A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region, Spondylolisthesis
Sponsor: 7D Surgical Inc.

 
 
Investigator Initiated Protocol, Spine Care Institute 
 
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SPONSORED RESEARCH AND COLLABORATION AGREEMENT 
BETWEEN 7D SURGICAL, INC. AND HOSPITAL FOR SPECIAL SURGERY 
 
(This is Addendum 1 to that certain Sponsored Research and Collaboration Agreement 
(SRCA) between the parties dated November 20, 2017, and this Addendum is subject to 
the terms of that SRCA, including but not limited to all the rights and obligations of the 
parties stated in such SRCA.) 
 
 
ADDENDUM 1 
 
 
 
A Single Center, Cohort Study Of The MvIGS Spine Navigation System 
 
 
 
Addendum Approved: 
 
 
Hospital for Special Surgery  
 
 
7D Surgical, Inc. 
By: _________________________  
 
By:  __________________________ 
Name: Vincent L. Grassia, Jr. 
 
 
Name: ________________________ 
Title: VP, Research Administration  
 
Title: _________________________ 
Date: ________________________  
 
Date: _________________________ 
 
 
Read, acknowledged and agreed: 
By:  
 
 
 
 
 
Name: Frank P. Cammisa, Jr., MD, FACS 
Title:   Chief Emeritus, Spinal Surgical Service 
Principal Investigator 
Date:   
 
 
 
 

 
 
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7D Surgical Protocol 
A Single-Center, Cohort Study of the MvIGS Spine Navigation System 
 
 
 
 
Protocol Approval Date: 
March 2, 2018 
 
 
 
 
 
 
Sponsor 
7D Surgical 
60 Scarsdale Road Unit 118 
Toronto, ON, M3B 2R7 
Canada 
 
 
 
 
 
 
Confidentiality Statement 
This document is a confidential communication of 7D Surgical.  The recipient agrees that no information 
contained herein will be published or disclosed without 7D Surgical’s written approval.  This document may 
be disclosed to appropriate institutional review boards, independent ethics committees, or duly authorized 
representatives of regulatory authorities as appropriate; under the condition that confidentiality is requested. 

 
 
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EU CLINICAL STUDY PROTOCOL SYNOPSIS 
Sponsor: 7D Surgical 
Product: Machine-vision Image guided Surgery Navigation System 
Title of Study: “A Single-Center, Prospective Cohort Study of the MvIGS (MvIGS) Spine 
Navigation System” 
Number of Centers Planned: 1 
Planned Study Period: 1Q2018-1Q2019  
Primary Objective: To prospectively investigate clinical outcomes following 
implementation of the Machine-vision Image Guided Surgery (MvIGS) spine navigation 
system in patients requiring posterior instrumentation. 
General Design and Methodology: This is a single center, prospective, non-randomized 
cohort study to assess clinical outcomes following the use of the MvIGS spine navigation 
system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar 
spine. There will be separate study arms for cases utilizing the three-dimensional (3D) 
MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) 
fluoroscopy.  
Study Arm 1: One, two and three-level posterior spine fusion surgery using bilateral pedicle 
screw instrumentation under 3D MvIGS intraoperative navigation guidance. 
Study Arm 2:  One, two and three-level posterior spine fusion surgery using bilateral pedicle 
screw instrumentation under 2D fluoroscopy. 
Primary Endpoint: The primary endpoint is based on the mean reduction in total length of 
operative time. Operative time will be determined by the official recorded operative notes. 
Secondary Endpoints:  Secondary endpoints include: 
 Length of stay 
o Aim: Decrease length of hospital stay 
o Measured: Time (Hours)  
 Length of time for initial image processing 
o Aim: Decrease disturbance to surgeon workflow 
o Measured: Time (Minutes) 
 Length of time to place all screws 
o Aim: Reduce the time for screw placement 
o Measured: Time (Minutes) 
 Length of time to confirm screw placement 
o Aim: Reduce the time needed for confirmation of screw location 
o Measured: Time (Minutes) 
 Length of time to register images 
o Aim: To reduce time for registration of reference images 
o Measured: Time (Seconds) 
 Estimated Blood Loss (EBL) 

 
 
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o Aim: To reduce the EBL of each case  
o Measured: Milliliters (mL) 
 Incidence of Malalignment 
o Aim: To decrease the incidence of pedicle screw malalignment 
o Measured: Misalignment angle between pilot hole and screw trajectory 
(degrees) 
 Complications: Neurological Deficits, Dural Tears, deep wound infections, etc. 
o Aim: To decrease the incidence of intraoperative complications 
o Measured: number of reported complications while hospitalized 
 Measurement of 2D fluoroscopy radiation exposure 
o Aim: to reduce patient and surgeon exposure to radiation 
o Measured: Exposure measured by Dose Area Product (DAP) 
Exploratory Analyses: Exploratory analyses include the number of vertebral levels 
involved, radiographic evaluations of anterior disc height, implant migration, and stability, 
and preservation of motion at the adjacent, un-instrumented level. 
Number of Patients Planned: A total of 130 patients, with 65 patients per group.   
Criteria for Inclusion: Patients are included in the study if all of the following criteria are 
met:  
1) Diagnosis of spinal stenosis of the lumbar spine with ≤ grade 2 degenerative 
spondylolisthesis 
2) Skeletally mature adults between the ages of 18-85 years at the time of surgery; 
3) Has completed at least 6 months of conservative therapy; 
4) Personally signed and dated informed consent document prior to any study-related 
procedures indicating that the patient has been informed of all pertinent aspects of 
the study. 
Criteria for Exclusion: Patients are excluded from participating in this study if any of the 
following criteria are met:  
1) Gross instability, defined as > 3 mm translational motion on flexion/extension 
studies;  
2) Degenerative spondylolisthesis > grade 2 
3) Degenerative scoliosis > 10° at any level in lumbar spine; 
4) Congenital lumbar spinal stenosis; 
5) Endplate changes; 
6) Visible change in disc height; 
7) Radiographic confirmation of facet joint disease or degeneration; 

 
 
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8) Prior surgery at any lumbar level including the level being treated except for: 
Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy; 
9) Any evidence of a prior/current fracture, compromised vertebra, current or past 
trauma, or tumor at affected level or the spinous processes at the adjacent levels; 
10) Requires destabilizing surgical decompression that adversely affects the functioning 
of the facets; 
11) Cauda equina syndrome defined as neural compression causing neurogenic bowel   
(rectal incontinence) or bladder dysfunction (bladder retention or incontinence); 
12)  Significant peripheral neuropathy or acute denervation secondary to radiculopathy, 
caused by conditions other than spinal stenosis;  
13)  Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses); 
14)  Morbid obesity, defined as BMI > 40 kg/m2; 
15) Active systemic or local infection; 
16) Active Hepatitis (receiving medical treatment within two years); 
17) Immunocompromised such as but not limited to Acquired Immunodeficiency 
Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, 
Thymic Hypoplasia;  
18) Insulin dependent diabetes mellitus or any other medical condition(s) that would 
represent a significant increase in surgical risk or interfere with normal healing; 
19) Immunologically suppressed, or has received systemic steroids, excluding nasal 
steroids, at any dose daily for > 1 month within last 12 months; 
20) History of Paget’s disease, osteomalacia, or any other metabolic bone disease; 
21) Active malignancy.  A patient with a history of any invasive malignancy (except non-
melanoma skin cancer), unless treated with curative intent and there has been no 
clinical signs or symptoms of the malignancy >5 years; 
22) Involved in study of another investigational product that may affect outcome; 
23) Women who are pregnant, lactating or anticipate becoming pregnant within 24 
months post-surgery;  
24) Patients who are incarcerated; 
25) Worker’s compensation cases; 
26) Patients involved in active litigation relating to his/her spinal condition;  
 
Duration of Follow-up: Patients will be clinically followed throughout the course of their 
hospital admission.  

 
 
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1 
INTRODUCTION 
1.1 
Background Information 
Medicine and technology have long enjoyed a symbiotic relationship whereby the success 
of one directly advances the other. In the past few decades, innovations in surgical equipment 
have dramatically enhanced proficiency and improved patient safety in the operating room, 
thus leading to precipitous reductions in complication rates. In spine surgery, where the 
inherent risks are great, recent advancements in pre and intraoperative imaging technology 
have been heavily relied upon for guidance in complex cases. Improvements from two-
dimensional (2D) plain radiographs to three-dimensional (3D) real-time imaging have given 
surgeons accessible accuracy in multiple planes of vision. Though there are many advantages 
to intraoperative imaging, there exist a number of drawbacks that have been extensively 
studied, most notably radiation exposure to both surgeon and patient and prolongation of 
operative time. In hopes to eliminate these drawbacks, an emergent technology in 
intraoperative spine navigation imaging, and the focus of this study, emits no radiation while 
simultaneously integrating into the surgeon driven workflow of the operating room. 
1.2 
Treatment Options 
Currently, there are a number of intraoperative imaging options available to aid spine 
surgeons. By far, the most commonly used modality is 2D fluoroscopy. A worldwide survey 
conducted in 2013 by Hartl et al. reported that 78% of surgeons utilize routine fluoroscopy 
during spine surgery as either a control at the end of a procedure or for active monitoring 
used throughout the procedure. Two dimensional anterior/posterior (AP) and lateral 
fluoroscopic views provide reasonable accuracy measurements but also subject the patient 
and surgeon to additional ionizing radiation exposure and increased operative timing.  
Computer assisted spine surgery is another imaging modality that has grown popular since 
its advent in the early 1990’s (Kalfas et al.). In computer assisted cases, surgeons are 
provided with patient specific and real-time three-dimensional (3D) images. Spine 
navigation systems typically integrate recently acquired pre-operative computer-
tomography (CT) images with proprietary software to help orient the surgeon through real-
time 3D reconstructed images. Numerous studies have shown a significant reduction in 
pedicle screw malalignment rates in cases where spine navigation systems are used versus 
conventional 2D fluoroscopic imaging, thus confirming an increase in accuracy (Patel et al, 
Hartl et al, 2012). Despite this reduction in pedicle screw malalignment, spine navigation 
imaging systems do have inherent drawbacks. As is common in most new technologies, the 
computer assisted surgery (CAS) systems are more expensive than 2D fluoroscopy. CAS 
systems also require the use of proprietor specific probes and tools during surgery and, 
therefore, subject the surgeon to a learning curve that initially may prolong operative times. 
It was that projected disturbance in workflow that Hartl et al. reported as the reason nearly 
80% of surgeons did not use CAS more frequently. 
In an effort to address the growing concerns of current computer assisted spine navigation 
systems, an emergent technology has been developed that does not require intraoperative 

 
 
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ionizing radiation exposure. In addition to sparing the patient and surgeon to radiation 
exposure, this new spine navigation system, named the Machine-vision Image Guided 
Surgery (MvIGS) system, is also projected to not increase mean operative. By use of Instant 
Flash™ registration, localizing reference images are generated in a matter of seconds, as 
opposed to minutes, and thereby mitigate the disturbance to normal surgeon-defined 
workflow. 
1.3 
Name of the Device and Intended Use 
The name of the device is the Machine-vision Image Guided Surgery (MvIGS) spine 
navigation system. The intended use of this device is to provide patient specific high quality 
intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical 
light with embedded tracking technology and Instant Flash™ registration allows for 
continuous and direct visualization of the surgical field with no disturbance to surgeon 
workflow.  
1.4 
Objective of Study 
The main objective of this study is to prospectively compare operative time of patients 
requiring posterior instrumentation utilizing the MvIGS spine navigation system to patients 
requiring posterior instrumentation under the guidance of conventional 2D fluoroscopy.   
1.5 
Clinical Study Rationale 
Posterior fixation is the standard of care for spinal instability and deformity. Of paramount 
importance are the accurate placement of transpedicular screws and the avoidance of 
adjacent neurovascular structures. Intraoperative 3D navigation systems are becoming 
increasingly popular yet conventional 2D fluoroscopy remains the more widely used 
modality (Hartl). Worldwide consensus from 677 spine surgeons reported the need for more 
data regarding surgical precision, operative time and radiation exposure, among other 
factors, for computer-assisted surgery (CAS) to become more widely accepted.   
The purpose of this study is to evaluate the use of the MvIGS spine navigation system for 
pedicle screw fixation guidance and its effect on the length of operation. It is projected that 
the length of operation will remain similar to cases where conventional 2D fluoroscopy is 
utilized.  
2 
CLINICAL ASSESSMENTS 
2.1 
Primary Endpoint 
The primary endpoint is based on the mean reduction in total length of operative time. 
Operative time will be determined by the official recorded operative notes. 
 
 

 
 
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2.2 
Secondary Endpoints  
 Length of stay 
o Aim: Decrease length of hospital stay 
o Measured: Time (Hours)  
 Length of time for initial image processing 
o Aim: Decrease disturbance to surgeon workflow 
o Measured: Time (Minutes) 
 Length of time to place all screws 
o Aim: Reduce the time for screw placement 
o Measured: Time (Minutes) 
 Length of time to confirm screw placement 
o Aim: Reduce the time needed for confirmation of screw location 
o Measured: Time (Minutes) 
 Length of time to register images 
o Aim: To reduce time for registration of reference images 
o Measured: Time (Seconds) 
 Estimated Blood Loss (EBL) 
o Aim: To reduce the EBL of each case  
o Measured: Milliliters (mL) 
 Incidence of Malalignment 
o Aim: To decrease the incidence of pedicle screw malalignment 
o Measured: Misalignment angle between pilot hole and screw trajectory 
(degrees) 
 Complications: Neurological Deficits, Dural Tears, deep wound infections, etc 
o Aim: To decrease the incidence of intraoperative complications 
o Measured: number of reported complications while hospitalized 
 Measurement of 2D fluoroscopy radiation exposure 
o Aim: to reduce patient and surgeon exposure to radiation 
o Measured: Exposure measured by Dose Area Product (DAP) 
 
3 
STUDY DESIGN 
3.1 
General Overview of the Study Design 
This is a single center, non-randomized, prospective cohort study to comparatively evaluate 
the implementation of the MvIGS spine navigation system to conventional 2D fluoroscopy 
for pedicle screw fixation for the treatment of spinal stenosis with degenerative 
spondylolisthesis of the lumbar spine. 

 
 
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3.2 
Duration of the Study 
The patients will be clinically followed throughout the course of their hospital admission. 
The data collected during surgery and postoperative course will be used to evaluate the 
efficacy of the MvIGS spine navigation system. 
As designed, a total of 130 patients are to be enrolled in the study, with 65 patients per 
treatment group. Based on this sample size, rate of patient accrual, and the prescribed follow-
up time, the total duration of the study is projected to be approximately 9 months.   
3.3 
Outcome Measures Recorded During the Study 
Time point measurements in surgery, including total operative length, will be recorded on 
the day of surgery. Radiographic measurements of the misalignment angle will be 
retrospectively recorded and analyzed. 
3.4 
Clinical Visits: Scheduling and Requirements 
No clinical visits will be required for patients enrolled in this study following discharge of 
index admission. 
3.5 
Selection of Patients 
3.5.1  Criteria for Inclusion 
Patients are included in the study if all of the following criteria are met:  
1) Diagnosis of spinal stenosis of the lumbar spine with ≤ grade 2 degenerative 
spondylolisthesis 
2) Skeletally mature adults between the ages of 18-85 years at the time of surgery; 
3) Has completed at least 6 months of conservative therapy; 
4) Personally signed and dated informed consent document prior to any study-related 
procedures indicating that the patient has been informed of all pertinent aspects of 
the study. 
3.5.2 Criteria for Exclusion 
Patients are excluded from participating in this study if any of the following criteria are met:  
1) Gross instability, defined as > 3 mm translational motion on flexion/extension 
studies;  
2) Degenerative spondylolisthesis > grade 2 
3) Degenerative scoliosis > 10° at any level in lumbar spine; 
4) Congenital lumbar spinal stenosis; 
5) Endplate changes; 

 
 
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6) Visible change in disc height; 
7) Radiographic confirmation of facet joint disease or degeneration; 
8) Prior surgery at any lumbar level including the level being treated except for: 
Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy; 
9) Any evidence of a prior/current fracture, compromised vertebra, current or past 
trauma, or tumor at affected level or the spinous processes at the adjacent levels; 
10) Requires destabilizing surgical decompression that adversely affects the functioning 
of the facets; 
11) Cauda equina syndrome defined as neural compression causing neurogenic bowel   
(rectal incontinence) or bladder dysfunction (bladder retention or incontinence); 
12)  Significant peripheral neuropathy or acute denervation secondary to radiculopathy, 
caused by conditions other than spinal stenosis;  
13)  Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses); 
14)  Morbid obesity, defined as BMI > 40 kg/m2; 
15) Active systemic or local infection; 
16) Active Hepatitis (receiving medical treatment within two years); 
17) Immunocompromised such as but not limited to Acquired Immunodeficiency 
Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, 
Thymic Hypoplasia;  
18) Insulin dependent diabetes mellitus or any other medical condition(s) that would 
represent a significant increase in surgical risk or interfere with normal healing; 
19) Immunologically suppressed, or has received systemic steroids, excluding nasal 
steroids, at any dose daily for > 1 month within last 12 months; 
20) History of Paget’s disease, osteomalacia, or any other metabolic bone disease; 
21) Active malignancy.  A patient with a history of any invasive malignancy (except non-
melanoma skin cancer), unless treated with curative intent and there has been no 
clinical signs or symptoms of the malignancy >5 years; 
22) Involved in study of another investigational product that may affect outcome; 
23) Women who are pregnant, lactating or anticipate becoming pregnant within 24 
months post-surgery;  
24) Patients who are incarcerated; 
25) Worker’s compensation cases; 
26) Patients involved in active litigation relating to his/her spinal condition;  

 
 
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3.6 
Description of MvIGS Spine Navigation System 
3.6.1 Materials 
The equipment includes:  
1. Proprietary imaging software 
2. Integrated surgical light with embedded tracking technology 
3. Cart with Arm and Head attachments 
4. Surgical Instruments: reference clamp, awl tip, and pedicle probe 
3.6.2 Intended Use of the Device 
The MvIGS spine navigation system is intended for spatial positioning and orientation of 
surgical instruments during pedicle screw implantation in patients undergoing posterior 
fixation in single or multiple levels. The surgical light is intended to be the sole luminaire 
during image guided surgery. 
3.6.3 Indication for Use under Study 
The MvIGS spine navigation system is a stereotaxic image guidance system indicated for 
use in posterior approach spine surgery where reference to a rigid anatomical structure can 
be identified.  
3.7 
Investigator Training 
The utilization of the MvIGS spine navigation system should be performed only by 
experienced spinal surgeons with specific training.  Implantation of pedicle screw spinal 
systems is a technically demanding procedure presenting a risk of serious injury to the 
patient.  All warnings, precautions, and recommendations must be fully understood by the 
operating surgeon prior to surgery.  Investigators will use a posterior surgical approach.  The 
use of the intraoperative spine navigation does not alter the surgical technique so much as it 
is a tool in which the surgeon can utilize to further refine their surgical technique.  
3.8 
Study Procedures 
3.8.1 Enrollment/Preoperative Visit 
Patients who meet all the inclusion criteria and who do not meet any of the exclusion 
criteria specified on the eligibility form will be asked to enroll in the study.  Information on 
screening failures will be collected in a screening log.  Patients agreeing to participate in 
this study must then sign the informed consent.   
3.8.2 Post-Operative Visits 
Patients will be clinically followed throughout the course of their hospital admission. No 
visits following discharge will be required. 

 
 
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3.8.3 Patient Disposition 
Patients will either complete all the necessary study requirements or their participation in 
the study may end prematurely for one or more reasons.   
Patients will be termed “discontinued” from the study for the following reasons: 
 Patient voluntarily withdraws from the study:  A patient may voluntarily 
withdraw from the study at any time. 
3.8.4 Withdrawal Documentation 
The reason for patient withdrawal must be fully documented.  Study numbers assigned to 
patients who do not complete the study or discontinue will not be reassigned to newly 
enrolled patients.  Patients who have discontinued should be requested to maintain contact 
and continue to have assessments whenever possible. 
4. 
STATISTICS 
4.1 
Sample Size Analysis 
 Student's t-test, ANOVA, chi-square, regression, etc.: Independent samples T-test 
 Alpha level: 0.05 
 Beta or power level: 0.883 
 Primary outcome variable estimate (mean +/- s.d. for continuous outcome, 
frequency/ percentage for categorical variable): Total length of operative time 
(minutes) as determined by the official recorded operative notes  
 Number of groups being compared (use 1 for paired analysis within the same 
subjects): 2 
 Effect size or change expected between groups: Estimated change difference in 
length of operative time of five (5) minutes with equivalence margins of 40 minutes 
 Resulting number per group: 65 per group; 130 patients total 
A priori power analysis is based on recorded estimates of operative time for 1, 2, 
and 3-level fusion surgeries. Average length of surgery for 1, 2, and 3-level fusion 
surgeries are 230, 275, and 325 minutes, respectively. Estimated pooled standard 
deviation was set at 70 minutes, representing 22 to 30% of the mean operation 
time for the single and multi-level surgeries. In a non-inferiority model using an 
independent sample t-test, group sample sizes of 65 patients in two study groups 
achieves 88% power (with statistical significance defined as alpha equal to 0.05) to 
detect non-inferiority where the margin of equivalence is 40 minutes and the true 
difference between study groups is estimated to be 5 minutes. 
 

 
 
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4.2 
Data Analysis 
Data analysis of the study will include: 
Descriptive statistics will report means and standard deviations for continuous variables of 
the study population. Frequencies and percentages will be used to report all discrete 
variables. Tests of normality for continuous variables will be evaluated using Shapiro-
Wilks tests. For those that are non-parametric, Mann-Whitney U tests will be used. 
Analysis of the primary outcome will use independent samples t-tests to compare the mean 
length of surgery between the two study arms.  
Comparison of secondary outcomes between patients who undergo posterior spine fusion 
surgery using 2D fluoroscopy versus those who undergo the same procedure under 3D 
MvIGS intraoperative navigation guidance will use independent samples t-tests to analyze 
length of hospital stay; time for initial image processing; time to place all pedicle screws; 
time to confirm screw placement; time to register images; estimated blood loss; and 
amount of radiation exposure. Chi-square (or Fisher’s exact) tests will be used to compare 
differences in incidence of malalignment and rate of complications between the two study 
groups.  
 
To adjust for any potential confounding, multivariable regression models will be generated 
to report the adjusted effect of which spine navigation technique is used on length of 
surgical time.  
5.  
ASSESSMENT OF SAFETY 
The events reported during the entire course of the study for patients will be evaluated.  
The data will be examined for the types of events reported and their frequency of 
occurrence.  Re-operations, revisions, removals or supplemental fixation will be assessed 
at each post-surgical follow-up visit.   
5.1 
Adverse Events 
An Adverse Event (AE) is any untoward medical occurrence in a clinical study patient.  
All AEs will be recorded in this study.  An AE can be any unfavorable and unintended 
sign, symptom, or disease regardless of the relationship to the product. 
5.2 
Recording and Reporting Adverse Events 
For the purpose of AE recording, the study period is defined as the time period from 
surgery through discharge from the hospital.  All AEs will be reported to 7D Surgical.  
Any reported AE that occurs after the study follow-up period (regardless of time after 
study participation) will be assessed for its relationship to the patient’s participation in the 
study.  If an AE occurs after the study follow-up period and is considered by the 
investigator to be possibly related to study participation, it must be recorded and reported.   

 
 
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5.3 
Relationship to the Imaging System 
The investigator will evaluate the relationship of the AE to the MvIGS spine navigation 
system according to the following definitions: 
Definite 
The AE is clearly related to the spine navigation system: the event 
has a temporal relationship, and no alternative cause is present. 
Probable 
The AE is likely related to the spine navigation system: the event 
has a temporal relationship, follows a known or suspected pattern of 
response, or is otherwise logically related, but an alternative cause 
may be present. 
Not Related The AE is clearly not related to the spine navigation system: the 
event has no temporal or other relationship to the use of navigation, 
follows no known or suspected pattern of response, and an 
alternative cause is present. 
Unknown 
Unable to determine the relationship based on all available 
information. 
6 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator(s) must maintain, at all times, the primary records (i.e., source documents) 
of each patient’s data.  Examples of source documents are hospital records, office visit 
records, films, examining physician’s finding or notes, consultant’s written opinion or 
notes. 
The investigator(s) will maintain a confidential patient identification list that allows the 
unambiguous identification of each patient.  All study-related documents must be kept 
until notification by 7D Surgical 
7 
QUALITY CONTROL AND QUALITY ASSURANCE 
7.1 
Protocol Amendments, Protocol Deviations and Violations 
7.1.1 Protocol Amendments 
No changes from the final approved protocol will be initiated without prior written 
approval or favorable opinion of a written amendment by 7D Surgical, except when 
necessary to eliminate immediate hazards to the patients or when the change involves only 
logistics or administration.   

 
 
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7.2 
Information to Study Personnel 
The investigator is responsible for giving information about the study to all staff members 
involved in the study or in any element of patient management, both before starting the 
practical performance of the study and during the course of the study (e.g., when new staff 
become involved).  The investigator must ensure that all study staff members are qualified 
by education, experience, and training to perform their specific responsibilities.  The 
monitor is responsible for explaining the protocol to all study staff, including the 
investigator, and for ensuring their compliance with the protocol.   
8 
ETHICS 
8.1 
Informed Consent 
Written informed consent will be obtained from each patient before any study-specific 
procedures or assessments are done, and after the aims, methods, anticipated benefits, and 
potential hazards are explained.  The patient’s willingness to participate in the study will 
be documented in writing in a consent form, which will be signed by the patient with the 
date of that signature indicated.  The investigator will keep the original consent forms and 
copies will be given to the patients.  It will also be explained to the patients that they are 
free to refuse entry into the study and free to withdraw from the study at any time without 
prejudice to future treatment. 
Written and/or oral information about the study will be provided in understandable 
language to all patients. 
8.2 
Institutional Review Board (IRB) 
Before commencement of this study, the protocol will be submitted to the CRP and IRB 
for evaluation. As required, the study will not start before approval to proceed. 
9 
REPORTING AND PUBLICATION OF RESULTS 
All unpublished information given to the investigator by 7D Surgical shall not be 
published or disclosed to a third party without the prior written consent of 7D Surgical.   
When 7D Surgical generates reports from the data collected in this study for presentation 
to regulatory authorities, drafts may be circulated to the investigator for comments and 
suggestions.  An endorsement of the final report will be sought from the investigator when 
required by local regulatory agencies. 
All information concerning the MvIGS, 7D Surgical operations, patent application 
drawings or formulas, manufacturing processes, basic scientific data and design or 
formulation information, supplied by the sponsor to the investigator and not previously 
published, is considered confidential and remains the sole property of 7D Surgical.  No 
patent application(s) based on the results of the study may be made by the investigator nor 

 
 
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may assistance be given to any third party to make such an application without the written 
authorization of 7D Surgical.  
The following is a listing of the reports the investigator shall submit to 7D Surgical: 
 Adverse event reports as required; 
 Progress reports on the clinical study;  
 A final report must be provided within 6 months following termination or 
completion of the investigation or the investigator’s part of the investigation. 
 
 
10 REFERENCES 
 
 
1. Härtl R, Lam KS, Wang J, Korge A, Kandziora F, Audigé L. Worldwide Survey on the 
Use of Navigation in Spine Surgery. World Neurosurgery. 2013;79(1):162-172. 
doi:10.1016/j.wneu.2012.03.011. 
2. Kalfas IH, Kormos DW, Murphy MA, et al. Application of frameless stereotaxy to 
pedicle screw fixation of the spine. Journal of Neurosurgery. 1995;83(4):641-647. 
doi:10.3171/jns.1995.83.4.0641. 
3. Patil S, Lindley EM, Burger EL, Yoshihara H, Patel VV. Pedicle Screw Placement With 
O-arm and Stealth Navigation. Orthopedics. 2012;35(1):e61-e65. doi:10.3928/01477447-
20111122-15.