welloStationX Determination of Clinical Accuracy
Conditions: Fever
Sponsor: Wello Inc.

 
CONFIDENTIAL AND PRIVATE INFORMATION OF WELLO, INC. 
Page 1 of 18 
Protocol Number:  WS-001 Rev. 6 
Original Issue Date:  8/28/2018 
 
 
 
INVESTIGATIONAL PLAN 
 
welloStationX™  Determination of Clinical Accuracy  
 
 
 
Protocol Number: 
 
 
3939002 
Revision: 
 
 
 
6 
Original Protocol Issue Date:  
September 21, 2018 
 
NCT#:  
 
 
 
NCT03758157 
 
 
Sponsor: 
 
 
 
Wello, Inc. 
 
 
 
 
 
3939 Belt Line Rd, Suite 400 
 
 
 
 
 
Addison, Texas, 75001 
 
 
 
CONFIDENTIALITY STATEMENT 
This document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by federal or state 
law or regulations.  In any event, persons to whom the information is disclosed must be 
informed that the information is privileged or confidential and may not be further disclosed 
by them.   These restrictions on disclosure will apply equally to all future information 
supplied to you which is indicated as privileged or confidential. 
 
 

 
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Protocol Number:  WS-001 
Original Issue Date:  08/18/2018 
 
Table of Contents 
WS-001 STUDY SYNOPSIS .............................................................................................2 
PROTOCOL APPROVALS .............................................................................................4 
WELLO, INC. REPRESENTATIVES ............................................................................5 
STUDY SPONSOR 5 
TEST SITES 
5 
STUDY MONITOR 5 
LIST OF ABBREVIATIONS ...........................................................................................6 
1.0 INTRODUCTION........................................................................................................7 
1.1 Study Purpose...................................................................................................7 
1.2 Indications for Use ...........................................................................................7 
2.0 DEVICE DESCRIPTION ...........................................................................................7 
2.1 Risk Analysis ....................................................................................................7 
3.0 DESIGN OF THE CLINICAL STUDY .....................................................................8 
3.1 Study Design .....................................................................................................8 
3.2 Subject Sample .................................................................................................8 
3.2.1 Subject SampleSize Justification .................................................................8 
3.2.2. Subject Qualification: Inclusion/ Exclusion Criteria ...............................9 
3.2.3 Subject Recruitment .....................................................................................9 
3.2.4 Subject Compensation ..................................................................................9 
3.3 Study Procedures ...........................................................................................10 
4.0 STATISTICAL ANALYSIS PLAN .........................................................................11 
4.1   Primary Outcome Measures .......................................................................11 
4.2   Primary Outcome Analysis .........................................................................11 
4.3   Study Success Evaluation ............................................................................11 
4.4   Safety Analysis .............................................................................................12 
4.5   Handling of Missing Data ............................................................................12 
APPENDIX A: 
INVESTIGATOR AGREEMENT .............................................14 
APPENDIX B: 
WELLOSTATIONX LABELING .............................................16 
APPENDIX C: 
REFERENCE THERMOMETER LABELING .......................17 
APPENDIX D: 
STUDY MONITORING .............................................................18 
 
WS-001 Study Synopsis 
Title 
welloStationX Determination of Clinical Accuracy 
Protocol Number 
WS-001 

 
CONFIDENTIAL AND PRIVATE INFORMATION OF WELLO, INC. 
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Protocol Number:  WS-001 
Original Issue Date:  08/18/2018 
 
Investigational Device 
welloStationX 
Objective 
• To evaluate clinical bias with stated uncertainty 
• To determine clinical repeatability. 
Inclusion Criteria  
For All Patients 
• Males or females  
• Age groups: 
o 5 and up 
• Each subject or guardian must sign an informed consent form. 
Exclusion Criteria  
For All Patients 
Use of medications known to affect body temperature (for example, 
antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) 
within 3 hours of the test, or immunization within seven days of the test. 
Study Design 
The study is a multi-site study designed to enroll subjects to obtain 
temperature readings with the welloStationX and a reference 
thermometer.  The data collected will be analyzed to determine clinical 
bias with stated uncertainty and repeatability of the welloStationX.   
Study Procedures 
All subjects will have their temperature taken 3 times with the 
WelloStation, a non-contact infrared thermometer.  Another single 
temperature reading will be taken with a Welch Allyn oral thermometer. 
Primary Endpoints 
• Calculation of clinical bias with stated uncertainty 
• Calculation of clinical repeatability  
• Calculation of limit of agreement 
Number of Patients 
A minimum of 105 subjects. 
Number of Sites 
Three test sites plus individual home locations. 
 
 
 

 
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Protocol Number:  WS-001 
Original Issue Date:  08/18/2018 
 
 
 
 
welloStationX Determination of Clinical Accuracy 
 
 
Protocol Number: 3939002 
 
 
 
 
PROTOCOL APPROVALS 
 
 
_________________________________________ ______________ 
Project Manager 
 
 
 
 
 
Date 
 
 
_________________________________________ ______________ 
Alan C. Heller 
Date 
Wello, Inc. 
 
 
 
INVESTIGATOR APPROVAL 
I have read and familiarized myself with this protocol and I agree to conduct the study as 
described. 
 
 
 
_________________________________________ ______________ 
Principal Investigator  
 
 
 
 
Date 
 

 
CONFIDENTIAL AND PRIVATE INFORMATION OF WELLO, INC. 
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Protocol Number:  WS-001 
Original Issue Date:  08/18/2018 
 
Wello, INC. REPRESENTATIVES  
 
STUDY SPONSOR 
The Clinical Study is sponsored by Wello, Inc.  Overall responsibility for the study will be held 
by and questions regarding clinical and scientific conduct of the study should be addressed 
to: 
Alan C. Heller  
Wello, Inc. 
3939 Belt Line  
Suite 400 
Dallas, Texas 75001 
Office telephone: 469.522.5200  
 
TEST SITES 
1. Wello Inc. Office 
3939 Belt Line Rd 
Addison, Texas, 75001 
 
2. Agape Clinic 
Gretchen Weaver, Director of Services 
4104 Junius Street  
Dallas, Texas 75246 
 
3. Community Council 
Denise Hugininnie, EVP 
1341 W Mockingbird Lane 
Dallas, Texas 75247 
 
4. Individual Homes located in Dallas, Ennis, Frisco and Plano, Texas  
 
STUDY MONITORS 
1. Stacey DiSpigno, MSc – Community Council, September 28; Agape Clinic, October 3rd 
and October 4th 
2. Maribeth Lipscomb – Agape October 5 and October 16th  
3. Alan C Heller – Wello Offices and various residences  
 
INSTITUTIONAL REVIEW BOARD (IRB) 
IntegReview IRB 
3815 S. Capital of Texas Hwy, Suite 320 
Austin, TX 78704 
Phone: 512-326-3001 
Email: integreview@integreview.com 

 
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Protocol Number:  WS-001 
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LIST OF ABBREVIATIONS 
 
C 
 
Celcius 
F 
 
Farenheit 
IRB 
 
Institutional Review Board 
ISO  
 
International Standard 
 
 

 
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Protocol Number:  WS-001 
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1.0 INTRODUCTION 
1.1 Study Purpose 
To determine the Clinical Accuracy of the welloStationX by: 
• evaluating clinical bias with stated uncertainty; and 
• determining clinical repeatability. 
1.2 Indications for Use 
The results of this clinical study are intended to support the following 
indications for use: ““The welloStationX is a non-contact device intended for 
use to measure the body temperature of individuals five years of age and 
older. The welloStationX can be used by medical professionals or laypersons 
in any public or private indoor facility including home use. The welloStationX 
has an ambient operating temperature range of 59F – 82.4F (15C – 28C).” 
 
2.0 Device Description 
The welloStationX is an automated No-Touch Self-Service Electronic Thermometer 
designed to provide an accurate temperature reading without the time and 
exposure of a skilled attendant to the possibility of infection. 
 
The welloStationX is an electronic thermometer using an infrared sensor of the 
surface of the forehead adjusting human body skin temperature to oral 
thermometer without contact.   
 
The welloStationX is being evaluated for use for the screening of individuals for 
fever.   
 
Deatiled information on the configuration and operation of the welloStationX can be 
found in the accompanying welloStationX Use and Care Manual. 
2.1 Risk Analysis 
The general risks associated with the welloStationX device are relatively 
minimal based on a review of published literature and known safety issues 
associated with the use of these types of infrared thermometer devices. 
Wello has taken steps throughout the manufacture and design of the 
welloStationX to reduce or eliminate all potential risks to the user.  Wello has 
identified the potential risks and actions taken to address each risk below: 
• The welloStationX is not intended to be used around water.  Do not set up 
the welloStationX near a sink or other wet area.  If it is necessary to place 
near a sink or other wet area, make sure the unit is plugged into a working 
GFCI outlet. 

 
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Protocol Number:  WS-001 
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• Always operate the thermometer in an operating temperature range 16°C 
to 40°C (60.8°F to 10°F), and relative humidity less than 95%. 
• Always store the welloStationX in a cool and dry place -20°C to 50°C (-4°F 
to 122°F) and relative humidity less than 95%. 
• Do Not Attempt Repairs – Do not attempt to open, take apart, service or 
modify the product or power supply to avoid the risk of electrical shock.  
Any attempt to open or service the product will void the Limited 
Warranty. 
• Important AC Adapter Safety 
• 
Use only the power supply units supplied with the unit. 
• 
Do not use non-standard sources for power such as generators or 
inverters.  Only use standard AC power provided by a standard wall 
outlet. 
• 
Do not overload the wall outlet or power strip or extension cord.   
• 
Check AC plug to make sure the prongs are configured properly and 
are of the proper configuration for the wall adapter. 
• 
Ensure the power cord is not left in a position where it can be walked 
on, pinched, tripped over or otherwise pulled from the wall 
 
3.0 DESIGN OF THE CLINICAL STUDY 
3.1 Study Design 
This is a non-randomized, non-blinded single arm study design with the 
subject as his or her own control to evaluate the clinical accuracy of the 
welloStationX thermometer in the screening of individuals with fever.   
3.2 Subject Sample 
Subjects will be males and females aged 5 years of age and older.  A total 
minimum of 105 subjects will be enrolled with 32-52 of those subjects being 
febrile.  For the purpose of this testing, fever is defined as a core 
temperature of 99.5°F (37.5°C) or higher. 
3.2.1 Subject SampleSize Justification 
Subject sample size selection is based on the specifications in ISO 80601-
2-56; 201.102.2: human subject population requirements: “The 
minimum number of subjects in the CLINICAL ACCURACY VALIDATION 
shall not be less than 105” and “The total number of febrile subjects 
shall be not less than 30% and not greater than 50% of all subjects in 
the selected age group.” 

 
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3.2.2. Subject Qualification: Inclusion/ Exclusion Criteria 
Inclusion Criteria 
All subjects must meet the following inclusion criteria to be eligible for 
the study: 
• Male or female. 
• Age group: 5 years and up. 
• Each subject or guardian must sign an informed consent form. 
 
Exclusion Criteria 
Subjects meeting any of the following criteria will be excluded from the 
study:  
• Use of medications known to affect body temperature (for example, 
antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) 
within 3 hours of the test. 
• immunization within seven days of the test. 
3.2.3 Subject Recruitment  
Subjects will be recruited from amongst the following sources: 
• Non-profit clinical sites, including a busy free clinic in downtown 
Dallas. 
• Social media posts which will invite subjects to come to the 
Wello,Inc. office in suburban Dallas, or will offer home visits by study 
staff if located in far off metro areas of Dallas/Fort Worth.   
• Social media posts offering free shared car service or a $25 gift card 
for transportation if able to come to the centrally located sites.    
3.2.4 Subject Compensation 
Afebrile subjects will be compensated with a $10 gift card and febrile 
subjects will be compensated $25, the additional amount intended to 
assist the febrile subject to recovery.   
 
 
 
 
 
 

 
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3.3 Study Procedures  
 
3.3.1 Demographics 
Age, gender and race will be recorded for each subject. 
3.3.2 Study Device Measurements 
1. Each subject’s temperature was measured three times sequentially 
using  the study device, the welloStationX® (DUT).  
2. Each measurement was recorded by following the instructions for  
use contained in the device labeling.  
3. Each measurement was recorded by a trained techninian. 
3.3.3 Oral (Reference) Thermometer Measurements 
1. Each subject’s temperature was measured one time using a new 
off-the-shelf calibrated Welch Allyn SureTemp oral thermometer 
with disposable probe covers.  
2. Each measurement was recorded by following the instructions for 
use contained in the device labeling.  
3. Each measurement was recorded by a trained techninian. 
3.3.4 Adverse Events Evaluation  
Throughout the four measurement recordings, any reported and/or 
observed adverse events will be recorded on the CRF and reported 
and dealt with applicably. 
There are no reasonably anticipated adverse events with use of the    
welloStationX infrared thermometer.  
3.3.5 Reporting of Febrile Temperature Recordings 
A subject for whom a febrile temperature measurement (99.5°F 
(37.5°C) or higher) was recorded using the Welch Allyn SureTemp oral 
thermometer will be reported immediately  to the subject or in the 
case of a minor, to the guardian.  The subject and/or guardian will be 
advised to consider seeking medical attention.   
 
 
 

 
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Protocol Number:  WS-001 
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4.0 STATISTICAL ANALYSIS PLAN 
4.1   Primary Outcome Measures 
The Primary Outcome Measures for this study are to evaluate: 
 
1. Clinical Accuracy of the welloStationX; and 
2. Clinical Repeatability of the welloStationX 
4.2   Primary Outcome Analysis 
As per ISO 80601-2-56, these measures will be recorded and analyzed as 
follows: 
 
1. Clinical Accuracy will be evaluated by comparing the first recorded 
measurement using the welloStationX with the single measurement 
recorded by the Welch Allyn SureTemp oral thermometer. 
  
Results will be presented through: 
(i) 
Descriptive presentation of means and standard deviations 
(ii) Evaluation of agreement calculated as the clinical bias (mean bias (±SD)) 
(iii) Limits of Agreement (LOA) calculations  
(iv) Band-Altman plot created using mean bias and standard deviation data  
(v) XY Plor and Correlation Coefficient caluclation 
 
2. Repeatability will be calculated using the pooled standard deviations 
formula.  
 
All analyses will be performed and presented by febrile status (febrile and 
afebrile) and by device (test device compared with reference device), as 
applicable. 
4.3   Study Success Evaluation  
Accuracy and reliability in welloStationX thermometer readings will be 
demonstrated if there is close agreement between the welloStationX and 
the reference device (Welch Allyn SureTemp oral thermometer).  
Additionally, agreement values will be referenced against those attained for 
the prior validation study for the CareGiverthermometer, with agreement 
values for the welloStationX to be comparable or better to the published 
data for the Caregiver. This reference is the following: 
Clinical validation of the CAREGIVER® non-contact thermometer model 
PRO-TF200/PRO-TF300 in febrile and afebrile patients of all ages 
Naja E. McKenzie PhD, RN, Alice Huang & Gary O’Hara MSE 
November 2013 Copyright ©2013 Thermomedics®, Inc. 

 
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4.4   Safety Analysis 
Safety analysis will be through evaluation of adverse events and comparison 
of adverse events between use of the welloStationX and the Welch Allyn 
SureTemp thermometers. 
4.5   Handling of Missing Data  
Missing data will be handled through multiple imputation methods.  
 
 
5.0 Consent and Confidentiality  
  
5.1 Informed Consent  
The Investigator will be responsible for obtaining from every patient prior to 
his/her participation in the Study an Informed Consent signed by the patient or 
legally authorized representative, in accordance with the code of Federal 
Regulations, Title 21, Part 50.20. The consent form that is used must be the 
current version and must be approved by both the reviewing IRB and by the 
Sponsor. Informed consent will be obtained from the patient after a full 
explanation of the purpose of the study, risks and discomforts involved, 
potential benefits, etc. have been provided by the Investigator both verbally 
and in writing. The original signed copy of the informed consent must be 
maintained in the institution’s records, and is patient to inspection by a 
Sponsor representative.  
• Informed consent will be an agreement between the study PI and each 
subject or the subject’s designated caregiver, having the capacity to 
understand and make an informed decision. Consent will be obtained prior 
to each potential subject’s participation in this clinical trial.   
• The subject or the caregiver for each subject participating in this clinical 
trial will be made aware of the fact that the subject’s participation involves 
research and the intent of the research, the expected duration of 
participation and a description of the procedures that will be followed.   
• The subject or the caregiver for each subject will be made aware of the 
reasonably expected benefits the subject might receive, as well as any risks 
or potential discomfort that are involved.   
• The subject or the caregiver for each subject will be made aware of 
alternative procedures that are available to the subject.   
• The subject or caregiver for each subject will be made aware that the 
subject’s records will remain confidential, but that the FDA and the IRB has 
the right to inspect those records.   

 
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• The subject or caregiver for each subject will be told that the subject’s 
participation in the clinical trial is voluntary, without force or influence 
from the investigator or sponsor. 
• The subject or caregiver for each subject will be given the name and 
method of contacting the appropriate person(s) to answer any questions 
about the research and in the event of research-related injury. 
 
7.2 Privacy and Confidentiality  
The sponsor is concerned for the individual patient’s privacy; therefore all 
collected patient data will be treated confidentially, identified only by a 
patient identification number and investigator initials.  
All information provided to the Investigator by the Sponsor, including 
nonclinical data, protocols, CRFs, and verbal and written information, will be 
kept strictly confidential and confined to the clinical personnel involved in 
conducting this study, and no disclosure shall be made except in accordance 
with any right of publication granted to the Investigator.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix A: 
Investigator Agreement 
Provision of my signature below indicates my desire to participate in the clinical study of 
Wello, Inc.’s welloStationX and my agreement to all terms of this Investigator Agreement. 
I have thoroughly familiarized myself with the protocol for the clinical study of the 
welloStationX and I believe that I am an individual who, because of my training and 
experience, is qualified to investigate the performance of the welloStationX under the 
purview of an appropriate Institutional Review Board (IRB) or Ethics Committee.  I will 
provide the Sponsor with a copy of my curriculum vitae. 
I specifically and further agree that: 
1. I will conduct the clinical investigation in accordance with this Investigator Agreement, 
the Investigation Plan, the FDA IDE regulations, other pertinent FDA regulations, and any 
conditions imposed by my IRB, Ethics Committee or federal/state/local regulatory 
agencies. 
2. I will ensure there is a copy of a written approval by an Institutional Review Board (IRB) 
Committee of the Wello, Inc. Investigational Plan prior to enrollment of the first patient. 
3. Prior to any study related procedure, I will obtain a signed Informed Consent from every 
patient, or his/her legal representative, who participates in this clinical investigation. 
4. I agree to complete all training required by Wello, Inc. in the use of the welloStationX 
prior to collection of temperature measurements of the first subject. 
5. All use of the welloStationX will be under my direct supervision and according to the 
approved Investigational Plan.  I will not allow access to the welloStationX to anyone 
other than those employees of my institution who, under my direct supervision, are 
participating in this study. 
6. Only patients satisfying the study inclusion/exclusion criteria and willing to provide 
informed consent will be enrolled into this clinical study. 
7. All information received from Wello, Inc. about the welloStationX and all knowledge 
obtained under or concerning this study including the study design, protocol, data, 
results, and any related written or orally-transmitted information, is considered the 
proprietary property of Wello, Inc., and I will retain it in confidence and not release it to 
anyone without written consent from Wello, Inc. 
8. I will obtain written permission in advance from Wello, Inc. to publish or present any 
aspect of the Investigational Plan and study, including, but not limited to, animal or 
human study design, data, and results. 
9. I agree to fully comply with all of the responsibilities of Investigators outlined in the Code 
of Federal Regulations. 

 
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Protocol Number:  WS-001 
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My managerial responsibilities as an Investigator are outlined below. 
1. I will attend Investigator meeting when requested by Wello, Inc. or arrange for a suitable 
representative from my institution. 
2. I will review all investigational product and study-related documents sent to me by 
Wello, Inc. in a thorough and timely fashion and will provide Wello, Inc. with pertinent 
feedback when requested. 
3. I will ensure that investigational data are collected and recorded in a complete and 
accurate manner.  I will sign all case report forms as testimony to my review of 
investigational data.  I understand that it is necessary that investigational data be 
submitted to the Sponsor in a timely manner so as to ensure a timely review and 
assimilation of results. 
4. I will submit interim and final reports to my IRB/Ethics Committee, the FDA and my 
federal, state, and local regulatory agencies as required by the conditions of approval 
from the respective agencies. 
5. I agree to personally meet with, and implement any corrective actions identified by, 
Wello, Inc.’s study monitors during periodic audits.  
I have never participated in any research project that has been terminated by an 
administrative body, financial sponsor, or regulatory agency for reasons of protocol 
noncompliance, misrepresentation of data, or any other reason. 
Printed Name of Investigator: 
 
 
 
 
 
Signature of Investigator: 
 
 
 
 
 
Date:  
 
 
 

 
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APPENDIX B: 
WELLOSTATIONX LABELING  
 
 
 
 
 
 
User Manual provided to site at site initiation visit. 
 
 
 
 
 
 

 
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APPENDIX C: 
Reference Thermometer Labeling 
 
User Manual provided to site at site initiation visit. 
 
 

 
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APPENDIX D: 
Study Monitoring 
 
Adverse event reporting including device issue and unanticipated events (reportable to IRB) are 
included in the Case Report Form.  None reported.