Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Phase: NA
Conditions: Distal Radius Fracture, Scaphoid Fracture
Sponsor: GE Healthcare

 
 
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Clinical Study Protocol 
Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection 
Study 
(STUDY NO.124.02-2018-GES-0001) 
Version: 2.0; 24/Oct/2018 
Sponsor: 
 
General Electric Company, acting through its GE Healthcare Business 
3000 N. Grandview Blvd 
 
Waukesha, WI 53005 
Investigational Device/Product: VolumeRAD 
Modality: Detection and Guidance 
Solutions (DGS) - X-Ray 
 
FOR QUALIFIED INVESTIGATORS, STUDY STAFF, AND THEIR 
ETHICS COMMITTEE(S) ONLY 
CONFIDENTIALITY STATEMENT 
Information in this RESEARCH STUDY PROTOCOL is for investigators, site personnel 
involved with the study, ethics committee(s), and/or their authorized representative(s) except 
as required to obtain consent from study participants or as otherwise required by law. Once 
signed, the terms of the protocol are binding for all parties. 
 
 
 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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The Sponsor and Principal Investigator have approved this protocol version, and I confirm hereby to 
conduct the study according to the protocol and in accordance with applicable principles of the World 
Medical Association Declaration of Helsinki and Good Clinical Practice (GCP) guidelines as per ISO 
14155:2011, any conditions of approval imposed by the reviewing EC or governing regulatory body, and 
applicable laws and regulations. The PI should not deviate from this protocol except for emergency use. I 
have read and understood and agree to abide by all the conditions and instructions contained in this 
protocol. 
Local Principal Investigator at study site: 
 
Investigator Signature 
 
Date 
 
 
 
Print Name 
 
 
 
 
 
Site Name, Department, Address 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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Table of Contents 
Document and Version Control................................................................................................ 5 
List of Abbreviations and Terms .............................................................................................. 6 
Study Synopsis ......................................................................................................................... 7 
Administrative Structure of Investigation ............................................................................. 10 
1. Background and Justification .......................................................................................... 11 
2. Device Description ............................................................................................................ 12 
 
Identity, Mechanism, and Function ......................................................................................... 12 
 
Intended Use ......................................................................................................................... 12 
 
Reference Standard ............................................................................................................... 12 
 
Concomitant/Ancillary Administrations .................................................................................... 12 
 
Accountability ........................................................................................................................ 13 
 
Anticipated Risks and Benefits ............................................................................................... 13 
3. Study Objectives and Endpoints ...................................................................................... 13 
 
Purpose of the Study ............................................................................................................. 13 
 
Study Endpoints ..................................................................................................................... 14 
4. Study Design ..................................................................................................................... 14 
 
Study Population .................................................................................................................... 14 
 
Number of Subjects ............................................................................................................... 14 
 
Protection of Vulnerable Subjects........................................................................................... 15 
 
Eligibility Criteria for Test-arm Subjects .................................................................................. 15 
 
Eligibility Criteria for Control-arm Subjects .............................................................................. 15 
 
Controls and Minimization of Bias .......................................................................................... 16 
 
Recruiting and Screening ....................................................................................................... 16 
 
Criteria for Withdrawal/Discontinuation ................................................................................... 16 
5. Study Procedures.............................................................................................................. 17 
 
Subject Preparation ............................................................................................................... 17 
 
Description of Study Procedures ............................................................................................ 17 
 
Follow-up ............................................................................................................................... 18 
6. Study Data Collection and Assessments ........................................................................ 18 
 
Primary Assessment .............................................................................................................. 18 
 
Secondary Assessments ........................................................................................................ 19 
 
Safety Assessments .............................................................................................................. 19 
7. Qualification and Training Plan ........................................................................................ 20 
 
Staff Qualifications ................................................................................................................. 20 
 
Training Plan for the Protocol and Research Device/Product .................................................. 20 
8. Safety ................................................................................................................................. 20 
 
Anticipated Adverse Events ................................................................................................... 20 
 
Adverse Event Definitions ...................................................................................................... 20 
 
Documentation of Safety Events ............................................................................................ 21 
 
Reporting of Safety Events and Device Deficiencies/Complaints ............................................ 22 
 
Device Deficiencies/Complaints ............................................................................................. 22 
9. Ethical Conduct of the Study............................................................................................ 22 
 
Ethics Committee ................................................................................................................... 22 
 
Regulatory Agencies and Competent Authority(ies) ................................................................ 23 
 
Management of Protocol Modifications and Amendments ....................................................... 23 
 
Participant Information and Informed Consent ........................................................................ 23 
 
Early Termination of the Study ............................................................................................... 23 
10. Statistical Methods............................................................................................................ 24 
 
Statistical Hypothesis ............................................................................................................. 24 
 
Sample Size Determination .................................................................................................... 24 
 
Statistical Analysis ................................................................................................................. 24 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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Handling of Missing Data ....................................................................................................... 24 
 
Deviation(s) from the Original Statistical Plan ......................................................................... 24 
11. Quality Assurance and Control ........................................................................................ 24 
 
Data Management ................................................................................................................. 24 
12. Monitoring Plan ................................................................................................................. 25 
 
Confidentiality and Data Protection ........................................................................................ 26 
 
Publication Policy ................................................................................................................... 26 
References .............................................................................................................................. 27 
Appendix A – Study Site and Investigator List ..................................................................... 28 
Appendix B – Amendments (Protocol Version 1.0 to 2.0) .................................................... 29 
 
List of Figures 
Figure 1. Study Procedures for Control-arm Subjects ............................................................................. 17 
Figure 2. Study Procedures for Test-arm Subjects ................................................................................. 18 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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DOCUMENT AND VERSION CONTROL 
This section records all changes made to the protocol for a specific study. In the table below, record every 
relevant change by indicating what changes were made. 
 
Revision 
Date 
(DD/Mmm/YYYY) 
Revision Author 
Comments/Changes 
1.0 
28/Jun/2018 
Aneysha Bhat 
Clinical Writer – This is the initial version. 
2.0 
24/Oct/2018 
Aneysha Bhat 
Clinical Writer – Revised device risk and safety 
information, as described in Appendix B – 
Amendments (Protocol Version 1.0 to 2.0). 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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LIST OF ABBREVIATIONS AND TERMS 
3D 
Three Dimensional 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
ALARP As Low as Reasonably Practicable 
AMA 
American Medical Association  
BS 
Bone scintigraphy 
CAPM GE Clinical Affairs Project Manager 
CCG 
Case Report Form Completion Guidelines 
CFR 
Code of Federal Regulations 
CHF 
Clinical History File (synonymous with e-Trial Master File) 
CRF 
Case Report Form 
CT 
Computed Tomography 
DTS 
Digital Tomosynthesis  
DCF 
Data Clarification Form 
EC 
Ethics Committee 
EU 
European Union 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice (see ISO 14155:2011) 1 
GE 
General Electric 
GEHC General Electric Healthcare 
ICF 
Informed Consent Form 
ISO 
International Standards Organization 
IRB 
Institutional Review Board  
ORIF 
Open Reduction Internal Fixation 
MRI 
Magnetic Resonance Imaging 
MWS 
GE MyWorkshop Internal Documentation System 
PI 
Principal Investigator 
SADE Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SOC 
Standard of Care  
SPR 
System Problem Report 
US 
United States 
USADE Unexpected Serious Adverse Device Effect 
XR 
X-Ray 
 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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STUDY SYNOPSIS 
 
Sponsor: 
General Electric Company, acting through its GE Healthcare Business 
Research Type: 
This is a clinical, open-label, prospective research study conducted at up to two (2) 
sites in the United States (US). 
Regulatory Status: 
This is a post-market research study of the following devices/products: 
Pre-market:  
None 
Post-market:  
VolumeRAD 
Background and 
Study Purpose: 
The purpose of this study is to support additional, on-label claims for GE 
Healthcare (GEHC) X-ray’s VolumeRAD advanced application. This study is 
designed to support the FDA 510(k) claims that VolumeRAD is superior to 
conventional X-ray in the detection and treatment of distal radius and scaphoid 
wrist fractures. 
Objectives: 
Primary Objective: 
The primary objective of this study is to collect image and technical data on routine 
X-ray, DTS, and CT (or MRI) imaging modalities.  
Secondary Objective: 
The secondary objective is to collect per-subject data including diagnosis and 
treatment information. 
Safety Objective: 
The safety objective is to collect safety information, including type and number of 
AEs, SAEs, and device issues. 
Endpoints: 
 
Primary Endpoint: 
The primary endpoint is the collection of image sets from X-ray, DTS, and CT (or 
MRI) imaging exams for each complete and evaluable subject case.  
Secondary Endpoint: 
The secondary endpoint is the collection of subject diagnosis and treatment 
information, including de-identified radiologist and surgical reports (which will be 
the truth status for all data collected), for each complete and evaluable subject 
case.   
Safety Endpoint: 
The safety objective is to collect safety information, including type and number of 
AEs, SAEs, and device issues. 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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Procedures/ 
Methods: 
Control-arm: Following subject enrollment and consent, control-arm subjects will 
undergo study-related X-ray imaging and DTS imaging. Imaging results and de-
identified radiologist reports will be collected and recorded.  
Test-arm: Eligible subjects shall consist of patients presenting with a wrist injury. 
The patients shall undergo initial X-ray imaging per standard of care (SOC) at the 
site. If the initial X-ray imaging shows a suspected or confirmed distal radius or 
scaphoid wrist fracture, additional imaging, including DTS and/or CT and/or MRI, 
shall be ordered.  
The patient may undergo DTS imaging per site SOC. The subject shall then 
undergo CT or MRI imaging. The point of enrollment in the study will be the 
completion of informed consent prior to or immediately after the completion of the 
SOC CT or MRI exam. The SOC X-ray and/or DTS imaging data shall be collected 
retroactively from these subjects. 
After SOC imaging has been completed, study-specific DTS shall be completed for 
subjects who have not previously completed SOC DTS imaging.  
Subjects shall receive treatment as needed. Diagnostic truth and treatment truth 
will be collected and recorded on a per-subject basis. De-identified radiologist and 
surgical reports will be collected for each subject. 
Eligibility criteria for 
Test-arm Subjects: 
 
Inclusion criteria: 
Subjects who meet all of the following 
inclusion criteria may be included in 
this study: 
1) Are adults aged 18 years or older; 
2) Have a confirmed or suspected 
distal radius or scaphoid wrist 
fracture;  
3) Have completed an X-ray imaging 
exam per standard of care;  
4) Have a standard of care CT or MRI 
exam ordered;  
5) Are able and willing to complete 
DTS imaging exam (if not already 
completed); 
6) Are able and willing to comply with 
study procedures; and  
7) Are able and willing to provide 
written informed consent to 
participate in this study. 
Exclusion criteria: 
Subjects who meet any of the following 
exclusion criteria will be excluded from 
this study: 
1) Are documented as pregnant based 
on PI’s medical judgment and in 
consideration of local clinical practice 
standards for evidence of pregnancy; 
2) Have additional trauma within the 
image field of view that either 
impacts the visualization or changes 
the treatment of the scaphoid or 
distal radius fracture;  
3) Have had prior reconstructive 
surgery or fixation in the wrist. 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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Eligibility criteria for 
Control-arm 
Subjects: 
 
Inclusion criteria: 
Subjects who meet all of the following 
inclusion criteria may be included in 
this study: 
1) Are adults aged 18 years or older; 
2) Are able and willing to comply with 
study procedures; and  
3) Are able and willing to provide 
written informed consent to 
participate in this study. 
Exclusion criteria: 
Subjects who meet any of the following 
exclusion criteria will be excluded from 
this study: 
1) Are documented as pregnant based 
on PI’s medical judgment and in 
consideration of local clinical 
practice standards for evidence of 
pregnancy; 
2) Have had known prior trauma in 
either wrist. 
Sample size and 
Sites: 
Up to 140 subjects shall be enrolled in this study from up to two (2) sites, including 
up to 50 subjects presenting suspected or confirmed scaphoid wrist fractures and 
up to 50 subjects presenting suspected or confirmed distal radius wrist fractures to 
achieve a target of at least 31 evaluable subjects in each of these two categories. 
Up to 40 healthy volunteers will be enrolled to achieve a target of at least 25 
normal image sets for collection in this study. 
Subjects who shall have ‘completed’ the study are defined as 1) subjects who have 
complete image sets available from X-ray (as per Standard of Care), Digital 
Tomosynthesis (DTS) (either SOC or research order), and CT or MRI (test-arm 
subjects); 2) have diagnostic truth known and available; and 3) have treatment 
truth known and available.  
Study duration: 
The expected study duration is approximately one year. 
 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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ADMINISTRATIVE STRUCTURE OF INVESTIGATION 
 
Clinical Affairs 
Project Manager 
(Sponsor 
Contact):  
 Beth Heckel  
Tel:         +1-262-312-7269 
e-mail:    Beth.Heckel@med.ge.com 
GE Healthcare (GEHC)  
Address:  3000 N Grandview Blvd 
Waukesha, WI 53188 US 
Research Manager:  
 
Alec Baenen 
Tel:  
+1-262-548-4874 
e-mail:  
Alec.Baenen@ge.com  
GEHC  
Address:  3000 N Grandview Blvd 
Waukesha, WI 53188 US 
Medical Monitor:  
Ron von Jako, MD PhD 
Tel:  
+1-617-669-3200  
e-mail:  
Ron.VonJako@med.ge.com  
GEHC  
Address:  1100 Technology Park Drive 
Billerica, MA 01821 US 
 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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1. BACKGROUND AND JUSTIFICATION 
Wrist radius fractures are one of the most common types of fractures, accounting for around 25% of 
fractures in the pediatric population and up to 18% of all fractures in the elderly age group. Current and 
past clinical data point to a rise in the incidence of distal radius fractures for the pediatric, adult, and 
elderly populations in recent years.2  
When a patient presents to the emergency department with a wrist injury and clinical signs of a scaphoid 
fracture, initial radiographs include detection of fractures. Approximately 20% of them do have a true 
scaphoid fracture and need additional imaging to establish a definitive diagnosis. However, due to the low 
healing potential of the scaphoid bone, adequate diagnosis and treatment is essential in order to prevent 
complications such as non-union, i.e. a fractured bone failing to heal after an extended period of recovery. 
If a patient is clinically suspected for a scaphoid fracture, their wrist will be immobilized in a cast until 
definitive diagnosis is obtained. This fear of under-treatment results in a large amount of over-treated 
wrist injuries.3 
X-ray is the most commonly used imaging tool in fractures; despite being a basic imaging tool, X-ray 
provides less sensitivity and accuracy than other imaging modalities such as MRI or CT, as stress or non-
displaced fractures are commonly missed in plain radiographs. Computed tomography (CT) and magnetic 
resonance imaging (MRI) are two imaging modalities that can be used at this stage in the primary 
evaluation of a suspected wrist fracture as well as the assessment of bone healing after the fracture.4 
However, these imaging modalities have several disadvantages, including metal artifacts, increased 
radiation exposure, and higher costs. 2,3,5 
Digital Tomosynthesis (DTS) is an application that uses the X-ray system to take high-resolution, low-
dose projection image slices during a single sweeping motion of the X-ray tube over a limited angle. A 
computer then assembles this information to provide up to 60 high-resolution slice images available in a 
three-dimensional (3D) viewing capacity.2,3 For orthopedic imaging applications, DTS has been reported 
to be advantageous for improved imaging of complex anatomic structures, subtle fractures, and articular 
surfaces of joints compared with conventional radiography. Compared with conventional 
radiography, DTS allows for easier detection of fractures, and can even demonstrate occult fractures not 
visible with conventional radiography, with less tissue overlap, better anatomic visualization, less 
dependence on the technical skill of the radiographers, and reduced need for painful patient positioning or 
multiple projections of different views in patients with suspected fractures of fine and complex osseous 
structures.6  GE Healthcare’s VolumeRAD application uses DTS to provide additional clinical information 
to radiologists necessary for optimal diagnosis and treatment purposes.  
The study described herein is being conducted to collect clinical data associated with diagnosis and 
treatment information to support additional, on-label claims for GEHC’s VolumeRAD advanced 
application. The results of this study are intended for use in the submission of FDA 510(k) claims in the 
United States. Results may be used by the Sponsor in future investigations, engineering, and regulatory 
purposes.   
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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2. DEVICE DESCRIPTION 
 Identity, Mechanism, and Function 
Name:  
VolumeRAD  
Modality/Type: 
Detection and Guidance Solutions (DGS)  
Manufacturer:  
GE  
Regulatory Status: Post-market  
Note: A record of number of devices issued, along with applicable identification numbers (e.g. 
serial/lot/batch) and components/accessories used in this study will be retained by the Sponsor as part of 
the clinical history file (CHF), as required by applicable laws and regulations. 
VolumeRAD is a digital tomosynthesis (DTS) feature (FDA 510(k): K132261) manufactured by GE 
Healthcare (GEHC). VolumeRAD is an X-ray system capable of generating radiographic and tomographic 
images of human anatomy.  
VolumeRAD provides multiple images of human anatomy in a single sweeping motion using a low 
radiation dose. During the sweep, up to 60 ultra-low dose exposures are obtained. Similar to CT exams, 
the acquired data is reconstructed into a set of tomographic images. These images, in DICOM format, 
can be reviewed sequentially on the acquisition console or on any standard review workstation.  
The research device, instructions for use, or packaging shall indicate that the research device is for use in 
a research investigation, in accordance with applicable regulations in the United States (US) and other 
applicable laws and regulations. 
Results may be used by the Sponsor in future investigations, engineering, and regulatory purposes. 
 Intended Use 
VolumeRAD is intended to be used to generate tomographic images of human anatomy including the 
skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. 
VolumeRAD is not intended for mammographic applications. 
The procedures conducted in this study are intended for research purposes and are not intended as a 
substitute for required medical care.  
 Reference Standard  
There is no reference device being used in this data collection study. 
 Concomitant/Ancillary Administrations  
 Medications and Biologic Products 
No medications or biologic products will be administered as part of study procedures. 
 Laboratory Tests and Sample Processing 
No laboratory tests or sample processing is planned as part of the study procedures. 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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 Accountability 
Devices used in this study will be site-owned. Accurate and adequate records will be maintained for all 
devices being used in this study. The Principal Investigator (PI) will be ultimately responsible for the 
security and integrity of research devices/products at the investigational site during the course of the 
study.  
 Issuance and Disposition 
The VolumeRAD DTS device used in this study will be site-owned. 
 Anticipated Risks and Benefits 
The device/product under study has undergone risk assessment, in accordance with International 
Standards Organization (ISO) 14971:2012. Risks have been mitigated to levels as low as reasonably 
practicable (ALARP) and are not expected to exceed risks associated with routine X-ray procedures as 
conducted in standard clinical practice. 
The risks of study participation are not expected to be greater than those of similar procedures routinely 
conducted in clinical practice. Follow-up shall be conducted as needed on a per-subject basis per site 
standard of care.  
There are no expected risks to subjects, operators, or others in this study beyond those of routine/similar 
devices/products in clinical care. 
Subjects are not expected to benefit directly from study participation. The results may benefit future 
patients by increasing knowledge about the use of VolumeRAD in clinical settings. 
 Risk Category and Rationale 
VolumeRAD is classified as a Class II medical device. As used in this study, it is not considered a 
significant risk device per the 21 CFR §812.3 definition:  
1) it is not intended as an implant;  
2) is not purported or represented to be for a use in supporting or sustaining human life;  
3) is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health;  
4) and it does not otherwise present a potential for serious risk to the health, safety, or welfare of a 
subject. 
3. STUDY OBJECTIVES AND ENDPOINTS 
 Purpose of the Study 
The purpose of the study is to collect clinical data associated with diagnostic and treatment information to 
support additional, on-label claims for GEHC’s X-ray VolumeRAD advanced application. 
 Primary Objective: 
The primary objective of this study is to collect image and technical data on routine X-ray, DTS, and CT 
(or MRI) imaging modalities. 
 Secondary Objective(s):  
The secondary objective is to collect per-subject data including diagnosis and treatment information. 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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 Safety Objective(s):  
The safety objective is to collect safety information, including type and number of AEs, SAEs, and device 
issues. 
 Study Endpoints  
 Primary Endpoints: 
The primary endpoint is the collection of image sets from X-ray, DTS, and CT (or MRI) imaging exams for 
each complete and evaluable subject case. 
 Secondary Endpoints:  
The secondary endpoint is the collection of subject diagnosis and treatment information, including de-
identified radiologist and surgical reports (which will be the truth status for all data collected), for each 
complete and evaluable subject case.  
 Safety Endpoints  
The safety endpoint will be the type and number of AEs, SAEs, and device issues. 
4. STUDY DESIGN 
This is a post-market, open-label prospective clinical research study conducted at up to two (2) sites in 
the United States (US).  
 Study Population 
Eligible test subjects shall be subjects ≥ eighteen (18) years who are presenting with a suspected or 
confirmed distal radius or scaphoid wrist fracture and are clinically indicated for advanced imaging. 
 Number of Subjects 
Up to 140 subjects shall be enrolled in this study from up to two (2) sites, including up to 50 subjects 
presenting suspected or confirmed scaphoid wrist fractures and up to 50 subjects presenting suspected 
or confirmed distal radius wrist fractures to achieve a target of at least 31 evaluable subjects in each of 
these two categories. Up to 40 healthy volunteers will be enrolled to achieve a target of at least 25 normal 
image sets for collection in this study. In this study, the term “normal” will refer to any non-fracture positive 
images from any subjects in the control-arm of the study (i.e. healthy volunteers). 
There will be two groups of subjects in this study – the test-arm group and the control-arm group.  
The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The 
diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no 
treatment.  
The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging 
results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic 
imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical 
diagnosis and the treatment truth will be the per-subject treatment received.  
Subjects who shall have completed the study are defined as 1) subjects who have complete image sets 
available from X-ray (per standard of care [SOC]), DTS (either SOC or research ordered), and CT or MRI 
(test-arm subjects); 2) have diagnostic truth known and available; and 3) have treatment truth known and 
available.   
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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 Protection of Vulnerable Subjects  
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation could be 
unduly influenced by the expectation, whether justified or not, of benefits associated with participation or 
of retaliatory response from senior members of a hierarchy in case of refusal to participate.  
The Sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any 
investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, or inducement of, the subject, Sponsor, monitor, other 
investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
This study does not examine any groups of subjects who are considered to be vulnerable subjects in the 
country in which the study is being conducted. 
 Eligibility Criteria for Test-arm Subjects  
 Inclusion Criteria  
Subjects who meet all of the following inclusion criteria may be enrolled in this study: 
1) Are adults aged 18 years or older; 
2) Have a confirmed or suspected distal radius or scaphoid wrist fracture;  
3) Have completed an X-ray imaging exam per standard of care;  
4) Have a standard of care (SOC) CT or MRI exam ordered;  
5) Are able and willing to complete DTS imaging exam (if not already completed); 
6) Are able and willing to comply with study procedures; and  
7) Are able and willing to provide written informed consent to participate in this study. 
 Exclusion Criteria  
Subjects who meet any of the following exclusion criteria will be excluded from this study: 
1) Are documented as pregnant based on PI’s medical judgment and in consideration of local 
clinical practice standards for evidence of pregnancy;  
2) Have additional trauma within the image field of view that either impacts the visualization or 
changes the treatment of the scaphoid or distal radius fracture;  
3) Have had prior reconstructive surgery or fixation in the wrist.  
 Eligibility Criteria for Control-arm Subjects  
 Inclusion Criteria  
Subjects who meet all of the following inclusion criteria may be enrolled in this study: 
1) Are adults aged 18 years or older;  
2) Are able and willing to comply with study procedures; and  
3) Are able and willing to provide written informed consent to participate in this study. 
 Exclusion Criteria  
Subjects who meet any of the following exclusion criteria will be excluded from this study: 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
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1) Are documented as pregnant based on PI’s medical judgment and in consideration of local 
clinical practice standards for evidence of pregnancy;  
2) Have had known prior trauma in either wrist. 
 Controls and Minimization of Bias 
The following bias control methods shall be employed in this study:  
• 
Selection bias will be limited by consecutively enrolling eligible subjects. 
• 
Spectrum bias will be limited by using a population expected to represent the general population at 
the site(s). 
 Recruiting and Screening   
Subjects in both groups of the study will be recruited for potential enrollment in this study according to the 
standard procedures of the site, unless otherwise specified by the Sponsor in this study protocol.  
Subjects in both groups of the study will be screened for enrollment in this study against the inclusion and 
exclusion criteria according to the standard procedures of the site. Enrollment determinations will be 
made by the PI. All subject participation will be voluntary. 
 Enrollment of Test-arm Subjects 
Patients who have SOC X-ray for a wrist injury and who have been referred for a SOC CT or MRI, shall 
be recruited.  
The subject shall be considered enrolled (the point of enrollment) once he/she signs and dates the 
informed consent form (ICF) prior to or immediately after completion of the SOC MRI or CT exam.  
Once enrolled, the subject will be assigned a unique subject number, which will not contain information 
that could identify the subject (such as subject name or date of birth). The unique subject number will be 
used to label case report form (CRF) data for the subject throughout his/her participation in the study.  
The unique subject number for test-arm subjects will begin with the site number (for example, 001) and 
follow with the subject number (for example, 001).  
 Enrollment of Control-arm Subjects 
Following recruitment, a subject shall be considered enrolled (the point of enrollment) once he or she 
signs and dates the informed consent form (ICF) prior to completing any study-specific imaging.  
Once enrolled, the subject will be assigned a unique subject number, which will not contain information 
that could identify the subject (such as subject name or date of birth). The unique subject number will be 
used to label case report form (CRF) data for the subject throughout her participation in the study.  
The unique subject number for control-arm subjects will begin with the site number (for example, 001) 
and follow with a three-digit subject number starting with 3 (for example, 301). 
 Criteria for Withdrawal/Discontinuation 
A subject may withdraw from study participation at any time, for any reason. The PI may withdraw a 
subject at any time, for any reason. The reasons for withdrawal and discontinuation for any subject shall 
be recorded. These will be reported to the Sponsor. The IRB should be notified per their notification of 
subject withdrawal policy. 
A subject shall be withdrawn from the study if diagnostic and/or treatment truth are not known and 
available. A subject shall also be withdrawn from the study if study-related DTS imaging has not been 

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completed (i.e. no image is acquired). Information about subject completion is further detailed in Section 
4.2 - Number of Subjects. 
Data from subjects who may not complete follow-up visits will still be included in analysis, as follow-up is 
not required as site standard of care. These subjects will not be withdrawn; however, this will be marked 
on the Case Report Form (CRF).  
If a subject withdraws or is withdrawn from the study, all efforts will be made to complete and report study 
data up to the time of withdrawal. Information about the subject’s withdrawal shall be completed and 
recorded on a CRF. If the reason for withdrawal is related to an adverse event (AE) or serious adverse 
event (SAE), monitoring of the subject will continue until the outcome is evident. 
Any data collected for the subject, up until the time of withdrawal or discontinuation, may still be included 
in the study results and provided to the Sponsor, unless the subject requests that their data not be used. 
The site(s) shall document all requests by subjects regarding their data use. 
5. STUDY PROCEDURES  
 Subject Preparation 
Study staff will confirm that subjects are eligible and willing to comply with applicable site requirements 
prior to starting study procedures. Demographic information, clinical history data, and 
pregnancy/menopausal status may be collected prior to the study-related imaging procedures. 
 Description of Study Procedures 
Site technologists will perform image acquisitions and study-related procedures. 
 Control-arm Subjects 
Following subject enrollment and consent, subjects will undergo study-related X-ray imaging and DTS 
imaging. Imaging results will be collected and recorded. The de-identified radiologist reports will also be 
collected via scanned copy or DICOM with the associated image sets for each subject. Figure 1 details 
the study procedures for control-arm subjects. 
 
Figure 1. Study Procedures for Control-arm Subjects 
 
 Test-arm Subjects 
Eligible subjects shall consist of patients presenting with a wrist injury. The patients shall undergo initial 
X-ray imaging per standard of care (SOC) at the site. If the initial X-ray imaging shows a suspected or 
No additional (CT/MRI) or subject follow-up is required
Subject undergoes research DTS imaging
Subject undergoes wrist X-ray imaging
Patient is consented

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confirmed distal radius or scaphoid wrist fracture, additional imaging, including DTS and/or CT and/or 
MRI, shall be ordered.  
The patient may undergo DTS imaging per site SOC. The subject shall then undergo CT or MRI imaging. 
The point of enrollment in the study will be the completion of informed consent prior to or immediately 
after the completion of the SOC CT or MRI exam. The SOC X-ray and/or DTS imaging data shall be 
collected retroactively from these subjects. 
After SOC imaging has been completed, study-specific DTS shall be completed for subjects who have not 
previously completed SOC DTS imaging.  
Subjects shall receive treatment as needed. Diagnostic truth and treatment truth will be collected and 
recorded on a per-subject basis. The de-identified radiologist and surgical reports will also be collected 
via scanned copy or DICOM with the associated image sets for each subject. Figure 2 details the study 
procedures for test-arm subjects. 
 
 
Figure 2. Study Procedures for Test-arm Subjects 
 Follow-up  
Follow-up may be conducted in this study. Follow-up shall be conducted on a per-subject basis per site 
standard of care in order to confirm the treatment outcome. Control-arm subjects will not be asked to 
follow-up. 
Subjects will be followed for AEs from the time they enter the imaging suite for their exam(s) until the time 
they exit the imaging suite after the exam(s).  
6. STUDY DATA COLLECTION AND ASSESSMENTS 
 Primary Assessment 
The device operator will save the images (DICOM and raw data) for all imaging modalities after the 
subject completes the imaging exams. 
Study data will be documented on case report forms (CRFs) as follows: 
1) Date of enrollment 
2) Demographic information, including age, sex, weight, height, ethnicity, and race 
Subject follow-up is completed per site SOC and documented for study purposes
Subject undergoes research DTS imaging if not completed as SOC
Patient undergoes SOC CT/MRI exam and is consented for study participation 
Patient undergoes SOC DTS if ordered
Advanced imaging (DTS/MRI/CT) is ordered per site SOC
Patient undergoes SOC wrist X-ray imaging
Patient presents with wrist injury

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3) Date of image acquisition for: 
a) XR 
b) DTS 
c) CT/MR 
  Secondary Assessments 
The de-identified radiologist reports will be collected via scanned copy or DICOM with the associated 
image sets for each subject.  
The diagnosis and treatment information on a per-subject basis will be recorded in the study CRF. The 
following data will be collected: 
I. 
XR Diagnosis  
a. Result of X-ray (Positive, Negative, or Inconclusive) 
b. Left or Right wrist 
c. Type of fracture (scaphoid, distal radius) 
d.  Any other fractures in the image field of view– specify  
 
II. 
DTS Diagnosis  
a. Result of DTS (Positive, Negative, or Inconclusive) 
b. Left or Right wrist 
c. Type of fracture (scaphoid, distal radius) 
d. Any other fractures in the image field of view – specify  
 
III. 
MRI or CT Diagnosis  
a. Result of CT or MRI (Positive, Negative, or Inconclusive) 
b. Left or Right wrist 
c. Type of fracture (scaphoid, distal radius 
d. Any other fractures in the image field of view – specify  
 
IV. 
Actual Treatment  
a. No treatment necessary 
b. Non-operative (e.g. splint, cast) 
c. Operative – select all that apply: 
i. 
Percutaneous Fixation 
ii. Open Reduction Internal Fixation (ORIF) (Volar) 
iii. ORIF (Dorsal) 
iv. ORIF (Volar and Dorsal) 
v. External Fixation/Spanning Plate 
 
V. 
Follow-up 
a. Was follow-up completed for the subject? (Yes or No) 
b. If Yes, was there a change in the treatment? (Yes or No) 
c. If Yes, record the change in treatment  
 Safety Assessments  
The description, severity, and device relatedness of any AE or SAE during the study will be recorded. 
Subjects will, if necessary, be provided with emergency care. In the event of any device issues, the event 
will be recorded. Safety reporting will be conducted as described in this protocol. 

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7. QUALIFICATION AND TRAINING PLAN 
 Staff Qualifications 
All members of the study staff participating in the conduct of the clinical investigation shall be qualified by 
education, training and/or experience to perform their tasks, and this shall be documented appropriately, 
as per ISO 14155:2011.  
 Training Plan for the Protocol and Research Device/Product 
Before starting the study, the study staff will be trained on the clinical investigation requirements set forth 
in this study protocol, including completion of ICFs, CRFs, and other study documentation. Training will 
also be provided to ensure appropriate storage and handling of data, and all study staff will be required to 
be trained on Good Clinical Practice (GCP) guidelines per ISO 14155: 2011. 
A record of all formal training will be stored in the Site Regulatory Binder and provided to the Sponsor for 
inclusion in the Sponsor’s CHF. Documentation of training will include: 
• 
Title of Training 
• 
Training objectives 
• 
Training logistics (trainer and training method) 
• 
Documentation of trainees 
• 
Training content (e.g. device operation, protocol review, CRF completion) 
Study staff directly operating or maintaining VolumeRAD will be qualified by the site(s) based on X-ray 
imaging experience. 
The PI will be ultimately responsible for execution of this study in accordance with the protocol and for 
device use in this study by members of the study staff. 
8. SAFETY 
 Anticipated Adverse Events 
X-ray imaging involves ionizing radiation. The amount of radiation from a standard X-ray imaging exam, 
even with the addition of VolumeRAD (study-related DTS), is small and equal in cancer risk to the total 
body radiation received naturally from the environment over a period of a few months. 
There are no known additional medical risks or side effects of VolumeRAD beyond those of similar 
conventional clinical procedures on other commercial X-ray imaging devices.  
The study staff conducting the research is trained to recognize these reactions, and should it be 
necessary, other medical care is available at the site. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and 
update safety information in study documents.  
 Adverse Event Definitions  
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device [ISO 14155:2011 3.2]. This includes events related to the 
investigational device or the comparator and to the procedures involved. For users or other persons, this 
is restricted to events related to the investigational medical device. 

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Serious Adverse Event (SAE): an adverse event that led to death; led to a serious deterioration in the 
health of the subject, that either resulted in a life-threatening illness or injury, a permanent impairment of 
a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a 
body function; or led to fetal distress, fetal death or a congenital abnormality or birth defect. Planned 
hospitalization for a pre-existing condition, or a procedure required by the protocol without serious 
deterioration in health, is not considered a SAE [ISO 14155:2011 3.37]. 
Adverse Device Effect (ADE): an adverse event related to the use of an investigational medical device 
[ISO 14155:2011 3.1]. This includes any adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. This includes any event that is a result of a user error or intentional misuse 
of the investigational device [ISO 14155:2011 3.43]. 
Serious Adverse Device Effect (SADE): an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event [ISO 14155:2011 3.36]. 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance, such as malfunctions, use errors, and inadequate labelling [ISO 
14155:2011 3.15]. 
Unanticipated serious adverse device effect (USADE): a serious adverse device effect, which by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis 
report [ISO 14155:2011 3.42]. In the United States, any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the study documents, will be 
reported in accordance with 21 CFR §812.3 and applicable laws and regulations. 
 Documentation of Safety Events  
All adverse events (AE), including all serious adverse events (SAE), are required to be collected, 
investigated, and documented during the study reporting period, as defined in the study procedure set 
forth in this protocol. Documentation will include: 
• 
Description of Event 
• 
Date of onset and resolution  
• 
Severity (mild, moderate, or severe)  
▪ 
Mild: Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. Prescription drugs 
are not ordinarily needed for relief of symptom(s). 
▪ 
Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be needed. 
▪ 
Severe: Symptom(s) of a sufficient severity to cause the subject severe discomfort. 
Treatment for symptom(s) may be given. 
• 
Serious (yes/no)  
• 
Causal relationship to investigational medical device? (not related, possibly related, or related) 
▪ 
Not related: The adverse event is reasonably expected to be related to (or caused by) a 
concurrent illness, effect of another device/drug or other cause, and is unlikely related to 
the investigational product. 
▪ 
Possibly related: The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less likely compared to 
the potential relationship to investigational product. 

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▪ 
Related: There is a strong relationship to investigational product or recurs on re-
challenge, and another etiology is unlikely or there is no other reasonable medical 
explanation for the event. 
• 
Treatment given and/or action taken (procedure stopped, withdrawn from study, or no action) 
• 
Anticipated (yes/no) 
 Reporting of Safety Events and Device Deficiencies/Complaints 
The following events are to be reported to the Sponsor within 72 hours of the event occurrence and to the 
EC per their policy: 
• 
All SAEs and USADEs 
• 
All device issues that could possible lead to an SAE 
Additional follow-up information may be requested by the Sponsor. In addition, safety information may be 
shared with regulatory agencies and other participating sites, as required by applicable law and 
regulation. If the event resulted in the death of a subject, the event shall also be reported via telephone to 
the Sponsor within 24 hours of knowledge of the event. SAEs will be reported to the IRB per their policy. 
Sponsor contact for SAEs and/or UADEs: 
Ron Von Jako, MD PhD 
Fax: +1-262-364-2544 (24 hours) 
E-mail: SAE@ge.com 
 Device Deficiencies/Complaints 
Device deficiencies/complaints should be reported to the study Sponsor contact identified on the cover 
page of this protocol. All device deficiencies/complaints will to be collected, fully investigated, and 
documented in the source document and appropriate case report form (CRF) during the study reporting 
period. The PI is responsible for notifying the Sponsor in the event that there is any device issue that 
could potentially lead to a serious adverse event (SAE).  
9. ETHICAL CONDUCT OF THE STUDY 
The study will be carried out in accordance with the protocol and with principles enunciated in the current 
version of the Declaration of Helsinki; the guidelines of Good Clinical Practice (GCP) for medical devices, 
as set forth by ISO 14155:2011 and ISO 14971:2012; applicable sections of US FDA 21 Code of Federal 
Regulations (CFR); and applicable regulatory authority’s requirements of the US. 
The study will be conducted and reported in accordance with applicable policies of the ethics committee 
(EC) and governing regulatory authorities. 
If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 
14155:2011 for medical devices, the Sponsor shall apply the requirements of this International Standard 
to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts. 
 Ethics Committee 
The responsible PI at each site will ensure that approval from the Institutional Review Board (IRB) is 
attained for the clinical study prior to enrolling subjects, and the PI will ensure that documentation of 
approval is maintained for the duration of the study.  

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The PI will ensure that the Sponsor is notified of any withdrawal of IRB approval within 5 working days of 
such occurrence. If approval is terminated or suspended, the Principal Investigator will promptly notify the 
Sponsor and provide written explanation. 
 Regulatory Agencies and Competent Authority(ies) 
The Sponsor will obtain approval from the IRB before the start of the clinical trial, if necessary, per 
applicable local laws and regulations. Any additional requirements imposed by the EC or regulatory 
authority shall be followed, if applicable. 
 Management of Protocol Modifications and Amendments  
Substantial amendments will only be implemented after approval of the IRB.  
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
protocol. Under emergency circumstances, deviations from the protocol to protect the rights, safety, and 
wellbeing of human subjects may proceed without prior approval of the Sponsor and the IRB. Such 
deviations shall be documented and reported to the Sponsor and the IRB as soon as possible. Deviations 
will be reported as: 
• 
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or conduct of 
the study. These deviations must be reported to the Sponsor no later than 5 working days from 
awareness of occurrence and reported to the IRB per the deviation reporting policy.  
• 
Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, efficacy, 
integrity, or conduct of the trial. These deviations must be documented on the CRF Protocol 
Deviation page and will be reviewed by the study monitor. 
Non-substantial modifications may be made during the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial modifications will be communicated to the IRB as 
soon as possible.  
 Participant Information and Informed Consent  
The PI will explain to each participant the nature of the study, its purpose, the procedures involved, the 
expected duration of exposure to the investigational device (if applicable), the potential risks and benefits, 
and any potential discomforts. Each participant will be informed that participation in the study is voluntary, 
that he/she may withdraw from the study at any time, and that withdrawal of consent will not affect his/her 
subsequent medical assistance and treatment. The participant must be informed that his/her medical 
records may be examined by authorized individuals other than their treating physician. 
All participants for the study will be provided an ICF, describing the study and providing sufficient 
information to allow the participant to make an informed decision about his/her participation in the study. 
Informed consent documents will be subject to approval by the IRB prior to enrolling subjects in the study. 
The participant should read and consider the statement before signing and dating the ICF, and shall be 
given a copy of the signed document. The ICF must also be signed and dated by the PI (or his/her 
designee), and it shall be retained as part of the study records.  
 Early Termination of the Study 
The Sponsor may terminate the study prematurely according to certain circumstances. Examples of such 
circumstances include ethical concerns, insufficient participant recruitment, participant safety concerns, 
alterations in accepted clinical practice that make the continuation of a clinical trial unwise, early evidence 
of benefit or harm of the research product, or for any other reason. 

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10. 
STATISTICAL METHODS 
 Statistical Hypothesis  
No statistical hypothesis is being tested in this data collection study. The results of this study will be 
reported in the form of descriptive statistics. 
 Sample Size Determination 
A target of at least 31 scaphoid and 31 distal radius wrist fractures are required in order to establish a 
sufficient data set for use in future research and/or clinical validation activities. Additionally, at least 25 
healthy subjects are required to compare diagnostic and treatment truth of subjects with a wrist fracture 
against a healthy subject population. The overall data set will consist of up to 140 subjects in the following 
categories: 
• 
Up to 50 subjects presenting scaphoid fractures, to achieve a target of at least 31 enrolled 
subjects 
• 
Up to 50 subjects presenting distal radius fractures, to achieve a target of at least 31 enrolled 
subjects 
• 
Up to 40 healthy subjects, to achieve a target of at least 25 enrolled healthy subjects  
 Statistical Analysis 
 
No statistical analysis is prospectively planned. The study data will be presented in tables, listings, and 
figures. Data will be summarized using descriptive statistics. The descriptive statistics for continuous 
variables will include mean, standard deviation, median, Q1 and Q3, minimum, maximum, and sample 
size, as appropriate. Categorical variables will be described with counts, percentages, and sample size, 
as appropriate. 
 Interim Analysis 
No interim analyses are intended to be conducted as part of this study. 
  Handling of Missing Data  
Analysis will be based on collected data, and no imputation will be done for missing data. 
  Deviation(s) from the Original Statistical Plan 
Any changes or deviations from the original statistical plan specified in this protocol will be described and 
justified in the study final report per ISO 14155:2011. 
11. 
 QUALITY ASSURANCE AND CONTROL 
  Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 

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  Completion of Case Report Forms (CRFs) 
The data reported on the eCRFs shall be derived from source documents and be consistent with these 
source documents. Electronic CRFs (eCRFs) will be used to collect data. The Sponsor will provide 
eCRFs and train study staff on completion of eCRFs using Good Documentation Practices (GDP). CRF 
Completion Guidelines (CCG) may be provided by the Sponsor to help facilitate training. 
eCRFs are to be completed as information becomes available at the site. CRFs should be signed by 
indicated parties, in indicated area(s), to certify the contents of the form. The PI is ultimately responsible 
for ensuring completion of eCRFs. 
In the event that any discrepancies are discovered on the eCRF, whether during monitoring or during 
data review by the study team, a query will be raised, and the site shall make the correction within the 
electronic database, noting the reason for change. Data will be considered clean once all queries are 
answered and closed.  
If the Sponsor discovers discrepancies on eCRFs, a query will be raised and necessary corrections will 
be made by the site. The reason for any changes will be noted. All queries will be resolved prior to study 
completion. 
  Data Handling and Record Keeping  
All documents and data shall be produced and maintained in a manner that assures control and 
traceability. 
  Source Data and Documents 
Source data includes information in original records, certified copies of original records of clinical findings, 
observations, or other activities for the study. Source documents for each subject must be retained 
throughout the investigation, including printed or electronic documents containing source data. Elements 
should include: 
• 
Source data and documentation relevant to data recorded for subject screening and CRF 
corroboration 
• 
Subject records containing the completed ICFs and CRFs   
• 
Regulatory binder containing the protocol and any subsequent amendments, EC submissions 
and approvals, blank ICF(s), and site logs 
• 
Reference manuals containing investigator responsibilities, Sponsor, AE/SAE and informed 
consent guidelines, applicable study aids and training materials 
The PI or institution shall provide direct access to source data during and after the clinical investigation for 
monitoring, audits, EC review, and regulatory authority inspections.  
  Archiving 
All study data must be archived for a minimum of four (4) years after study termination or premature 
termination of the clinical trial. No source documents or study records will be destroyed without Sponsor 
notification and approval. 
12. 
MONITORING PLAN  
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm that all the 
research requirements are met. Monitoring visits will oversee the progress of a clinical investigation and 
ensure that it is conducted, recorded, and reported in accordance with the protocol, written procedures, 
Good Clinical Practice (GCP) ISO 14155:2011, and the applicable regulatory requirements. 

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  Confidentiality and Data Protection  
The PI affirms and upholds the principle of the participant's right to privacy, and the PI shall comply with 
applicable privacy laws. Especially, anonymity of the participants shall be guaranteed when presenting 
the data at scientific meetings or publishing data in scientific journals. 
Individual subject medical information obtained as a result of this study will be considered confidential, 
and disclosure to third parties will be prohibited. Subject confidentiality will be further ensured by utilizing 
subject identification code numbers. For data verification purposes, authorized representatives of the 
Sponsor or IRB may require direct access to parts of the medical records relevant to the study, including 
subject medical history. 
  Storage of Images and Associated Health Data 
Images and associated data will be collected and disclosed to the Sponsor as part of this study. Fully de-
identified data, which has had all personal identifying information removed, may be stored and used by 
the Sponsor indefinitely. The Sponsor and/or its authorized representatives may use any de-identified 
data collected in this study for future technology and engineering development, marketing purposes, 
education, regulatory submissions, publications, or other possible uses. 
 Publication Policy 
The results of this study may be used in future publications. The conditions of publication are described in 
a separate contractual agreement. 
 
 

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REFERENCES 
  
 
 
 
1. ISO. Clinical investigation of medical devices for human subjects - Good Clinical Practice: 
International Organization for Standardization; 2011. ISO 14155:2011(E). 
2. Nellans KW, Kowalski E, Chung KC. The Epidemiology of Distal Radius Fractures. Hand Clinics . 
2012;28(2). 
3. Mallee WH, Poolman RW, Kloen P, Maas M, de Vet HCW, Doornberg JN. Cochrane. Effect of cutting 
down the fat we eat on body weight | Cochrane. 
http://www.cochrane.org/CD010023/MUSKINJ_comparing-different-types-of-scan-ct-mri-bone-scan-for-
diagnosis-of-clinically-suspected-scaphoid-fractures-when-initial-radiographs-are-negative.  
4. Welling R, Jacobson JA, Jamadar DA, Chong S, Caoili EM, Jebson PJL. MDCT and Radiography of 
Wrist Fractures: Radiographic Sensitivity and Fracture Patterns : American Journal of Roentgenology : 
Vol. 190, No. 1 (AJR). American Journal of Roentgenology. 
https://www.ajronline.org/doi/10.2214/AJR.07.2699. Published 2008. 
5. Ha AS, Hippe DS, Chou SH, Chew FS. Digital Tomosynthesis to Evaluate Fracture Healing: 
Prospective Comparison With Radiography and CT : American Journal of Roentgenology : Vol. 205, 
No. 1 (AJR). American Journal of Roentgenology. 
https://www.ajronline.org/doi/abs/10.2214/AJR.14.13833. Accessed May 24, 2018. 
6. Machida H, Yuhara T, Tamura Y, et al. Whole-Body Clinical Applications of Digital 
Tomosynthesis. Imaging Physics. January 2016. https://pubs.rsna.org/doi/full/10.1148/rg.2016150184. 
7. 510(k) Summary Premarket Notification Submission. FDA.gov. 
https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132261.pdf. Published July 18, 2013. 
8. Center for Devices and Radiological Health. Medical X-ray Imaging. U S Food and Drug 
Administration Home Page. https://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-
Rays/default.htm.  

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
Page 28 of 29 
 
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GE Healthcare - Confidential 
 
APPENDIX A – STUDY SITE AND INVESTIGATOR LIST  
The following investigators at each study site will be responsible for the conduct of this study:  
Investigator(s):1 
 
David R. Steinberg, MD 
Tel:  
+1-856-220-6985 
e-mail:  
David.Steinberg@uphs.upenn.edu 
University of Pennsylvania Hospital – 
Department of Orthopaedic Surgery  
(Site 001) 
Address:  3737 Market Street, Penn 
Medicine University City 
Philadelphia, PA 19104 US 
Investigator Name TBD  
Tel:  
TBD 
e-mail:  
TBD   
Site Name (Site 002) 
Address:   
 
1 The role of the Principal Investigator is to implement and manage the conduct of the investigation as well as 
ensure data integrity and the rights, safety, and well-being of humans involved in the study [ISO 14155:2011 9.1]. Co-
Investigators share all responsibilities of the Principal Investigator, and Sub-investigators share only those 
responsibilities designated by the Principal Investigator. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: Use of Digital Tomosynthesis for Detection and Case Management of 
Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study 
Study No: 124.02-2018-GES-0001 
 
 
Page 29 of 29 
 
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Ver: 2.0; 24/Oct/2018 
GE Healthcare - Confidential 
 
APPENDIX B – AMENDMENTS (PROTOCOL VERSION 1.0 TO 2.0) 
A detailed amendment is provided for Version 1.0 to Version 2.0. Version 1.0 received EC approval but 
was not active at the site. 
Purpose of Amendment: This amendment was generated to update the Sponsor contact information as 
well as device risk and safety information. These changes are not expected to impact operator risk or to 
adversely impact the scientific integrity or conduct of the study. Administrative changes that improve 
grammatical clarity and formatting changes were not recorded.  
In the table below, point-by-point revisions are shown as additions in double-underline (double-underline) 
and deletions in strikethrough (strikethrough) for each change made in this amendment from the previous 
version. 
Item 
Section 
Revision or Clarification 
Justification 
1 
8.1 
Anticipated 
Adverse 
Events 
X-ray imaging involves ionizing radiation. The amount of radiation from a standard X-ray 
imaging exam, even with the addition of VolumeRAD (study-related DTS), is small and 
equal in cancer risk to the total body radiation received naturally from the environment 
over a period of a few months. 
There are no known additional medical risks or side effects of VolumeRAD beyond those 
of similar conventional clinical procedures on other commercial X-ray imaging devices. 
Foreseeable AEs that apply to X-ray imaging and are also applicable to imaging using 
VolumeRAD may include, but are not limited to: 
• 
Skin reddening or irritation that may occur due to long periods of exposure to 
relatively high levels of radiation (rare for many types of imaging exams) 
The study staff conducting the research is trained to recognize these reactions, and should 
it be necessary, other medical care is available at the site. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will 
evaluate and update safety information in study documents.  
Updated to 
provide 
clarity per 
recommend
ation from 
EC review. 
2 
Administrative 
Structure of 
Investigation 
Clinical Affairs Project 
Manager 
(Sponsor Contact):  
Stephanie Karwedsky Beth 
Heckel 
Tel:         +1-262-443-7008312-
7269 
e-mail:    
Stephanie.Karweds
ky@ge.com 
Beth.Heckel@med.ge.com  
GE Healthcare (GEHC)  
Address:  
 
3000 N Grandview Blvd 
Waukesha, WI 53188 US 
 
Updated to 
reflect 
change in 
Sponsor 
contact 
information.