Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Conditions: Spinal Diseases
Sponsor: Philips Clinical & Medical Affairs Global

Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
  
 
Clinical Investigation Plan 
Observational clinical study with Surgical Navigation to 
plan, position and check instrument placement for 
spine surgery interventions 
 
 
Security Classification: 
Confidential 
 
 
 
 
Author:  
Xxxxxxxxxxxxxxxxx 
 
InCs: Clinical Study Specialist 
 
 
Sponsor’s Legal Entity:  
Philips Medical Systems Nederland B.V., a Philips Healthcare company 
Veenpluis 4-6  
5684 PC Best  
The Netherlands 
Business Unit:  
Interventional X-Ray Best 
Department:  
Clinical Science 
 
 
Document ID:  
XCY607-130099 
 
Date:  
2016 Oct 04 
Revision:  
7.0 
Status:  
Final 
 
 
 
 
 
 
 
 
 
APPROVAL PHILIPS 
 
Name 
Function 
Date (yyyy Mon dd) 
Signature 
 
xxxxxxxxxxx 
InCs: Clinical Study 
Specialist Manager 
xxxxxxxxxxx 
xxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxx 
InCs: Study Leader 
xxxxxxxxxxx 
xxxxxxxxxxxxx 
xxxxxxxxxxxxxxx 
Q&R: RA officer 
xxxxxxxxxxxx 
xxxxxxxxxxxxx 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 2 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
REVISION HISTORY 
Date 
Rev. 
Author 
Changes/Comments 
2015 May 26 
1.0 
Xxxxxxxxxxxxxxxxx 
Initial version 
2016 June 30 
2.0 
Xxxxxxxxxxxxxxxxx 
Changes: 
• Name of investigational device 
Light2C replaced with Surgical 
Navigation 
• Optical marker supplier company  
has been changed from xxxx   
xxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxx 
• Human cadaver study section 
updated with additional human 
cadaver experiments 
• Risk of Surgical Navigation and 
unanticipated adverse events 
have been updated after latest 
risk assessment and 
implementation of mitigations  
• Inclusion criteria change: age 
decreased from 18 to 16 years 
to allow also scoliotic patients in 
the study.  
• Sample size has been updated to 
240 screws and anticipated 
number of patients has been 
changed to 15 to 25 patients 
due to the expected inclusion of 
scoliotic patients. 
• Typographical error have been 
corrected 
2016 July 08 
3.0 
Xxxxxxxxxxxxxxxxx 
• Removed sterile drapes from 
device description. Sterile 
drapes for detector compatible 
with the Allura and surgical 
navigation (Microtek Medical, 
Zutphen, The Netherlands) is a 
separate disposable that can be 
used in combination with the 
Allura system, like common 
used drapes. CE-labeled 
drapes are used in the study 
and they are not part of the 
surgical navigation device.  
• Added clarification that optical 
markers will be supplied via 
Philips Healthcare during the 
study. 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 3 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Date 
Rev. 
Author 
Changes/Comments 
2016 July 14 
4.0 
Xxxxxxxxxxxxxxxxx 
• Added a Data Monitoring 
Committee (DMC/DSMB) since 
subject with age of 16 years 
and older are included in the 
study. DMC will review adverse 
events and serious adverse 
events and will provide 
recommendations of 
continuation of the study at 
multiple moments. 
2016 Aug 15 
5.0 
Xxxxxxxxxxxxxxxxx 
• Clarified that final risk 
assessment has been 
performed and included 
conclusion of final risk 
assessment on request of the 
MPA 
2016 Sep 16 
6.0 
Xxxxxxxxxxxxxxxxx 
• Added clarification of “Entry 
point” 
• Explanation has been added to 
why an observation, non- 
randomized study design has 
been chosen. 
• Reference to Light2C has been 
replaced with Surgical 
Navigation in Figure 5 and 7 
• XperGuide clinical experience 
section has been updated with 
reference for general 
complication of vertebral 
augmentation and post-market 
safety data. 
• Anticipated adverse device 
effects section has been 
updated with likely incidence, 
mitigation or treatment. 
• Retention period has been 
updated at the investigational 
site to address only national 
requirements of Sweden 
• Amendment section had been 
updated with approval 
requirements  
• Adverse event definitions and 
reporting has been updated 
according to MEDDEV 2.7/3 rev 
3 
• Definitions for entry point and 
placement has been added to 
the section abbreviations 
2016 Oct 04 
7.0 
Xxxxxxxxxxxxxxxxx 
• Removal of Section 12.1 since 
patients unable to read, 
understand and sign for 
themselves are excluded from 
study participation as per 
Informed Consent. 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 4 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
TABLE OF CONTENTS 
 
APPROVAL PHILIPS ..........................................................................................................................................1 
REVISION HISTORY ..........................................................................................................................................2 
TABLE OF CONTENTS ......................................................................................................................................4 
SUMMARY .........................................................................................................................................................6 
1. 
DEVICE DESCRIPTION .......................................................................................................................... 11 
1.1. Summary description of the investigational device.............................................................................. 11 
1.2. Intended Purpose ................................................................................................................................ 14 
1.3. Necessary training and experience needed to use the investigational device .................................... 14 
1.4. Materials that will be in contact with tissues or body fluids ................................................................. 14 
1.5. Device Traceability .............................................................................................................................. 14 
2. 
JUSTIFICATION FOR THE DESIGN OF THE STUDY ........................................................................... 14 
2.1. Evaluation of preclinical testing ........................................................................................................... 18 
2.1.1. 
xxxxxxxxxxxxx.......................................................................................................................... 18 
2.1.2. 
xxxxxxxxxxxxx.......................................................................................................................... 18 
2.1.3. 
Xxxxxxxxxxxxxxxxxxxxx .......................................................................................................... 18 
2.2. Evaluation of clinical dataxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ................................................... 21 
2.2.1. 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ................................................................................ 21 
2.2.2. 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ................................................................................ 22 
2.3. Conclusion of the justification for the design of the study ................................................................... 22 
2.4. Purpose of the study ............................................................................................................................ 23 
3. 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION ...... 23 
4. 
OBJECTIVES .......................................................................................................................................... 24 
4.1. Primary objective ................................................................................................................................. 24 
4.2. Secondary objective(s) ........................................................................................................................ 24 
5. 
STUDY DESIGN ...................................................................................................................................... 25 
5.1. General ................................................................................................................................................ 25 
5.2. Investigational device exposure .......................................................................................................... 25 
5.3. Subjects ............................................................................................................................................... 25 
5.3.1. 
In- and exclusion criteria .......................................................................................................... 25 
5.3.2. 
Enrollment and duration ........................................................................................................... 25 
5.3.3. 
Number of subjects .................................................................................................................. 26 
5.3.4. 
Subject withdrawal or discontinuation ..................................................................................... 26 
5.4. Procedures........................................................................................................................................... 26 
5.5. Monitoring Plan .................................................................................................................................... 27 
5.5.1. 
Maintenance and calibration .................................................................................................... 28 
6. 
STATISTICAL CONSIDERATIONS ........................................................................................................ 28 
6.1. Sample Size Justification ..................................................................................................................... 28 
6.2. General Consideration ......................................................................................................................... 29 
6.3. Subject disposition ............................................................................................................................... 29 
6.4. Demographics and Baseline Characteristics ....................................................................................... 29 
6.5. Primary objective ................................................................................................................................. 29 
6.6. Secondary objectives ........................................................................................................................... 30 
6.6.1. 
Secondary objective: Procedure Time ..................................................................................... 30 
6.6.2. 
Secondary objective: Time to insert a pedicle screw............................................................... 30 
6.6.3. 
Secondary objective: Length of hospital stay .......................................................................... 30 
6.6.4. 
Secondary objective: System usability .................................................................................... 30 
6.6.5. 
Secondary objective: Patient Dose .......................................................................................... 31 
6.6.6. 
Secondary objective: Occupational dose ................................................................................ 31 
6.6.7. 
Secondary objective: Procedure related complications ........................................................... 32 
6.6.8. 
Secondary objective: Adverse events ..................................................................................... 32 
6.6.9. 
Secondary objective: Adverse Device Effects ......................................................................... 32 
6.6.10. 
Secondary objective: Device Deficiencies that could have led to Serious Adverse Event...... 32 
7. 
DATA MANAGEMENT ............................................................................................................................ 32 
7.1. Retention period .................................................................................................................................. 33 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 5 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
8. 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN AND INFORMED CONSENT ................ 33 
9. 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN .............................................................. 33 
10. DEVICE ACCOUNTABILITY ................................................................................................................... 33 
11. STATEMENTS OF COMPLIANCE .......................................................................................................... 33 
12. INFORMED CONSENT PROCESS ........................................................................................................ 34 
13. ADVERSE EVENT REPORTING ............................................................................................................ 34 
13.1. Definitions ............................................................................................................................................ 34 
13.2. Reporting ............................................................................................................................................. 35 
13.3. Xxxxxxxxxxxxxxxxxxxxxxxxxxxxx ........................................................................................................ 36 
13.4. Unavoidable adverse events ............................................................................................................... 36 
13.5. Data Monitoring Committee ................................................................................................................. 37 
14. EARLY TERMINATION OR SUSPENSION OF THE CLINICAL INVESTIGATION ............................... 37 
15. PUBLICATION POLICY ........................................................................................................................... 37 
16. DEFINITIONS AND ABBREVIATIONS ................................................................................................... 37 
17. REFERENCES ........................................................................................................................................ 38 
APPENDIX I: LIST OF INVESTIGATORS AND SITES .................................................................................. 41 
APPENDIX II: LIST OF MONITOR(S)/CLINICAL SCIENTIST ........................................................................ 42 
APPENDIX III: USABILITY TESTING BACKGROUND ............................................................................... 43 
APPENDIX IV: SYSTEM USABILITY SCALE ................................................................................................. 45 
APPENDIX V: BACKGROUND INFORMATION PRIMARY OBJECTIVE ...................................................... 46 
 
TABLE OF TABLES 
Table 1: Medical devices involved in this clinical study with Surgical Navigation to perform image-guided 
spine surgery navigation .................................................................................................................................. 11 
Table 2: Overview of publication related to accuracy of pedicle screw placements comparing conventional 
method and image-guided navigation. ............................................................................................................ 16 
Table 3: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
x ....................................................................................................................................................................... 20 
Table 4: Time measurement ............................................................................................................................ 30 
Table 5: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxs ........................................................................................ 36 
Table 6: Unavoidable adverse events ............................................................................................................. 36 
Table 7: List of principle Investigators ............................................................................................................. 41 
Table 8: Independent reviewers ...................................................................................................................... 41 
Table 9: List of monitor/clinical scientist .......................................................................................................... 42 
 
TABLES OF FIGURES 
Figure 1: Graphic overview of the Surgical Navigation applications and angiographic X-ray system Allura 
used in this study. ............................................................................................................................................ 12 
Figure 2: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ................................................................................................ 13 
Figure 3: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ............................................................................................. 13 
Figure 4: pedicle screw diameter ..................................................................................................................... 15 
Figure 5: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx .......................................................... 19 
Figure 6: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx................................................................................................. 20 
Figure 7: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ...................................................................... 21 
Figure 8: Flowchart for patient undergoing pedicle screw placement ............................................................. 27 
Figure 9: percentile ranks associated with SUS scores. ................................................................................. 43 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 6 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
SUMMARY 
 
Identification of investigational device 
Three medical devices will be used in this observational clinical study with Surgical Navigation to perform 
image-guided spine surgery navigation (see Table 1 and Figure 1).  
Table 1: Medical devices involved in this clinical study with Surgical Navigation to perform 
image-guided spine surgery navigation  
# Device description 
Manufacture 
Investigational/ 
CE labeled during 
the study 
1 Angiographic X-ray 
system Allura FD20 
Philips Medical Systems, a Philips Healthcare company, 
Best, The Netherlands 
CE label 
2 Surgical Navigation 
application 
Philips Medical Systems, a Philips Healthcare company, 
Best, The Netherlands 
Investigational 
device 
3 Fiducials/optical 
markers (disposal) 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxx (item Optical Marker or similar) 
Supplied via Philips Healthcare during the trial 
CE label 
 
 
Figure 1: Graphic overview of the Surgical Navigation applications and angiographic X-ray 
system Allura used in this study. 
A=detector frame of the C-arm with four small optical cameras, B= Surgical Navigation application 
software running on a PC. 
 
Surgical Navigation is an intra-operative image-guidance software application used during surgical and 
interventional therapy. Surgical Navigation is intended to be used in combination with a Philips 
interventional X-ray system Allura with ORT table. 
 
Angiographic X-ray system Allura FD20 
Angiographic X-ray system Allura FD20 (further called Allura in this study plan) will contain four small 
optical cameras in the detector frame of the C-arm. On each side of the detector one camera is located. 
The cameras are connected to a PC where the Surgical Navigation application is running. 
The optical images and X-ray images (e.g. 2D fluoro, 3D Cone Beam Computed Tomography 
(CBCT/XperCT/CT-like image)) are acquired with the Allura. Since the cameras are rigidly connected to 
the detector-suspension frame in the Allura, the relative position between camera and detector can be 
measured once and does not change. So a position registration before a clinical procedure is not 
Surgical 
Navigation 
A
li
ti
PC
A 
Exam room 
Cameras  
B 
Allura 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 7 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
necessary (the camera-to-detector position & orientation is calibrated by Philips). 
 
Surgical Navigation application 
The Surgical Navigation application-software (further called Surgical Navigation in this study plan) is an 
investigational device and is running on an application PC. 
Xxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxx 
. 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
Figure 2: xxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 8 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Figure 4: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxx  
Study design 
This is a prospectively planned, single arm, single center study designed to estimate the accuracy of the 
pedicle screw placement using the Surgical Navigation procedure in patients undergoing pedicle screw 
fixation surgery.  Accuracy will be reported by the proportion of pedicles having either grade 0 or 1 
according to a slightly adapted Gertzbein4 classification. The slightly adapted Gertzbein4 classification for 
pedicle screw breach is defined as follows: 
• grade 0 = breach 0 mm 
• grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
• grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance 
• grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance. 
 
The proportion of screws placed according to grade 0-3 will be estimated overall, and by region (e.g., 
cervical, lumbar, and thoracic).   
Objectives  
Primary objective: 
to estimate the accuracy of pedicle screw placement using Surgical Navigation on post-procedural CBCT: 
 
Screw placement will be evaluated using a slightly adapted Gertzbein4 classification for pedicle screw 
breach as follows: 
grade 0 = breach 0 mm 
grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance  
grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance. 
 
Accuracy will be reported by the proportion of pedicles having either grade 0 or 1. 
 
Secondary objective(s): 
1) To estimate the procedure time.   
2) To estimate the average time to insert a pedicle screw.  
3) To estimate the length of hospitalization (LOH) 
4) Collect System Usability Scale (SUS) and assess the clinical workflow related to easiness to work, 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 9 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
image quality, real-time image update, preparation of patient tracking, confidence in image 
guidance, access planning, 3D segmentation, motion compensation, identify unknown potential 
use errors and evaluate risk controls. 
5) To estimate radiation dose (Dose Area Product (DAP) and Air Kerma (AK)) delivered to patient for: 
a. Total procedure  
b. During preparation and acquisition of CBCT for path planning 
c. During screw/instrument placement (using fluoro). 
d. During preparation and acquisition of CBCT for confirmation 
e. Average procedure dose per planned path   
6) To estimate the total radiation dose (effective dose) received by operator, if DoseAware Xtend is 
available. 
7) To describe procedure related complications 
8) Report all adverse events 
9) Report all adverse device effects  
10) Report all device deficiencies that could have led to a serious adverse event  
  
 
Primary and secondary endpoints  
The primary endpoint of the study is accuracy.  
1) This is measured according to an adapted version of the in literature reported classification method by 
Gerztbein, so that it includes distance of breaches applicable for cervical region besides the lumbar and 
thoracic region. 
 
Furthermore, accuracy will also be reported by direction of breach (lateral/medial), and distance between 
planned path and screw in smallest area of the pedicle (mm) and the distance between screw tip and 
planned target of screw (mm). 
 
Secondary endpoints are: 
Procedure time, time to insert a pedicle screw, Length of hospital Stay, System Usability Score, patient 
radiation dose (DAP and AK and fluoro time), occupational radiation dose (effective dose), procedure 
related complications, adverse events, adverse device effects, device deficiencies that could have led to 
a serious adverse event. 
Main inclusion criteria 
• Subject will be undergoing a spine surgery with pedicle screw placement 
• Subject is 16 years of age or older 
• Subject is able to give informed consent  
 
Main exclusion criteria 
• Subject participates in a potentially confounding device or drug trial during the course of the study. 
• Subject meets an exclusion criteria according to national law (e.g. pregnant woman, breast feeding 
woman) 
 
No. of subjects 
In total 240 screws placement are needed. It is expected that approximately 15 to 25 subjects with 
pedicle screw surgery are necessary to collect sufficient data for the evaluation of the primary and 
secondary objectives of this clinical investigation. After the first two subjects have been treated with 
pedicle screws there will be a delay of at least 1 week until the third and fourth subjects will be 
undergoing the procedure with Surgical Navigation. After subject one to four have been treated and the 
DMC/DSMB have been given recommendations of continuation of the study then there is no limit on how 
many subjects can be treated during one day. Enrollment of subjects will be stopped after approximately 
240 screws are placed. This is a common number of screws used in studies showing accuracy of pedicle 
screw placement in the cervical.  The enrollment period is expected to last for 7 months. 
 
Study procedures 
Pedicle screw placement  
Pedicle screws will be placed using Surgical Navigation image guidance during spine surgery. The 
specific clinical investigation related steps for this spine surgery are (see also Figure 8): 
• Sterile drapes compatible with the Allura and Surgical Navigation with transparent windows are 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 10 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
placed over the detector. 
• Several optical markers stickers (4-6 depending on the size of the region of interest) are placed at 
the back of the patient around the area of interest. 
• A 3D CT like image is made (CBCT) of the relevant vertebrae. 
• The spine image can be segmented using Surgical Navigation, if desired. 
• The optimal path for the screw/instrument is planned in the CBCT volume. 
• The optical view of Surgical Navigation is used to align the instrument (e.g. K-wires, screws 
instrumentation) with the planned path at the entry point. Progression view (view perpendicular to 
the planned path) using fluoro can be used during insertion of the screw, if desired. With this 
progression view function, the user can check on an x-ray image the actual placement of the 
screw at each moment in the procedure. 
• The pedicle screws/instrumentation are further inserted in the vertebra using tools according to 
standard of care. 
• Acquisition of a CBCT showing all placed pedicle screws/instrumentation to check the success of 
the procedure. This CBCT replaces the standard post-operative CT to check the procedure. 
For pedicle screw placement: Like in normal clinical practice, the necessity for revision of a pedicle 
screws is determined based on 3D information. This CBCT with the pedicle screws will be used to 
determine the accuracy of pedicle screw placement for the objectives of this study. The physician 
will indicate the classification according to the classification system (grade 0-3, see section 4.1). 
This classification can be done post-procedure.  
• Time of the total procedure will be measured. 
• Patient and occupational dose data will be collected using Surgical Navigation and DoseAware 
Xtend (if available at the hospital), respectively. 
 
Patients participating in this study are subject to follow-up until hospital discharge to collect the length of 
hospital stay.  
 
All other things are the same as the current standard of care. 
 
All post-procedural CBCT acquisitions will be evaluated by an independent reviewer (neurosurgeon, 
orthopedic surgeon or spine surgeon experienced in pedicle screw placements) to determine the 
accuracy of pedicle screw placement according to the modified Gertzbein grading system (grade 0-3, see 
section 4.1) and direction (lateral/medial breach).  
Furthermore, the distance (mm) between the following two points will be measured: 
• The planned path and screw axis at smallest pedicle diameter 
• The planned path and at the tip of the screw 
The classification by the independent reviewer will be used for the objectives. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 11 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
 Figure 8: Flowchart for patient undergoing pedicle screw placement 
 
 
Workflow feedback and usability information 
Observations related to the workflow for the spine procedure will be performed by a Philips representative 
during some of the procedures. Workflow feedback will also be obtained through a short interview with 
the physician performing the procedure.  
At the end of the study the physician(s) performing the procedure will be requested to complete a System 
Usability Scale (SUS) questionnaire to obtain general information related to the usability of Surgical 
Navigation related to these spine procedures. 
 
Follow up 
The subjects will be followed-up for this study until hospital discharge. After this the patient will be 
followed up according to standard of care outside the study.   
Duration of the study 
The total duration of the study is expected to take approximately 1 year 
 
 
1. 
 DEVICE DESCRIPTION 
1.1. 
Summary description of the investigational device 
Three medical devices will be used in this observational clinical study with Surgical Navigation to perform 
image-guided spine surgery navigation (see Table 1 and Figure 1, duplicated below).  
Table 1: Medical devices involved in this clinical study with Surgical Navigation to perform image-
guided spine surgery navigation  
# Device description 
Manufacture 
Investigational/ 
CE labeled during 
the study 
1 Angiographic X-ray 
system Allura FD20 
Philips Medical Systems, a Philips Healthcare company, 
Best, The Netherlands 
CE label 
2 Surgical Navigation 
application 
Philips Medical Systems, a Philips Healthcare company, 
Best, The Netherlands 
Investigational 
device 
3 Fiducials/optical 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
CE label 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 12 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
markers (disposal) 
xxxxxxxxxxxxxxxx.(item Optical marker or similar) 
Supplied via Philips Healthcare during the trial 
 
 
Figure 1: Graphic overview of the Surgical Navigation applications and angiographic X-ray system 
Allura used in this study. 
A=detector frame of the C-arm with four small optical cameras, B= Surgical Navigation application software 
running on a PC. 
 
Surgical Navigation is an intra-operative image-guidance software application used during surgical and 
interventional therapy. Surgical Navigation is intended to be used in combination with a Philips interventional 
X-ray system Allura with ORT table. 
 
Angiographic X-ray system Allura FD20 
Angiographic X-ray system Allura FD20 (further called Allura in this study plan) will contain four small optical 
cameras in the detector frame of the C-arm. On each side of the detector one camera is located. The 
cameras are connected to a PC where the Surgical Navigation application is running. 
The optical images and X-ray images (e.g. 2D fluoro, 3D Cone Beam Computed Tomography 
(CBCT/XperCT/CT-like image)) are acquired with the Allura. Since the cameras are rigidly connected to the 
detector-suspension frame in the Allura, the relative position between camera and detector can be measured 
once and does not change. So a position registration before a clinical procedure is not necessary (the 
camera-to-detector position & orientation is calibrated by Philips). 
 
Surgical Navigation application 
The Surgical Navigation application-software (further called Surgical Navigation in this study plan) is an 
investigational device and is running on an application PC. 
Xxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Surgical 
Navigation 
A
li
ti
PC
A 
Exam room 
Cameras  
B 
Allura 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 13 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxx 
 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
Figure 2: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
Figure 3: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
.  
 
The manufacturer of the investigational device Surgical Navigation is: 
Philips Medical Systems Nederland B.V., a Philips Healthcare company 
Veenpluis 4-6  
5684 PC Best  
The Netherlands 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 14 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
1.2. 
Intended Purpose  
The intended purpose of the investigational device in the proposed clinical investigation is: 
 
Medical purpose 
Surgical Navigation is intended to be an intra-operative image-guidance tool used during surgical and 
interventional therapy. It provides assistance to the performing physician to align an instrument with a virtual 
path, that is planned on a 3D volume of the anatomy. The virtual path is superimposed with a live video 
image of the area of interest. It is intended to assist in the treatment of spinal diseases during procedures 
such as pedicle screw placements and biopsies.  
 
Patient population  
Surgical Navigation is suitable for use on patients who have been elected for pedicle screw placement or 
biopsy 
 
Intended operator profile 
The Operator is a physician who is fully skilled and responsible for sound clinical judgment and for applying 
the best clinical procedure, for example (but not limited to): 
• Orthopedic/spine/neuro surgeon 
• Skilled radiology technician (or nurse) assisting the physician 
 
To facilitate safe and efficacious operation of the system by a trained healthcare professional, instructions for 
use are provided as part of the device labelling, as well as a basic training at system handover. The 
Instruction for Use (IFU) contains safety precautions and handling of the investigational device. 
1.3. 
Necessary training and experience needed to use the investigational device 
Adequately trained, qualified, and authorized health care professionals who have understanding of the safety 
information and emergency procedures as defined by local laws and regulations for radiation workers and 
staff is needed to use the Surgical Navigation.  
1.4. 
Materials that will be in contact with tissues or body fluids 
No materials of the investigational device will be in contact with tissue or body fluids.  
1.5. 
Device Traceability 
Traceability of investigational device will be achieved during the study and after the clinical study by the 
following identification. 
 
Surgical Navigation Device  
Identified by: 
Software system installation 
sets 
Will be identified by Surgical Navigation software archive ID in 
combination with unique software revision number   
 
Records shall be kept to document when the device is received, installed or uninstalled at the hospital. 
2. 
JUSTIFICATION FOR THE DESIGN OF THE STUDY 
 
In spine surgery pedicle screws are used for fixation of the vertebrae to stabilize the vertebral column. 
Conditions where spinal fusion with pedicle screws may be considered include: degenerative disc disease, 
disc herniations, spinal deformity (scoliosis, kyphosis), spinal stenosis, sciatica, and radiculopathy, spine 
fractures and trauma, vertebral compression fracture, spine tumors, spondylolisthesis, spondylolysis, and 
spinal instability. 
 
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good 
accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).  
 
Thoracic levels (T3-T9) have the narrowest pedicles1 and have decreased space between the medial border 
of the pedicle and spinal cord. Studies have estimated that screws placed in this region have a maximum 
permissible translational/rotational error tolerances ranged from 0.0 mm/0.0° at T5 to 3.8 mm/12.7° at L5 due 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 15 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
to anatomically small pedicle diameters2. Screw revision can be difficult and time-consuming (13.8±9.9 min), 
as the faulty screw track often hinders effective screw repositioning3. When considering screw revision time 
and possible decreases in biomechanical stability, it is important to place the pedicle screws correctly in the 
first attempt. 
 
 
 
Figure 4: pedicle screw diameter 
 
Image-guided spine surgery 
The vast majority of pedicle screw placements in spine are performed using free-hand technique with or 
without use of 2D fluoro-guidance to place pedicle screws. Next to these conventional methods, image-
guided navigation has become available as another technique to improve the accuracy of pedicle screw 
placement. Navigation systems are using different types of image data, i.e. either pre-operatively acquired 
CT images or intra-operatively acquired fluoroscopy images, intraoperative CBCT (e.g. O-arm (Medtronic)) 
or intra-operative acquired CT (e.g. AIRO iCT (Brainlab)). Intra-operative registration relies on the 
identification of anatomical landmarks, surface contours or pre-operatively implanted fiducial markers.  
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
The accuracy of pedicle screw placements and the misplacements have been reported in the past using the 
conventional methods. Misplacement has been reported up to 30% in the lumbar and 55% in the thoracic 
spine 4,5,6. Image-guided approaches have been investigated and partially implemented into clinical routine 
in virtually any field of spine surgery. However, the data available is mostly limited to small clinical series, 
case reports or retrospective studies. Only a couple of Randomized Controlled Trials (RCT) and a couple of 
meta-analysis have been retrieved concerning image-guided approaches for pedicle screw insertion. Overall, 
image-guided navigation for pedicle screw placement results in a higher pedicle screw placement accuracy 
than with conventional methods.  

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 16 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Results of the randomized trials and meta-analysis are summarized below and Table 2, ranging from 81%-
100% accuracy for image-guided navigated and 68%-94% with conventional methods. 
 
Tjardes7 made an overview on the current knowledge concerning the technical capabilities of image-guided 
approaches. He selected 276 relevant papers in the analysis. Since the advent of high-speed computer 
workstations allowing the integration of 3D image processing and real time tracking of smart tools the 
feasibility of image-guided approaches of virtually any application in spine surgery has been proven. Clinical 
data suggest that image-guided techniques assist in placing pedicle screws accurately; however the thoracic 
spine remains a critical area due to the small diameters of the pedicle.   
Laine describes that in the randomized study the pedicle perforation rate was 13.4% in the conventional 
group and 4.6% in the computer-assisted group (P =0.006) for thoracolumbar and lumbosacral pedicle 
screws. Pedicle perforations of more than 4 mm were found in 1.4% (4/277) of the screw insertions in the 
conventional group, and none in the computer-assisted group8. 
In another randomized study, Rajasekaran9 reported 54 (23%) pedicle breaches in the thoracic region in the 
non-navigation group as compared to only 5 (2%) in the navigation group (P < 0.001). Thirty-eight screws 
(16%) in the non-navigation group had penetrated the anterior or lateral cortex compared to 2 screws (0.8%) 
in the navigation group.  
A meta-analysis by Kosmopoulos and Schizas describes that the use of image guidance techniques 
improves the accuracy (95.2%) of pedicle screw placement in spinal surgery compared to the subgroup 
without the use of navigation (90.3%)10 . 
A more recent review included a total of 30 studies by Mason11. These studies included 1973 patients in 
whom 9310 pedicle screws were inserted. Accurate placement was observed in 68% with conventional 
fluoroscopy, 84% with 2D fluoroscopic navigation, and 96% with 3D fluoroscopic navigation. The accuracy 
rates when using 3D navigation were also consistently higher throughout all individual spinal levels 
compared with 2D fluoroscopic navigation.  
Significantly increased pedicle screw placement accuracy was also observed when navigation techniques in 
a meta-analysis by Tang in 2014 concerning accuracy of pedicle screw placement with or without image-
guided navigation techniques (OR (Odds Ratio) =3.36 for perfect placed screws and OR=4.72 for screws 
placed in a “safe zone”, 732 patients with 4953 screws) 12. 
 
In a review by Gelasis, the percentage of the screws fully contained in the pedicle ranged using free-hand 
technique ranged from 69 to 94%, with the aid of fluoroscopy from 28 to 85%, using CT navigation from 89 to 
100% and using fluoroscopy-based navigation from 81 to 92%13. 
 
Table 2: Overview of publication related to accuracy of pedicle screw placements comparing 
conventional method and image-guided navigation. 
First author 
Study type 
Measured item 
Conventional 
method 
Image-guided 
Navigation 
Comment 
Laine (2000) 
Randomized 
study  
Perforation rate 
Perforation>4 mm 
13.4% (87% 
accuracy) 
1.4% (4/277) 
4.6% (95% accuracy) 
None 
P =0.006  
91 pts/ 
496 screws 
(pre-op CT) 
Rajasekaran 
(2007) 
Randomized 
study  
Pedicle breaches  
Penetrated the 
anterior or lateral 
cortex 
23% (77% 
accuracy) 
16% 
2% (98% accuracy) 
0.8%  
P < 0.001 
27 pts 
scoliosis/ 
478 screws 
(Siemens 
Brainlab) 
Kosmopoulos 
(2007) 
Meta-
analysis 
Accuracy 
90.3% 
95.2% 
130 studies 
37337 screws 
Mason 
(2014) 
Review  
Accuracy 
68% conventional 
fluoro 
84% 2D fluoro 
navigation 
96% 3D fluoro 
navigation 
2D/3D stat 
sign more 
accurate than 
conventional 
3D stat. sign. 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 17 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
More accurate 
than 2D 
30 studies 
1973 pts/  
9310 screws 
Tang (2014) 
Meta-
analysis 
Accuracy:  
Perfect screws 
 Safe zones 
Significant 
difference 
favoring 
procedure using 
navigation vs. 
non-navigated 
 
OR=3.36 
OR=4.72  
 
P<0.00001 
P<0.0001 
12 studies 
732 pts/  
4953 screws
  
Gelasis 
(2012) 
Review 
Accuracy 
69 – 94% (free 
hand) 
28 – 85% (fluoro)  
89 – 100%  
(CT-navigated) 
81 – 92% (fluoro 
navigated) 
26 studies 
1105 pts/ 
6617 screws 
Tian (2011) 
Review and 
meta 
analysis 
Pedicle screw 
violation 
Significantly less 
pedicle screw 
violations in 
navigation group 
than conventional 
group 
OR 95% CI* (0.32-0.60) 
CT based 
OR 95% CI (0.27-0.48) 
2D fluoro 
OR 95% CI (0.09-0.38) 
3D fluoro 
P<0.01 
P<0.01 
P<0.01 
Incl. 28 clinical 
studies 
Summary 
 
Accuracy 
28%-94%  
81%-100%  
 
*CI=Confidence Interval 
 
Gebhard et al.14 showed a clear reduction of radiation dose when using imaged guided surgery. They 
quantified the radiation doses during spine surgery in different types of image-guided surgery procedures 
(i.e., computerized tomography [CT] based and C-arm) compared to standard methods and the Iso-C3D C-
arm (Siemens). The duration of radiation was reduced from 177 seconds in the standard spine procedure to 
75 seconds in CT-based image-guided surgery. The radiation doses at the C-arm tube (source) are reduced 
from a median of 1091 mGy in the standard procedure versus 432 mGy in CT-based and 664 mGy in C-arm 
based guided surgery. In this study, the median dose of an Iso-C3D C-arm was 152 mGy. 
 
Minimal invasive spine surgery 
Besides using imaging guidance there is also a trend towards minimal invasive surgery. The advantages of 
minimal invasive spine surgery include; less post-operative pain, quicker recovery, reduced blood loss, less 
soft tissue damage, smaller surgical incisions, less scarring, improved function according to the Society for 
Minimally Invasive Spine Surgery15. For sacroiliac minimally invasive spine surgery operating room time, 
estimated blood loss, hospital length of stay is decreased significantly compared to open surgery. 
Furthermore, when matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain 
scores were on average 3.0 points (95% CI 2.1 – 4.0) lower in minimal invasive surgery vs. open surgery 
(rANOVA p < 0.001)16 . A literature review by Wong et al. of clinical outcomes and complications associated 
with the minimally invasive surgical decompression of lumbar stenosis reported a decreased blood loss, 
shorter operative time, shorter hospital duration, decreased postoperative narcotic requirement, decreased 
rate of infection and cerebrospinal fluid leak, and a decrease in time required for return to work17. Wong et al. 
mention in their literature review that despite many of the benefits from a minimally invasive spine surgery 
approach to lumbar stenosis, there remains a high rate of initial complications related to the steep learning 
curve of a new surgical technique.  
Another subpopulation of patients that may benefit from minimally invasive spine surgery approaches would 
be obese patients. Obese patients tend to have longer operative times, increased blood loss, larger incisions 
and soft-tissue dissection for exposure, and increased complications (36–67% higher e.g. wound infections 
and pulmonary disease)17 . 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 18 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
2.1. 
Evaluation of preclinical testing 
2.1.1. 
xxxxxxxxxxxxx 
 
 
 
 
 
 
2.1.2. 
xxxxxxxxxxxxx 
18.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.1.3. 
Xxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 19 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 5: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 20 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 6: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3: 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 21 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 7: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.2. 
Evaluation of clinical dataxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
19  20, 21, 22, 23, 24. 20,21,23,24,.25. 
. 26  
2.2.1. 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 22 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
2.2.2. 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.3. 
Conclusion of the justification for the design of the study 
There is a clear need for accurate pedicle screw placement when stabilizing the spine to prevent damage to 
important structures. Image-guided navigation has shown to result in significantly accurate pedicle screw 
placement. With Surgical Navigation we have a similar image-guided technique as described in literature, but 
using real-time video overlay to align an instrument with a planned path.  
The positive results of pre-clinical testing and a clinical study with Surgical Navigation has provided 
confidence to perform a clinical study related to pedicle screw placement in humans to further evaluate 
Surgical Navigation. An observational pilot study using Surgical Navigation in a small group of patients 
undergoing a spine surgery involving pedicle screw placement is the next step in evaluating Surgical 
Navigation in clinical use. An observational, non-comparative study design has been chosen based on the 
primary objective of the study (i.e., to estimate the overall proportion of screws accurately placed with the 
research procedure). The outcome of the study will provide for estimation of the mean accuracy and 
confidence intervals for Surgical Navigation system.  These result will be compared with earlier found results 
in the pre-clinical testing and may be used to design future studies.  
 
Alternative studies design were evaluated but not chosen for the following reasons: 
• Based on previous literature studies with procedure where pedicle screws are placed, there is a large 
variability between the accuracy of placing pedicle screws (mostly 68%-94%, one study even 
reported 28% accuracy for the standard of care method (See table 1 in the Investigator Brochure). 
This is due to differences in pedicle width in the different areas in the spine (cervical/higher thoracic 
versus lumbar) and deformation of spine (especially with scoliotic patients). So there is an expected 
difference for the outcome for pedicle screw placement accuracy between different subjects and 
between different screws within a subject. 
• Randomizing treatment groups, during procedure, within a patient (i.e., left versus right side) for a 
paired study design that control for the between subject variability is cumbersome and may affect the 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 23 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
normal workflow for the procedure. Also, such step will increase the procedure time where patients 
are under sedation and lying with a large incision (increasing possible infections). 
• Randomizing treatment groups to different subjects (i.e., standard of care and surgical navigation) 
may require extremely large study as the study will need to account for the variability within and 
between subjects.  Also, the outcome of such comparison may not truly represent the therapy rather 
the patient condition. 
 
2.4. 
Purpose of the study 
The purpose of the study is to estimate the accuracy of the use of Surgical Navigation during spine 
procedures. Surgical Navigation is expected to provide assistance to the performing physician in aligning an 
instrument with a virtual path, planned on 3D image of the anatomy and overlaid on a live video image of the 
area of interest. Alignment of the instrument with the virtual planned path will potentially lead to placing the 
instrument.at the desired location. Therefore the primary objective of the study is to estimate the accuracy of 
placement of pedicle screw with the assistance of Surgical Navigation. Secondary objectives will further 
asses other aspects of the use of Surgical Navigation in spine procedures, such as procedure time, usability 
(see APPENDIX III: USABILITY TESTING BACKGROUND) and workflow, patient dose and safety. 
 
3. 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION 
 
The risk assessment process that Philips follows is in accordance with ISO 14971.This will ensure that the 
level of risk is assessed and risk mitigation measures (i.e. acceptable risk) are in place prior to start of the 
study. 
 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
o Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx27xxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• XxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxXxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• XxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxXxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
Participation in the clinical study will provide no additional risk other than using the Surgical Navigation. 
 
There are no possible interactions with concomitant medical treatments. 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 24 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
• Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxx 
• xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
A final risk assessment has been performed. The overall residual safety risk for the investigational device 
Surgical Navigation for the purpose of the clinical study is assessed to be acceptable. The investigational 
device Surgical Navigation is safe for clinical use based on the assessment of the individual risk profiles, the 
overall residual risks and supported by the earlier clinical study performed. 
 
To facilitate safe and effective operation of the system by a trained healthcare professional, instructions for 
use are provided as part of the device labelling, as well as training at system handover.  
 
The performed final safety assessment concluded that the potential benefits, as outlined above, clearly 
outweigh any potential risks associated with the use of this device in the clinical study. 
 
Other documents which are related to the risk management activities (e.g. informed consent, Investigator 
Brochure, IFU) are in agreement with both the Risk Management File and the final conclusions given in the 
Risk Management Report  
 
4. 
OBJECTIVES  
4.1. 
Primary objective  
The primary objective of this clinical investigation is to estimate the accuracy of pedicle screw placement 
using Surgical Navigation on post-procedural CBCT: 
 
Screw placement will be evaluated using a slightly adapted Gertzbein4 classification for pedicle screw breach 
as follows: 
grade 0 = breach 0 mm 
grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance  
grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance. 
 
Accuracy will be reported by the proportion of pedicles having either grade 0 or 1. 
4.2. 
Secondary objective(s) 
The secondary objectives are: 
1) To estimate the procedure time.   
2) To estimate the average time to insert a pedicle screw.  
3) To estimate the length of hospitalization (LOH) 
4) Collect System Usability Scale (SUS) and assess the clinical workflow related to easiness to work, 
image quality, real-time image update, preparation of patient tracking, confidence in image guidance, 
access planning, 3D segmentation, motion compensation, identify unknown potential use errors and 
evaluate risk controls. 
5) To estimate radiation dose (Dose Area Product (DAP) and Air Kerma (AK)) delivered to patient for: 
a. Total procedure  
b. During preparation and acquisition of CBCT for path planning 
c. During screw/instrument placement (using fluoro). 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 25 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
d. During preparation and acquisition of CBCT for confirmation 
e. Average procedure dose per planned path   
6) To estimate the total radiation dose (effective dose) received by operator, if DoseAware Xtend is 
available. 
7) To describe procedure related complications 
8) Report all adverse events 
9) Report all adverse device effects  
10) Report all device deficiencies that could have led to a serious adverse event  
 
The objectives are descriptive in nature and are intended to provide additional information. There will be no 
pass or fail criteria.  
 
5. 
STUDY DESIGN  
5.1. 
General 
This is a prospectively planned, single arm, single center study designed to estimate the accuracy of the 
pedicle screw placement using the Surgical Navigation procedure in patients undergoing pedicle screw 
fixation surgery.  Accuracy will be reported by the proportion of pedicles having either grade 0 or 1 according 
to a slightly adapted Gertzbein4 classification. The slightly adapted Gertzbein4 classification for pedicle screw 
breach is defined as follows: 
• grade 0 = breach 0 mm 
• grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
• grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance 
• grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance. 
 
The proportion of screws placed according to grade 0-3 will be estimated overall, and by region (e.g., 
cervical, lumbar, and thoracic).  In addition, the number of lateral or medial perforations, the distance of the 
longitudinal axis of the screw and the planned path at the smallest diameter of the pedicle (mm), and the 
largest distance between screw tip and planned target of screw (mm) will be reported. 
5.2. 
Investigational device exposure 
Surgical Navigation is used for image-guided navigation during pedicle screw placements procedures for 
subjects participating in the study.  
 
There are no additional devices or medications required for the study. 
5.3. 
Subjects 
5.3.1. 
In- and exclusion criteria 
Subjects participating in the study will be carefully selected based on the next inclusion and exclusion 
criteria. 
5.3.1.1. Inclusion criteria 
• Subject will be undergoing a spine surgery with pedicle screw placement 
• Subject is 16 years of age or older 
• Subject is able to give informed consent  
5.3.1.2. Exclusion criteria 
• Subject participates in a potentially confounding device or drug trial during the course of the study. 
• Subject meets an exclusion criteria according to national law (e.g. pregnant woman, breast feeding 
woman) 
5.3.2. 
Enrollment and duration 
Subjects are considered to be enrolled in the clinical investigation after they have signed the informed 
consent form. No study procedures will be performed before this moment.  

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 26 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
 
The subjects will be followed-up for this study until hospital discharge. After this the patient will be followed 
up according to standard of care outside the study.   
 
The total duration of the study is expected to take approximately 1 year 
5.3.3. 
Number of subjects 
In total 240 screws placement are needed. It is expected that approximately 15 to 25 subjects with pedicle 
screw surgery are necessary to collect sufficient data for the evaluation of the primary and secondary 
objectives of this clinical investigation. After the first two subjects have been treated with pedicle screws 
there will be a delay of at least 1 week until the third and fourth subjects will be undergoing the procedure 
with Surgical Navigation. After subject one to four have been treated and the DMC/DSMB have been given 
recommendations of continuation of the study then there is no limit on how many subjects can be treated 
during one day. Enrollment of subjects will be stopped after approximately 240 screws are placed. This is a 
common number of screws used in studies showing accuracy of pedicle screw placement in the cervical28.  
The enrollment period is expected to last for 7 months. 
 
See section 6 Statistical considerations for more detail on the number of subjects. 
5.3.4. 
Subject withdrawal or discontinuation 
Subjects can withdraw informed consent at any time during the clinical investigation. There are no specific 
criteria for subject withdrawal or discontinuation. 
5.4. 
Procedures 
Pedicle screw placement  
Pedicle screws will be placed using Surgical Navigation image guidance during spine surgery. The specific 
clinical investigation related steps for this spine surgery are (see also Figure 8): 
• Sterile drapes compatible with the Allura and Surgical Navigation with transparent windows are placed 
over the detector. 
• Several optical markers stickers (4-6 depending on the size of the region of interest) are placed at the 
back of the patient around the area of interest. 
• A 3D CT like image is made (CBCT) of the relevant vertebrae. 
• The spine image can be segmented using Surgical Navigation, if desired. 
• The optimal path for the screw/instrument is planned in the CBCT volume. 
• The optical view of Surgical Navigation is used to align the instrument (e.g. K-wires, screws 
instrumentation) with the planned path at the entry point. Progression view (view perpendicular to the 
planned path) using fluoro can be used during insertion of the screw, if desired. With this progression 
view function, the user can check on an x-ray image the actual placement of the screw at each 
moment in the procedure. 
• The pedicle screws/instrumentation are further inserted in the vertebra using tools according to 
standard of care. 
• Acquisition of a CBCT showing all placed pedicle screws/instrumentation to check the success of the 
procedure. This CBCT replaces the standard post-operative CT to check the procedure. 
For pedicle screw placement: Like in normal clinical practice, the necessity for revision of a pedicle 
screws is determined based on 3D information. This CBCT with the pedicle screws will be used to 
determine the accuracy of pedicle screw placement for the objectives of this study. The physician will 
indicate the classification according to the classification system (grade 0-3, see section 4.1). This 
classification can be done post-procedure.  
• Time of the total procedure will be measured. 
• Patient and occupational dose data will be collected using Surgical Navigation and DoseAware Xtend 
(if available at the hospital), respectively. 
 
Patients participating in this study are subject to follow-up until hospital discharge to collect the length of 
hospital stay.  
 
All other things are the same as the current standard of care. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 27 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
All post-procedural CBCT acquisitions will be evaluated by an independent reviewer (neurosurgeon, 
orthopedic surgeon or spine surgeon experienced in pedicle screw placements) to determine the accuracy of 
pedicle screw placement according to the modified Gertzbein grading system (grade 0-3, see section 4.1) 
and direction (lateral/medial breach).  
Furthermore, the distance (mm) between the following two points will be measured: 
• The planned path and screw axis at smallest pedicle diameter 
• The planned path and at the tip of the screw 
The classification by the independent reviewer will be used for the objectives. 
 
 
 Figure 8: Flowchart for patient undergoing pedicle screw placement 
 
 
Workflow feedback and usability information 
Observations related to the workflow for the spine procedure will be performed by a Philips representative 
during some of the procedures. Workflow feedback will also be obtained through a short interview with the 
physician performing the procedure.  
At the end of the study the physician(s) performing the procedure will be requested to complete a System 
Usability Scale (SUS) questionnaire to obtain general information related to the usability of Surgical 
Navigation related to these spine procedures. 
5.5. 
Monitoring Plan 
A detailed plan for monitoring arrangement will be described separately from the Clinical Investigation Plan. 
 
Monitoring will be performed by a trained person appointed by Philips to ensure compliance with the Clinical 
investigation plan, applicable national regulations and international standards, patient safety and data 
validity. The Sponsor, Philips, may designate one or more individuals to monitor the progress of a clinical 
study. The Sponsor may also delegate the monitoring responsibilities to a third party. However, the Sponsor 
remains ultimately responsible for the conduct of the study. The Institution is responsible for the appropriate 
de-identification of subject data. The investigational site should provide access to the source data of the 
subjects. 
 
The first visit will occur as soon as possible after the first subject is enrolled at each study site. The 
monitoring schedule is based on the following considerations: enrollment rate, study compliance at the 
center, magnitude of data corrections required, complexity of the investigation, IRB/MEC request, 
audit/inspection. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 28 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Critical data and processes will be monitored for this study prior to clinical report completion based on a risk 
based monitoring approach. Dependent on the risk a high or lower sample will be monitored. 
The monitor will review critical clinical data that affect study endpoints.  
 
A close-out visit at a site that has enrolled subjects will be conducted once the site has completed collecting 
data for the study. 
 
The monitor activities include: 
• Check that the study is conducted, recorded and reported in compliance with this clinical investigation 
plan, and applicable regulations. Acts to oversee the progress of the study. 
• Check signed and dated informed consent of the subjects and check that this is signed before any 
study-related procedures are undertaken. 
• Ensure that essential documents (e.g. contract, MEC approval) are maintained in the Investigator Site 
File. 
• Ensure recording of deviations from protocol and store in Investigator Site File or CRF. 
• Ensure that all adverse events and device deficiencies are reported to the sponsor, and all serious 
adverse events and device deficiencies that could have led to a serious adverse device effect are 
reported to the sponsor without unjustified delay. 
• Ensure that adverse event and device deficiency are reported to the MEC/IRB, if required. 
• Ensure that the principal investigator is informed and knowledgeable of all relevant document updates 
concerning the clinical investigation (e.g. clinical investigation plan and Investigator Brochure). 
Ensure that amendments to the protocol and/or Investigators Brochure are provided to the MEC/IRB 
by the principal investigator.  
• Ensure device accountability and check unapproved use outside the study. 
• Source data verification is anticipated. 
 
Names of the monitor(s) can be found in Appendix II: List of monitor(s) of this protocol. An update of this list 
can be provided to the site under separate cover.  
5.5.1. 
Maintenance and calibration 
The equipment relevant for the dose measurements during the clinical investigation are the Allura and 
DoseAwareExtend. Allura is calibrated at the time of installation and mostly after one year. 
DoseAwareExtend is calibrated once before providing it to the hospital. Since the duration of the study is 
expected to be less than one year after installation, both will not be monitored for calibration during the 
course of the study. 
 
The optical cameras and the X-ray system in the Allura system will be calibrated during the installation in the 
hospital. Regular check will be performed by trained Philips personnel during the clinical study if recalibration 
of the camera and X-ray system alignment is needed.  
6. 
STATISTICAL CONSIDERATIONS 
6.1. 
Sample Size Justification 
Mason et al (2014) reported on a meta-analysis of 30 studies evaluating screw placement using 2D, 3D, and 
conventional fluoroscopic image guidance systems. Using the conventional fluoroscopy, 2532 of 3719 
screws were inserted accurately (68.1% accuracy); with 2D fluoroscopic navigation, 1031 of 1223 screws 
were inserted accurately (84.3% accuracy); and with 3D fluoroscopic navigation, 4170 of 4368 screws were 
inserted accurately (95.5% accuracy). 
 
In a human cadaver study using Surgical Navigation system the accuracy was 85 % (95% CI of 72%, 95% 
and 74%, 96% using vertebras within a cadaver as a cluster), compared to 64% (95% CI of 44%, 77%) for 
the conventional free-hand method. In another human cadaver feasibility study, 21 screws were placed using 
the fluoroscopy guidance system and another 21 screws using Surgical Navigation system. In 95% of 
insertions (20) the pedicle screws were placed in accordance with the predefined paths using the Surgical 
Navigation compared to 71% of the insertions with fluoro-guidance system. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 29 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Assuming that the screw placement accuracy for this study will be similar to that observed in the cadaver 
study (i.e., 85%), a sample size of 240 screws will be required to estimate a 95% two-sided confidence 
interval so that the lower bound of the 95% CI is greater than the upper bound of the 95% CI observed for 
the cadaver study (i.e., 64% with upper bound of 95% CI of 77 with approximately 80% power (%) (i.e., 
approximately 5% Half Width). Assuming that the subjects will have 2 to 10 vertebrae’s treated and the 
assumption that the majority of the patients will be scoliotic patients, approximately 15 to 25 patients will be 
needed to reach 240 screw placements. 
Any deviation from the planned analysis described below will be documented with justification in the final 
clinical end report. 
6.2. 
General Consideration 
The primary analysis of safety and efficacy will be performed including all subjects who underwent treatment 
(ITT population).  All variables will be summarized by descriptive statistics  The statistics for continuous 
variables includes mean, median, standard deviation, 95% confidence interval for the means, and the 
number of observations.  For categorical variables, number events, event rate, and 95% confidence interval 
for the event rate will be presented. 
6.3. 
Subject disposition 
Subject disposition, including the total number of subjects evaluated will be presented. In addition, a listing 
will be provided with the reasons for why the subject was not evaluated. 
6.4. 
Demographics and Baseline Characteristics 
Basic subject characteristics such as age, gender, height and weight will be summarized.  In addition, the 
main reason for surgery will be presented. 
6.5. 
Primary objective 
Objective 
The primary objective of this clinical investigation is to estimate the accuracy of pedicle screw placement 
using Surgical Navigation based on post-procedural CBCT: 
 
Endpoint 
The primary endpoint is the accuracy of screw placement.  Screw placement will be evaluated using the 
slightly adapted Gertzbein4 classification for pedicle screw breach as follows: 
• grade 0 = breach 0 mm 
• grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
• grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance  
• grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance  
 
Accuracy is defined as the proportion of screws with Gertzbein grade 0 or 1. The proportion of screws 
accurately placed will be estimated overall, and by region (e.g., cervical, lumbar, and thoracic).   
 
In addition, the number of lateral or medial perforations, the distance of the longitudinal axis of the screw and 
the planned path at the smallest diameter of the pedicle (mm), and the largest distance between screw tip 
and planned target of screw (mm) will be reported. 
See Appendix V: Background information primary objective for more information on the primary objective. 
 
Analysis 
The primary objective for this study is to estimate the overall proportion of screws accurately placed.  All 
subjects who underwent treatment (ITT population) will be included in the primary efficacy analysis. Analysis 
will be performed assuming independence among different screws within a subject using Exact Clopper-
Pearson 95% confidence interval. In addition, analysis will be performed using each subject as the unit for 
analysis. For this analysis, a two-sided 95% CI calculated for the accuracy of screw placement will be 
calculated using clustered binary data methodology as described by Zhou (2011)29.  
 
In addition, the proportion of screws accurately placed will be summarized by region (e.g., cervical, lumbar, 
and thoracic) and by grade 0-3. The 95%confidence interval will be presented. 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 30 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
6.6. 
Secondary objectives 
6.6.1. 
Secondary objective: Procedure Time 
Objective 
To estimate the procedure time. 
 
Endpoint 
Besides the procedure time, also the time for preparation steps will be measured (see Table 4 for more 
specification). 
 
Table 4: Time measurement 
Endpoint 
Measured by the time between 
Total preparation time 
Nurse in room to prepare room – Time-out 
  Preparation time before patient on table 
Nurse in room to prepare room – Patient on table 
  Patient preparation time 
Patient on table-Start anesthesia 
  Anesthesia time 
Start anesthesia-End anesthesia 
  Patient preparation after anesthesia + 
  use system for patient preparation 
End anesthesia-Time-out 
Procedure time 
Incision time - Wound closure  
 
Analysis: 
Summary statistics will be calculated using Kaplan-Meier procedure. 
6.6.2. 
Secondary objective: Time to insert a pedicle screw 
Objective 
To estimate the average time to insert a pedicle screw.  
 
Endpoint 
The time to insert a screw is calculated from: 
• Start time of the CBCT to plan the path until last screw placed, divided by the number of screws. 
• Start time from choosing the path to place the first screw until last screw placed, divided by the 
number of screws 
 
The first represent the time it takes to place a screw taking into account the path planning and the second 
represent just the time it takes to place a screw during the live guidance work step. Time points are logged 
via the Surgical Navigation. 
 
Analysis 
Summary statistics will be calculated using Kaplan-Meier procedure. 
6.6.3. 
Secondary objective: Length of hospital stay 
Objective 
To estimate the length of hospitalization (LOH) 
 
Endpoint 
The endpoint is length of hospitalization. This is calculated by the day of procedure until hospital discharge in 
days. 
 
Analysis.  
Summary statistics will be calculated using Kaplan-Meier procedure. 
6.6.4. 
Secondary objective: System usability 
Objective 
Collect System Usability Scale (SUS) and assess the clinical workflow related to easiness to work, image 
quality, real-time image update, preparation of patient tracking, confidence in image guidance, access 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 31 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
planning, 3D segmentation, motion compensation, identify unknown potential use errors and evaluate risk 
controls. 
 
Endpoint 
The endpoint is System Usability Scale measured at the end of the study. Furthermore the clinical workflow 
will be described. 
 
All users that entirely completed the SUS questionnaire will be included in the analysis. 
 
Analysis 
The SUS scores of each respondent will be categorized according to the SUS score.  
Calculation of the scoring SUS will be done according to the following principle: 
• For odd items: subtract one from the user response. 
• For even-numbered items: subtract the user responses from 5 
• This scales all values from 0 to 4 (with four being the most positive response).  
• Add up the converted responses for each user and multiply that total by 2.5. This converts the range 
of possible values from 0 to 100 instead of from 0 to 40. 
 
A SUS score above a 68 would be considered above average and anything below 68 is below average. 
6.6.5. 
Secondary objective: Patient Dose 
Objective 
To estimate radiation dose (Dose Area Product (DAP) and Air Kerma (AK)) delivered to patient for: 
Total procedure  
a) During preparation and acquisition of CBCT for path planning 
b) During screw/instrument placement (using fluoro). 
c) During preparation and acquisition of CBCT for confirmation 
d) Average procedure dose per planned path   
 
Endpoint 
The endpoint is Radiation Dose (DAP and AK) delivered to the patient: 
a) For Total procedure (including CBCT and fluoro) 
b) During preparation and acquisition of CBCT for path planning 
c) During screw/instrument placement (using fluoro) (DAP and AK and fluoro time). 
d) During preparation and acquisition of CBCT for confirmation 
e) Average procedure dose per planned path. Calculated based on dose described at b) and c) divided 
by the number of screws. Average procedure dose per planned path will also be reported per region 
(e.g. cervical, thoracic and lumbar) 
 
Analysis 
All subjects who underwent the procedure will be included in this analysis. 
Radiation dose will be summarized using descriptive statistics.  Mean, median, standard deviation and 95% 
confidence interval for the mean will be presented. 
6.6.6. 
Secondary objective: Occupational dose  
Objective 
11) To estimate the total radiation dose (effective dose) received by operator, if DoseAware Xtend is 
available. 
 
Endpoint 
The endpoint is occupational dose measured via DoseAware Xtend. DoseAware Xtend is a CE labeled 
device. DoseAware Xtend measures real-time dose for the operator in the interventional suite via the use of 
Personal Dose Meter (PDM). The PDM is worn by the operator. This badge measures scatter radiation and 
transmits this information. 
 
Analysis 
This objective will only be done when DoseAware Xtend is present at a site.  

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 32 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Occupational dose will be summarized using descriptive statistics. Mean, median, standard deviation and 
95% confidence interval for the mean will be presented. 
6.6.7. 
Secondary objective: Procedure related complications  
Objective 
12) To describe procedure related complications 
 
Endpoint 
Procedure related complications  
Definition of complication: An adverse event that results in invasive intervention. Intravenous (IV) and 
intramuscular (IM) drug therapies are considered as invasive treatment. 
 
Analysis 
All procedure related complications will be presented in a tabular format.  
6.6.8. 
Secondary objective: Adverse events 
Objective 
Report all adverse events 
 
Endpoint 
Adverse events, including information of the seriousness, treatment needed, resolution and relevant 
judgment concerning the causal relationship with the investigational devices or procedure will be 
summarized for safety information. 
 
Analysis 
All adverse events will be presented in a tabular format.  
6.6.9. 
Secondary objective: Adverse Device Effects 
Objective 
Report all adverse device effects  
 
Endpoint 
Adverse device effects, including information of the seriousness, treatment needed, resolution and relevant 
judgment concerning the causal relationship with the investigational devices or procedure will be 
summarized for safety information. 
 
Analysis 
All adverse device effects will be presented in a tabular format.  
 
6.6.10. Secondary objective: Device Deficiencies that could have led to Serious Adverse 
Event 
Objective 
Report all device deficiencies that could have led to a serious adverse event  
 
Endpoint 
Device deficiencies that could have led to Serious Adverse Events, including any corrective actions taken 
during the study, if any, will be summarized for safety information. 
 
Analysis 
All device deficiency that could have led to a serious adverse device effect will be presented in tabular 
format.  
7. 
DATA MANAGEMENT 
Electronic Case Report Form (e-CRF) will be used to collect medical history, subjects demographics, 
procedure related information, protocol deviations, adverse events and device deficiencies. The e-CRF will 
be used for data review, data cleaning and issuing and resolving queries. This e-CRF is a web-based e-CRF 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 33 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
which is password protected and is 21 CFR part 11 compliant. At the end of the study the data will be stored 
as a frozen dataset and will be retained. Workflow analysis and SUS questionnaire will be performed 
separately from the e-CRF. 
 
The e-CRF data from the subjects will be key-coded (pseudonymized). The information related to the 
subjects (like name) is kept separately in the enrollment log at the hospital. Date and time of the procedure 
and date of discharge will be collected. Patient dose data will not contain any patient names or numbers. 
Procedure date and time will be used to link the dose data to the corresponding CRF data. 
Exported (image) data will be de-identified. The remaining data will be de-identified.  
The data will be collected and stored in a secure location. 
7.1. 
Retention period 
The investigator shall maintain the records related to this study during the investigation and for a period after 
the study according to national regulations (5 years) 
Philips will maintain the records for a period of device End of Life (EoL) plus 15 years. 
 
The sponsor and principal investigator shall take measures to prevent accidental or premature destruction of 
these documents. 
8. 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN AND INFORMED 
CONSENT 
Amendment to the Clinical investigational plan and the informed consent shall be notified to, or approved by 
the Medical Ethics Committee (MEC) and regulatory authority. The version number and date of amendments 
shall be documented. 
Significant changes (such as device modifications, study procedures) shall be discussed with the principal 
investigator prior approval. All changes will be documented with a justification and described in the latest 
version of the Clinical Investigation Plan.  
9. 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The Investigator is not allowed to deviate from the Clinical Investigation Plan or to enroll subjects that do not 
comply with all inclusion and exclusion criteria. Under emergency circumstances, deviations from the Clinical 
Investigation Plan to protect the rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the MEC. Such deviations shall be documented and reported to the sponsor and 
the MEC as soon as possible  
All deviations from the Clinical Investigation Plan will be documented with date, subject, reason, actions 
taken and if the deviation affects subject’s rights, safety and well-being or the scientific integrity of the clinical 
Investigation. The deviation shall be notified to the Sponsor as soon as possible via the e-CRF. Deviations 
will be reviewed by the sponsor and in case of serious or repetitive deviations a corrective action plan may 
represent a need to initiate a corrective action plan with the principal investigator. In some cases, necessitate 
suspension of enrollment at the site or ultimately the principal investigator will be disqualified. 
 
10. 
DEVICE ACCOUNTABILITY 
Access to the investigational device shall be controlled and the investigational devices shall be used only in 
the clinical investigation and according to the Clinical Investigation Plan. 
 
The sponsor shall keep records to document the physical location of all investigational devices from 
shipment of investigational device to the Investigation site until return or disposal. 
 
The principal investigator shall keep records documenting the receipt, installation, use, return and disposal of 
the investigational device, including date of receipt, identification of each investigational device, the date of 
use, and date on which the investigational device was returned/disposed.  
11. 
STATEMENTS OF COMPLIANCE 
This clinical Investigation shall be conducted in accordance with the clinical Investigation plan, and with the 
ethical principles that have their origin in the Declaration of Helsinki and all applicable regional and/or 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 34 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
national regulations. Furthermore, in Europe this clinical Investigation shall be conducted in accordance with 
the International Standards ISO 14155 Clinical investigation of medical devices for human subjects – Good 
clinical practice and the Medical Device Directive (MDD). Furthermore all investigators will complete financial 
disclosures, as outlined in the 21 CFR part 54.   
 
This clinical Investigation shall not be started prior to obtaining a favorable opinion from a Medical Ethics 
Committee (MEC) and Regulatory authority, if required. Any additional requirements imposed by the 
MEC/IRB and/or regulatory authority shall be followed. 
 
Insurance shall be provided for the subjects participating in this clinical trial according to local law. 
 
12. 
INFORMED CONSENT PROCESS 
Informed consent will be obtained from every subject in writing by the Investigator or his authorized designee 
before the clinical Investigation is started. The subject will be informed both orally and in writing about all 
aspects that are relevant to the subject’s decision to participate in the trial, including the trial procedures and 
risks and benefits of participation in the clinical investigation. Ample time should be provided for the subject 
to read and understand the informed consent form and to consider participation. The informed consent will 
include personally dated signatures of the subject and the principal investigator or an authorized designee 
responsible for conducting the informed consent process. A copy of the signed and dated informed consent 
form and any other written information will be provided to the subject. 
 
If new information becomes available that might significantly affect the subject’s future health and medical 
care, it shall be provided to the subjects in written form. If relevant, subject shall be asked to reconfirm their 
continuing informed consent in writing. 
 
13. 
ADVERSE EVENT REPORTING 
13.1. 
Definitions 
Adverse Event 
An Adverse Event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether 
or not related to the investigational device. 
NOTE 1 This definition includes events related to the investigational medical device or the comparator. 
NOTE 2 This definition includes events related to the procedures involved. 
NOTE 3 For users or other persons, this definition is restricted to events related to investigational medical devices. 
 
Adverse Device Effect 
An Adverse Device Effect (ADE) is defined as an adverse event related to the use of an investigational 
medical device. Note 1. This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of 
the investigational medical device. Note 2.  This includes and any event that is a result of a use error or 
intentional abnormal of the investigational device. 
 
Serious Adverse Event 
A Serious Adverse Event (SAE) is an adverse event that 
a) led to death, injury or permanent impairment to a body structure or body function 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient hospitalization or prolongation of existing hospitalization, or 
medical or surgical intervention to prevent life-threatening illness c) led to foetal distress, foetal death or a 
congenital abnormality or birth defect 
 
NOTE Planned hospitalization for a pre-existing condition, or a procedure required by the Clinical Investigation Plan, 
without a serious deterioration in health, is not considered a serious adverse event. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 35 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that resulted in any of the consequences characteristic of a serious adverse event 
 
Unanticipated Serious Adverse Device Effect  
Unanticipated Serious Adverse Device Effect (USADE) is 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 
NOTE Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome 
has been previously identified in the risk analysis report. 
 
Device Deficiency 
Inadequacy of an investigational medical device with respect to its identity, quality, durability, reliability, 
safety or performance. This may include malfunctions, use error, or inadequacy in the information supplied 
by the manufacturer. 
• .  
13.2. 
Reporting 
The following are considered reportable events: 
 
• Any  SAE; 
• Any Device deficiency that could have led to a SAE if  
o a) suitable action had not been taken or;  
o b) intervention had not been made or;  
o c) if circumstances had been less fortunate; 
o New findings/updates in relation to already reported events. 
 
The sponsor will report to the Competent Authority (MPA): 
• All reportable events as described above, which indicate imminent risk of death, serious injury, or 
serious illness and requires prompt remedial actions for other patients/subjects, users or other 
persons, or a new finding to it: immediately, but not later than 2 calendar days following the date of 
awareness of the sponsor of a new reportable event or new information in relation to an already 
reported event. 
 
• Any other reportable event or a new finding/update to it: immediately, but not later than 7 calendar days 
following the date of awareness of the sponsor of a new reportable event or new information in relation 
to an already reported event. 
 
.  
The investigator shall document these reportable events in the e-CRF which must be provided to the 
sponsor immediately, but not later than 3 calendar days after the investigational study site personnel’s 
awareness of the event. 
 
In Appendix II: List of monitor(s) provided by the sponsor which should be contacted by the investigator in 
the event of a reportable event is given. 
 
• Other adverse events shall be recorded on the adverse event forms in the e-CRF. The Sponsor and 
Monitor can request access to this information at any time. 
 
 
The CRF will include the following information for adverse event reporting: date of the adverse event, 
description, actions taken, resolution, assessment of both the seriousness and the relationship to Surgical 
Navigation application and procedure. It will be determined if the SAE is related to the device or procedure 
and classified according to five different levels of casualty:  
• Not related (relationship to the device or procedures); 
• Unlikely (relationship with use of the device seems not relevant and/or the event can be reasonably 
explained by another cause); 
• Possible (the relationship with the use of the device is weak but cannot be ruled out completely); 
• Probable (relationship with use of the device seems relevant and/or the event cannot be reasonably 
explained by another cause); 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 36 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
• Cause relationship (the serious event is associated with the device or the procedures beyond 
reasonable doubt). 
 
Information collected for device deficiencies are: date of device deficiency, whether this could have led to a 
Serious Adverse Device Effect (SADE) if a) suitable action had not been taken or b) intervention had not 
been made or c) if circumstances had been less fortunate.  
The investigator should report to the MEC and/or competent authority these serious adverse events and 
device deficiencies that might have led to a serious adverse device effect, if required by MEC or competent 
authority. 
 
 
13.3. 
Xxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
Table 5: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxs 
 
13.4. 
Unavoidable adverse events 
The following unavoidable adverse events are very common during the procedures performed in this clinical 
trial. Unavoidable adverse events do not need to be reported if occurred in the timeframe indicated below. 
Table 6: Unavoidable adverse events 
 
Unavoidable adverse event 
Time frame 
Incision pain/bruising after the intervention at point of entrance for the 
2 weeks 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 37 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
intervention  
 
13.5. 
Data Monitoring Committee 
Since the study will include subjects with the age of 16 years and older an independent Data Monitoring 
Committee (DMC/DSMB) will review all adverse events and all serious adverse events during the whole 
study period. The DMC/DSMB will review all adverse events that may occur after the first two subject have 
been treated. The DMC will provide a recommendation of continuation of the study. The third and fourth 
subject could be included 1 week after the first two subject have been treated with pedicle screws. The 
DMC/DSMB will review again and will provide a recommendation of continuation of the study. 
The DMC/DSMB will have regular meetings to evaluate any kind of events and provide recommendations 
regarding continuation of the study. 
14. 
EARLY TERMINATION OR SUSPENSION OF THE CLINICAL INVESTIGATION 
There are no provisions or interim analyses planned that can result in an early termination of the trial.  
Any signs of unknown or increased risks for the subjects will be discussed by the sponsor and investigator to 
assess the impact on the subjects and clinical investigation. Serious or repetitive occurrence of deviations 
from study protocol or non-compliance with regulations may also be reason for early termination or 
suspension of a study site.  
 
15. 
PUBLICATION POLICY 
It is the intention of the investigator and sponsor to submit the clinical investigation data for publication. Prior 
to submission, claims on intellectual property will be assessed. 
 
This study will also be registered on clinicaltrial.gov before first enrollment. 
 
16. 
DEFINITIONS AND ABBREVIATIONS  
 
Abbreviations 
Explanation of abbreviation 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AK 
Air Kerma 
CBCT 
Cone Beam Computed Tomography 
CFR 
Code Federal Regulations 
CI 
Confidence Interval 
CRF 
Case Report Form 
DAP 
Dose Area Product 
DMC/DSMB 
Data Monitoring Committee 
e-CRF 
Electronic Case Report Form 
Entry point 
The entry point is the point where the instrument (e.g. pedicle 
screws, screwdrivers, needle) will enter the body. The entry point 
can be the skin or the vertebrae, dependent on the type of 
procedure (Minimally invasive surgery or open surgery, 
respectively). 
IFU 
Instructions for Use 
IM 
Intramuscular 
ISO 
International Organization for Standardization 
IV 
Intravenous 
MEC 
Medical Ethic Committee 
MDD 
Medical Device Directive 
OR 
Odds Ratio 
Placement 
The actual position of the screw in the human body 
SAE 
Serious Adverse Event 
SUS  
System Usability Scale 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 38 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
USADE 
Unanticipated Serious Adverse Device Effect 
 
17. 
REFERENCES 
 
                                                     
1 Waschke A, Walter J, Duenisch P, Reichart R, Kalff R, Ewald C, CT-navigation versus fluoroscopy-guided 
placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur 
Spine J (2013) 22:654–660 
 
2 Rampersaud YR, Simon DA, Foley KT. Accuracy requirements for image-guided spinal pedicle screw 
placement. Spine (Phila Pa 1976) 2001; 26: 352-359  
 
3 Lee MH. Lin MH. Weng HH. Cheng WC. Tsai YH. Wang TC. Yang JT. Feasibility of Intra-operative 
Computed Tomography Navigation System for Pedicle Screw Insertion of the Thoraco-lumbar Spine. J 
Spinal Disord Tech. July 2013 Vol 26, issue 5 E183-E187 
 
4 Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 
Jan; 15(1):11-4. 
 
5 Weinstein JN , Spratt KF, Spengler D, Brick C, Reid S. Spinal pedicle fixation: reliability and validity of 
roentgenogram-based assessment and surgical factors on successful screw placement. 
Spine (Phila Pa 1976) 1988 Sep; 13(9):1012-8. 
 
6 Xu R , Ebraheim NA, Ou Y, Yeasting RA. Anatomic considerations of pedicle screw placement in the 
thoracic spine. Roy-Camille technique versus open-lamina technique. Spine (Phila Pa 1976). 1998 May 
1;23(9):1065-8. 
 
7 Thorsten Tjardes, Sven Shafizadeh, Dieter Rixen, Thomas Paffrath, Bertil Bouillon, Eva S. Steinhausen, 
Holger Baethis, Image-guided spine surgery: state of the art and future directions, Eur Spine J (2010) 19:25–
45 
 
8  Laine T, Lund T, Ylikoski M, Lohikoski J, Schlenzka D. Accuracy of pedicle screw insertion with and 
without computer assistance: a randomised controlled clinical study in 100 consecutive patients. Eur Spine J. 
2000 Jun. 9(3):235-40. 
 
9 Rajasekaran S1, Vidyadhara S, Ramesh P, Shetty AP Randomized clinical study to compare the accuracy 
of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries Spine (Phila Pa 
1976). 2007 Jan 15;32(2):E56-64. 
 
10 Kosmopoulos, Victor PhD; Schizas, Constantin MD, PD, FRCS Pedicle Screw Placement Accuracy: A 
Meta-analysis. Spine. 2007 Feb 1. 32(3):E111-20 
 
11 Mason A. Paulsen R. Babuska JM. Rajpal S. Burneikiene S. Nelson EL. Villavicencio AT. The accuracy of 
pedicle screw placement using intraoperative image guidance systems. J Neurosurg Spine. 2014 Feb. 
20(2):196-203. 
 
12 Tang J, Zhu Z, Sui T, Kong D., Cao X Position and complications of pedicle screw insertion with or without 
image-navigation techniques in the thoracolumbar spine: a meta-analysis of comparative studies.  J Biomed 
Res. May 2014; 28(3): 228–239.  
 
13 Gelalis ID, Paschos NK, Pakos EE, Politis AN, Arnaoutoglou CM, Karageorgos AC, Ploumis A, Xenakis 
TA  Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free 
hand, fluoroscopy guidance and navigation techniques. Eur Spine J. 2012 Feb. 21(2):247-55 
. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 39 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
                                                                                                                                                                                
14 Gebhard FT1, Kraus MD, Schneider E, Liener UC, Kinzl L, Arand M, Does computer-assisted spine 
surgery reduce intraoperative radiation doses?, Spine (Phila Pa 1976). 2006 Aug 1;31(17):2024-7; 
discussion 2028. 
 
15 Society of minimally invasive spine surgery http://www.smiss.org/ (dated 14 April 2014)  
 
16 Smith AG, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Mody MG, Shamie AN. 
Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures 
and clinical outcomes. Ann Surg Innov Res. 2013 Oct 30. 7(1):14.  
 
17  Wong AP, Smith ZA, Lall RR, Bresnahan LE, Fessler RG, The Microendoscopic Decompression of 
Lumbar Stenosis: A Review of the Current Literature and Clinical Results. Minimally Invasive Surgery 
Volume 2012 (2012), Article ID 325095 
 
18 Racadio JM, Babic D, Homan R, Rampton JW, Patel MN, Racadio JM, Johnson ND. “Live 3D guidance in 
the interventional radiology suite”. Am. J. Roentgenology. 2007 Dec; 189(6): W357-364 
 
19 Braak SJ1, van Strijen MJ, van Leersum M, van Es HW, van Heesewijk JP Real-Time 3D fluoroscopy 
guidance during needle interventions: technique, accuracy, and feasibility. AJR Am J Roentgenol. 2010 
May;194(5):W445-51.  
 
20 Braak SJ, Herder GJ, van Heesewijk JP, van Strijen MJ. Pulmonary masses: initial results of cone-beam 
CT guidance with needle planning software for percutaneous lung biopsy. Cardiovasc Intervent Radiol. 2012 
Dec;35(6):1414-21. Epub 2011 Dec 7. 
 
21 Braak SJ1, van Melick HH, Onaca MG, van Heesewijk JP, van Strijen MJ. 3D cone-beam CT guidance, a 
novel technique in renal biopsy--results in 41 patients with suspected renal masses. Eur Radiol. 2012 
Nov;22(11):2547-52. Epub 2012 Jun 2. 
 
22 Leschka SC, Babic D, ElShikh S, Wossmann C, Schumacher M, Taschner CA. C-arm cone beam 
computed tomography needle path overlay for image-guided procedures of the spine and pelvis. 
Neuroradiology. 2012 Mar; 54(3): 285-293. 
 
23 Carrafiello G , Fontana F, Mangini M, Ierardi AM, Cotta E, Floridi C, Piacentino F, Fugazzola C. Initial 
experience with percutaneous biopsies of bone lesions using XperGuide cone-beam CT (CBCT): technical 
note. Radiol Med. 2012 Dec;117(8):1386-97. Epub 2012 Feb 10. 
 
24 Busser WM, Hoogeveen YL, Veth RP, Schreuder HW, Balguid A, Renema WK, Schultzekool LJ. 
Percutaneous radiofrequency ablation of osteoid osteomas with use of real-time needle guidance for 
accurate needle placement: a pilot study. Cardiovasc Intervent Radiol. 2011 Feb;34(1):180-3.Epub 2010 Jul 
29. 
 
25 Braak SJ, van Strijen MJ, van Es HW, Nievelstein RA, van Heesewijk JP. Effective dose during needle 
interventions: cone-beam CT guidance compared with conventional CT guidance. J Vasc Interv Radiol. 
2011;22(4):455-61. 
 
26 Chandra RV, Meyers PM, Hirsch JA, Abruzzo T, Eskey CJ, Hussain MS, Lee SK, Narayanan S, Bulsara 
KR, Gandhi CD, Do HM, Prestigiacomo CJ, Albuquerque FC, Frei D, Kelly ME, Mack WJ, Pride GL 
Jayaraman MV, on behalf of the society of Neurointerventional surgery. Vertrebral augmentation: Report of 
the Standards and Guidelines Committee of the society of NeuroInterventional Surgery. J NeuroIntervent 
Surg 2014;6:7-15 
 
27 Tang J, Zhu Z, Sui T, Kong D, Cao X, Position and complication of pedicle screw insertion with or without 
image navigation techniques in the thoracolumbar spine: a meta-analysis of comparative studies. Journal of 
Biomedical Research 2014; 28(3): 228-239 
 
28 RECLASSIFICATION PETITION: Lateral Mass and Pedicle Screw Spinal Systems (cervical spine uses) 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 40 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
                                                                                                                                                                                
EXECUTIVE SUMMARY Orthopedic Surgical Manufacturers Association (OSMA). 
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalD
evicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM319946.pdf (verified on 20 Feb 
2015) 
 
29 Zhou, X; Obuchowski, N.A., and McClish, D.K. (2011). Statistical Methods in Diagnostic Medicine, 2nd 
edition, 110-111p. 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 41 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
APPENDIX I: LIST OF INVESTIGATORS AND SITES 
 
Update of this list can be provided to the investigation site under separate cover. 
Table 7: List of principle Investigators 
Name Clinical Coordinating Investigator 
Name and address investigation site 
Adrian Elmi-Terander, MD  
Neurosurgeon 
 
 
Karolinska University Hospital 
Department of Neurosurgery 
SE-171 76 Stockholm 
 
xxxxxxxxxxxxxxxxxxxxxxxxx  
 
Table 8: Independent reviewers 
Name and address other Institution(s) 
Name of the independent reviewers is pending 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 42 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
APPENDIX II: LIST OF MONITOR(S)/CLINICAL SCIENTIST 
 
Update of this list can be provided to the Investigational sites under separate cover. 
Table 9: List of monitor/clinical scientist 
Name Monitor(s)/Clinical Scientist 
Contact Information of Monitors 
Xxxxxxxxxxxxxxxxx 
Clinical Science study manager 
Emergency contact 
Philips Healthcare, Image-guided Therapy Systems 
Veenpluis 4-6  
5684 PC Best  
The Netherlands 
Xxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxx 
Drazenko Babic 
Clinical Fellow 
Philips Healthcare, interventional X-ray 
Veenpluis 4-6  
5684 PC Best  
The Netherlands 
Xxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxx 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 43 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
APPENDIX III: USABILITY TESTING BACKGROUND 
 
Usability testing refers to evaluating a device by testing it with representative users. Typically, during a test, 
participants will try to complete typical tasks while observers watch, listen and takes notes.  The goal is to 
identify any usability problems, collect qualitative and quantitative data and determine the participant's 
satisfaction with the device. The intent is to improve the usability of devices to reduce use error. 
 
During an usability test, observers will: 
• Learn if participants are able to complete specified tasks (such as essential tasks and safety related 
tasks to measure effectiveness) successfully  
• Identify how much effort does it takes to complete specified tasks (efficiency) 
• Find out how satisfied participants are with the product 
• Identify changes required to improve user performance and satisfaction 
• Analyze the performance to see if it meets the usability objectives 
 
 
System usability scale (SUS) 
The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability 
developed by Brooke, J30,31,32,33. The user needs to provide agreement or disagreement for the 10 
statements. (See also Appendix IV: System usability scale) After the appearing of the SUS in literature and 
once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for 
over 25 years to measure usability. 
 
To interpret the SUS score, it is converted to a percentile rank through a process called normalizing. The 
graph below shows how the percentile ranks associate with SUS scores and letter grades. For example, a 
raw SUS score of a 74 converts to a percentile rank of 70%. A SUS score of 74 has higher perceived 
usability than 74% of all products tested. It can be interpreted as a grade of a B.  
 
Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 
would be considered above average and anything below 68 is below average.34 
 
 
 
Figure 9: percentile ranks associated with SUS scores. 
                                                     
30 Bangor, A., Kortum, P.T. and Miller, J.A. (2008) An empirical evaluation of the System Usability Scale 
(SUS). International Journal of Human-Computer Interaction 24(6). 574–594 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 44 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
                                                                                                                                                                                
   
31 Lewis, J.R. & Sauro, J. (2009). The factor structure of the system usability scale. Chapter in human 
Centered Design First International Conference, HCD 2009, Held as Part of HCI International 2009, San 
Diego, CA, USA, July 19-24, 2009 Proceedings p 94-103 . 
   
32 Brooke, J. (1996). "SUS: a "quick and dirty" usability scale". In P. W. Jordan, B. Thomas, B. A. 
Weerdmeester, & A. L. McClelland. Usability Evaluation in Industry. London: Taylor and Francis. 
   
33   SUS score background information http://www.measuringusability.com/sus.php (checked 24 Feb 2015) 
 
34 Jeff Sauro(2011), A Practical Guide to the System Usability Scale. 978-1461062707 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 45 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
APPENDIX IV: SYSTEM USABILITY SCALE 
Instruction: Please fill in this questionnaire, which asks you to indicate whether you agree or disagree with 
ten statements.  You don’t need to take a lot of time thinking about each question, just give your first 
impression.  If you can’t answer a particular question, please mark the center point. 
 
Date of completion: 
 // 
Example:    05  / Jan  /  2016 
Initials of person: 
 
Function: 
 Physician  Technician 
How many spine procedures do you 
perform on average per month? 
 
________Months 
How many years of experience do you 
have with the Allura? 
_______Years 
How many interventions with Surgical 
Navigation did you approximately 
perform? 
Total of :______________ procedures with Surgical 
Navigation 
Age range (Years): 
 20-39 
 40-59 
 60 and above 
 
Please indicate how much you disagree or agree with 
the following statements: 
Strongly 
Disagree 
 
 
 
Strongly 
Agree 
1. I think that I would like to use this system frequently. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
2. I found the system unnecessarily complex. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
3. I thought the system was easy to use. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
4. I think that I would need the support of a technical 
person to be able to use this system. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
5. I found the various functions in the system were well 
integrated. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
6. I thought there was too much inconsistency in this 
system. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
7. I imagine that most people would learn to use this 
system very quickly. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
8. I found the system very awkward/cumbersome to 
use. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
9. I felt very confident using the system. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
10. I needed to learn a lot of things before I could get 
going with this system. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 

 
IGT systems 
Best 
 
Status: Final 
Clinical Investigation Plan 
 
Observational clinical study with Surgical 
Navigation to plan, position and check instrument 
placement for spine surgery interventions 
XCY607-130099 
2016 Sep 16 
Revision: 6.0 
Page 46 of 46 
 
Form ID: XCT-0302015 rev05 / 2015 Apr 10 
Philips' proprietary information. Unauthorized use is prohibited. 
 
APPENDIX V: BACKGROUND INFORMATION PRIMARY OBJECTIVE 
 
The classification system used in this study is as follows: 
• grade 0 = breach 0 mm 
• grade 1 = lumbar and thoracic < 2 mm, cervical <1 mm breach distance 
• grade 2 = lumbar and thoracic 2-4 mm, cervical 1-2 mm breach distance  
• grade 3 = lumbar and thoracic > 4 mm, cervical >2 mm breach distance  
 
This classification system describes the distance of breach. This is measured according to an adapted 
version of the in literature reported classification method by Gerztbein. This classification system is used for 
lumbar and thoracic region and is for this study adapted to also include the distance of the breach for 
pedicles placed in the cervical area. 
 
Furthermore the direction of perforation is interesting to measure (lateral or medial breach), since the 
consequences of the breach in a different direction might lead to different complications. Therefore additional 
information will be collected to report on the direction of perforation. 
 
Additionally, the distance between the planned path and the longitudinal axis of the screw indicate how 
accurate the pedicle screw can be placed according to the planned path. When using the distance between 
planned path and longitudinal axis of the screw in smallest area of the pedicle (mm), one measures at the 
most critical point in the pedicle. When measuring the distance between screw tip of the screw and the 
planned target of screw (mm), this is measured at the somewhat less critical point at the point of the screw.