A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
Conditions: Wrinkle
Sponsor: Candela Corporation

Name: Matrix Pro Retrospective Clinical Study Protocol 
Number: MXP23001 
Effective Date: September 21, 2023 
Revision:  01 
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CONFIDENTIAL 
Title Page 
Study Protocol Number: 
MXP23001 
Study Protocol Title: 
A Retrospective Review Evaluating the Matrix Pro Applicator 
for Treatment of Wrinkles 
Study Device: 
Profound Matrix System, Matrix Pro Applicator 
Study Sponsor: 
 Candela Corporation 
251 Locke Drive  
Marlborough, MA, 01752 
Principal Investigator(s): 
Dr. Konika Patel Schallen 
Candela Institute for Excellence 
251 Locke Drive  
Marlborough, MA, 01752  
Study Lead: 
Maya Duffy, Clinical Affairs Manager 
Candela Corporation 
This document is the property of Candela Corporation No part of 
this document may be reproduced, stored in retrieval system, or 
transmitted in any form or any means, electronic, mechanical, 
photocopying, recording or otherwise without prior written 
9  29   2023
NCT: NCT06219278

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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Abbreviations and Definitions 
AE Adverse Event 
cm Centimeter 
FST Fitzpatrick Skin Type 
FU Follow Up 
IRB Institutional Review Board 
J Joule 
MEND Micro Epidermal Necrotic Debris 
µbeam Microbeam 
µm Micron 
MTZ  Micro Thermal Zone 
mJ Millijoule 
mm Millimeter 
ms Millisecond 
nm Nanometer 
NSR Non-Significant Risk 
UADE Unanticipated Adverse Device Effect 
SOP Standard Operating Procedure 
SPF Sun Protection Factor 
Tx Treatment 
 
 
 
 
 
 
 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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Table of Contents 
 
1. Study Synopsis ......................................................................................................... 5 
2. Study Introduction and Rationale .............................................................................. 7 
3. Study Device Description .......................................................................................... 7 
Figure 1: Profound Matrix System ............................................................................... 7 
Figure 2: Sublative RF, Sublime, and Matrix Pro Applicators ...................................... 7 
Figure 3: Matrix Pro Cartridge...................................................................................... 8 
Table 1: Profound Matrix Applicators Technical Specifications* .................................. 9 
Regulatory Status ........................................................................................................ 9 
4. Investigation Plan ................................................................................................... 10 
Study Design and Plan .............................................................................................. 10 
Study Endpoints and List of Measures ...................................................................... 10 
5. Study Population..................................................................................................... 10 
Inclusion Criteria ........................................................................................................ 10 
Exclusion Criteria ....................................................................................................... 10 
Study Participant Retention Plan ............................................................................... 11 
Participant Compensation .......................................................................................... 11 
6. Study Procedures ................................................................................................... 11 
7. Ethical Conduct of the Study .................................................................................. 11 
8. Adverse Events....................................................................................................... 13 
9. Data Monitoring Plan .............................................................................................. 13 
10. 
Data Management Plan ...................................................................................... 14 
11. 
Statistical Analysis Plan ...................................................................................... 16 
Sample Size Determination and Justification ............................................................. 16 
General Overview of Statistical Plan .......................................................................... 17 
Tools and Resources for Data Analysis ..................................................................... 18 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
Revision:  01 
 
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12. 
Publication Policy ............................................................................................... 18 
13. 
Roles and Responsibilities.................................................................................. 19 
Table 2. Roles and Responsibilities .................................................................... 19 
14. 
Documentation Checklist .................................................................................... 19 
15. 
Reference List .................................................................................................... 19 
16. 
Appendices ......................................................................................................... 19 
 
 
 
 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
Revision:  01 
 
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1. 
Study Synopsis 
Study Information 
Study Type 
Retrospective chart review  
Study Device(s) 
Profound Matrix System is a platform of 3 applicators: Sublime, 
Sublative RF and Matrix Pro. The Matrix Pro applicator, a new short 
pulse RF micro-needling device that treats with an array of RF micro-
needles penetrating the skin, will be assessed in this retrospective 
analysis. 
Indication(s) 
Wrinkles 
Treatment area(s) 
Full face 
Overall Study 
Objective 
Evaluate the safety and efficacy of the Profound Matrix System with 
the Matrix Pro applicator for treatment of wrinkles 
Target Enrollment 
This is a retrospective chart review evaluating all subjects enrolled 
into the FUFT2002 source study meeting inclusion criteria and none 
of the exclusion criteria of this study protocol for retrospective 
analysis. 
Study duration 
N/A – this is a retrospective chart review 
Study Site(s) 
In the source study from which data for the current retrospective 
study will be extracted, subject enrollment occurred at up to five (5) 
clinical sites.  
Study Design 
This study is a retrospective analysis of de-identified subject data 
collected during implementation of the clinical study, “Functional 
Usability and Feasibility Testing of the Profound MatrixTM System 
(FUFT2002)” (source study). The FUFT2002 clinical study was a 
multi-site prospective clinical trial. The current retrospective study 
will analysis data extracted from the FUFT2002 database according 
to prespecified study selection criteria.  
List of Measures 
• 
 Before and after photograph assessment  
• 
Subject satisfaction questionnaire   
• 
Pain/ discomfort during treatment using Numerical Rating Scale 
(NRS) 
• 
Adverse events evaluation 
Primary Efficacy 
Endpoint(s) 
The Primary Efficacy Endpoint is pre-defined as the percentage 
correct before and after photograph determinations made by blinded 
evaluators based on perception of facial wrinkles. 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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There will be 3 independent blinded evaluators partaking in the 
study. Each will receive the set of subject photographs in de-
identified coded randomized order (randomized for before and after 
treatment presentation order with respect to each subject 
photograph set, and with respect to order of subject set 
presentation). The blinded evaluators will be required to determine 
within each presented photographic set which of the images is the 
‘Before’ image (prior to treatment initiation) and which is the ‘After’ 
image (post-treatment administration) based on his or her perception 
of the presentation of facial wrinkles. Each blinded evaluator will 
perform this task independently of the other. A minimum of 2 out of 
the 3 blinded evaluators correctly determining Before-After 
assignment for an individual subject’s photograph set will indicate 
success for that individual subject with respect to positive treatment 
response. 70% overall individual responder rate will be positive for 
study success.   
Secondary Efficacy 
Endpoint(s) 
Subject satisfaction ratings at study endpoint. 
Safety Endpoint(s) 
Adverse events will be tabulated by type, incidence, severity, related 
to treatment, action taken and outcome 
Tolerability 
Endpoint(s) 
Subject assessment of treatment discomfort/pain immediately post-
treatment via Numerical Rating Scale (NRS)  
Exploratory 
Endpoint(s)  
Skin response as assessed immediately after treatment by type and 
severity for all subjects  
 
 
 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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2. 
Study Introduction and Rationale 
The objective of this retrospective chart review study is to extract existing de-identified data 
according to prespecified study selection criteria from that collected during implementation of 
the clinical study, “Functional Usability and Feasibility Testing of the Profound MatrixTM System 
(FUFT2002)”, a multi-site prospective clinical trial. The goal of extracting this data is to evaluate 
the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of 
wrinkles using pre-existing data from a clinical trial wherein the device to be evaluated for this 
indication was administered to study subjects per the intended treatment protocol to be 
administered for the treatment of wrinkles. 
3. 
Study Device Description 
Candela Corporation has developed its next generation radiofrequency (RF) system: Profound 
Matrix System (Figure 1) with Matrix Pro, Sublative RF and Sublime applicators (Figure 2). 
 
 
 
 
 
 
 
 
 
Figure 2: Sublative RF, Sublime, and Matrix Pro Applicators 
Figure 1: Profound Matrix System 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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The Matrix Pro applicator cartridge is designed with an 7x7 matrix array (49 RF micro-needles, 
34 gauge) that penetrate the skin, covering an area of 1 cm2 (see Figure 3). The RF active length 
in each micro-needle is 0.6 mm. Each micro-needle is semi-insulated such that the needle is 
insulated except for distal end where there is no insulation so that RF energy can be released. 
The active length of the needle refers to the length of the needle that is uninsulated (see Figure 
4). 
 
 
 
 
 
 
     Figure 3: Matrix Pro Cartridge 
The RF micro-needling performs 1-3 unique levels of thermal injuries in one secure application 
(insertion). RF energy can be selected to fire at depths between 0.8 to 3.5 mm, with up to three 
RF applications per insertion, and each RF application at least 0.8 mm apart with RF energy 
ranges from 0.5-4J, in increments of 0.5J, at each depth with use of the Matrix Pro applicator. 
 
 
 Figure 4: Matrix Pro Treatment Effect Illustration 
For each needle insertion, the user shall select the energy level and the depth(s) (“1”, “2” or “3”) 
in which the energy will be delivered within the given insertion. If the user selects only one depth 
“1”, the needles will deliver an energy pulse between 0.8-3.5 mm. In cases of selecting “2” depths, 
the needles will apply the first pulse at the defined deeper depth (1.6-3.5 mm), then as the needles 
retract, the system will automatically apply the second pulse between 0.8-2.7 mm. In cases of 
selecting “3” depths, the needles will apply the first pulse at the defined deeper depth (2.4-3.5 
mm), then as the needles retract, the system will automatically apply the second pulse between 
1.6-2.7 mm and at the third pulse between 0.8-1.9 mm. If more than one depth is chosen, the 
system is designed to provide a minimum of 0.8 mm distance between each selected depth. 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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Technical specifications for the Profound Matrix are provided in Table 1. 
Table 1: Profound Matrix Applicators Technical Specifications* 
Parameter 
Profound Matrix Applicators 
Sublative RF 
Sublime 
27W Matrix Pro 
RF Energy 
up to 100 mJ per pin 
50 to 200 J/cm3 
0.5 to 4J 
Wavelength 
n/a 
700 – 2000 nm 
n/a 
Optical Fluence 
n/a 
6 W/cm2 ± 20%** 
n/a 
Number of Electrodes 
and 
Frequency 
and 
Type of RF Energy 
Two Active 
1 megahertzbi-polar 
Two Active 
1 megahertz bi-polar 
7x7 Needles Array 
Active 
1 megahertz bi-polar 
Surface Area Covered 
12x12 mm or 3x11 
mm 
8x12 mm 
10x10 mm 
# of electrode pins per 
cartridge (tip) 
44 or 64 
NA 
49 
*All values provided in Table above are within ±20% as required by regulatory standards. 
** The Sublime procedure uses a combination of bi-polar RF energy and infrared light energy (700-2000nm). Optical fluence for 
sublime applicator is applicable for IR energy only, not RF energy. 
 
Regulatory Status 
Sublime and Sublative RF applicators are FDA cleared (K141507) and approved by CE and 
AMAR (25980003) for years with the elosPlus and eTwo devices platforms. Those applicators 
can be treated also with the Profound Matrix device without change in the specifications. The only 
changes for these two applicators with Profound Matrix will be changes made in the Graphical 
User Interface (GUI). 
 
The Matrix Pro applicator is a short pulse radiofrequency (RF) micro-needling device. The Matrix 
Pro predicate devices are the Infini (Lutronic Corporation) and the Profound System (Syneron 
Candela). The Infini (Lutronic Corporation) has been cleared by the FDA (K121481) and has 
AMAR approval (120708). In addition, the Profound System is FDA cleared (K161043), CE 
approved, and AMAR approved (8980405). The Profound Matrix system has been cleared by the 
FDA (K211217) and is intended for dermatological procedures as follows: 
• 
The MATRIX PRO applicator is indicated for general dermatological procedures for 
electrocoagulation and hemostasis. 
• 
The SUBLATIVE RF applicator is indicated for dermatological procedures requiring 
ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher 
energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick 
Skin Types I-IV. 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
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• 
The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy 
levels, greater than 100 J/cm3, the Sublime applicator is limited to Fitzpatrick Skin Types 
I-IV. 
510(k) Number 
Applicant 
Device Name 
Decision Date 
K211217 
Candela Corporation 
Profound Matrix 
12/16/2021 
4. 
Investigation Plan 
Study Design and Plan 
A retrospective medical record (chart) review will be conducted at up to five (5) 
investigational sites that have prior experience treating patients with the Profound Matrix 
System (Candela Corporation, Marlborough, MA) for electrocoagulation and for treatment 
of wrinkles, acne scars or skin texture improvement.  Data will be extracted from the 
medical records by a member of the clinical site study staff in a non-identifying manner 
and will include relevant demographic, safety and efficacy information but no patient 
identifiers. Data will be compiled and retrospectively analyzed to evaluate the treatment 
of wrinkles with the Matrix Pro applicator. 
Study Endpoints and List of Measures 
Safety will be assessed by analysis of the incidence, severity and relatedness of adverse 
events that were reported in the patient charts.  Safety will include adverse events and 
optionally will include immediate skin response and discomfort during treatment.     
Efficacy will be assessed by analysis of data collected by the sites from the patient chart 
review. 
5. 
Study Population  
Inclusion Criteria 
1. Met eligibility criteria under FUFT2002 and enrolled into FUFT2002 study. 
2. Received full face treatment with 27W Matrix Pro applicator only. 
3. Have baseline and follow-up assessments obtained. 
4. Have photography obtained with the VISIA standardized camera system. 
Exclusion Criteria 
1. Sun exposure during the course of the study 
2. Aesthetic procedures and/or treatments during the course of the study 
3. Any violation of study treatment instructions 

 
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4. Upon inspection, any differences in baseline and follow up photos that would not 
make evaluation of photos viable (e.g.  chin placement, facial expression) 
5. Any protocol deviation or change in study visit activities that would jeopardize 
reliability or validity of the retrospective review. 
Study Participant Retention Plan 
In the source FUFT2002 study, the study participant retention plan was the following: 
Subjects enrolled in the study can discontinue their participation at any time for any reason 
without prejudice or reduction in the quality of their medical care. The investigator or 
sponsor can terminate a subject's participation in this study to protect the subject's health 
or if the subject fails to follow directions that results in non-compliance with study 
procedures. In the event that a participant drops out of the study or is withdrawn from the 
study, the exit/termination CRF form will be completed. A reasonable effort should be 
made to contact any participant lost to follow up during the course of the study in order to 
complete assessments and retrieve any outstanding data and study medication/supplies. 
The records of participants who terminate prior to completing the study will be retained 
and the reason for termination will be documented.  
Possible reasons for participant dropout/withdrawal include but are not limited to: 
• 
Adverse event that would prevent participant compliance with the protocol; 
• 
Participant withdrawal from the study; 
• 
Participant non-compliance with study procedures; 
• 
Participant lost to follow-up (e.g., participant cannot be located or contacted and 
does not return for follow-up visits); 
• 
Participant death; 
• 
Investigator’s decision to withdraw the participant. 
 
Participant Compensation 
As part of the FUFT2002 study, subjects received the Profound Matrix study treatment at 
no cost. There is no plan to compensate subjects for participation in this study. 
6. 
Study Procedures 
There are no visits for this study. FUFT2002 source study consisted of up to three treatment 
visits with treatment intervals 6 weeks ± 2 weeks and follow-up visits at 1 month (4 ± 2 weeks) 
and 3 month (12 ± 4 weeks) after last treatment). 
7. 
Ethical Conduct of the Study 
This study will be conducted only after receipt of determination of exempt status by a recognized 
Institutional Review Board (IRB).  The IRB helps protect and ensure the rights and welfare of all 
research participants and ensures the research is conducted in an ethical manner.  

 
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This retrospective study qualifies for ‘exempt’ status under human subject regulations. Exempt 
studies are not subject to certain federal research requirements and do not require yearly 
recertification.  
The determination of ‘exempt status’ for this study is based on satisfaction of the following three 
required criteria:  
1) 
The study involves the use of existing data, documents, and records, with ‘existing’ defined 
as ‘materials that are already in existence at the time of the study protocol development’, 
2) 
The protocol specifies a date for data collection and review, that is, this study will only 
collect information that has been recorded in the subject database for subjects who participated 
in the clinical study, “Functional Usability and Feasibility Testing of the Profound Matrix™ System 
(FUFT2002)” (under approval of the Allendale IRB, IRB #00005829) that was conducted from 
10/29/2020 to 12/31/2022, and 
3) 
Information extracted from the source study and entered in the retrospective study 
database will be de-identified; that is, it will not contain any individual subject identifying 
information or data elements that may potentially link a subject to his or her data. That is, it will 
not be possible to figure out what data in the retrospective study belongs to which subject in the 
prospective study from which it was extracted, which in turn contains de-identified data that is not 
able to be linked in any way to the identification of an individual subject. 
 
Additionally, this retrospective study meets Health Insurance Portability and Accountability Act 
(HIPAA) Privacy Requirements by satisfying the criteria for waiver of privacy authorization 
according to the following required criteria:  
1) 
There is an adequate plan to protect identifiers from improper use and disclosure, 
2) 
There is an adequate plan to destroy any identifiers at the earliest opportunity,  
3) 
Protected health information (PHI) will not be re-used or disclosed for another purpose,  
4) 
The research could not practicably be conducted without the waiver of privacy 
authorization, and  
5) 
The research could not practicably be conducted without the use of PHI. 
 
A study Informed Consent Form for this retrospective data of record review of medical records is 
not required based on HHS regulation 45 CFR 46.101(b)(4), as described below:   
This retrospective study meets the criteria for waiver of consent, assent and HIPAA authorization 
according to the following required criteria:  
1) 
There is an adequate plan to protect identifiers from improper use and disclosure, 
2) 
There is an adequate plan to destroy any identifiers at the earliest opportunity, 
3) 
Protected health information (PHI) will not be re-used or disclosed for another purpose, 
4) 
The research could not practicably be conducted without the waiver of privacy 
authorization, and 
5) 
The research could not practicably be conducted without the use of PHI. 
 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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All data will be collected retrospectively from existing information already recorded in the study 
database from subjects who were consented, qualified, and enrolled in the completed prospective 
clinical study, “Functional Usability and Feasibility Testing of the Profound Matrix™ System 
(FUFT2002)”, under approval of the Allendale IRB, (IRB #00005829). 
Potential Benefits and Risks 
As this is a retrospective chart review there are no anticipated risks or benefits to the 
subjects.  The risk of breach of patient confidentiality will be mitigated by use of the de-
identified Patient Study Number assigned by the clinical site.  The Sponsor will not request 
access to the clinical sites’ patient charts.  
8. 
Adverse Events 
Safety management, including adverse event evaluation and reporting, is not applicable to this 
retrospective study as all evaluations are being performed on prior existing data. 
However, as the data being evaluated under this retrospective protocol will be sourced from a 
prior completed prospective clinical study, safety management, including adverse event 
evaluation, assessment, and reporting, as applicable, was in effect under that protocol. As such, 
any and all adverse event information for subjects in the source study whose data is being 
evaluated in this retrospective study will be extracted, assessed, and reported as part of the 
analysis under this retrospective study protocol. 
The procedures for adverse event evaluation, assessment, and reporting for all clinical studies of 
Candela devices and which was employed in the source study are the following:  
Adverse events, and unanticipated adverse device effects (UADE) are collected from the time of 
subject consent until the subject exits the study. A description of the adverse event or device 
event, date of onset, severity, action taken, relationship to study treatment and outcome are 
documented in the case report form. 
The Investigator submits to Candela and to the reviewing IRB/EC a report of any unanticipated 
adverse device effect (UADE) as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the event (CFR 812.150(a)(1)).  
Candela, upon learning of any unanticipated adverse device effect, shall immediately conduct an 
evaluation and report the results to FDA, all reviewing IRBs, and participating investigators within 
10 working days after Candela first receives notice of the effect (CFR 812.46(b), 812.150(b)(1)). 
9. 
Data Monitoring Plan 
As this is a retrospective study, establishment of a data monitoring to ensure study and data 
compliance is not applicable.  

 
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The source study from which the data for analysis within this retrospective study is extracted; 
however, was executed under a pre-specified monitoring plan whose details were contained in 
the FUFT2002 source study’s protocol and were in compliance with Candela Medical’s Global 
Field Monitoring Procedure.  
10. 
Data Management Plan 
Demographic, treatment settings, clinical safety and efficacy information will identify patients only 
by the assigned patient study number at the study site.  These data will not contain any personal 
identifying information that would link the data to the patient; however, they will contain 
photographs and images which subjects have consented to use of the use of their photography 
for scientific, education, and/or promotional purposes and acknowledge the risk of potential loss 
of confidentiality due to use of photography if they chose to participate in the source study.   
This study will be performed in accordance with US Health Insurance Portability and 
Accountability Act and the EU’s General Data Protection Regulation (GDPR). These guidelines 
will be followed specifically with regards to the privacy and confidentiality of subject care and study 
records.    
Personnel associated with Investigator’s office and the governing Institutional Review Board have 
the right to review the data, including photographs, collected during this study.    
Procedures to Maintain Confidentiality 
All study records and information will be identified by the subject number. All subject identifiers 
will be removed from all documents.  Documents containing identifying information will be kept in 
locked files in the research staff’s locked office. Limited access to electronic data will only be 
made available to members of the research team.  No direct identifying information will be shared 
with any outside entities.  
Protocol Deviations 
All deviations will be tracked on a CRF and summarized in the progress report for the next 
continuing IRB/EC review.   
Data Source 
The data source in this study is existing information already recorded in the study database from 
subjects who were consented, qualified, and enrolled in the completed prospective clinical study, 
“Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)”, under 
approval of the Allendale IRB, (IRB #00005829), and who the satisfy the retrospective study 
selection criteria. This study is a pure retrospective study. No additional information will be 
collected for any subject in this study other than the required information that is already existing 
in the database from the source study.  

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
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Data Collection Methodology 
For extraction of qualifying subject data from the FUFT2002 clinical study database into the 
current retrospective study database, the FUFT2002 data will be queried for satisfaction of the 
retrospective study selection criteria (inclusion/exclusion criteria). Data extraction will be strictly 
limited to the subject data already existing in the FUFT2002 clinical study database, and 
furthermore restricted to only subject entries that satisfy the retrospective study selection criteria 
and to only the protocol-specified data elements for the qualifying subject records. 
There will be no identifying information entered into the retrospective study database that could 
potentially connect an individual data record to an individual subject. Unique de-identified codes 
will be used for each subject data set extracted from the source study database and entered into 
the retrospective study database. 
The collected retrospective data will only be used for the purposes of evaluating the efficacy, 
safety, and tolerability objectives of this study.  
The parties who will have access to the retrospective and source study databases will be the 
designated Candela employees, and the study biostatistician.  Access to the database will not be 
given to outside parties at any time during the data collation and analysis process or in the future 
for any reason.  
Data Elements  
The following data elements will be extracted from the qualifying identified existing subject data  
records in the FUFT2002 study database. 
1) Subject Information  
a) Sex 
b) Age (years)  
c) Ethnicity  
d) Fitzpatrick Skin Type 
2) Treatment Variables  
a) Treatment Area Location 
b) Depth (deep, middle, and shallow) 
c) Energy (deep, middle, and shallow) 
d) Number of insertions 
3) Outcome Variables 
a) Skin response assessment 
b) Pain assessment via Numerical Rating Scale (NRS) rating 
c) Digital photographs  
d) Subject satisfaction questionnaire  
e) Adverse event and other safety information 
 

 
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Data Storage And Management 
Primary records (source study database and documents) will continue to be maintained in the 
respective study sites and study site subject files as before. The study data elements extracted 
from the source study database will be directly entered into the retrospective study database to 
which only the designated Candela Medical study staff and the study biostatistician will have 
access. 
Confidentiality and Privacy   
All data and records generated during this study will be kept confidential in accordance with 
HIPAA regulations on subject privacy. Privacy of subjects and confidentiality of the collected data 
elements will be secured through use of a de-identified coding system that will comprise of study 
subject unique study identification number. The coded de-identifiers will be used for all data 
entries. 
Providing Results to Subjects 
Results will not be provided to subjects as there is no diagnostic or otherwise medical purpose 
associated with this retrospective analysis that could in any potential way benefit the subjects 
whose data was included in the analysis or alert them to potential risks or issues in any other 
regard. 
11. 
Statistical Analysis Plan 
Sample Size Determination and Justification 
A sample size of 24 study subjects has been determined sufficient to provide an 
appropriate sample population for statistical analysis and generalizability of results. 
Statistical justification for sample size determination and the success criteria determination 
on which it is based is presented below.  
Primary Efficacy Endpoint is pre-defined as the percentage correct before and after 
treatment photograph determinations made by blinded evaluators based on perception of 
facial wrinkles. 
There will be 3 independent blinded evaluators partaking in the study. Each will receive 
the set of subject photographs in de-identified coded randomized order (randomized for 
before and after treatment presentation order with respect to each subject photograph set, 
and with respect to order of subject set presentation). The blinded evaluators will be 
required to determine within each presented photographic set which of the images is the 
‘Before’ image (prior to treatment initiation) and which is the ‘After’ image (3-months post-
treatment administration) based on his or her perception of the presentation of facial 
wrinkles. Each blinded evaluator will perform this task independently of the other. A 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
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minimum of 2 out of the 3 blinded evaluators correctly determining Before-After 
assignment for an individual subject’s photograph set will indicate success for that 
individual subject with respect to positive treatment response. 70% overall individual 
responder rate will be positive for study success.   
The rationale for selection of a minimum responder rate criterion of 70% (based on a 2 
out of 3 blinded evaluator concordance) is based on the minimum requirement established 
by the United States Food and Drug Administration (U.S. FDA) to which Candela 
Corporation has been upheld and successfully employed previously to attain FDA market 
clearance for similar devices and indications. 
Employing these parameters, the minimum pre-determined sample size to provide 
sufficient power for a statistical comparison of the proportion of treatment responders (P) 
versus a reasonable cutoff (P0) is based on a power calculation utilizing the (one 
proportion) binomial exact test and based on the following assumptions.  
 • H0: P ≤ P0 versus Ha: P > P0  
• Type I error rate: α = 0.05   
• Power = 80% 
• Population proportion under the null hypothesis: P0 = 0.70  
• Population proportion under the alternative hypothesis: P = 0.90  
• Total N = 24 study participants 
Therefore, a sample size of 24 study subjects is determined to be sufficient to provide 
appropriate sample population for statistical analysis such that the results of this 
retrospective study can be considered statistically and clinically meaningful and 
generalizable to the broader intended population. 
General Overview of Statistical Plan 
Efficacy analysis will be performed for both the primary modified intent-to-treat (mITT) and 
the secondary per protocol (PP) populations. Safety will be evaluated for the safety 
population. Each is defined below. 
• 
The modified Intent-to-Treat (mITT) study analysis population includes all enrolled 
subjects who received at least one treatment with the study device. The mITT study 
analysis population forms the primary study analysis population. 
• 
The Per Protocol population (PP) excludes subjects who dropped out or were 
terminated from the trial by the PI or sponsor prior to completing the study per protocol. 
Therefore, the Per Protocol population comprises all subjects who completed the protocol 
without deviation through to and inclusive of the 3-month follow visit. The PP population 
forms the secondary study analysis population.  

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
Revision:  01 
 
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• 
The Safety analysis population comprises all subjects who were enrolled in the 
study and had any part of at least one treatment administration with the study device. 
Summary statistics (arithmetic mean, standard deviation, median and range) for 
quantitative variables will be presented. Frequency tables for qualitative data will be 
provided. Unless otherwise specified, all statistical comparisons will be carried out using 
two-tailed tests. 
The data analysis will be carried out following the FUFT2002 Statistical Analysis Plan. 
Handling Missing Data 
Missing data will be handled using the Last Observation Carried Forward data imputation 
method. The number and proportion of subjects with missing data will be presented in a 
separate table tabulated with timepoint, date, and with reasons for the missing data 
provided. 
Tools and Resources for Data Analysis 
The data will be captured by transferring specified extracted data from the source 
database and any other applicable study documentation directly into a database created 
to capture data for this retrospective study. The final database will be verified against 
source case report forms and locked prior to writing the final clinical study report. Data 
may be analyzed using Microsoft Office Excel (Microsoft, Redmond, WA) or equivalent 
statistical software. 
The clinical findings will be consolidated and communicated using the company’s Clinical 
Study Report Template and other deliverables as applicable (clinical bulletins, white 
paper, publications, etc.) 
The sample size calculation and statistical analysis plan was performed by an external 
clinical and regulatory consultant.  
12. 
Publication Policy 
Site and Investigator shall have the right to publish the results of the trial in accordance with the 
clause in the clinical trial agreement, if applicable, provided sponsor has given its prior written 
approval.  Sponsor shall have the right to review for a minimum of thirty (30) days all proposed 
publications or announcements related to the study and shall further have the right to require 
removal of information from such publication or announcement if sponsor believes removal is 
necessary to comply with applicable regulatory responsibilities or to allow the sponsor sufficient 
time to protect its intellectual property rights (IPR), through the filing of patents or the pursuit of 
other protection.  Sponsor reserves the right to remove all Confidential Information from any 
publications or presentations, or if sponsor deems that such removal does not sufficiently protect 
its intellectual property rights, to require that investigator refrain from making such publication or 

 
Name: Matrix Pro Retrospective Clinical Study Protocol  
Number: MXP23001 
Effective Date: September 21, 2023  
Revision:  01 
 
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presentation. Investigator agrees that if the trial is part of a multi-center trial, any publication by 
investigator of the trial results shall not be made before the first multi-center publication. 
13. 
Roles and Responsibilities 
Table 2. Roles and Responsibilities 
Study Personnel 
Role 
Responsibilities 
Maya Duffy 
Study Manager 
Oversee study related procedures  
Bhumi Vinay Patel 
Data Management Lead Oversee data monitoring and 
management 
Katherine Coleman, 
Liuping Li, and 
Nardeen Badarny 
Clinical Research 
Associates 
Oversee study related procedures, site 
monitoring, and collection of data  
Elvira Cawthon 
Clinical and Regulatory 
Consultant and 
Biostatistician for 
Sample Size Calculation 
and Data Analysis Plan 
Provide statistics for sample size 
calculation and input to data analysis 
plan. 
Dr. Konika Patel 
Schallen 
Principal Investigator of 
FUFT2002 Source 
Study  
Ensuring that the source clinical study is 
conducted according to the investigational 
plan, and applicable FDA regulations. 
Protecting the rights, safety, and welfare 
of study subjects. 
Nicolle Dest 
Senior Nurse Research 
Manager 
Ensure study staff are following regulatory 
requirements and following protocol 
activities for source study. Providing de-
identified clinical data to Candela 
Raylene Piretti,  
Christina McCarthy-
Greenwood, and 
Alexis Husson 
Candela Institute for 
Excellence Study Staff 
Adhere to regulatory requirements  
and protocol activities for FUFT2002 
source study 
14. 
Documentation Checklist 
Retrospective chart review of de-identified FUFT2002 source study case report forms. 
15. 
Reference List 
Not applicable. 
16. 
Appendices 
Not applicable.