject 
outcome, if possible.  The investigator should inquire about the reason for withdrawal, 
request the subject return for a final visit, and if applicable, follow-up with the subject 
regarding any unresolved adverse events. 
If the subject withdraws from the study and also withdraws consent for disclosure of 
future information, no further evaluations will be performed and no additional data will 
be collected.  The Sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
8.6.1 
Protocol Deviations 
Protocol deviations will be tracked and managed during the conduct of the study.  A 
protocol deviation is defined as a non-conformance from the protocol which occurs at 
any time during the conduct of the study.  Exceptions will not be granted by the sponsor 
for any planned or unplanned deviation. All protocol deviations will be tracked. 
8.6.2 
Status Classification 
 
Classification 
Criteria 
Screen Failure 
Signs the ICD but does not meet entry criteria or withdraws prior 
to Visit 2. 
Enrolled 
Signs the ICD and met all inclusion/exclusion criteria  
Treated 
Signs the ICD and successfully completes V2  
Discontinued/Withdrawal 
Signed the ICD but does not successfully complete any visits 
Completed 
Signs the ICD and successfully completes all study visits  

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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9. 
ASSESSMENTS    
9.1. 
Clinical Evaluations 
 
The following clinical evaluations will be conducted during the study review: 
 
x Medical and medication history – An assessment of the participant’s health status 
prior to enrollment to ascertain appropriateness for study participation based on 
inclusion/exclusion criteria. 
 
x Brief Physical Examination – A brief physical exam of the major organ systems will 
be performed at Visit 1 (screening) to assess the subject’s physical/medical state prior 
to Visit 2.  Adverse events reported during the conduct of the study will be evaluated 
by organ system with respect to the baseline physical evaluation. 
 
x Vital Signs - Collected at Visit 1 (screening) and will include pulse, respiration, heart 
rate (systolic and diastolic), temperature, height and weight.  The height and weight 
will be used to calculate and confirm the body mass index (BMI) requirement.     
 
x Urine Pregnancy Assessments - Urine pregnancy test will be collected (for females 
of child bearing potential) at Visit 2 prior to treatment.  Subjects with a positive result 
will be excluded from the study. 
 
x Adverse Event Reporting – Investigator examination of the treatment area and 
surrounding anatomy and notation of any observations made by the study investigator 
of a potential adverse event. 
 
x Cutometer Elasticity Measurement – an elasticity measurement use to determine 
skin pliability prior to, and post treatment.  This measurement may serve as an 
indicator for how the subject’s dermis will behave after exposure to RF treatment 
(Appendix 6). 
 
x Numerical Rating Scale (NRS) – a unidimensional 10-point scale used to measure 
pain intensity from “no pain” to “worst pain possible” (Appendix 7). 
 
x Photography - Standard photo images (2D) and 3D photography using the Vectra 
XT will be collected for study visits as defined in the protocol.  The subject 
positioning is planned to deliver the following views: 
 
o “frontal view”; 
o “lateral Right and Left view”; 
o “ 450 angle Right and Left”.   
 
For reproducibility of the subject’s positioning during the photo session, every effort will 
be made by the investigator to replicate the same position and facial expressions from 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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baseline at every required time point.  Additionally, every effort will be made by the 
investigator to ensure the same person (study staff member) will take all photos on the 
same subject during their participation.   
 
x Submental Skin Laxity Confirmation: This assessment integrates three features: 
skin fat and muscle neck structures and redundancy (horizontal and vertical folds).  
This assessment will be performed by the investigator to ensure the subject’s 
eligibility at Visit 1. 
x Global Assessment of Improvement Questionnaires:  A subject and physician 
appraisals of treatment outcomes.   
9.2. 
Effectiveness Assessments 
x Objective: 
o 3D Photography 
o Standard 2D Photography 
o Blinded panel assessment on 2D photography 
o Elasticity Measurement 
 
x Subjective: 
o S-GAIS 
o P-GAIS 
o SGSQ 
o PGSQ  
9.3. 
Assessment of Safety 
 
Safety assessment will include an evaluation of the treatment area to assess overall quality 
and integrity of tissue layers for subjects that have completed treatment.  All known and 
unknown events including known risks (see below) will be collected during the conduct of 
the study regardless of causality. 
 
x Edema 
x Infections 
x Thermo-injury (i.e. Burns) 
x Scarring 
x Erythema 
x Postoperative pain 
x Second-degree burn treatment 
x Transient paresthesia 
 
Sensory assessment will be collected using the Numerical Rating Scale (NRS) a 10-point 
scale to measure pain after treatment. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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10. 
ADVERSE EVENT REPORTING 
10.1. 
Introduction 
All observed or volunteered adverse events regardless of treatment group or suspected 
causal relationship to the ID(s) will be reported as described in the following sections.  
For all adverse events, the investigator must pursue and obtain information adequate both 
to determine the outcome of the adverse event and to assess whether it meets the criteria 
for classification as a serious adverse event requiring immediate notification to the 
sponsor or its designated representative.  For all adverse events, sufficient information 
should be obtained by the investigator to try to determine the causality of the event.  For 
adverse events with a suspected causal relationship to the ID, follow-up by the 
investigator is required until the event or its sequel resolve or stabilize at a level 
acceptable to the investigator, and Sponsor concurs with that assessment. 
10.2. 
Reporting Period 
Serious adverse events require immediate notification within 24 hours to the Sponsor or 
its designated representative. When reporting a serious adverse event, the investigator or 
designee completes the SAE form with as much information as possible however, at a 
minimum the Subject ID, Name of ID, SAE, and Name of person reporting the event. 
The completed form must be: 
x Emails to the sponsor: 
Attention: Toni Fournier __ (Vice President Commercialization)  
PH: 617- 216-8211  
Email: Tfournier@thermi.com 
And,  
Attention: Claudia Jennings __ (Study Manager-Thermi Consultant)  
Phone: 973-222-8335  
Email: Cjennings@Thermi.com 
 
All adverse events (serious and non-serious) must be collected on the subject’s CRF from 
the time the subject signed informed consent through last subject visit. 
10.3. 
Definition of an Adverse Event 
An adverse event is any untoward medical occurrence in a clinical investigation 
associated with the use of an investigational product in human subjects.  The event need 
not necessarily have a suspected causal relationship with the treatment or usage.   
Examples of adverse events include but are not limited to:   

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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x Abnormal test findings 
x Clinically significant symptoms and signs 
x Changes in physical examination findings 
x Hypersensitivity 
x Progression/worsening of underlying disease 
Additionally, they may include the signs or symptoms resulting from: 
x Product misuse 
x Product dependency 
x Extravasation 
x Study related procedure 
10.4. 
Serious Adverse Events 
A medical device adverse event is serious when both of the following criteria are 
fulfilled: 
x The event involves patient/subject/consumer contact 
x The event results in: 
 Death 
 Serious deterioration in state of health.  This includes: 
o Life-threatening illness or injury 
o Permanent impairment of a body function 
o Permanent damage to a body structure 
 Requires medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
 Requires inpatient hospitalization or prolongation of existing 
hospitalization 
10.5. 
Severity Assessment 
If required on the adverse event case report forms, the investigator will use the 
adjectives MILD, MODERATE, or SEVERE to describe the maximum intensity of 
the adverse event.  For purposes of consistency, these intensity grades are defined as 
follows: 
MILD 
Does not interfere with subject's usual function. 
MODERATE 
Interferes to some extent with subject's usual function. 
SEVERE 
Interferes significantly with subject's usual function. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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Note the distinction between the severity and the seriousness of an adverse event.  A 
severe event is not necessarily a serious event.  For example, a headache may be severe 
(interferes significantly with subject's usual function) but would not be classified as 
serious unless it met one of the criteria for serious adverse events, listed above. 
10.6. 
Causality Assessment 
The investigator’s assessment of causality must be provided for all adverse events 
(serious and non-serious).  An investigator’s causality assessment is the determination of 
whether there exists a reasonable possibility that the ID caused or contributed to an 
adverse event.  If the investigator’s final determination of causality is unknown and the 
investigator does not know whether or not ID caused the event, then the event will be 
handled as “related to ID” for reporting purposes.  If the investigator's causality 
assessment is "unknown but not related to ID", this should be clearly documented on 
study records.   
In addition, if the investigator determines a serious adverse event is associated with study 
procedures, the investigator must record this suspected causal relationship in the source 
documents and CRF, as appropriate, and report such an assessment in accordance with 
the serious adverse event reporting requirements, if applicable. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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11. 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE 
SIZE 
All data collected on CRFs will be presented in data listings. The safety analyses will be 
carried out using the safety population. All efficacy analyses will be analyzed using the 
Intent-to-Treat (ITT) population.  Any formal statistical tests will be performed at α = 
0.05 and will be two-sided, unless otherwise specified. All statistical analyses will be 
conducted in a validated instance of SAS 9.1 or higher.  Other analyses, including the 
creation of figures, may be performed in SAS 9.1 or higher or R 3.2.4 or higher. 
11.1. 
Study Hypothesis 
The aim of this study is to evaluate the safety and effectiveness of the ThermiRF™ in the 
treatment of submental skin laxity with respect to “Lift”.  The study design assumes that 
at least 70% of the population that consists of the target demographic (those that meet the 
inclusion/exclusion criteria) will have 20 mm2 or more of lift.  The null hypothesis is that 
subjects have a response rate of 45% or lower. 
11.2. 
Sample Size Determination 
The sample size calculation is based on the following assumptions: 
x The true response rate for subjects that do not drop out will be 70%. 
x The null response rate is 45%, so a successful trial will reject the null hypothesis 
that the true response rate is less than or equal to 45%. 
x The dropout rate will be approximately 12.5%.  While some subjects that drop out 
may have data from Day 60 that can be carried forward in the primary 
effectiveness analysis, the sample size calculation assumes that none does and 
will therefore be treated as non-responders. 
x The primary effectiveness analysis is based on a one-sided binomial proportion 
test that compares the null proportion to the alternative proportion. 
Based on these assumptions, a minimum of 68 subjects is required to achieve 80% power 
at one-sided α = 0.05, so a sample size of 70 subjects provides greater than 80% power. 
Additionally based on the rule of three, sample size of at least 60 makes it possible to 
observe any adverse event that occurs with a frequency > 5% with  95% confidence. 
11.3. 
Analysis Populations 
x Intent-to-Treat (ITT): The ITT population includes all subjects that meet 
inclusion/exclusion criteria, have a signed informed consent form, and are 
enrolled in the study.  The primary effectiveness analysis will be on the ITT 
population. 
x Safety: The safety population will include all randomized subjects who received 
at least one treatment. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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x Per-Protocol Population (PPP): The PPP will include all subjects who: 
o Completed the Day 90 visit 
o Have an evaluable photograph to estimate area of lift from the Day 90 
visit 
o Have not used an excluded medication 
11.4. 
Demographics and Baseline Characteristics 
Demographic data and baseline characteristics will be summarized for the Safety 
population.  Demographic data (age, gender, ethnicity and race) and baseline 
characteristics (height, weight, BMI, heart rate, respiration, blood pressure, and 
temperature) will be summarized in a table and presented in a listing.  A summary of all 
prior and concomitant medications will be presented. 
11.5. 
Analyses 
11.5.1 
Primary Effectiveness Analysis 
 
The primary effectiveness analysis will compare the proportion of subjects who respond 
to treatment by achieving at least 20 mm2 of lift of the submental region to a null 
proportion 45% using a one-sided binomial proportion test at α = 0.05.  Responders will 
be determined based on change from baseline of area as measured by Vectra XT 3D 
photography in standard lighting conditions.  The primary effectiveness analysis will be 
based on the ITT population, so any missing data, including withdrawn consent and lost 
to follow up, will be treated as non-response. 
11.5.2 
Secondary Effectiveness Analyses 
 
Analysis of all effectiveness endpoints will be conducted on the ITT population and on 
the PP population.  Continuous endpoints will be tested using the paired t-test, ordinal 
endpoints will use the Wilcoxon-Pratt signed rank test, and binary endpoints will be 
tested using the binomial proportion test. 
 
Raters’ assessment of improvement will be validated based on a comparison of the 
blinded raters’ assessments to unblinded raters’ assessments at Day 60 as outlined in Kim 
et al. (Kim et al. 2004) using 30 subjects at Day 60 selected at random.  Two unblinded 
clinicians, who know which photos are baseline and which are Day 60, will assess the 2D 
photography at baseline and Day 60.  Three blinded clinicians, who do not know which 
photos are baseline and which are Day 60, will assess the same photos.  The assessments 
of the unblinded and blinded raters will be compared using Cohen’s unweighted kappa 
statistic (Fleiss et al. 1969).  The assessments will be considered validated according to 
the scale detailed by Landis et al. (Landis & Koch 1977), where <0.00 is considered poor 
agreement, 0.00-0.20 is slight agreement, 0.21-0.40 is fair agreement, 0.41-0.60 is 
moderate agreement, 0.61-0.80 is substantial agreement, and >0.80 is almost perfect 
agreement.  Accordingly, any score greater than 0.60 will validate the method. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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11.5.3 
Interim Analysis 
N/A 
11.5.4 
Safety Analysis 
All safety analyses and summaries will be based on the Safety population. The number 
and percentage of subjects reporting AEs during the study will be tabulated by MedDRA 
system organ class (SOC) and preferred term within each SOC.  SOCs will be listed in 
order of descending frequency.  Preferred terms will be listed in order of descending 
frequency within each SOC.  Summaries and listings will be provided for subjects 
reporting SAEs, subjects experiencing AEs related to study medication and subjects 
withdrawing due to an AE.   
Subjects experiencing serious adverse events, treatment-related adverse events and 
discontinuation from the study due to adverse events will also be summarized.   
Treatment-related adverse events will include events marked as being at least possibly or 
probably related to the study treatment.  Adverse events will be presented by severity and 
by relation to treatment.   
Subject disposition at Visit 1 will be presented.  Enrollment status with respect to number 
of subjects enrolled, completed, lost-to-follow and discontinuation regardless of reason 
will be presented. 
Concomitant medications will be summarized. 
11.6. 
Statistical Analysis Plan 
 
A separate statistical analysis plan (SAP) will contain all details needed to carry out the 
statistical analysis, including specific statistical tests for all effectiveness endpoints, 
adjustments for multiple testing, specific derivations, and specifications for the tables, 
listings, and figures. 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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12. 
QUALITY CONTROL AND QUALITY ASSURANCE 
During study conduct, the sponsor or its agent will conduct periodic monitoring reviews 
(in person or remote) to oversee the progress of the clinical trial and to ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating 
Procedures (SOPs) as applicable, Good Clinical Practice (GCP), and the applicable 
regulatory requirement(s).  
The sponsor representative may review source documents to confirm that the data 
recorded on CRFs/eCRF is accurate.  The investigator and institution will allow 
Sponsor’s representative or its agents, and appropriate regulatory authorities, direct 
access to source documents to perform this verification. 
The study site may be subject to review by the institutional review board 
(IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed 
by Sponsor, and/or to inspection by appropriate regulatory authorities. 
It is important that the investigator(s) and their relevant personnel are available during 
any in-person monitoring visits and possible audits or inspections, and that sufficient time 
is devoted to the process.  

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
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13. 
ADMINISTRATIVE REQUIREMENTS 
13.1. 
Protocol Amendments and Administrative Changes 
Amendments and administrative changes are not to be made to this protocol without 
consultation with and the agreement of the Sponsor.  The investigator and Sponsor should 
discuss amendment or administrative change.  If agreement is reached, such amendment 
or administrative change will be developed in writing by the Sponsor and submitted to 
the investigator. 
The investigator will be responsible for ensuring that all protocol amendments are 
approved in writing by the appropriate IRB or IEC before the institution of the changes 
specified in the amendment (except when necessary to eliminate an immediate hazard to 
the subjects).  The investigator will also ensure that the Sponsor receives a copy of the 
written IRB or IEC approval of these changes. 
The investigator will be responsible for ensuring that the IRB or IEC receives written 
notification of all administrative changes to the protocol prior to institution of the 
specified changes.  The investigator will ensure that the Sponsor receives a copy of these 
written notifications. 
13.2. 
Data Handling and Record Keeping 
The investigator will document all study related procedures directly on the source record 
or medical chart as the primary source of data collection.  Study related information/data 
points required by the sponsor for analysis will be transcribed by the investigator or 
designee from the source record, onto the CRF/eCRF (data collection tool) for this study 
using good documentation practices.   
In some instances, the sponsor will provide a CRF template for use as the primary source 
of data collection. 
The investigator is encouraged, however not required to maintain additional source 
records on matters respective to the subject’s safety and wellbeing not already captured 
on the CRFs/eCRF or source template.   
Black or blue ink must be used on all data collection requirements.  All errors and 
omissions must be crossed out by means of a single line, and the date and initials of the 
correction or addition of correct information must be provided.  Use of white-out or 
write-overs will not be permitted.  All study related records will be kept in a secure and 
locked location, and shall only be accessible to the assigned study personnel during the 
conduct of the study, and to the regulatory authorities in the event of an inspection. 
13.3. 
Case Report Forms / Electronic Data Record 
As used in this protocol, the term case report form (CRF) should be understood to refer to 
either a paper form or an electronic data record or both, depending on the data collection 
method used in this study. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
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A CRF is required and should be completed for each enrolled subject.  The completed 
original CRFs are the sole property of the sponsor and should not be made available in 
any form to third parties, except for authorized representatives of the sponsor or 
appropriate regulatory authorities, without written permission from the sponsor. 
It is the investigator's responsibility to ensure completion, review and approve all CRFs.  
CRFs must be signed by the investigator or by an authorized staff member.  These 
signatures serve to attest that the information contained on the CRFs is true and accurate.   
At all times, the investigator has final personal responsibility for the accuracy and 
authenticity of all clinical and laboratory data entered on the CRFs.    In cases where the 
source documents are the hospital or the physician's chart, the information collected on 
the CRFs must match those charts.  
13.4. 
Record Retention 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the 
investigator agrees to keep records including the identity of all participating subjects 
(sufficient information to link records, e.g., CRFs and hospital records), all original 
signed informed consent forms, copies of all CRFs, serious adverse event forms, source 
documents, and detailed records of treatment disposition.  The records should be retained 
by the investigator according to ICH guidelines, local regulations, or as specified in the 
Clinical Study Agreement, whichever is longer. 
If the investigator relocates, retires, or for any reason withdraws from the study, the 
Sponsor should be prospectively notified of the event, and the location of study records. 
The study records must be transferred to an acceptable designee, such as another 
investigator, another institution, or to the Sponsor.   
The investigator must obtain Sponsor's written permission before disposing of any 
records, even if retention requirements have been met. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 36 of 51 
14. 
SPONSOR DISCONTINUATION CRITERIA 
Premature termination of this clinical study may occur because of a regulatory authority 
decision, change in opinion of the IRB/IEC, device safety problems, or at the discretion 
of the sponsor.  In addition, the sponsor retains the right to discontinue development of 
the device at any time. 
If a study is prematurely terminated or discontinued, the sponsor will promptly notify the 
investigator.  After notification, the investigator must contact all participating subjects 
within 2 weeks from study termination.  All study materials must be collected and all 
CRFs completed to the greatest extent possible. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 37 of 51 
15. 
PUBLICATION OF STUDY RESULTS 
Publication of study results by the investigator is discussed in the Clinical Study 
Agreement, as appropriate.  Results from this study may be published in the form of oral 
or written presentations at scientific meetings or as one or more peer-reviewed journal 
articles.  In these cases, no information on individual subjects will be revealed. 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 38 of 51 
16. 
REFERENCES 
1 DiBernardo B. The Aging Neck: A diagnostic approach to surgical and nonsurgical 
options. Journal of Cosmetic and Laser Therapy 2013; 15: 56-64 
2 J. Multicenter study of noninvasive radiofrequency for periorbital tissue tightening.   
Lasers Surg Med. 2003; 33(4):232-42. 
3 Hernandez-Zendejas G, et al. Percutaneous selective radiofrequency neuroablation in 
plast surgery. Aesth Plast Surg 1994;18:41-48 
4 New J. Radiofrequency ablation for the reduction of glabellar frowning. Facial Plast 
Surg. 2010;26:266-274 
5 Kim EJ, Reeck JB, Maas CS. A validated rating scale for hyperkinetic facial lines. 
Arch. Fac. Plast. Surg. 2004, Vol. 6 July/Aug., 253-256. 
6 Courage + Khazaka Electronic GmbH. Scientific Measurements of Skin and Hair. 
Koln, Germany: Courage + Khazaka Electronic GmbH. CK Electronics. Web. 18 
Sept. 2010. http://www.courage-khazaka.de/start.htm 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 39 of 51 
APPENDIX 1 
SCHEDULE OF EVALUATIONS  
 
Visit 1 
Screening 
Visit 2 
(Treatment) 
(n=70) 
Visit 3 
Day 30 
Visit 4 (F/U) 4 
Day 60 
(n=first 30) 
Visit 5 (F/U) 
Day 90 
Visit 6 (F/U) 
Day 180 (EOS) 
Informed consent 
X 
 
 
 
 
 
Medical /Medication History 
X 
 
 
 
 
 
Demographics and Baseline Characteristics 
X 
 
 
 
 
 
Inclusion/Exclusion criteria/conformance 
X 
X1 
 
 
 
 
Urine Pregnancy Test 
 
X1 
 
 
 
 
Brief Physical Evaluation and Medical Clearance 
X 
 
 
 
 
 
Vital Signs (incl. Height & Weight) 
X 
 
 
 
 
 
Photography – 2D (Left, Right and Front views) 
X2 
 
 
X2 
X2 
X2 
Photography 3D  
X3 
 
 
X3 
X3 
X3 
Elasticity measurement 
X 
 
 
 
X 
X 
Treatment Administration 
 
X 
 
 
 
 
NRS pain scale 
 
 
X 
X 
X 
X 
S-GAIS,  S-GSQ 
 
 
 
X 
X 
X 
P-GAIS, P-GSQ 
 
 
 
X 
X 
X 
Concomitant  Medications 
 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
1 Urine pregnancy test must be conducted prior to treatment 
2 All 2D images must be collected using standard camera and lighting.  Positioning of images must be Front View, Right and Left Lateral view and Right and Left views at a 450 
angle. 
3 All 3D images must be collected using the Vectra XT camera. 
4  Visit 4 only applies to the first 30 subjects enrolled in the study. 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 40 of 51 
APPENDIX 2 
PHYSICIAN GLOBAL AESTHETIC IMPROVEMENT SCALE (P-GAIS) 
PHYSICIAN GLOBAL AESTHETIC IMPROVEMENT SCALE (P-GAIS) 
Compared to baseline 
photography, how 
would you rate the 
appearance of the 
subjects neck laxity 
with respect to “lift” 
5.
 Very Much Improved 
Optimal cosmetic result for this volunteer. 
4.
 Much Improved 
Marked improvement in appearance from the initial condition, but 
not completely optimal for this volunteer.  A touch-up would 
slightly improve the result. 
3.
 Improved 
Obvious improvement in appearance from the initial condition, but 
a touch-up or retreatment is indicated 
2.
 No Change 
The appearance is essentially the same as the original condition 
1.
 Worse 
The appearance is worse than the original condition 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 41 of 51 
APPENDIX 3 
SUBJECT- GLOBAL AESTHETIC IMPROVEMENT SCALE (S-GAIS) 
SUBJECT GLOBAL AESTHETIC IMPROVEMENT SCALE (S-GAIS) 
Compared to baseline 
how would you rate 
the appearance of 
your neck with respect 
to “lift” 
5.
 Very Much Improved 
Optimal cosmetic result for this volunteer. 
4.
 Much Improved 
Marked improvement in appearance from the initial condition, but 
not completely optimal for this volunteer.  A touch-up would 
slightly improve the result. 
3.
 Improved 
Obvious improvement in appearance from the initial condition, but 
a touch-up or retreatment is indicated 
2.
 No Change 
The appearance is essentially the same as the original condition 
1.
 Worse 
The appearance is worse than the original condition 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 42 of 51 
APPENDIX 4 
PHYSICIAN- GLOBAL SATISFACTION QUESTIONNAIRE (P-GSQ) OF 
THE NECK 
STUDY NO.:  THERMI_005 
SUBJECT ID:_____________ 
VISIT DAE:______________________ 
VISIT DAY:      
 90    
 180 
PHYSICIAN GLOBAL SATISFACTION QUESTIONNAIRE (P-GSQ) OF THE NECK 
1. When looking at the photo images and 
respective to your clinician assessment during this 
visit, do you see any change on the treated area 
with respect to “improvement” of the skin and 
overall area? 
 Yes,  if “yes” please check all that apply:            
 Less sagging on the jawline and cheeks 
 Tighter/lift under the chin area 
 Smoother skin texture 
 Jaw line more defined 
 less wrinkles/lines  
 Other (specify);_________________ 
  No 
2. Compared to “BEFORE” treatment how does 
the subject’s skin feel today (check all that apply? 
 Tighter 
 Firmer 
 Smoother 
 Make-up application easier 
 Shaving easier 
 No change from prior to treatment 
3. How satisfied are you with the results of the 
treatment. 
 Very Satisfied 
 Satisfied 
 Neutral 
 Dissatisfied 
 Very dissatisfied 
4. How likely are you to recommend the treatment 
to your patients? 
 Very likely 
 Likely 
 Neutral 
 Unlikely 
 Vert unlikely 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 43 of 51 
APPENDIX 5 
SUBJECT- GLOBAL SATISFACTION QUESTIONNAIRE (S-GSQ) OF 
THE NECK 
STUDY NO.:  THERMI_005 
SUBJECT ID:_____________ 
VISIT DAE:______________________ 
VISIT DAY:      
 90    
 180 
SUBJECT GLOBAL SATISFACTION QUESTIONNAIRE (S-GSQ) OF THE NECK 
Instruction:  
x 
Provide a copy of the before and after photo to the study participant PRIOR to administering the G 
x 
Direct the subject to the photo and review the lower part of the face using the “jawline”, “upper neck – 
under the chin” and “lower neck” 
x 
Have the subject provide responses to the following questions. 
1. Have you noticed any change with respect to 
“improvement” of the skin appearance of your 
neck? 
 Yes,  if “yes” please check all that apply:            
 Less sagging on the jawline and cheeks 
 Tighter/lift under the chin area 
 Smoother skin texture 
 Jaw line more defined 
 less wrinkles/lines  
 Other (specify);_________________ 
  No 
2. Compared to “BEFORE” treatment how does 
your skin feel today (check all that apply? 
 Tighter 
 Firmer 
 Smoother 
 Make-up application easier 
 Shaving easier 
 No change from prior to treatment 
3. How satisfied are you with the results of your 
treatment. 
 Very Satisfied 
 Satisfied 
 Neutral 
 Dissatisfied 
 Very dissatisfied 
4. How likely are you to recommend this treatment 
to family and friends? 
 Very likely 
 Likely 
 Neutral 
 Unlikely 
 Vert unlikely 
 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 44 of 51 
APPENDIX 6 
CUTOMETER BROCHURE 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 45 of 51 
APPENDIX 7 
NUMERICAL RATING SCALE  
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 46 of 51 
APPENDIX 8 
APPLICATION OF NON-SIGNIFICANT RISK 
THERMIAGEN, LLC LETTER OF APPLICATION FOR NONSIGNIFICANT RISK 
DETERMINATION FOR THE THERMIRF® DEVICE (V0.1 12.07.14) 
 
Description of Investigational Product: 
 
Name of the device: ThermiRF  
 
Description of the device: The ThermiGen, LLC ThermiRF is a non-invasive, transcutaneous radiofrequency 
device that is FDA cleared for dermatological and general surgical procedures for electrocoagulation and 
hemostasis (K130689). 
 
The ThermiRF has been tested by a third party (Intertek Testing Services NA Inc.) for conformance to IEC 
60601-1-2 (EMC) and IEC 60601-1 (electrical safety). Third party verification of IEC 60601-1-4 and IEC 
60601-1-6 Collateral Standards was performed as well. 
 
The ThermiRF is a 20 watt electrothermal RF generator that continuously monitors temperature and 
impedance.  It provides controlled temperature tissue heating as its mechanism of action.  
 
Name: ThermiRF  
 
 
 
Control/Connections 
Function 
1. RF ON (blue light) 
Illuminated when generator is delivering RF power 
2. STIM ON (yellow light) 
Illuminated when generator is delivering Stimulate Power 
3. FAULT (red light) 
Illuminated when a fault condition is detected 
4. Neutral electrode connection port 
Used to connect a neutral electrode (grounding pad) to the generator 
5. Device connection port 
Used to connect RF electrode accessories to  generator 
6. Display window 
Displays generator information, modes, and operating parameters.  
7. Soft Keys 
STIM: 
Motor; 
ThermiTight, 
ThermiSmooth, 
ThermiRase, 
Help/Exit, Start, Reset, and OK 
8. RF ON Button 
Start or stops RF power delivery 
9.  Up/down buttons 
Used to increase or decrease function settings 
10. Stim output knob 
Adjusts the stimulate output voltage.  Push and release the knob to 
turn Stimulate power on/off.  
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 47 of 51 
 
 
Control/Connections 
Function 
1. On/Off rocker switch 
Turn the generator main power on/of 
2. Fuse access door 
Access for fuse replacement 
3. Power cord connector 
Input module 
4. RS-232 connector 
For service use only 
5. Equipotential compensator terminal 
(case ground) 
Bring equipment into the same case potential as 
the generator 
6. Footswitch connector 
Connect pneumatic footswitch to the generator 
7. Security door 
Access for software upgrades (Authorized user 
only) 
 
ThermiRF is a main powered device; the specifications of which are: 
 
 
Height: 5.75” 
 
Width: 12.5” 
 
Depth: 13.0” 
 
Weight: 12.6 lbs. 
 
SPECIFICATIONS 
 
Parameters 
ThermiRF  
Dimensions ThermiRF Generator 
W:12.5 * D:13.0 * H:5.75 
Internal Display 
LCD Display 
ThermiRF Generator Specifications 
Input Power 
100-120/200-240 + 10%, 50/60 Hz 
Output Power 
20 watts (maximum) into 50-300Ω 
Output Voltage in Stimulate Mode 
0-10 V 
Output Voltage in RF Lesion Mode 
0-20 V 
Operating Frequency 
460 kHz (+5 kHz) 
Power Delivery Modes 
Stimulate Mode, ThermiTight Mode, ThermiRase 
Mode, ThermiSmooth Mode Pulsed RF Mode, 
Biomed (calibration-test) Mode 
 
Set Temperature Range 
35-90oC, this range varies for each 
Power Delivery Mode 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 48 of 51 
Waveform 
Sine wave for RF Lesion and Pulsed 
RF Modes, Square wave for Stimulate Modes 
Protection (per IEC 60601-1) 
Class I, Type BF Applied Part- 
defibrillator proof, IXP0, Continuous Operation. Not 
suitable for use in the presence of a flammable 
anesthetic mixture. 
Controls 
Line Power On/OFF, RF On/OFF, 
Stimulate Output, Front Panel Soft Keys (Start, Set 
Temp, Set Profile, Reset, Width, Frequency, and 
Mode Selection) 
Displays 
Impedance, Actual Temp, Elapsed 
Time, Paused, Volts, Frequency 
Electrode surface 
180 mm2 
Subject contacting part 
Yes 
Subject contacting materials 
Surgical Stainless Steel 
Device Preparation and Administration of Study Intervention/Investigational Product: 
 
The device will administer up to 20 Watts of radiofrequency energy. 
 
DETERMINATION OF DEVICE SAFETY 
 
RISK AND PREVENTION  
 
The ThermiRF® Device is classified by the FDA/IEC as a Class 2 radiofrequency device. The device has risk of 
burns or fire, and therefore, cannot be used near conductive materials such as metal bed parts, inner-spring mattress, 
etc. A disposable grounding pad is used to ground the electrical current. Furthermore, the subject will not be placed 
into contact with metal parts which are grounded or which have appreciable capacitance to earth. The device cannot 
be used in subjects with a pacemaker, implantable defibrillators, or monitoring equipment. 
  
FDA DETERMINATION OF NON-SIGNIFICANT RISK (NSR) STATUS 
 
The ThermiGen LLC ThermiRF is a radiofrequency device that is FDA cleared for dermatological and general 
surgical procedures for electrocoagulation and hemostasis (K130689). 
 
N.B.; The ThermiRF is technically identical to the Symphony RF, the marketing name of the device was changed 
from Symphony RF to ThermiRF. No technical modifications were made. (K130689). 
 
1. 510(k)# 130689 
Device Name: SymphonyRF Generator (ThermiRF) 
Indication for use: dermatological and general surgical procedures for electrocoagulation and hemostasis; 
and to create lesions in nervous tissue  
 
 
2.  510(k) #: K-033981 
Device Name: Smith and Nephew ElectroThermal 20S Spine Generator 
Indication of use: Intended to create lesions in nervous tissue, and to coagulate and decompress disc 
material when used in combination with Smith and Nephew thermal/coagulating probes. 
 
3.  510(k) #: K121858 
Device Name: The Acessa System 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 49 of 51 
Indication of use: Percutaneous use for laparoscopic coagulation and ablation of soft tissue 
 
4.  510(k) #: K121481 
Device Name: The INFINI Radiofrequency System 
Indication  of  use:  For  use  in  dermatologic  and  general  surgical  procedures  for electrocoagulation 
and hemostasis, and the percutaneous treatment of facial wrinkles 
5.  510(k) #: K082391 
Device Name: Primaeva Medical 
Indication  for  use:  For  use  in  dermatologic  and  general  surgical  procedures  for electrocoagulation 
and hemostasis, and the percutaneous treatment of wrinkles 
IRB  approved  study:  The  protocol  was  reviewed  and  approved  by  the  local  ethics committee 
(Independent Investigational Review Board, Inc, Plantation, FL, USA Millheiser LS, Pauls RN, Herbst SJ, 
Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: non-surgical vaginal 
tightening. J Sex Med. 2010; 7(9):3088-95. 
 
DEVICE LABELING 
 
The ThermiRF is manufactured in accordance with the Good Manufacturing Procedures set forth by the 
FDA. Per CE (Certified European) standards and testing results and has been validated by a third party 
(Intertek Testing Services NA Inc. Report Reference No. 100584146BOX-004) for conformance to IEC 
60601-1-2 (EMC) and IEC 60601-1 (electrical safety). Third party verification of IEC 60601-1-4 and IEC 
60601-1-6 Collateral Standards was performed as well. 
 
 
 
In addition, the device used in this clinical study shall be labeled with the following statement: NON-
SIGNIFICANT RISK STATEMENTS 
“CAUTION – Investigational device. 
Limited by United States law to Investigational use.” 
 
Do you contend that this device as used in this protocol is an NSR device? 
_9_ Yes  ___No 
Has another IRB decided this device is SR? 
  
___  Yes  _9_ No 
Does this type of device appear as SR on the FDA Information Sheet? 
  
____Yes _9_ No 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 50 of 51 
APPENDIX 9 
THERMI_RF USER MANUAL 4002-01 REV C.PDF (1MB) 
 
The User Manual is on-file in the sponsor Trial Master File (TMF), and a copy provided to the 
investigator in the Site Master File. 
 
 

Investigational Device:  ThermiRF 
Protocol No.:  Thermi_0005 
Version Date:  Final 10-May-2016 
 
COMPANY CONFIDENTIAL 
Page 51 of 51 
APPENDIX 10 
BLINDED RATER VALIDATION GUIDELINES 
 
The blinded-rater validation guidelines can be found in the sponsor Trial Master File (TMF)