A Prospective, Single-center, Single-arm, Pivotal Trial to Evaluate Safety and Efficacy of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System (Hello Hugo)
Conditions: Prostate Cancer, Cholelithiases, Cholecystitis, Gallbladder Polyp
Sponsor: Medtronic - MITG

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  A prospective, single-center, single-arm, pivotal trial to 
evaluate safety and effectiveness of the Medtronic 
Hugo™ Robotic Assisted Surgery (RAS) system in 
prostatectomy or cholecystectomy 
Clinical Investigation Plan Identifier MDT21028 
Study Product Name Medtronic Hugo™ Robotic Assisted Surgery (RAS) 
System 
Sponsor/Local Sponsor Medtronic Korea Ltd.  
Glass Tower, 17F, 534 Teheran-ro, Gangnam-gu, Seoul, 
Korea 06181 
Document Version V6.0 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 

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Table of Contents  
 
Table of Contents ...................................................................................................................... 2 
List of Tables ............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1. 
Glossary .............................................................................................................................. 7 
2. 
Synopsis ............................................................................................................................. 8 
3. 
Investigators and Study Administrative Structures ........................................................ 15 
3.1. Investigation Site .............................................................................................................. 15 
3.2. Principal Investigator ......................................................................................................... 15 
3.3. Sponsor ........................................................................................................................... 15 
4. 
Background and Objectives ............................................................................................. 16 
4.1. Background ...................................................................................................................... 16 
4.2. Objectives ........................................................................................................................ 19 
4.2.1. 
Primary Objective ............................................................................................................. 19 
4.2.2. 
Secondary Objective ......................................................................................................... 19 
5. 
Product Description.......................................................................................................... 21 
5.1. General ............................................................................................................................ 21 
5.1.1. 
Hugo™ RAS Surgeon Console ............................................................................................ 21 
5.1.2. 
Hugo™ RAS Arm Cart Assembly......................................................................................... 22 
5.1.3. 
Hugo™ RAS Tower ............................................................................................................ 23 
5.1.4. 
Hugo™ RAS Endoscope Adapter ........................................................................................ 23 
5.1.5. 
Other Components ........................................................................................................... 23 
5.2. Manufacturer .................................................................................................................... 24 
5.3. Equipment ........................................................................................................................ 24 
5.4. Intended Use .................................................................................................................... 24 
5.5. Intended Population .......................................................................................................... 25 
5.6. Product Use ...................................................................................................................... 25 
5.6.1. 
Operating Room Setup ..................................................................................................... 25 
5.6.2. 
Preparing for Surgery........................................................................................................ 26 

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5.6.3. 
Port Placement ................................................................................................................. 26 
5.6.4. 
Working with the Endoscope and Instruments at the Bedside .......................................... 26 
5.6.5. 
Post Surgery Disassembly, Procedures, and Cleaning ........................................................ 27 
5.6.6. 
Shutting Down and Moving Hugo™ ................................................................................... 27 
5.7. Product Training Requirements ........................................................................................... 27 
5.8. Packaging ......................................................................................................................... 28 
5.9. Product Receipt and Tracking ............................................................................................. 28 
5.10. 
Product Storage ........................................................................................................... 29 
5.11. 
Product Accountability .................................................................................................. 29 
6. 
Selection of Subjects ........................................................................................................ 30 
6.1. Study Population ............................................................................................................... 30 
6.2. Subject Enrollment ............................................................................................................ 30 
6.3. Inclusion Criteria ............................................................................................................... 30 
6.4. Exclusion Criteria ............................................................................................................... 30 
6.5. Sample Size Determination ................................................................................................. 31 
7. 
Study Method ................................................................................................................... 33 
7.1. Duration ........................................................................................................................... 33 
7.2. Design ............................................................................................................................. 33 
7.3. Rationale .......................................................................................................................... 33 
8. 
Study Procedures ............................................................................................................. 34 
8.1. Schedule of Events ............................................................................................................ 34 
8.2. Subject Consent ................................................................................................................ 35 
8.3. Enrollment ........................................................................................................................ 36 
8.4. Baseline (Day -28 to 0) ...................................................................................................... 36 
8.5. Surgical Procedure (Day 0) ................................................................................................. 37 
8.5.1. 
Prostatectomy Procedures ............................................................................................... 39 
8.5.2. 
Cholecystectomy Procedures ............................................................................................ 40 
8.6. Up to Hospital Discharge (After Surgery~Discharge) ............................................................. 41 
8.7. Post-Operative Follow-up (Up to Day 30) ............................................................................. 42 
8.7.1. 
Prostatectomy Subjects (Day 7, Day 14, and Day 30) ......................................................... 42 
8.7.2. 
Cholecystectomy Subjects (Day 30)................................................................................... 43 

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8.8. Subject Exit, Withdrawal or Discontinuation .......................................................................... 43 
8.9. Prior and Concomitant Medications/Therapies ....................................................................... 44 
8.10. 
Assessment of Effectiveness .......................................................................................... 44 
8.11. 
Assessment of Safety ................................................................................................... 45 
8.12. 
Recording Data ............................................................................................................ 45 
8.13. 
Deviation Handling ....................................................................................................... 46 
9. 
Statistical Design and Methods ........................................................................................ 47 
9.1. General Aspects of Analysis ................................................................................................ 47 
9.2. Pre-operative Characteristics .............................................................................................. 48 
9.3. Surgical Data .................................................................................................................... 48 
9.4. Primary Endpoint ............................................................................................................... 48 
9.5. Secondary Endpoints ......................................................................................................... 48 
9.6. Other Pre-Specified Measures ............................................................................................. 49 
9.7. Interim Analysis ................................................................................................................ 49 
9.8. Subgroup Analyses ............................................................................................................ 49 
10. 
Adverse Events and Device Deficiencies ....................................................................... 50 
10.1. 
Adverse Events and Device Deficiencies .......................................................................... 50 
10.2. 
Definitions/Classifications .............................................................................................. 50 
10.3. 
Reporting of Adverse Events and Device Deficiencies ....................................................... 55 
11. 
Data Review Committees .............................................................................................. 57 
12. 
Ethical and Administrative Considerations.................................................................... 58 
12.1. 
Statement(s) of Compliance .......................................................................................... 58 
12.2. 
CIP Amendments ......................................................................................................... 58 
12.3. 
Role of the Investigation Site ........................................................................................ 58 
12.4. 
Role of the Institutional Review Board ............................................................................ 59 
12.5. 
Role of the Investigators and Study Staff ........................................................................ 59 
12.6. 
Role of the Sponsor ...................................................................................................... 60 
12.7. 
Data Management........................................................................................................ 60 
12.8. 
Monitoring .................................................................................................................. 61 
12.9. 
Direct Access to Source Data/Documents ........................................................................ 61 
12.10. 
Confidentiality ............................................................................................................. 61 
12.11. 
Liability/Insurance Information ...................................................................................... 62 

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12.12. 
Treatment after the Completion of the Trial .................................................................... 62 
12.13. 
Record Retention ......................................................................................................... 62 
12.14. 
Reporting Requirements ............................................................................................... 62 
12.15. 
Publication and Use of Information ................................................................................ 63 
12.16. 
Planned Study Closure .................................................................................................. 63 
12.17. 
Suspension or Early Termination .................................................................................... 64 
13. 
References ..................................................................................................................... 65 
14. 
Appendices .................................................................................................................... 66 
14.1. 
Investigator Agreement and Signature Page ................................................................... 66 
14.2. 
List of the Investigators and Study Staff ......................................................................... 66 
14.3. 
Investigational Device and Compatible Components ......................................................... 66 
14.4. 
Instructions for Use/Labeling ......................................................................................... 66 
14.5. 
Sample Informed Consent Form .................................................................................... 66 
14.6. 
Sample Case Report Form ............................................................................................. 66 
14.7. 
Foreseeable Adverse Event List...................................................................................... 66 
14.8. 
Precautions ................................................................................................................. 67 
15. 
Version History .............................................................................................................. 68 
 
List of Tables 
Table 1. Summary of Pre-Clinical Studies on the Hugo™ RAS System...................................................... 17 
Table 2. Summary of Cadaveric Studies on the Hugo™ RAS System ........................................................ 18 
Table 3. Comparison between the Investigational Device and Locally Marketed Device ......................... 24 
Table 4. Product Training Requirements ................................................................................................ 28 
Table 5. Data Collection and Study Procedure Requirements at Subject Visits ....................................... 34 
Table 6. Medications Taken within 30 Days prior to Surgery .................................................................. 44 
Table 7. Adverse Event and Device Deficiency Definitions ...................................................................... 51 
Table 8. Unavoidable Adverse Events .................................................................................................... 53 
Table 9. Adverse Event Classification Responsibilities ............................................................................ 53 
Table 10. Clavien-Dindo Classification .................................................................................................... 55 
Table 11. Safety Reporting Requirements .............................................................................................. 55 
Table 12. Investigator Reports Applicable per Medtronic Requirements ................................................ 63 

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 List of Figures 
Figure 1. Hugo™ RAS System Overview .................................................................................................. 21 
Figure 2. Surgeon Console ..................................................................................................................... 22 
Figure 3. Arm Carts ................................................................................................................................ 22 
Figure 4. System Tower ......................................................................................................................... 23 
Figure 5. Port Placement and Arm Cart Positioning (Prostatectomy) ...................................................... 40 
Figure 6. Port Placement and Arm Cart Positioning (Cholecystectomy) .................................................. 41 
 
 

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1. Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AJCC 
American Joint Committee on Cancer 
ASA 
American Society of Anesthesiologists 
BMI 
Body Mass Index 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CRIS 
Clinical Research Information Service 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
ERCP 
Endoscopic retrograde cholangiopancreatography 
FAS 
Full Analysis Set 
GS 
General Surgery 
IC 
Informed Consent 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
KGCP 
Korean Good Clinical Practice 
KUB 
Kidney, Ureter and Bladder 
MAOI 
Monoamine Oxidase Inhibitor 
MedDRA 
Medical Dictionary for Regulatory Activities 
MFDS 
Ministry of Food and Drug Safety 
OR 
Operating Room 
PPS 
Per Protocol Set 
PSA 
Prostate Specific Antigen 
RAS 
Robotic Assisted Surgery 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

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2. Synopsis 
Version 
V6.0 (2023-04-03) 
Study Title 
A prospective, single-center, single-arm, pivotal trial to evaluate safety and 
effectiveness of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) system in 
prostatectomy or cholecystectomy 
Investigational 
Device 
Product Name: Hugo™ RAS System 
Product Code/Class: Robotic surgical system, navigation (A67050.04), Class III 
License Holder: Medtronic Korea Ltd. (Manufacturer: Plexus Corp) 
Intended Use: The Hugo™ RAS System is intended to assist in the accurate 
control of instruments and accessories including rigid endoscopes, blunt and 
sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, 
endoscopic retractors, electrosurgical tools and accessories for endoscopic 
manipulation of tissue, including grasping, cutting, blunt and sharp dissection, 
approximation, ligation, electrosurgery, and suturing during urologic and general 
endoscopic (laparoscopic) surgical procedures including prostatectomy and 
cholecystectomy.  
Sponsor 
Medtronic Korea Ltd.  
Glass Tower, 17F, 534 Teheran-ro, Gangnam-gu, Seoul, Korea 06181 
Principal 
Investigator(s) 
Prof. Jin-Young Jang (Dept. of Hepatobiliary and Pancreatic Surgery, Seoul 
National University Hospital) 
Indication under 
Investigation 
Patients have been indicated for a radical prostatectomy or cholecystectomy 
[Rationale for study indication] 
This trial will collect patient data undergoing two representative procedures in 
robotic surgery field to minimize potential confounding effect due to surgeon’s 
proficiency, or learning curve. To be specific, indications under the study 
include one procedure each in the non-general surgery (GS) specialty (e.g., 
prostatectomy) and the GS specialty (e.g., cholecystectomy).  
- Prostatectomy: The number of prostatectomy has been increased in recent 
years, upon prevalence increase of prostate cancer in Korea. Robot-assisted 
prostatectomy has been preferred over open, or laparoscopic prostatectomy in 
Korea. According to report from the National Evidence-based Healthcare 
Collaborating Agency in 2013, prostatectomy is the most frequently performed 
robotic procedure in Korea.  
- Cholecystectomy: According to the Main Surgery Statistical Yearbook 2019, 
cholecystectomy is the fifth most frequently performed surgery in Korea 
(84,500 cases as of 2019) so that there are many patients who can get 
therapeutic benefits through product approval. Furthermore, since the 
effectiveness of robotic cholecystectomy has been proven from clinical data of 

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commercialized products such as da Vinci and Revo-i, there will be minimal 
impact on the product safety and effectiveness from factors other than the 
product itself, such as surgeon’s proficiency in robot-assisted procedures. 
Study Purpose 
This study aims to evaluate the safety and effectiveness of the Medtronic 
Hugo™ RAS System when used for prostatectomy or cholecystectomy. 
Study Design 
Prospective, single-center, single-arm, pivotal trial 
Study Duration 
9 months after protocol approval 
- IRB submission and site activation: 3 months  
- Subject enrollment to follow-up completion: 3 months 
- Statistical analysis and report writing: 3 months 
Sample Size 
At least 40 patients (20 radical prostatectomy, 20 cholecystectomy patients) 
[Sample size determination] 
To estimate the number of sample size, two things are taken into account: The 
number of subjects from previous studies, and the minimum number to show 
whether the primary objective is met. 
We plan to include 40 patients (20 prostatectomy patients, and 20 
cholecystectomy patients) for the study. The sample size is greater than the 
minimum analyzable number of subjects. The study will be considered 
successful when the point estimate of the completion rate is greater than or 
equal to 95%.  
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
1) Adult subjects (22 years old or greater) who are willing to participate and 
provide informed consent 
2) Subjects indicated for a radical prostatectomy or a cholecystectomy 
  - Prostatectomy: Male patients requiring radical prostatectomy for clinically 
localized prostate cancer 
    * Clinically localized prostate cancer is defined as following: biopsy-proven 
prostate adenocarcinoma, clinical staged as T1-T2N0M0 upon standard 
imaging findings such as bone scan, MRI, or CT 
  - Cholecystectomy: Patients requiring cholecystectomy for cholelithiasis, 
cholecystitis, or gallbladder polyps 
    * For gallbladder polyps, only followings will be considered: gallbladder 
polyps ≥10 mm, enlarging polyps, or symptomatic gallbladder polyps 
Exclusion Criteria 
1) Patient with a considerable risk for laparoscopic surgery (e.g., severe 
cardiopulmonary diseases which contraindicated to general anesthesia, 
uncontrolled coagulopathy, etc.) 
2) Patients requiring urgent surgery 
3) Pregnant or lactating women 

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4) Patients with either of followings: 
  - Prostatectomy: Metastatic prostate cancer or estimated life expectancy less 
than 10 years 
  - Cholecystectomy: Severe liver cirrhosis (Child-Pugh class C) with portal 
hypertension, suspicion of gallbladder cancer 
5) Previous abdominal surgery (open or laparoscopic) within 2 years before 
enrollment 
6) Concurrent participation in another clinical study that may confound study 
results 
7) Patient has a condition that could compromise study compliance (e.g., 
mentally incompetent, alcohol or drug abuse) as determined by the 
investigator 
8) Subjects who are considered unsuitable to conduct the trial as determined 
by the investigator 
Study Procedures 
The study visits include baseline visit, admission (surgery to discharge), and 
follow-up visit after discharge: 
- 
Baseline: To determine study eligibility and collect baseline information 
(demographics, medications, medical history, surgical history, etc.) 
- 
Surgical procedure: To re-confirm eligibility criteria, procedure set-up 
and take-down, medication changes, intraoperative complication 
evaluation, disease state evaluation, procedure success, conversion 
rates, protocol deviation, adverse event evaluation, and device 
deficiency collection 
- 
Up to hospital discharge: Adverse event evaluation, complication rate, 
disease state evaluation, medication changes and protocol deviation 
- 
Follow-up after discharge: Adverse event evaluation, complication rate, 
disease state evaluation, length of hospital stay, readmission (if 
applicable), reoperation (if applicable), medication changes, protocol 
deviation and study exit 
Prior to subject enrollment, investigators who participate in surgical procedure 
will be properly trained on the investigational device. When a subject provides 
written informed consent, the principal investigator reviews the subject’s 
medical records and confirms the eligibility criteria. The subject will be 
hospitalized and prepped for surgery according to site standard practices.  
On the day of surgery (Day 0), robot-assisted prostatectomy or 
cholecystectomy using Hugo™ RAS System is performed according to patient’s 
indication. Intraoperative complication during the surgery will be monitored. 
For prostatectomy subjects, pathological examination on the resected 
specimen shall be performed. 

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Subjects will be followed through 30-day post-operative visit. Prostatectomy 
subjects will be followed at the day of discharge, 7-, 14-, and 30-day post-
operative visits. Cholecystectomy subjects will be followed at the day of 
discharge, and 30-day post-operative visit. Post-operative complications will be 
evaluated. Subject’s study participation will be terminated when the subject 
expires, is lost to follow-up, or at the last follow-up visit (whichever occurs 
first). 
Study Assessments 
and Endpoints 
Study Assessments 
Following information will be collected during the study. 
Category 
Measurements 
Demographics 
Sex, date of birth, height, weight, BMI 
Medical history 
Comorbidities, past surgical history, family 
history, ASA class 
Laboratory tests 
Blood test 
Vital signs 
Vital signs (blood pressure, pulse rate, respiration 
rate, body temperature),  
Indication under study 
Indication for robotic surgery, date of diagnosis 
[Prostatectomy] Prostate volume, Biopsy Gleason 
score, PSA, clinical stage, prior neoadjuvant 
hormonal therapy 
[Cholecystectomy] Concomitant bile duct stones, 
ERCP 
Device/Procedure 
information 
Device identification, setup time, console time, 
total operative time, takedown time, estimated 
blood loss, conversion to open/laparoscopic 
surgery, blood transfusion, date of admission, 
date of discharge, changes to port placement, 
delay in robot setup time, delay in total operative 
time 
[Prostatectomy] Pelvic lymph node dissection, 
nerve-sparing, date of urinary catheter removal 
[Cholecystectomy] Amount of gallbladder 
adhesions, concomitant gallbladder stones, type 
of gallbladder polyps, acute cholecystitis, other 
concomitant procedures, use of drainage tube, 
date of drain removal 
Pathological exam 
[Prostatectomy] Pathological stage, tumor size, 
positive surgical margin 

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Post-operative imaging 
findings (collected only 
if it is related to adverse 
events) 
[Prostatectomy] chest X-ray, abdomen X-ray, KUB 
X-ray, and cystography findings 
Medication 
Study-related prior/concomitant medication, 
indication 
Safety information 
Any adverse events (including post-operative 
complications), device deficiencies 
Study Endpoints 
- Primary endpoint 
1) Completion rate (A proportion of subjects who completed the surgery 
without conversion (to laparoscopic or open surgery) due to system serious 
malfunction, and without any major complications within 24-hour post-
surgery) 
    * Major complication is defined as Clavien-Dindo grade ≥3 
- Secondary endpoints 
1) Overall complication rate through 30-day post-surgery: A proportion of 
subjects with any post-operative complication within 30-days post-surgery 
using the investigational device 
2) Major complication rate through 30-day post-surgery: A proportion of 
subjects with any post-operative complication classified ≥3 by the Clavien-
Dindo system within 30-days post-surgery using the investigational device 
3) Readmission rate through 30-day post-surgery: A proportion of subjects 
hospitalized within 30 days post-surgery 
4) Reoperation rate through 30-day post-surgery: A proportion of subjects go 
through reoperation for the same indication within 30 days post-surgery 
5) Device deficiency rate: A proportion of subjects with any device deficiency 
during robotic assisted surgery using the investigational device 
Statistical Analysis 
General Aspects of Analysis 
The statistical analysis will be performed respectively on all subjects treated 
with the investigational device (Full analysis set) and subjects completed the 
study per the clinical investigation plan (Per protocol set). The full analysis set 
will be the primary analysis set for the primary and secondary endpoints.  
Descriptive summary will be provided: number of subjects (n), mean, standard 
deviation, median, and range for continuous variables, and frequency, 
percentage for categorical variables. If necessary, continuous variables will be 
grouped into several categories for descriptive summary. If applicable, power 
of 80%, and significance level of 5% (two-sided) will be used for statistical test, 
unless otherwise specified. Data analysis will be performed using SAS for 

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Windows (version 9.4 or higher, SAS Institute Inc. Cary, NC) or other widely 
accepted statistical or graphical software. 
Statistical Analysis 
1) Pre-operative characteristics: Demographics, medical history, vital signs, 
laboratory values, ASA class, etc. will be summarized using descriptive 
statistics. 
2) Surgical data: Setup time, console time, operative time, takedown time, 
estimated blood loss, conversion to open/laparoscopic surgery, blood 
transfusion during the surgery, length of hospital stay, delay in setup time, 
and delay in total operative time will be summarized. 
3) Primary endpoint: The Clopper-Pearson Exact test for single proportion will 
be conducted. The number of subjects successfully completed the surgical 
procedure, percentage, and its 95% confidence interval will be summarized. 
If the point estimate of the completion rate is greater than or equal to the 
pre-determined value (i.e., 0.95), it is considered that the primary objective 
is met.  
4) Secondary endpoints: Descriptive statistics will be used. Frequency, 
percentage, and its 95% confidence interval will be presented for each 
endpoint. The Clopper-Pearson Exact test with 95% confidence interval for 
single proportion will be conducted. 
5) Other pre-specified measures: Adverse event rate will be summarized. 
Adverse events during the study period will be summarized by MedDRA 
term (system organ class and preferred term). For prostatectomy subjects, 
pathological findings will be also presented.  
 
 

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Data collection and study procedure requirements of subject visits 
Procedure/Assessments 
Baseline 
Surgery 
Discharge 
Follow-up1) 
 
-28D~0D 
0D 
0D~Day of 
discharge 
7D 
(±3D)2) 
14D 
(±3D)2) 
30D 
(±7D) 
Informed consent 
X 
 
 
 
 
 
Eligibility check 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Laboratory tests3) 
X 
 
X4) 
 
X 
X 
Vital signs 
X 
X 
X4) 
 
X 
X 
Indication under study5) 
X 
 
 
 
 
 
Procedure information5) 
 
X 
 
 
 
 
Device deficiency 
 
As they 
occur 
 
 
 
 
Pathological exam6) 
 
 
X 
 
 
 
Post-operative imagings7) 
 
 
X 
X 
 
 
Medication8) 
X 
X 
X 
X 
X 
X 
Adverse event9) 
As they occur 
Protocol deviation 
As they occur 
Readmission/Reoperation 
 
 
 
As they occur 
Study Exit 
 
 
 
 
 
X 
1) If any unscheduled visit occurs other than planned follow-up visit, subject’s data (e.g., adverse event, medication, 
etc.) can be collected if applicable.  
2) Applicable for prostatectomy subjects only. 
3) Laboratory tests include complete blood cell and serum chemistry.  
4) Timing of laboratory tests and vital sign assessments up to discharge will be immediately after surgery (Day 0; 
laboratory tests only), Day 1, and Day 3 for prostatectomy subjects, and Day 1 for cholecystectomy subjects. 
5) Procedure-specific information will be collected each for prostatectomy or cholecystectomy. 
6) Applicable for prostatectomy subjects only.  
7) Applicable for prostatectomy subjects only. Post-operative imaging includes chest X-ray (AP view), abdomen X-
ray (Supine or erect view), KUB X-ray, and cystography. The cystography will be conducted on Day 7, while other 
radiographs will be obtained on immediately after surgery (Day 0; except KUB X-ray), Day 1, and Day 3. Post-
operative imaging findings will be only collected to in the CRF if it is related to adverse events. 
8) Following study-related medications will be collected: Pre-procedure anticoagulants or monoamine oxidase 
inhibitors (which may affect hemostasis) within 30 days prior to surgery, any relevant medication related to the 
study indication, pain medications due to an adverse event, medications given as treatment for an adverse event. 
Medication will be coded using WHO Drug Dictionary. 
9) Adverse events will be collected after subject has agreed to participate and provided the written informed consent. 

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3. Investigators and Study Administrative Structures 
3.1. Investigation Site 
Site 
Address 
Contact 
Seoul National University Hospital 101, Daehak-ro Jongno-gu, Seoul 03080, Korea 
+82-1588-5700 
3.2. Principal Investigator 
Role 
Name 
Department 
Title 
Contact 
Principal Investigator 
Jin-Young Jang 
Hepatobiliary and 
Pancreatic Surgery 
Professor 
+82-2-2072-2318 
3.3. Sponsor 
Company Name 
Address 
Contact 
Medtronic Korea Ltd. 
17F, 534 Teheran-ro, Gangnam-gu, Seoul 06181, Korea 
+82-2-3404-3600 
 
 

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4. Background and Objectives 
4.1. Background  
Laparoscopic surgery, has the advantage of less pain and shorter hospital stay compared to open 
surgery as it enables to minimize incision length. However, laparoscopic approach has drawbacks such 
as limited field of view, weak feeling of contact, and learning curve for surgeons. Advancement in 
medical technology such as robot-assisted surgery (RAS) empowered surgeon to overcome these 
challenges, with 3-dimensional vision and better movements with improved degrees of freedom, during 
operational procedure [1]. The safety and performance of commercially available RAS systems have 
been evaluated in previous literature showing that robotic-assisted surgery was comparable or superior 
to open or traditional laparoscopic surgery in terms of length of hospital stay, complication rate, 
intraoperative blood loss, and intraoperative conversion rate. 
In Korea, the first robotic surgery was performed in 2005 and several robotic surgery devices (e.g., da 
Vinci® Surgical System, Revo-i) are commercially available. According to National Evidence-based 
Healthcare Collaborating Agency report in 2010, robotic assisted surgery has been widely performed in 
urological procedures (e.g., prostatectomy, nephrectomy, cystectomy, etc.) and general surgery 
procedures (e.g., cholecystectomy, gastrectomy, colectomy). As of 2018, annual robotic procedure 
volume was 20,000 cases [2, 3]. 
The Medtronic Hugo™ RAS System is a modular robotic platform for performing robotically assisted 
minimally invasive surgery. Preclinical studies demonstrate that the Hugo™ RAS Platform performs as 
intended when used for partial nephrectomy, radical prostatectomy (pelvic lymphadenectomy), radical 
cystectomy (ureteroneocystostomy), and radical hysterectomy/myomectomy (ovariohysterectomy).  
Pre-clinical studies were conducted using 36 Yorkshire swine to evaluate the safety and performance of 
the Hugo™ RAS System (4 groups of 6 pigs per type of urological and gynecological procedures, 2 groups 
of 6 pigs per type of general surgery procedures). The studies met all pre-defined criteria, as evidence by 
successfully completing all procedures using the Hugo™ RAS System across all surgical models with no 
occurrence of a serious adverse event. Furthermore, necropsies of the animals show no signs of device-
related findings or adverse events (e.g., bleeding). The results of the pre-clinical studies are summarized 
below. 

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Table 1. Summary of Pre-Clinical Studies on the Hugo™ RAS System 
Group 
No. 
(# of 
animals) 
Procedure 
Results1) 
Procedure time 
(hh:mm)2) 
Estimated 
blood 
loss (mL) 
Malfunction 
recovery 
time (min) 
Tissue damage 
due to 
electrosurgical 
instruments 
Urologic and gynecological procedures 
1 (N=6) 
Ureteroneocystostomy 
00:55~01:15 
(Total operative 
time: 
01:46~02:19) 
2~10 
<1~9 
None 
2 (N=6) 
Ovariohysterectomy 
00:23~00:55 
(Total operative 
time: 
01:11~01:48) 
2~25 
<1~3 
None 
3 (N=6) 
Partial nephrectomy 
00:45~01:24 
(Total operative 
time: 
01:33~02:14) 
<5~100 
<1~23 
None 
4 (N=6) 
Pelvic lymphadenectomy 
01:05~01:24 
(Total operative 
time: 
01:47~02:16) 
1~<5 
≤1 
None 
General surgery procedures 
1 (N=6) 
Partial descending 
colectomy and pelvic 
lymphadenectomy  
00:38~00:55 
(Total operative 
time: 
00:54~01:21) 
2~5 
<1~6 
None 
2 (N=6) 
Nissen fundoplication 
followed by gastrectomy, 
gastrojejunostomy, and 
jejunojejunostomy 
01:05~01:34 
(Total operative 
time: 
01:21~02:00) 
<10~50 
<1~10 
None 
1) The study was considered successful if: 
- Instruments could be used to perform the specified surgical tasks successfully with no device related serious 
adverse events. 
- No serious adverse events that originated from a device related malfunction presented during the intra-operative 
or post-operative period that inhibited the recovery of the animal. 
- The RASD manipulated tissue and surgical sites appeared healed at the time of necropsy as assessed by a 
qualified person (board-certified veterinary pathologist). 
2) Procedure time is defined as time between the start of the surgical procedure to the completion of the surgical 
procedure. 
 

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The Hugo™ RAS System was tested using human cadaver models to evaluate the system performance 
intraoperatively across a range of tasks and surgical working volumes. Procedures selected to evaluate 
system performance were chosen for complexity in the given specialty. These more complex procedures 
are referred to as Umbrella procedures. Covered procedures have less complexity and risk for the 
specialty. For example, Cholecystectomy is a covered procedure under the umbrella procedures for 
Roux-en-Y Gastric Bypass and Nissen Fundoplication. Thus, successful clinical application of the umbrella 
procedures also demonstrate success in covered procedures of less complexity and risk. A total of 42 
procedures were performed including urological, gynecological, and general surgery procedures. The 
results demonstrate that the Hugo™ RAS System met all pre-defined criteria – the surgeon was able to 
perform the surgical procedure in an acceptable time and with acceptable system performance. The 
results of the cadaveric studies are summarized below. 
Table 2. Summary of Cadaveric Studies on the Hugo™ RAS System 
Procedure1) 
# of 
samples2) 
Results 
Procedure 
time 
(min) 
Surgical 
downtime 
(min) 
Malfunction 
exceeding 15 min. 
(single) or 30 min. 
(cumulative)  
Acceptance 
criteria for 
customer 
requirements3) 
Radical prostatectomy 
N=6 
95.2 
1.2 
None 
PASS 
Nephrectomy 
(Partial/Radical) with 
lymph node dissection 
N=6 
99.8 
None 
PASS 
Radical hysterectomy 
N=6 
89.3 
None 
PASS 
Roux-en-Y Gastric 
Bypass 
N=3 
112.7 
3.4 
None 
PASS 
Nissen fundoplication 
N=3 
42.3 
None 
PASS 
Ventral Hernia Repair 
N=6 
43.8 
None 
PASS 
Lower Anterior 
Resection (LAR) 
N=6 
121.7 
None 
PASS 
Inguinal Hernia Repair 
N=6 
50.0 
None 
PASS 
1) Each procedure was considered a failure if any single malfunction (if occurs) not resolved within 15 minutes of 
its occurrence in any one procedure. In the event that an Arm Cart Assembly malfunctions, it will be considered 
acceptable to convert to a 3-arm procedure so long as the procedure can be resumed within 15 minutes of the arm 
malfunctioning. 
2) Three surgical teams per procedure were recruited. Each team performed the designated procedures for one or 
two samples. 
3) Acceptable criteria for customer requirements include below: Image quality, Field of view, Acceptable patient 
positioning, Setup to achieve acceptable surgical workspace, Acceptable redocking efforts, Acceptable port 
locations, and Bedside access to patient 
 

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This trial will collect patient data undergoing two representative procedures in robotic surgery field. To 
be specific, indications under the study include one procedure each in the non-general surgery (GS) 
specialty (e.g., prostatectomy), and the GS specialty (e.g., cholecystectomy) were chosen for following 
reasons. First, robot-assisted prostatectomy is the first procedure performed in Korea as well as the 
most frequently performed robotic procedure in Korea [4]. The number of prostatectomy is expected to 
increase as increasing prevalence of prostate cancer in Korea. 
Next, according to the Main Surgery Statistical Yearbook 2019 [5], cholecystectomy is the fifth most 
frequently performed surgery in Korea (84,500 cases as of 2019) so that there are many patients who 
can get therapeutic benefits through product approval. Furthermore, robotic cholecystectomy has 
gained popularity as a gateway procedure during the initial phase of robotic training [6], and the clinical 
effectiveness has been proven using commercialized products such as da Vinci and Revo-i. 
This study will evaluate the safety and effectiveness of the Medtronic Hugo™ RAS System when used for 
representative procedures. 
4.2. Objectives 
This study aims to evaluate the safety and effectiveness of the Medtronic Hugo™ RAS System when used 
for prostatectomy or cholecystectomy. 
4.2.1. 
Primary Objective 
The primary objective is to confirm that the Medtronic Hugo™ RAS System performs as intended when 
used for prostatectomy or cholecystectomy. Primary endpoint is below: 
• 
Completion rate: A proportion of subjects who completed the surgery without conversion (to 
open or conventional laparoscopic surgery) due to system serious malfunction, and without 
any major complications within 24-hour post-surgery 
* Major complication is defined as Clavien-Dindo grade ≥3 
4.2.2. 
Secondary Objective 
The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System 
when used for prostatectomy or cholecystectomy. Secondary endpoints are below: 
• 
Overall complication rate through 30-day post-surgery: A proportion of subjects with any post-
operative complication within 30-days post-surgery using the investigational device 
• 
Major complication rate through 30-day post-surgery: A proportion of subjects with any post-
operative complication classified ≥3 by the Clavien-Dindo system within 30-days post-surgery 
using the investigational device 

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• 
Readmission rate through 30-day post-surgery: A proportion of subjects hospitalized within 30 
days post-surgery 
• 
Reoperation rate through 30-day post-surgery: A proportion of subjects go through 
reoperation for the same indication within 30 days post-surgery 
• 
Device deficiency rate: A proportion of subjects with any device deficiency (DD) during robotic 
assisted surgery using the investigational device 
 
 

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5. Product Description 
5.1. General 
The Medtronic Hugo™ RAS System is a modular robotic platform for performing robotically assisted 
minimally invasive surgery. As per the Regulations for Product Classification of Medical Device and Class 
by Product (MFDS Notification No. 2021-83. Oct 28, 2021), it is a class III medical device (Robotic surgical 
system, navigation). It enables the surgeon, sitting at an ergonomically adjustable console, to view the 
surgical field in three dimensions (3D) and control movements of the endoscope and instruments with 
individual robotic arms at the operating table. The Medtronic Hugo™ RAS System platform supports a 
portfolio of wristed instruments. The main components of the Medtronic Hugo™ RAS System are 
described in the following subsections. Refer Appendix 14.4. Instructions for Use for details. 
 
(Left to Right: System Tower, Surgeon Console, Arm Carts (4)) 
Figure 1. Hugo™ RAS System Overview 
5.1.1. 
Hugo™ RAS Surgeon Console 
The surgeon console is an open console that consists of a large flat screen with a high-definition 3D 
passive display, a small touchscreen interactive display, adjustable ergonomic controls, an armrest, two 
surgeon hand controllers, a set of foot pedals, and 3D surgeon and observer glasses. The surgeon hand 
controllers are easy to move and respond to wrist movement. Sensors in the surgeon console track the 
movement of the 3D glasses worn by the surgeon and can clutch movement of the instruments if the 
surgeon looks away from the 3D display.  

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Figure 2. Surgeon Console 
5.1.2. 
Hugo™ RAS Arm Cart Assembly 
The arm carts consist of movable platforms with casters, each supporting a modular and extendable 
arm. Up to four arm carts can be connected to the system tower for simultaneous use during RAS. The 
arm carts are portable and easily movable within the operating room (OR) and the hospital. Prior to 
surgery, the OR team positions the arm carts around the surgical table according to the surgical 
procedure. The team can adjust the arm carts and arms to accommodate patient positioning and 
optimize bedside access to the patient. 
 
Figure 3. Arm Carts 
 

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5.1.3. 
Hugo™ RAS Tower 
The system tower houses computers, the endoscope system, the electrosurgical generator, the power 
management system with a backup battery, and the high-definition OR team touchscreen interactive 
display. The system tower allows the surgeon console to control the movements of up to four arms. It 
may also be used without the surgeon console to power up to four arms for standalone manual control 
at the bedside, or by itself for standard laparoscopic visualization and electrosurgery. 
 
Figure 4. System Tower 
5.1.4. 
Hugo™ RAS Endoscope Adapter 
The Hugo™ RAS endoscope adapter is intended to hold the compatible Karl Storz TIPCAM®1 S 3D 
endoscope used with the Medtronic Hugo™ RAS System. The endoscope adapter will be attached to the 
robotic arm for the Medtronic Hugo™ RAS System during the surgical procedures. 
5.1.5. 
Other Components 
• 
The Hugo™ RAS sterile interface module: It is intended to be used with the Hugo™ RAS system 
as a universal connection on the robotic arm for the Hugo™ RAS sterile instruments and 
endoscope adapter during the representative surgical procedures set forth in the Hugo™ RAS 
system user guide. 
• 
The Hugo™ RAS Arm Cart Sterile Drape: The Arm Cart Sterile Drape (single-use) covers the non-
sterile robotic arm, or upper part of the arm cart, or lower part of the arm cart of the Hugo™ 
RAS System in order to allow the system to be used within the sterile field.  

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• 
The Hugo™ RAS system’s wristed instruments: They are minimally invasive instruments that 
provide two degrees of freedom (pitch, yaw) at the distal end of the instrument. These degrees 
of freedom, when commanded from the surgeon console, allow for precise and dexterous 
control of the instrument by the surgeon.  
• 
Software: Software versions will be captured in shipment records, including the clinical 
shipment/return form. 
5.2. Manufacturer 
Company Name 
Address 
Country 
Plexus Corp 
62400 Millbrook Dr. Buffalo Grove, IL 60089 USA 
USA 
5.3. Equipment 
The necessary equipment to complete study procedure, includes but is not limited to (1) Investigational 
Device (Medtronic Hugo™ RAS System), (2) Medtronic Hugo™ RAS System-Compatible Components. The 
investigational device and the compatible components will be provided to the study site by the sponsor. 
The investigational device and compatible components are listed in Appendix 14.3. 
5.4. Intended Use 
The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of 
instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 
forceps/graspers, needle holders, endoscopic retractors, electrosurgical tools and accessories for 
endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, 
approximation, ligation, electrosurgery, and suturing during urologic and general endoscopic 
(laparoscopic) surgical procedures including prostatectomy and cholecystectomy. 
The intended use is the same as that of locally commercialized devices. Table 3 compares the 
investigational device and commercialized devices in Korea. 
Table 3. Comparison between the Investigational Device and Locally Marketed Device 
Category 
Investigational device 
Locally marketed device 
(Revo-i) 
Locally marketed device 
(da Vinci) 
Intended 
population 
Patients under general 
endoscopic (laparoscopic) 
surgery 
Patients under general 
endoscopic (laparoscopic) 
surgery 
Patients under general 
endoscopic (laparoscopic) 
surgery 
Components 
Master console (open 
type), slave robot, vision 
system 
Master console (immersive 
type), slave robot, vision 
cart 
Master console (immersive 
type), slave robot, vision 
system 

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Category 
Investigational device 
Locally marketed device 
(Revo-i) 
Locally marketed device 
(da Vinci) 
Robotic 
arms 
4 robotic arms (1 camera, 
3 working), with 
modularity 
4 robotic arms (1 camera, 
3 working), without 
modularity 
4 robotic arms (1 camera, 
3 working), without 
modularity 
Robotic 
control 
Finger grip type 
Grip control 
Finger grip type 
Main 
instruments 
Monopolar, bipolar, vessel 
sealer 
Monopolar, bipolar 
Monopolar, bipolar, 
harmonic, vessel sealer, 
endo-stapler 
5.5. Intended Population 
The study population will consist of patients 22 years of age or older indicated for a robotic assisted 
prostatectomy or cholecystectomy with Hugo™ RAS.  
5.6. Product Use 
The instructions for use are summarized below. For the full instructions on investigational device scope 
of use and handling, please refer to Appendix 14.4. Instructions for Use. 
5.6.1. 
Operating Room Setup 
• 
Selecting system components: Before preparing the operating room (OR) for surgery, the OR 
team will need to select which Hugo™ RAS System components to retrieve from central stores. 
• 
Preparing the operating room: Position the system tower as close to the surgical table as 
possible. Prepare the surgical table and patient-positioning aids according to the surgical 
procedure and patient. Position the arm carts according to the surgeon’s preference and the 
Setup Guide. Position the surgeon console to maximize operating room awareness for the 
surgeon while seated at the surgeon console. 
• 
System connections: Carefully plug in power cords, data cables (e.g., Surgeon console data 
cable, Arm cart data cables), and any external video equipment needed. Connect a cable to the 
video output on the rear panel of the system tower. 
• 
Starting up the system: The surgeon console power cord and three system tower power cords 
will each need to be plugged into a separate, dedicated electrical circuit in the operating room 
to prevent circuit overload. The system will start up once the tower power cords are plugged in 
or when pressing the blue power button. 
• 
Electrosurgical generator setup: Ensure that the electrosurgical generator is powered on and 
connected to the system. 
• 
Adjusting brightness and contrast on the OR team interactive display 

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5.6.2. 
Preparing for Surgery 
• 
Confirming components from the system tower: Check the OR team interactive display and 
confirm that the arms and surgeon console needed for the surgical procedure are connected.  
• 
Arm setup: Calibrate arms on the OR team interactive display then complete arm setup 
according to the Arm Setup Guide. The following steps appear in the Arm Setup Guide: Draping 
arm cart, attaching instrument interface, placing port in patient (refer to 5.6.3 port placement 
for detail), positioning arm cart at bedside, docking arm to port, and checking arm positioning. 
• 
Endoscope setup: Place the endoscope in the endoscope adapter 
• 
Performing minimally invasive surgery prior to RAS (as needed): Perform any non-robotic 
surgical procedures as needed prior to performing robotic-assisted surgery. 
• 
Setting up the surgeon console and initial arm assignments: Complete ergonomic setup 
5.6.3. 
Port Placement 
Port placement is dependent on a variety of factors, including target anatomy, planned procedures, 
pathology, and the experience and preference of the surgeon. 
• 
Hugo™ RAS-specific port placement: Place ports referring to the setup guide covering particular 
specialty or target anatomical region of the specific procedure. During port placement the port 
should be inserted so that the Fulcrum Point (indicated by a thick black band on the port) is in 
the patient body wall or directly between the ribs. When placing ports, apply the following 
principles: 
o 2cm distance (minimum) between robotic port and any bony prominences 
o 10-16cm distance between tip of endoscope robotic port and deepest (or furthest) target 
anatomy 
o Place robotic ports for left hand and right hand closer to the target anatomy than 
endoscope port 
o 8cm distance (minimum) between adjacent robotic ports 
o Place assist port at least 5cm distance (minimum) from adjacent robotic ports 
5.6.4. 
Working with the Endoscope and Instruments at the Bedside 
The endoscope can be used with the system in multiple ways and configurations. The endoscope can be 
used for non-robotically-assisted minimally invasive surgery, or attached to an arm for general 
visualization of regional anatomy, ensuring safe port placement and instrument insertion. 
• 
Adjusting the angle and position of the arm: During the surgical procedure, the angle or the 
position of the arm may need to be adjusted, for example to aim the endoscope manually or to 
address a collision between arms. 
• 
Attaching and inserting the endoscope: Attach the endoscope adapter to an arm and move the 
endoscope forward into the port. The endoscope should then be used for direct visualization of 
the robotic port while inserting instruments. 

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• 
Attaching and inserting instruments: Select the appropriate instrument for the surgical task 
and determine to which arm to attach the instrument. The surgeon may request instruments 
from the OR team during the surgical procedures. 
• 
Withdrawing and removing an instrument or endoscope: After the surgical task, withdraw the 
instrument or endoscope from the port and the arm. 
• 
Repositioning the patient and surgical table (as needed): The patient and/or surgical table may 
need to be repositioned during the surgical procedure. If necessary, withdraw all instruments 
from the ports and disconnect all arms from the ports before repositioning. 
5.6.5. 
Post Surgery Disassembly, Procedures, and Cleaning 
• 
Withdrawing instruments or endoscope: Once the surgical procedure is complete, withdraw 
and remove the instruments and the endoscope from the port and the arm. 
• 
Moving the arm carts: Disconnect the arms from the ports and move the arm carts away from 
the surgical table. Remove the most accessible arm carts first to ensure a safe removal. After 
moving the arm carts to an open area, remove the drapes. 
• 
Post-case instrument care: Once the instruments have been removed from the arms at the end 
of a procedure, disassemble them as necessary and prepare for reprocessing. 
• 
Wiping down the system: Follow the facility’s protocol regarding the cleaning of capital 
equipment. 
5.6.6. 
Shutting Down and Moving Hugo™ 
• 
Placing the arms in the transport and storage configuration: Before shutting down and 
disconnecting the system, place the arms in the transport and storage configuration for safe 
movement in the hospital. 
• 
Shutting down the system: Press the blue power button on the front panel of the system tower 
or the left side of the surgeon console arm rest. When transporting or storing the surgeon 
console, locate the red AC power switch on the rear panel of the surgeon console and switch it 
to the off (O) position. 
• 
Disconnecting the system: Disconnect the system data cables from the rear panel of the system 
tower and coil the cables. Unplug the surgeon console power cord and the system tower 
power cords (when transporting only). 
• 
Transporting the system: Move the arm carts, the system tower, and the surgeon console for 
storage. 
5.7. Product Training Requirements 
The Medtronic Hugo™ RAS System should only be used by surgeons and OR staff who have received 
specific product training provided by Medtronic in the use of this device. Surgeons and hospital staff 
performing study procedures will be required to demonstrate a minimum level of professional 

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competency and product training outlined below prior to performing study procedures. Training 
evidence shall be documented. 
Technical training focus areas include: 
• 
Hugo™ System Operation 
• 
Hugo™ System Surgical Field Set-up 
• 
Hugo™ System Console Skills 
• 
Hugo™ System Clinical Application 
• 
RAS Fundamental Surgical Task Skills  
 
Table 4 describes product training requirements. 
Table 4. Product Training Requirements 
Role 
Product Training 
Operating 
surgeons 
• Completed simulator exercises on the Medtronic Hugo™ RAS System 
• Didactic training on the capability and features of the Medtronic Hugo™ RAS System 
• Completed hands-on training course 
OR staff 
• Didactic training on the capability and features of the Medtronic Hugo™ RAS System 
• Completed hands-on training course 
5.8. Packaging 
The Medtronic Hugo™ RAS System components and instruments will be labelled as investigational 
according to the Medical Device Act Enforcement Regulation (Prime Minister Decree No. 1786, Feb 18, 
2022), including followings: 
1. Label of “Investigational Purpose” 
2. Product name and model name 
3. Lot number and date of manufacture (or expiration date, if indicated) 
4. Method of storage 
5. Name of manufacturer or importer (for subcontracted manufacturer or importer, the origin of 
manufacture and country name shall be included) 
6. Label the device with “Not for use other than for clinical trial” 
5.9. Product Receipt and Tracking 
Medtronic Hugo™ RAS System and necessary equipment will be shipped to each site and tracked. The 
study site will review content of the shipping form and investigational device and sign upon receipt. The 

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use of the device for a procedure or disposition of the devices (e.g., if returned due to damage upon 
arrival) will be recorded on a site device accountability log to be maintained at the site.  
Medtronic Hugo™ RAS System and necessary instruments will be provided to each site upon sponsor 
collection and approval of all required regulatory documents. Each Medtronic Device and Device 
Instrument will be traced with the serial or lot number. 
In case of a cybersecurity incident of the investigational device, the study site shall contact emergency 
contact of Medtronic Korea Ltd. and wait for appropriate action. The study site must not use the 
investigational device until the incident has been resolved. The Hugo™ RAS System does not support 
hospital network or other Ethernet connectivity. DO NOT connect the system to a network or other 
devices via Ethernet, to avoid unintended system or network behavior. 
5.10. Product Storage 
Per regulation, investigational device shall be managed by the investigational device manager 
designated by the head of the study site. However, due to the nature of the investigational device in this 
study, it will be managed by the principal investigator and designated study staff. 
Study devices should be kept in or otherwise contained where only qualified study personnel can access 
the device (i.e., locked or secured). This area/container should be kept at ambient temperatures without 
exposure to water with adequate provisions for maintaining ambient temperatures if a loss of power is 
experienced. If the devices are exposed to water or a drastic change in temperature, sites should 
contact the sponsor for possible replacement devices. 
5.11. Product Accountability  
Access should be limited to designated study staff only. A device accountability log will be maintained at 
the site and reconciled by the end of the study. It is the site’s responsibility to document the receipt 
(which includes shipping/dispersal date, the quantity, model, lot, and serial numbers, and expiration 
date), disposition of the product (per subject use, including amount used, amount remaining, etc.), 
transfer (if applicable), and return of all unopened investigational medical devices at the end of the trial.  
It is the responsibility of the site to return the Medtronic Hugo™ RAS System to Medtronic at the end of 
study, along with any unused or expired Medtronic instruments or other components. Sites should 
follow instructions and complete all appropriate forms provided by the sponsor for product return. 
The sponsor shall also keep records to document the physical location of all investigational devices from 
shipment of investigational devices to the investigation sites until return or disposal. Medtronic will 
perform periodic reconciliation of the investigational device to ensure traceability through monitoring. 

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6. Selection of Subjects 
6.1. Study Population 
A minimum of 40 subjects will be enrolled at single site in Korea. The subjects must be acceptable 
candidates for a fully robotic assisted procedure with the Medtronic Hugo™ RAS System, as determined 
by the principal investigator. 
6.2. Subject Enrollment 
A subject is considered enrolled in the study when the consent process is signed and dated. Subject 
enrollment will be consecutive at the institution according to required procedure types and eligibility 
criteria. 
6.3. Inclusion Criteria 
1) Adult subjects (22 years old or greater) who are willing to participate and provide informed consent 
2) Subjects indicated for a radical prostatectomy or a cholecystectomy 
  - Prostatectomy: Male patients requiring radical prostatectomy for clinically localized prostate cancer 
    * Clinically localized prostate cancer is defined as following: biopsy-proven prostate adenocarcinoma, 
clinical staged as T1-T2N0M0 upon standard imaging findings such as bone scan, MRI, or CT   
  - Cholecystectomy: Patients requiring cholecystectomy for cholelithiasis, cholecystitis, or gallbladder 
polyps1 
    * For gallbladder polyps, only followings will be considered: gallbladder polyps ≥10 mm, enlarging 
polyps, or symptomatic gallbladder polyps2 
6.4. Exclusion Criteria 
1) Patient with a considerable risk for laparoscopic surgery (e.g., severe cardiopulmonary diseases which 
contraindicated to general anesthesia, uncontrolled coagulopathy, etc.) 
2) Patients requiring urgent surgery 
3) Pregnant or lactating women 
4) Patients with either of followings: 
 
1 Indications for laparoscopic cholecystectomy include followings: Symptomatic cholecystitis, acute cholecystitis, 
chronic cholecystitis, acalculous cholecystitis, gallstones ≥3 cm, nonfunctioning gallbladder, anomalous union of 
pancreaticobiliary duct, thickened gallbladder wall, calcified gallbladder or porcelain gallbladder, gallbladder 
polyps, gallbladder mass, typhoid carrier, and asymptomatic sickle cell anemia (Kim & Seo. Hepato-Biliary-
Pancreatic Surgery (4th ed.). 2019) 
2 Practical Guidelines for Management of Gallbladder Polyps (Korean Association of Hepato-Biliary-Pancreatic 
Surgery, 2010) 

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  - Prostatectomy: Metastatic prostate cancer or estimated life expectancy less than 10 years3 
  - Cholecystectomy: Severe liver cirrhosis (Child-Pugh class C) with portal hypertension, suspicion of 
gallbladder cancer4 
5) Previous abdominal surgery (open or laparoscopic) within 2 years before enrollment 
6) Concurrent participation in another clinical study that may confound study results 
7) Patient has a condition that could compromise study compliance (e.g., mentally incompetent, alcohol 
or drug abuse) as determined by the investigator 
8) Subjects who are considered unsuitable to conduct the trial as determined by the investigator 
6.5. Sample Size Determination 
To estimate the number of sample size, two things are taken into account: The number of subjects from 
previous studies, and the minimum number [8]5 to show whether the primary objective is met. We plan 
to include 40 patients for the study.  
- Research hypotheses: The completion rate is greater than or equal to 95% (point estimate). 
 
The completion is defined that surgery completion without conversion (to laparoscopic or open surgery) 
due to system serious malfunction, and without any major complications within 24-hour post-surgery. 
Therefore, when a subject who inevitably converted not due to the Hugo™ RAS system, it is not 
considered as a surgery failure as per the definition and the subject will be excluded from the primary 
endpoint analysis. Also, a complication within 24-hour post-surgery will not be considered as a surgery 
failure unless it falls under the definition of major complication. 
According to previous literature on adverse events in robotic surgeries over 14 years using da Vinci, the 
average rates of device malfunctions and failure-related conversions was 3% (varied between 0.4% and 
8.0%) and 0.9% (varied between 0.1% and 2.7%), respectively [9]. In Korea, the reported rate of system 
malfunctions and failures was less than 2% among over 10,000 da Vinci robotic procedure cases 
between 2005 to 2013. However, no cases of malfunction led to conversion to open or laparoscopic 
surgery [10].  
 
3 According to the Korean Clinical Practice Guideline for the Treatment of Prostate Cancer (The Korean Urological 
Oncology Society, 2020)[7], radical prostatectomy is an appropriate therapy for any patient with clinically localized 
prostate cancer that can be completely excised surgically, who has a life expectancy of ≥10 years, and who has no 
serious comorbid conditions that would contraindicate an elective operation. 
4 Relative contraindications for laparoscopic cholecystectomy include followings: Inability to tolerate general 
anesthesia due to cardiopulmonary diseases, hemodynamic instability, pregnancy (3rd trimester), malignant 
tumors, liver cirrhosis and portal hypertension, and intestinal adhesions (Kim & Seo. Hepato-Biliary-Pancreatic 
Surgery (4th ed.). 2019) 
5 N≥30 according to the central limit theorems 

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With regards to the previous studies, the completion rate of surgery–the primary endpoint of this 
study–is expected to be over 90%. The study will be considered successful when the point estimate of 
the completion rate is greater than or equal to 95%, which is when ≤2 patients (among 40) does not 
reach the surgery completion. The primary endpoint is evaluated within short period (i.e., 24-hour post 
surgery) period so the dropout rate is not considered. Note that it is not possible to assess the surgery 
completion per the study definition when a subject who inevitably converted not due to the Hugo™ RAS 
system. In such cases, new enrollment is allowed until the minimum sample size (i.e., 40) is reached. 
In summary, the estimated sample size is adequate to demonstrate the safety and performance of the 
investigational device regarding following reasons: (1) the estimated sample size is higher than the 
number of patients from recent pivotal trial (which used the same primary endpoint) of the locally 
commercialized product (i.e., 32; 17 prostatectomy cases and 15 cholecystectomy cases) [11, 12], and 
(2) the investigational device is intended to be used for the same patient population of the 
commercialized product. 
 

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7. Study Method  
7.1. Duration 
The expected study duration is approximately 9 months after protocol approval 
- IRB submission and site activation: 3 months  
- Subject enrollment to follow-up completion: 3 months 
- Statistical analysis and report writing: 3 months 
7.2. Design 
This study is a prospective, single-center, single-arm, pivotal trial in 40 patients undergoing 
prostatectomy (20) or cholecystectomy (20) using the Medtronic Hugo™ RAS System. Subjects will be 
followed for 30 days post procedure. As this study is a single-arm trial, no randomization or blinding will 
be applied.  
7.3. Rationale  
This trial will collect patient data undergoing two representative procedures (i.e., prostatectomy, 
cholecystectomy) in robotic surgery field to minimize potential confounding effect due to surgeon’s 
proficiency or learning curve. 
The study is designed as single-arm trial due to following logistics issues: Room to setup the 
investigational device, space for storage, and the number of commercialized products at the study site.  
The primary endpoint of this study is the completion rate, which is defined as a proportion of subjects 
who completed the surgery without conversion due to system serious malfunction, and without any 
major complications within 24-hour post-surgery. Recent pivotal trial approved from the MFDS also 
utilized completion rate as the primary endpoint [11, 12]. 
 
 

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8. Study Procedures  
8.1. Schedule of Events 
Data collection requirements are summarized in Table 5. 
Table 5. Data Collection and Study Procedure Requirements at Subject Visits 
Procedure/Assessments 
Baseline 
Surgery 
Discharge 
Follow-up1) 
 
-28D~0D 
0D 
0D~Day of 
discharge 
7D 
(±3D)2) 
14D 
(±3D)2) 
30D 
(±7D) 
Informed consent 
X 
 
 
 
 
 
Eligibility check 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Laboratory tests3) 
X 
 
X4) 
 
X 
X 
Vital signs 
X 
X 
X4) 
 
X 
X 
Indication under study5) 
X 
 
 
 
 
 
Procedure information5) 
 
X 
 
 
 
 
Device deficiency 
 
As they 
occur 
 
 
 
 
Pathological exam6) 
 
 
X 
 
 
 
Post-operative imagings7) 
 
 
X 
X 
 
 
Medication8) 
X 
X 
X 
X 
X 
X 
Adverse event9) 
As they occur 
Protocol deviation 
As they occur 
Readmission/Reoperation 
 
 
 
As they occur 
Study Exit 
 
 
 
 
 
X 
1) If any unscheduled visit occurs other than planned follow-up visit, subject’s data (e.g., adverse event, medication, 
etc.) can be collected if applicable.  
2) Applicable for prostatectomy subjects only. 
3) Laboratory tests include complete blood cell and serum chemistry.  
4) Timing of laboratory tests and vital sign assessments up to discharge will be immediately after surgery (Day 0; 
laboratory tests only), Day 1, and Day 3 for prostatectomy subjects, and Day 1 for cholecystectomy subjects. 
5) Procedure-specific information will be collected each for prostatectomy or cholecystectomy. 
6) Applicable for prostatectomy subjects only.  
7) Applicable for prostatectomy subjects only. Post-operative imaging includes chest X-ray (AP view), abdomen X-
ray (Supine or erect view), KUB X-ray, and cystography. The cystography will be conducted on Day 7, while other 
radiographs will be obtained on immediately after surgery (Day 0; except KUB X-ray), Day 1, and Day 3. Post-
operative imaging findings will be only collected to in the CRF if it is related to adverse events. 
8) Following study-related medications will be collected: Pre-procedure anticoagulants or monoamine oxidase 
inhibitors (which may affect hemostasis) within 30 days prior to surgery, any relevant medication related to the 

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study indication, pain medications due to an adverse event, medications given as treatment for an adverse event. 
Medication will be coded using WHO Drug Dictionary. 
9) Adverse events will be collected after subject has agreed to participate and provided the written informed 
consent. 
The study visits include baseline visit, admission (surgery to discharge), and follow-up visit after 
discharge: 
• 
Baseline: To determine study eligibility and collect baseline information (demographics, 
medications, medical history, surgical history, etc.) 
• 
Surgical procedure: To re-confirm eligibility criteria, procedure set-up and take-down, 
medication changes, intraoperative complication evaluation, disease state evaluation, 
procedure success, conversion rates, protocol deviation, adverse event evaluation, and device 
deficiency collection 
• 
Up to hospital discharge: Adverse event evaluation, complication rate, disease state 
evaluation, medication changes and protocol deviation 
• 
Follow-up after discharge: Adverse event evaluation, complication rate, disease state 
evaluation, length of hospital stay, readmission (if applicable), reoperation (if applicable), 
medication changes, protocol deviation and study exit 
8.2. Subject Consent 
Prior to initiation of any study-specific procedures, informed consent (IC) must be obtained from the 
subject. The informed consent form (ICF) must be personally signed and dated by the subject 
themselves and the principal investigator or a delegated investigator (physicians only) at the time of 
consent. The subject has the right to refuse and the refusal will not affect the routine care of the 
subject. 
A subject may only consent after information has been given and explained to the subject on all aspects 
of the clinical investigation that are relevant to the subject’s decision to participate. The subject must 
have ample time and opportunity to read and understand the ICF, to inquire about details of the study, 
and to decide whether or not to participate in the study. All questions about the study should be 
answered to the satisfaction of the subject. When required per regulation, the subject will be required 
to sign additional forms such as Personal Information Collection and Use Agreement, etc. 
In the event the subject or legally designated representative cannot read and/or write, witnessed 
(impartial witness) IC will be allowed, provided detailed documentation of the process is recorded in the 
subject’s case history and the witness signs and dates the IC. The IC and any other information must be 
read aloud to the prospective subject or his/her legally designated representative. Whenever possible, 
either the subject or his/her legally designated representative shall sign and personally date the 
informed consent form. The witness signs and personally dates the IC attesting that the information was 
accurately explained and that informed consent was freely given. 

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The IC process must be conducted by the principal investigator or an authorized designee. The process 
of IC must be conducted without using coercion or undue improper influence on or inducement of the 
subject to participate by the investigator or other study site personnel. The IC process shall not waive or 
appear to waive subject’s legal right. The language used shall be as non-technical as possible and must 
be understandable to the subject. 
Subjects will be informed that despite signing IC, the screening assessment may demonstrate the 
subject is not a suitable candidate for the study or the procedure and may be withdrawn. Subjects will 
also be informed that after the investigation visits are completed, the subjects will receive the standard 
medical care, just as they would have had they not participated in the study. 
Prior to enrolling subjects, the site IC must be approved by the IRB. The document(s) must be controlled 
(i.e., versioned and/or dated) to ensure it is clear which version(s) were approved by the IRB. Any 
adaptation of the sample IC must be reviewed and approved by Medtronic and the IRB reviewing the 
application prior to enrolling subjects. 
A copy of the IC signed and dated as required by law, must be provided to the subject. The original of 
the signed ICF (and any other privacy language if required) must be filed with the subject’s study 
documents and made available for review by sponsor site monitors, auditors, or regulatory inspectors. 
It is best practice for the IC process to be documented in the subject’s case history, regardless of 
circumstance. If the IC is obtained the same day the subject begins participating in study-related 
procedures, it must be documented in the subject’s case history that consent was obtained prior to 
participation in any study-related procedures. 
The investigator must notify the subject of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the subject, 
as this could impact a subject’s willingness to participate in the study. If relevant, consent may be 
requested from subjects to confirm their continued participation. 
8.3. Enrollment 
A subject is considered enrolled when the consent is provided. The date the subject signed the IC must 
be documented in the subject’s medical records. Enrollment can be a stand-alone visit or can occur on 
the same day as the baseline visit. Once consent is obtained, a subject identification number will be 
assigned and data collection on adverse events (AEs), study deviations and subject exits will occur. 
8.4. Baseline (Day -28 to 0) 
When a subject is consented, the principal investigator will review the subject’s medical record and 
confirms if they meet all specified inclusion criteria and none of the exclusion criteria. The baseline visit 

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can be a stand-alone visit or can be performed on the same day prior to the surgical procedure. The 
following information is required to be collected at the baseline visit: 
• 
Enrollment status: Date of consent, eligibility check 
• 
Demographics: Sex (male/female), date of birth, height (cm), weight (kg), body mass index 
(BMI) 
• 
Medical history: Comorbidities or past surgical history (within the last year), family history of 
study indication (i.e., prostate cancer, cholelithiasis, cholecystitis, or gallbladder polyps), ASA 
class [13] 
• 
Laboratory tests: Complete blood cell, serum chemistry (e.g., Complete blood cell (RBC, WBC, 
Hb, Hct, Platelet, ESR, etc.), admission panel (Glucose, Calcium, Phosphorous, BUN, Uric acid, 
Creatinine, eGFR (MDRD), AST, ALT, ALP, Total bilirubin, Albumin, Total protein, etc.), 
electrolyte panel (Sodium, Potassium, Chloride, etc.), hs-CRP 
• 
Vital signs: pulse rate (bpm), respiration rate (bpm), blood pressure (mmHg), body 
temperature (℃) 
• 
Indication under study: Date of diagnosis (i.e., prostate cancer, cholelithiasis, cholecystitis, or 
gallbladder polyps), and following items (collected per indication) 
o Prostatectomy: Prostate volume (g), Biopsy Gleason score [14], PSA (ng/mL), clinical stage 
per AJCC rules [15], prior neoadjuvant hormonal therapy 
o Cholecystectomy: Concomitant bile duct stones, ERCP 
• 
Prior medications: Brand name, indication (see Section 8.9 for details) 
• 
Adverse event (if any): Diagnosis, seriousness, severity, action taken, outcome, relatedness, 
etc. 
8.5. Surgical Procedure (Day 0) 
The subject will arrive for admission to the hospital and prepped for surgery. On the day of surgery, the 
subject will receive a robotic assisted prostatectomy or cholecystectomy per indication. Pre-operative 
and operative procedures are according to local standard practices. The following information is 
required to be collected at the surgery visit: 
• 
Pre-operative vital signs: pulse rate (bpm), respiration rate (bpm), blood pressure (mmHg), 
body temperature (℃) 
• 
Procedure information 
o Date of admission, date of surgery 

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o Operative time: Setup time6, console time, total operative time (skin to skin time), 
takedown time 
o Estimated blood loss (mL) 
o Conversion: Conversion to open/laparoscopic surgery during procedure (and reason for 
conversion, if conversion occurs) 
o Blood transfusion: Blood transfusion during surgery (and the number of blood pack used if 
transfusion required) 
o Changes to port placement (and reason for change, if occurs) 
o Delay in robot setup time or total operative time (and reason for delay, if occurs) 
o Device information: Lot number, software version, compatible instruments 
o Other measurements: Collected per indication 
 
Prostatectomy: Pelvic lymph node dissection, nerve-sparing prostatectomy 
 
Cholecystectomy: Amount of gallbladder adhesions, concomitant gallbladder 
stones, type of gallbladder polyps (if applicable), acute cholecystitis, other 
concomitant procedures, use of drainage tube 
• 
Medication: Brand name, indication (see Section 8.9 for details) 
• 
Adverse event (if any): Diagnosis, seriousness, severity, Clavien-Dindo grade, action taken, 
outcome, relatedness, etc. 
• 
Device deficiency (if any): Diagnosis, applicable device information (e.g., device type, Lot 
number, etc.) 
 
In addition to above, below information is to be collected immediately after prostatectomy. 
• 
Laboratory tests: Complete blood cell, serum chemistry (e.g., Complete blood cell (RBC, WBC, 
Hb, Hct, Platelet, ESR, etc.), admission panel (Glucose, Calcium, Phosphorous, BUN, Uric acid, 
Creatinine, eGFR (MDRD), AST, ALT, ALP, Total bilirubin, Albumin, Total protein, etc.), 
electrolyte panel (Sodium, Potassium, Chloride, etc.),  
• 
Post-operative imaging (only collected if it is related to adverse events): Chest X-ray (Chest AP) 
findings, abdomen supine X-ray findings 
 
The detailed procedural steps are described below7. The steps can vary based on surgeon’s technique, 
preference, and patient’s condition. 
 
 
6 Setup time is defined as sum of following durations: Time from the first robot arm plugged in to all arms fully 
calibrated, time spent to drape all robotic arms, and time from the movement of the first arm to the patient to all 
arms docked to ports. 
7 See Hugo Set-up Guide and Hugo User Guide for detailed information 

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8.5.1. 
Prostatectomy Procedures 
The key steps in robotic radical prostatectomy are below: 
• 
Patient positioning: The patient is prepped and draped in lithotomy and Steep Trendelenburg 
(>20°) position under general anesthesia.  
• 
Port placement: Incisions for port placement are made. The camera port is placed through a 
periumbilical incision. Three remaining ports (i.e., left, right, and reserve) are placed at a safe 
distance from the camera port and/or adjacent ports. If necessary, non-robotic assist ports can 
be placed at a safe distance from adjacent robotic ports. 
• 
Arm cart positioning: The robotic arms are connected to the robotic ports. The endoscope and 
wristed instruments are attached to robotic arms and inserted to ports. 
• 
Dropping the bladder: The bladder is separated from the peritoneum down to the vas deferens 
and then deep into perirectal space. The anterior prostatic fat is dissected and further 
dissected off of the anterior prostatic capsule from the apex to the bladder neck.  
• 
Endopelvic fascia: The endopelvic fascia is initially incised laterally closer to muscle than the 
nerve. At the apex, completely release Myer’s muscle to visualize and protect the apex, 
neurovascular bundle (NVB), and urethra when transecting the dorsal venous complex (DVC) 
and remaining apical structures. 
• 
Anterior or posterior bladder neck: The site of transection of the anterior bladder neck is 
visually facilitated by retracting the Foley balloon. Transection of the bladder from the 
prostate. 
• 
Seminal vesicles and rectum: The seminal vesicles are used to lift the prostate for separation 
from the rectum. Denonvilliers’ fascia is grasped and lifted and incised sharply until the 
perirectal fat is seen. 
• 
Transection of the prostatic pedicles and the NVBs: Nerve preservation with athermal coldcut 
resection sharply releasing the nerve from the prostate without traction. 
• 
DVC and urethral transection: The dorsal vein and urethra are cut then oversew the DVC. 
• 
Vesicoureteral anastomosis: Circular anastomosis between urethra and bladder. 
• 
Specimen removal and closure: The resected prostate gland and attached seminal vesicles are 
removed and the incised port site is closed.. 
• 
Arm cart undocking: The arms are disconnected from the ports. The patient is moved off the 
table and taken to the recovery room. 
 
 

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Figure 5 describes port placement and arm cart positioning during the robotic prostatectomy. Deviations 
may need to be made for specific patient body habitus, patient pathology, or surgeon preference. 
Port placement 
Arm cart positioning 
 
 
Figure 5. Port Placement and Arm Cart Positioning (Prostatectomy) 
8.5.2. 
Cholecystectomy Procedures 
The key steps in robotic cholecystectomy are below: 
• 
Patient positioning: The patient is prepped and draped in reverse Trendelenburg (>20°) 
position under general anesthesia.  
• 
Port placement: Incisions for port placement are made. The camera port is placed through a 
periumbilical incision. Three remaining ports (i.e., left, right, and reserve) are placed at a safe 
distance from the camera port and/or adjacent ports. If necessary, non-robotic assist ports can 
be placed at a safe distance from adjacent robotic ports. 
• 
Arm cart positioning: The robotic arms are connected to the robotic ports. The endoscope and 
wristed instruments are attached to robotic arms and inserted to ports. 
• 
Identification of gallbladder after insertion of endoscope: After identification of the 
gallbladder, the fundus is retracted cephalad over the liver with a grasping instrument. 
• 
Dissection of cystic pedicle: Adhesions are taken down using the Maryland dissector. Using an 
additional grasper, the gallbladder is retracted inferolaterally to expose the triangle of Calot. 
• 
Separation of cystic artery from cystic duct: The separation of the cystic duct anteriorly from 
the cystic artery behind and can be performed by a Maryland grasper. 
• 
Clipping of cystic artery: The cystic artery is clipped and then divided by hook scissors and the 
dissection of the cystic pedicle is completed by placement of a clip to occlude the cystic duct. 

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• 
Dissection of gallbladder from liver bed: Gallbladder should be separated from the liver 
performed with scissors with electrosurgical attachment or Monopolar hook or knife. 
• 
Extraction of gallbladder and closure: After completion of the gallbladder resection, it will be 
placed in a retrieval bag and removed through the umbilical port. All incised port site is closed. 
• 
Arm cart undocking: The arms are disconnected from the ports. The patient is moved off the 
table and taken to the recovery room. 
 
Figure 6 describes port placement and arm cart positioning during the robotic cholecystectomy. 
Deviations may need to be made for specific patient body habitus, patient pathology, or surgeon 
preference. 
Port placement 
Arm cart positioning 
 
 
Figure 6. Port Placement and Arm Cart Positioning (Cholecystectomy) 
8.6. Up to Hospital Discharge (After Surgery~Discharge) 
The subject’s condition will be closely monitored until discharge. Vital signs and laboratory test will be 
conducted on Day 1, 3 for prostatectomy subjects, and Day 1 for cholecystectomy subjects. AE will be 
collected and assessed according to Clavien-Dindo classification system. The following information is 
required to be collected: 
• 
Date of discharge 
• 
Laboratory tests: Complete blood cell, serum chemistry (e.g., Complete blood cell (RBC, WBC, 
Hb, Hct, Platelet, ESR, etc.), admission panel (Glucose, Calcium, Phosphorous, BUN, Uric acid, 
Creatinine, eGFR (MDRD), AST, ALT, ALP, Total bilirubin, Albumin, Total protein, etc.), 
electrolyte panel (Sodium, Potassium, Chloride, etc.), hs-CRP) 

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• 
Vital signs: pulse rate (bpm), respiration rate (bpm), blood pressure (mmHg), body 
temperature (℃) 
• 
Medication: Brand name, indication (see Section 8.9 for details) 
• 
Adverse event (if any): Diagnosis, seriousness, severity, Clavien-Dindo grade, action taken, 
outcome, relatedness, etc. 
• 
Other measurements: Collected per indication 
o Prostatectomy: Date of urinary catheter removal 
o Cholecystectomy: Date of drain removal 
 
In addition to above, below information is to be collected for prostatectomy subjects. Post-operative 
imaging will be conducted on Day 1 and 3, but findings will be only collected if it is related to adverse 
events.  
• 
Pathological exam: Pathological stage per AJCC rules, tumor size (mm), positive surgical margin 
(and its location, if positive) 
• 
Post-operative imaging (only collected if it is related to adverse events): Chest X-ray (Chest AP) 
findings, abdomen erect X-ray findings, KUB X-ray findings 
8.7. Post-Operative Follow-up (Up to Day 30) 
Subject will be followed through 30-day post-surgery.  
8.7.1. 
Prostatectomy Subjects (Day 7, Day 14, and Day 30) 
Prostatectomy subjects will be followed at 7-day (±3 days), 14-day (±3 days), and 30-day (±7 days) post-
operative outpatient visits. The following information will be collected:  
NOTE: Laboratory tests and vital sign assessments will be done at Day 14 and 30 only, and cystography 
will be done on Day 7 only. 
• 
Laboratory tests (Day 14, Day 30 only): Complete blood cell, serum chemistry (e.g., Complete 
blood cell (RBC, WBC, Hb, Hct, Platelet, ESR, etc.), admission panel (Glucose, Calcium, 
Phosphorous, BUN, Uric acid, Creatinine, eGFR (MDRD), AST, ALT, ALP, Total bilirubin, Albumin, 
Total protein, etc.), electrolyte panel (Sodium, Potassium, Chloride, etc.), hs-CRP), PSA (ng/mL) 
(Day 30 only) 
• 
Vital signs: pulse rate (bpm), respiration rate (bpm), blood pressure (mmHg), body 
temperature (℃) 
• 
Post-operative imaging (only collected if it is related to adverse events): Cystography findings 
(Day 7 only) 
• 
Medication: Brand name, indication (see Section 8.9 for details) 
• 
Adverse event (if any): Diagnosis, seriousness, severity, Clavien-Dindo grade, action taken, 
outcome, relatedness, readmission/reoperation (and surgeon comments on the AE form if 
occurs), etc. 

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8.7.2. 
Cholecystectomy Subjects (Day 30) 
Cholecystectomy subjects will be followed at 30-day (±7 days) post-operative outpatient visit. The 
following information will be collected:  
• 
Laboratory tests: Complete blood cell, serum chemistry (e.g., Complete blood cell (RBC, WBC, 
Hb, Hct, Platelet, ESR, etc.), admission panel (Glucose, Calcium, Phosphorous, BUN, Uric acid, 
Creatinine, eGFR (MDRD), AST, ALT, ALP, Total bilirubin, Albumin, Total protein, etc.), 
electrolyte panel (Sodium, Potassium, Chloride, etc.), hs-CRP) 
• 
Vital signs: pulse rate (bpm), respiration rate (bpm), blood pressure (mmHg), body 
temperature (℃) 
• 
Medication: Brand name, indication (see Section 8.9 for details) 
• 
Adverse event (if any): Diagnosis, seriousness, severity, Clavien-Dindo grade, action taken, 
outcome, relatedness, readmission/reoperation (and surgeon comments on the AE form if 
occurs), etc. 
8.8. Subject Exit, Withdrawal or Discontinuation  
Subjects have the right to refuse to participate the study as well as voluntarily withdraw from the study 
at any time. In case of study exit, the reason and date for study exit of all enrolled subjects will be 
documented on the applicable page of case report form (CRF). Subjects may be exited from the study 
for any of the following situations: 
• 
Study completed (i.e., completed 30-day post-operative visit) 
• 
Subject did not provide consent 
• 
Subject chooses to withdraw 
• 
Subject did not meet inclusion/exclusion criteria 
• 
Subject did not receive surgery using the investigational device 
• 
Subject death 
• 
Subject lost to follow-up (i.e., up to 30-day post-operative visit) 
• 
Unacceptable AEs 
• 
Investigator deems withdrawal necessary (e.g., medically justified, failure of subject to 
maintain adequate study compliance) 
 
All AEs must be followed until the AE has been resolved, is unresolved with no further actions planned, 
the subject dies or exits the study, whichever occurs first. In cases of early study exits, all data collected 
from the time of consent to the time of exit may be used. For subjects who complete the 30-day follow-
up visit, the 30-day follow-up visit and exit visit should be combined, and CRF for both need to be 
completed. 

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8.9. Prior and Concomitant Medications/Therapies  
There is no prohibited medication during the study, and the investigator shall follow institutional 
standard of care to manage medications. Follow the guidelines below to report medications relevant to 
this study: 
• 
Report applicable pre-procedure medications if taken within 30 days of the study procedure as 
listed Table 6 
• 
Any relevant medication related to the study indication 
• 
Pain medication(s) must be reported if given when pain (Clavien Dindo Grade 1 or higher – pain 
exceeds that which is considered within normal limits) is reported as an AE 
• 
Medications given as treatment for an AE should be captured 
Table 6. Medications Taken within 30 Days prior to Surgery 
Anticoagulants taken within 30 days prior to 
surgery 
Monoamine Oxidase Inhibitors (MAOIs) taken 
within 30 days prior to surgery 
• Warfarin (Coumadin) 
• Enoxaparin (Lovenox) 
• Clopidogrel (Plavix) 
• Ticlopidine (Ticlid) 
• Aspirin (in many versions) 
• Non-steroidal anti-inflammatory (NSAIDS) (in 
many versions) 
• Dipyridamole (Persantine) 
• Vitamin E 
• Garlic 
• Ginger 
• Ginkgo biloba 
and other anticoagulants not mentioned above 
• Tranylcypromine (Parnate, Sicoton) 
• Phenelzine (Nardil, Nardelzine) 
• Isocarbonazid (Marplan) 
• Rasagiline (Azilect) 
• Selegiline (Eldepryl, Deprenyl) 
• Linezolid (Zuvox) (an antibiotic) 
• St. John’s Wort 
and other MAOIs not mentioned above 
 
Exclude the reporting of antiemetics, antipyretics, analgesics, diuretics, electrolytes, antibiotics, 
digestives, antitussives, expectorants, physiotherapy and so forth when given per standard of care 
procedures and/or within normal limits (dosage and frequency).  
All collected medications will be coded using WHO Drug Dictionary. 
8.10. Assessment of Effectiveness 
Effectiveness of the Hugo™ RAS System will be evaluated through the study primary endpoint 
(completion rate). Effectiveness assessment will be done on the day of surgery as below. 

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• 
Completion rate: A proportion of subjects who completed the surgery without conversion due 
to system serious malfunction, and without any major complications within 24-hour post-
surgery 
 
Surgery completion is defined if procedure is completed without conversion to open or laparoscopic 
surgery due to system serious malfunction per surgery record, and no major complication reported within 
24-hour post-surgery period. Note that unavoidable Aes are inherent to the procedure (see Section 10.2 
for details) are not included in this definition of major complication within 24-hour post-surgery. 
8.11. Assessment of Safety 
Safety will be assessed by monitoring the occurrence of Aes and DDs. AE assessments will take place 
starting with the point of consent through study exit and will be recorded in the CRF. The secondary 
endpoints of this study (i.e., complication rate and readmission/reoperation rate (through 30-day post-
surgery), DD rate) will assess the safety of the investigational device. See Section 10 for further 
information on the collection of safety information. 
8.12. Recording Data 
Data collected on each subject will be recorded on a web-based electronic case report form (eCRF). The 
electronic data capture system maintains an audit trail on entries, changes or corrections in the CRFs. 
Instructions for proper completion of the CRF will be provided to the site at the start of the study. The 
investigator must ensure accuracy, completeness and timeliness of the data in the CRFs. CRFs shall be 
signed by the principal investigator or a delegated investigator (physicians only).  
Data entered must be traceable to source documents. The investigator must ensure the availability of 
source documents from which the information on the eCRFs was derived. Source documents, which may 
include subject medical records, clinical charts, procedure reports, and laboratory notes, must be 
created and maintained by the investigational study site team. The type and location of source 
documents should be documented. Where printouts of electronic medical records, are provided as 
source documents, or where copies of source documents are retained as source documents, those 
should be certified. Certification must contain (1) the signature of the individual making the copy, (2) the 
date the copy was made and (3) a statement attesting to the accuracy and completeness of the copy. 
In general, eCRFs (or paper copies) may not serve as source documents. For data elements not routinely 
captured in medical records, the study site may use source document worksheets if identified as source 
documents. On the other hand, the CRF may be considered source for the following data collection 
elements: 

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Enrollment status: Study site assigned subject reference, study exit, reason for exit 
• 
Adverse event: Date study site became aware of event, severity, Clavien-Dindo grade, 
relatedness 
• 
Device deficiency: Date study site became aware of event 
• 
Study deviations: Reason for deviation 
 
The source documents must be made available for monitoring or auditing by Medtronic’s representative 
or representatives of the competent authorities and other applicable regulatory agencies.  
8.13. Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan (CIP) or the Clinical Trial Agreement (CTA). Prior approval by the sponsor of deviation 
is expected unless when a deviation is necessary to protect the safety, rights or well-being of a subject in 
an emergency or in unforeseen situations beyond the investigator’s control (e.g., subject failure to 
attend scheduled follow-up visit, inadvertent loss of data due to computer malfunction, inability to 
perform required procedures due to subject illness). All study deviations must be reported on the CRF 
regardless of whether medically justifiable, preapproved by the sponsor, an inadvertent occurrence, or 
taken to protect the subject in an emergency. 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life 
or physical well-being of a subject in an emergency, the deviation must be reported to the IRB as well as 
sponsor within five working days. All other study deviations must be reported to the sponsor as soon as 
possible upon the study site becoming aware of the deviation, per IRB policies and/or local laws. 
The sponsor is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g., amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation 
of a corrective action plan with the investigator and study site, and in some cases, may necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the investigator’s 
participation in the study.  
Examples of major study deviations include but are not limited to: 
• 
Failure to obtain proper IC 
• 
Subject did not meet Inclusion/exclusion criteria 
• 
Failure to collect required study data up to 30-day post-surgery 
 
Other minor deviations shall be recorded along with reason for deviation. Subjects with minor deviation 
only may not be excluded from the final analysis unless the deviation affects the study outcome. 

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9. Statistical Design and Methods 
9.1. General Aspects of Analysis 
The study analysis will occur after all patients complete the 30-day follow-up and data entry error or 
non-reasonable values are cleaned. Data analysis will be performed by Medtronic or its designee using 
SAS for Windows (version 9.4 or higher, SAS Institute Inc. Cary, NC) or other widely accepted statistical 
or graphical software. 
Statistical tests will be conducted at a two-sided alpha level of 0.05. Confidence intervals will be 
presented as 95% confidence intervals. 
The following populations will be considered for the analysis of data for this study: 
• 
Full Analysis Set (FAS): The full analysis set is defined as all enrolled subjects in whom the 
Hugo™ RAS procedure is begun (defined as the first skin incision). In the event that a subject is 
consented but the first incision does not occur (e.g., if the subject becomes ineligible during 
the timeframe between consent and the procedure day), that subject will be excluded. Also, a 
subject who inevitably converted (to open or conventional laparoscopic surgery) not due to the 
Hugo™ RAS system will be included in the safety and other descriptive analyses but excluded 
from the primary endpoint analysis (since the subject is not evaluable). 
• 
Per Protocol Set (PPS): The per protocol set is a subset of the FAS including only those without 
any major protocol deviations. Following subjects from the FAS will be excluded from the PPS: 
o Subject who inevitably converted (to open or conventional laparoscopic surgery) not due to 
the Hugo™ RAS system 
o Subject did not meet Inclusion/exclusion criteria 
o Subject chooses to withdraw 
o Failure to collect required study data up to 30-day post-surgery 
 
The FAS will be the primary analysis set for the evaluation of the primary and secondary endpoints. 
Statistical analysis will be performed for each analysis set. However, if all subjects complete the study 
per the CIP, the results can be presented regardless of the analysis set. 
Subject disposition will be illustrated in a CONSORT diagram. All enrolled subjects will be included in a 
subject disposition table indicating reasons for exclusion from the FAS and PPS analysis sets. 
Descriptive statistics will be used to present the data and to summarize the results. Continuous variables 
will be summarized with number of subjects (n), mean, standard deviation, median, and ranges. 
Categorical variables will be summarized by frequencies and percentages. The 95% confidence intervals 
for means and/or percentages will be also presented. 

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The study will be considered successful when the primary endpoint is met: if the point estimate of the 
completion rate is greater than or equal to the pre-determined value (i.e., 0.95) in the FAS. 
Missing data will not be imputed for the primary analysis, and multiple testing adjustments are not 
considered. Sensitivity analysis (e.g., multiple imputations for missing data) may be performed to ensure 
the study results are robust.  
9.2. Pre-operative Characteristics 
Descriptive statistics will be used to summarize pre-operative characteristics of subjects per indication, 
including: demographics, medical history, vital signs, laboratory test results, ASA class, etc. 
9.3. Surgical Data 
Descriptive statistics will be used to summarize procedure information, including but not limited to: 
setup time, console time, total operative time, takedown time, estimated blood loss, conversion to 
open/laparoscopic surgery, blood transfusion during the surgery, length of hospital stay, delay in robot 
setup time, and delay in total operative time. 
9.4. Primary Endpoint 
The Clopper-Pearson Exact test for single proportion will be conducted. The number of subjects 
successfully completed the surgical procedure, percentage, and its 95% confidence interval will be 
summarized. If the point estimate of the completion rate is greater than or equal to the pre-determined 
value (i.e., 0.95), it is considered that the primary objective is met. 
9.5. Secondary Endpoints 
Descriptive statistics will be used. Frequency, percentage, and its 95% confidence interval will be 
presented for each secondary endpoint: overall complication rate through 30-day post-surgery, major 
complication rate through 30-day post-surgery, readmission rate through 30-day post-surgery, 
reoperation through 30-day post-surgery, and DD rate. The Clopper-Pearson Exact test with 95% 
confidence interval for single proportion will be conducted. 
Any post-operative complication or major complication will be summarized by MedDRA term (system 
organ class and preferred term), along with the number of events and the number of subjects with an 
event. Regarding DD, the number of DDs and the number of subjects with a DD shall be presented. 

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9.6. Other Pre-Specified Measures 
Descriptive analyses of other pre-specified measures beyond the primary and secondary objectives will 
be performed for followings: AE rate, pathological findings (only for prostatectomy subjects).  
AEs during the study period will be summarized by MedDRA term (system organ class and preferred 
term), along with the number of events and the number of subjects with an event. 
9.7. Interim Analysis 
No interim analyses are planned for this study. 
9.8. Subgroup Analyses 
Subgroup analyses may be used to explore the safety and performance of the study device given various 
patient, medical, and procedural factors. Subgroup factors include below but not limited to: 
• 
Sex (Male vs. Female) (Cholecystectomy only) 
• 
Age group 
• 
ASA class 
• 
Obesity (BMI <25 kg/m2 vs. BMI ≥25 and <30 kg/m2 vs. BMI ≥30 kg/m2) 
• 
Comorbidities (Yes vs. No) 
• 
Procedure-specific characteristics (e.g., nerve-sparing in prostatectomy) 
 
 

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10. Adverse Events and Device Deficiencies 
10.1. Adverse Events and Device Deficiencies 
All AEs will be collected throughout a subject’s participation, starting from the time the IC is provided, 
regardless of their severity or relationship to the Hugo™ RAS or study procedures. Assessment of the 
occurrence of an AE will be based on changes in the subject’s physical examination, laboratory results, 
and/or signs and symptoms. Reporting of these events to the sponsor will occur on an AE CRF, including 
date of AE, event description, treatment, resolution, assessment of both the seriousness of the AE and 
the relatedness to the system components. The completed AE CRF must be submitted to Medtronic as 
soon as possible. 
In addition, DD information will be collected throughout the study and reported to the sponsor on a DD 
CRF. Note that DDs that result in an AE to the subject should be captured as an AE only. DD that could 
have led to a serious adverse device effect (SADE) (i.e., if suitable action had not been taken, if 
intervention had not been made, or if the circumstances had been less fortunate) require immediate 
reporting. 
Upon receipt of AE or DD at Medtronic, a sponsor representative will review the AE/DD for 
completeness and accuracy and when necessary will request clarification and/or additional information 
from the investigator. If the event is unanticipated or unanticipated serious ADE, the sponsor will review 
the specific details behind those observations and determine what, if any, action is appropriate. 
For any changes in status of a previously reported AE or DD (i.e., change in actions taken, change in 
outcome, change in relatedness), information needs to be updated on, or added to the original AE or DD 
CRF.  
All AEs must be followed until the AE has been resolved, is unresolved with no further actions planned, 
the subject dies or exits the study, whichever occurs first. At the time of study exit, all collected AEs that 
are unresolved must be reviewed and an update to the original AE must be reported. 
Adverse events that have not resolved at the time of the subject’s discontinuation or completion of the 
study should have an outcome of Not Recovered/Not Resolved at study end in subject source and on 
eCRF. The investigator should ensure that subject is aware of any follow-up or additional treatment that 
is required for any ongoing AE at the end of study participation; however, there will be no eCRF entry for 
the ongoing follow-up. 
10.2. Definitions/Classifications 
This study will use AE definitions according to KGCP and/or ISO 14155:2020 for consistency in reporting, 
as in Table 7.  

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Table 7. Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE)* 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device 
and whether anticipated or unanticipated. 
 
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 or comparators. 
(ISO 14155:2020 section 3.2) 
*The ISO 14155 definition is equivalent to AE under KGCP Article 2 item M. 
Adverse Device 
Effect (ADE)* 
Adverse event related to the use of an investigational medical device 
 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. 
(ISO 14155:2020 section 3.1) 
* The ISO 14155 definition is equivalent to ADE under KGCP Article 2 item N. 
Unanticipated 
Adverse Device 
Effect (UADE) 
Deviation from the aspect of ADEs or the degree of harm reflecting from the 
available medical device related information such as investigator’s brochure 
or medical device package insert (KGCP Article 2 item P) 
Device Deficiency 
(DD) 
Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety or performance 
 
NOTE 1: Device deficiencies include malfunctions, use errors and inadequacy 
in the information supplied by the manufacturer including labeling. 
NOTE 2: This definition includes device deficiencies related to the 
investigational medical device or the comparator. 
(ISO 14155:2020 section 3.19) 
Relatedness 
Study Device 
An AE that results from the presence or performance of any component of the 
system and its compatible components 

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Study Procedure 
An AE that occurs due to any procedure related to the Hugo™ RAS System 
Underlying condition 
or disease 
Event related to condition or disease of the subject 
Seriousness 
Serious Adverse 
Event (SAE)* 
Adverse event that led to any of following: 
1) death 
2) a serious deterioration in the health of the subject, users, or other 
persons as defined by one or more of the following: 
- 
A life-threatening illness or injury, or 
- 
A permanent impairment of a body structure or a body function 
including chronic diseases, or 
- 
In-patient or prolonged hospitalization, or 
- 
Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function, 
3) foetal distress, foetal death or a congenital abnormality or birth defect 
including physical or mental impairment 
 
NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered 
an SAE.  
(ISO 14155:2020 section 3.45) 
* The ISO 14155 definition is equivalent to SAE under KGCP Article 2 item O. 
Serious Adverse 
Device Effect 
(SADE)* 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
(ISO 14155:2020 section 3.44) 
* The ISO 14155 definition is equivalent to SADE under KGCP Article 2 item O. 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current risk assessment 
 
NOTE 1: Anticipated Serious Adverse Device Effect (ASADE) is an effect which 
by its nature, incidence, severity or outcome has been identified in the risk 
assessment.  
(ISO 14155:2020 section 3.51) 
 
Unavoidable AEs are those that, according to the investigator’s opinion, are inherent to the procedure 
and are expected to occur in all subjects for an expected duration. Unavoidable AEs will not be captured 
or reported unless the AE worsens or persists outside the stated timeframe. Unavoidable AEs include, 
but are not limited to, events listed in Table 8. 

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Table 8. Unavoidable Adverse Events 
Unavoidable Event Description 
Hours from the procedure 
Anesthesia related nausea/vomiting) 
24 
Low-grade fever (<37.8°C) 
48 
Incisional pain 
72 
Sleep problems (insomnia) 
72 
Constipation 
72 
Mild to moderate bruising/ecchymosis 
168 
 
The sponsor will utilize MedDRA for Regulatory Activities, to assign a MedDRA term for each AE/DD 
based on the information provided by the investigator. AE classification responsibilities listed below in 
Table 9.  
Table 9. Adverse Event Classification Responsibilities 
What is 
classified? 
Who 
classifies? 
Classification parameters 
Relatedness Investigator, 
Sponsor 
Levels of causality will be assessed and categorized as ”Not related”, 
“Possible”, “Probable”, or “Causal” for each of following parameters: Study 
Device, Study Procedure, Underlying condition or disease 
- 
Not related: The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained by another 
cause, but additional information may be obtained. 
- 
Possible: The relationship with the use of the investigational device 
is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g., an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment). 
Cases were relatedness cannot be assessed or no information has 
been obtained should also be classified as possible. 
- 
Probable: The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably be explained by 
another cause, but additional information may be obtained. 
- 
Causal: The event is associated with the investigational device or 
with procedures beyond reasonable doubt when one of followings 
is met: 
 
the event is a known side effect of the product category the 
device belongs to or of similar devices and procedures 
 
the event has a temporal relationship with investigational device 
use/application or procedures 
 
the event involves a body-site or organ that the investigational 
device or procedures are applied to; investigational device or 
procedures have an effect on 

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What is 
classified? 
Who 
classifies? 
Classification parameters 
 
the event follows a known response pattern to the medical device 
(if the response pattern is previously known) 
 
the discontinuation of medical device application (or reduction of 
the level of activation/exposure) and reintroduction of its use (or 
increase of the level of activation/exposure), impact on the event 
(when clinically feasible) 
 
other possible causes (e.g., an underlying or concurrent 
illness/clinical condition or/and an effect of another device, drug 
or treatment) have been adequately ruled out 
 
harm to the subject is due to error in use 
 
the event depends on a false result given by the investigational 
device used for diagnosis, when applicable 
Severity 
Investigator 
Severity will be assessed and categorized as ”Negligible”, “Minor”, 
“Moderate”, “Major”, or “Critical”. 
- 
Negligible: No/minimal impact on the patient’s health condition 
- 
Minor: Presence or risk of temporary problem on the patient’s 
health condition, regardless of underlying diseases of the patient 
- 
Moderate: Presence or risk of reversible reduction in function 
(sensory, motor, physiological, or cognitive) on the patient’s health 
condition, regardless of underlying diseases of the patient 
- 
Major: Presence or risk of permanent reduction in function 
(sensory, motor, physiological, or cognitive) on the patient’s health 
condition, regardless of underlying diseases of the patient 
- 
Critical: Presence or risk of death or serious irreversible impairment 
in function (sensory, motor, physiological, or cognitive) on the 
patient’s health condition, regardless of underlying diseases of the 
patient 
Seriousness Investigator, 
Sponsor 
SAE, SADE, DD with SADE potential 
Expectedness Sponsor 
UADE, USADE 
Diagnosis 
Investigator Based on presenting signs and symptoms and other supporting data 
Sponsor 
MedDRA term (System Organ Class and Preferred Term) assigned based on 
the data provided by the investigator 
 
In addition, all post-operative AEs will be classified by the investigator according to the Clavien-Dindo 
classification system below in Table 10.  

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Table 10. Clavien-Dindo Classification 
Grade[16] Description 
Grade I 
Any deviation from the normal post-operative course without the need for 
pharmacological treatment or surgical, endoscopic, and radiological interventions. 
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, 
diuretics, electrolytes, and physiotherapy. This grade also includes wound infections 
opened at the bedside. 
Grade II 
Requiring pharmacological treatment with drugs other than such allowed for grade I 
complications Blood transfusions and total parenteral nutrition are also included. 
Grade III 
Requiring surgical, endoscopic or radiological intervention  
Grade IIIa: Intervention not under general anesthesia 
Grade IIIb: Intervention under general anesthesia 
Grade IV 
Life-threatening complication (including central nervous system complications)* 
requiring intermediate care or intensive care unit management 
Grade IVa: Single organ dysfunction (including dialysis) 
Grade IVb: Multiorgan dysfunction 
*Brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient 
ischemic attacks.  
Grade V 
Death of a patient 
10.3. Reporting of Adverse Events and Device Deficiencies 
Regulatory reporting of AEs and DDs will be recorded and reported according to local regulatory 
requirements. Refer to Table 11 for a list of required investigator and Medtronic reporting requirements 
and timeframes.  
Table 11. Safety Reporting Requirements 
SAEs 
Investigator shall submit to: 
Medtronic 
Report to the sponsor, without unjustified delay, all serious adverse events. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
Sponsor shall submit to: 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
ADEs 
Investigator shall submit to: 

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Medtronic 
Submit in a timely manner after the investigator first learns of the effect. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
Sponsor shall submit to: 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
SADEs, UADEs, USADEs 
Investigator shall submit to: 
Medtronic 
Immediately after the investigator learns of the event or of new information 
in relation to an already reported event. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
Sponsor shall submit to: 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
Investigators 
Submit per local reporting requirement. 
All other reportable AEs  
Investigator shall submit to: 
Medtronic 
Submit in a timely manner after the investigator first learns of the event. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
DDs with SADE potential 
Investigator shall submit to: 
Medtronic 
Submit or report as required per local reporting requirements. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
Sponsor shall submit to: 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
All other Device Deficiencies 
Investigator shall submit to: 
Medtronic 
Submit in a timely manner after the investigator first learns of the deficiency. 
Regulatory authorities 
Submit to regulatory authorities per local reporting requirement. 
IRB 
Submit to IRB per local reporting requirement. 
 
 

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11. Data Review Committees  
Not applicable 
 

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12. Ethical and Administrative Considerations 
12.1. Statement(s) of Compliance  
This study shall be conducted in compliance with the Declaration of Helsinki, applicable regulatory 
requirements in Korea including the Medical Device Act and its subordinate laws and regulations, 
Personal Information Protection Act, and Korea Medical Devices Industry Association Fair Trade 
Competition, the CIP, the CTA, and the site IRB requirements. 
The principles of the Declaration of Helsinki have been implemented through the IC process, IRB 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy. Ultimately, the sponsor and investigators will follow and comply with relevant laws 
and regulations. 
The sponsor shall avoid improper influence on or inducement of the subject, monitor, investigators or 
other parties participating in or contributing to the clinical investigation. In addition, investigators shall 
avoid improper influence on or inducement of the subject, sponsor, monitor, other investigator(s) or 
other parties participating in or contributing to the clinical investigation. Pediatric, legally incompetent, 
or other vulnerable subjects are not eligible for the study.  
The study will be publicly registered prior to in accordance with the Declaration of Helsinki on 
ClinicalTrials.gov (http://clinicaltrials.gov) or CRIS (http://cris.nih.go.kr). Approval of the CIP and CIP 
amendments is required from the following groups prior to any study procedures at a study site: The 
sponsor, principal investigators, MFDS, and the site IRB. 
12.2. CIP Amendments 
Any revisions or amendments to the CIP or IC document, will be submitted to the MFDS and/or IRBs 
along with a statement of justification for changes, for their approval prior to implementing the 
amendment. All amendments to the CIP shall be agreed upon between Medtronic and the principal 
investigator(s), or the coordinating investigator. Subject enrollment must stop until the amendment is 
approved. 
Minor amendment including administrative changes to the CIP will be submitted to the MFDS and/or 
IRB for notification, if applicable. Minor amendments do not necessarily require MFDS approval. 
12.3. Role of the Investigation Site 
The head of the study site shall establish IRB which operates independently in the institution and provide 
SOPs to help the IRB execute its duties. In addition, the head of the study site shall ensure that the site 

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facility, professional staff, and appropriate measures for an emergency are prepared for the precise 
execution of the study. The study site shall:  
• 
Be designated as the Medical Device Clinical Trial Institute per the Regulation for Designation 
of Medical Device Clinical Trial Institute (MFDS Notification No. 2017-55. Jun 27, 2017) 
• 
Be able to enroll the required number of eligible subjects needed for the study 
• 
Ensure that it has one or more qualified investigators, a qualified investigational study site 
team and adequate facilities for the foreseen duration of the clinical investigation 
 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following: 
• 
MFDS and IRB approval of the current version of the CIP and IC 
• 
Fully executed CTA 
• 
CV of investigators 
• 
Documentation of delegated tasks 
• 
Documentation of study training 
12.4. Role of the Institutional Review Board 
The IRB shall be organized and operates according to applicable laws and regulations to safeguard the 
rights, safety, and well-being of all study subjects. The IRB shall implement expedite review in case of 
followings: improper consent process, the study is not conducted per the CIP, or unanticipated serious 
harm to subjects such as SAE or SADE reporting. 
12.5. Role of the Investigators and Study Staff 
All investigators managing the subject’s condition must be qualified practitioners and experienced in the 
diagnosis and treatment of subjects with study specific conditions (i.e., prostate cancer, cholelithiasis, 
cholecystitis, or gallbladder polyps). All physicians must be experienced and/or trained in the handling of 
the investigational device and the study procedure.  
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the clinical investigation. The principal investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be experienced in the field of application and training in the use of the Medtronic Hugo™ RAS 
System 

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• 
Disclose potential conflicts of interest, including financial, that interfere with the conduct of 
the clinical investigation or interpretation of results 
 
All study site staff must be trained on the current version of the CIP as well as on the applicable study 
requirements depending on their role and must be delegated by the principal investigator to perform 
study related activities. In case of delegated task changes (e.g., new member join the study site team), 
they will receive training on the applicable study requirements relevant to their role before contributing 
to the study. Certification of study site personnel training will be documented. 
12.6. Role of the Sponsor 
The sponsor shall ensure that trials are conducted in compliance with the CIP, and the applicable 
regulatory requirements. In addition to performing monitoring and auditing activities, sponsor 
representatives may provide support at the study site as required for the study, including: 
• 
Provide study training relevant and pertinent to the involvement of personnel conducting 
study activities and investigator responsibilities 
• 
Technical support at under the supervision of a study investigator, but no data entry, shall be 
performed by Medtronic personnel or their representatives at study sites 
 
In addition, for this study, sponsor representatives may be authorized by the principal investigator to 
perform the following significant trial related duties:  
• 
Support study investigators in performing the study procedure 
• 
Support data collection during the procedure and device testing 
• 
Support data collection during the study follow-up visit 
12.7. Data Management 
Data will be collected using an electronic data management system for studies. eCRF data will be stored 
in a secure, password-protected database which will be backed up nightly.  
Data will be reviewed using programmed and manual data checks to ensure the accuracy, completeness, 
and consistency. Data queries will be made available to study sites for resolution. At the end of the 
study, the data will be frozen and will be retained by the sponsor in accordance with applicable 
regulations. All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form. 

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The investigator’s signature for specific eCRFs will be documented in compliance with local regulations. 
Changes to data previously submitted to the sponsor will require a new electronic signature by the 
investigator to acknowledge/approve the changes. 
12.8. Monitoring  
It is the responsibility of the sponsor to ensure monitoring of this study. Trained sponsor representatives 
may perform study monitoring at the study site in order to ensure that the study is conducted in 
accordance with the CIP, the CTA, and applicable regulatory requirements. These representatives must 
therefore be allowed direct access to the subjects’ medical records, and other source 
data/documentation) upon request. 
Monitoring visits will be conducted at the start, during and at the closure of the study in accordance 
with Medtronic SOPs and the Monitoring Plan. Frequency of monitoring visits may be based upon 
subject enrollment, study compliance, number of events or deviations, observations from previous 
monitoring visits and any suspected inconsistency in data that requires investigation.  
Monitors review study compliance by identifying non-compliance and provide study site personnel with 
recommendations for preventative/corrective actions. Monitors may work with study personnel to 
determine appropriate corrective action recommendations and to identify trends within the study or at 
a particular study site. 
12.9. Direct Access to Source Data/Documents  
The sponsor, the site IRB, or MFDS may conduct site visits for the purpose of monitoring, audit, or 
regulatory inspection of the study site to verify the performance of the monitoring process and the 
study conduct. The investigators and/or study site will permit direct access to original source 
data/documents per applicable laws and regulations by signing the CTA. 
12.10. 
Confidentiality 
Subject confidentiality will be maintained throughout the study to the extent permitted by law. Study 
sites will assign a unique subject identification (SID) number to each subject. The SID number is to be 
recorded on all study documents to link them to the subject’s medical records at the study site. Any 
information which would identify the subject shall not leave the site. Confidentiality of data will be 
observed by all parties involved at all times throughout the clinical investigation. All data shall be 
secured against unauthorized access. 
The privacy of each subject and confidentiality of his/her information shall be preserved in reports and 
when publishing any data. To maintain confidentiality, the subject’s name or any other sensitive 
information should not be recorded on any study document other than the IC. In the event of inability to 

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blind the identification (e.g., digital media), it will be handled in a confidential manner by the authorized 
personnel.  
Data relating to the study might be made available to third parties (e.g., auditors or regulatory 
inspectors), provided the data are treated as confidential and that the subject’s privacy is guaranteed. 
No identifiable subject information will be published under any circumstance. 
12.11. 
Liability/Insurance Information 
Medtronic Korea Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate clinical trial liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical trial insurance statement/certificate will be provided to the IRB. 
12.12. 
Treatment after the Completion of the Trial 
The investigator shall ensure that subject who dropped out or terminated early will receive alternative 
treatment. In case of study suspension or termination, the site shall provide subjects treatment per local 
standard practices. Treatment after the completion of the study shall comply with the standard medical 
care of the site, and the subject shall cover his/her treatment at own expense. 
12.13. 
Record Retention 
According to the Medical Device Act Enforcement Regulation, all study-related documents must be 
retained for a period of at least 3 years after product approval (or longer if required by Medtronic SOPs). 
Study records include the CIP with any/all amendments, all correspondence with and approval from the 
MFDS and IRB, the CTA, the Investigator Statement, individual subject records, and signed ICFs, etc. 
Medtronic will inform the investigator/study site when these documents are no longer required to be 
retained. 
No study document or record will be destroyed without prior written agreement between the sponsor 
and investigator. The investigator should take measures to prevent accidental or premature destruction 
of documents. Should the investigator wish to assign the study records to another party or move them 
to another location, advance written notice must be given to the sponsor. The sponsor will not store any 
personal data longer than necessary and always in line with the required storage periods.  
12.14. 
Reporting Requirements 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all CRFs, AEs and ADEs (reported per the country-specific collection requirements), DDs, and any 

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deviations from the CIP. If any action is taken by an IRB with respect to this study, copies of all pertinent 
documentation must be forwarded to sponsor in a timely manner. Reports are subject to inspection and 
to the retention requirements as described above for investigator records. The investigator shall prepare 
and submit in a complete, accurate and timely manner the reports listed in Table 12. 
Table 12. Investigator Reports Applicable per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of IRB 
approval 
Sponsor and 
MFDS 
The investigator must report a withdrawal of approval by the 
reviewing IRB of the investigator’s part of the investigation 
within 5 working days. 
Study Deviations  
Sponsor and IRB 
Any deviation from the clinical investigational plan shall be 
recorded together with the explanation of the deviation. Notice 
of deviations from the CIP to protect the life or physical well-
being of a subject in an emergency shall be given as soon as 
possible, but no later than 5 working days after the emergency 
occurred. Except in such emergency, prior approval is required 
for changes in the plan or deviations.  
Adverse Events 
Sponsor and IRB 
Report according to reporting timelines provided in Table 11. 
Final Report 
IRBs and MFDS 
This report must be submitted within 3 months of study 
completion or termination. 
12.15. 
Publication and Use of Information 
Publications from this study will be handled according to Medtronic SOPs and as indicated in the CTA. 
Medtronic, as the sponsor and the owner of the data, can use the data and/or any results derived from 
the data or publications based on that data for marketing purposes, further research and development 
of devices or educational use. 
12.16. 
Planned Study Closure 
When all planned procedures are completed per the CIP, the sponsor will distribute a study closure 
letter to the MFDS and IRB. Upon study closure, the study data will be reviewed, validated and frozen 
for the analysis. Then the sponsor shall analyze the study data and submit the clinical trial report. The 
study closure process is complete upon distribution of the final clinical trial report or after final 
payments, whichever occurs last. 

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12.17. 
Suspension or Early Termination 
The sponsor, IRB or MFDS may decide to suspend or prematurely terminate an investigation site or the 
study itself when applicable. Early Termination is the closure of a study that occurs prior to meeting the 
primary objective. Suspension is a temporary postponement of study activities related to enrollment 
and distribution of the product. Possible reasons for considering suspension or termination of the study 
include but are not limited to: 
• 
AEs associated with the system or product under investigation which might endanger the 
safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or MFDS 
• 
Technical issues during the manufacturing process 
• 
Failure to obtain initial IRB approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g., failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups) 
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g., failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring observations in a timely manner, 
etc.) 
• 
IRB suspension of the study site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 
• 
Investigator request (e.g., no longer able to support the study) 
 
If the study is suspended or prematurely terminated, the sponsor shall promptly inform the 
investigator(s) of the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing IRB (if required) and the study subjects and ensure appropriate care and 
follow-up is provided. In the case of a study suspension, subject enrollment must stop until the 
suspension is lifted by the sponsor. However, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare.  
The investigator shall not withdraw a subject’s study participation unless compelling medical 
justification is present. Every attempt will be made to complete the subject’s study per the CIP, and 
regular telephone follow-up is acceptable to have the subject engage in study procedures. However, 
when the risks are found to outweigh the potential benefits or when there is conclusive proof of definite 
outcomes, investigators must assess whether to continue, modify or immediately stop the study in the 
respective site and immediately inform the sponsor and IRB, if applicable. 
 
 

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13. References 
1. Lanfranco AR, Castellanos AE, Desai JP, Meyers WC. Robotic Surgery: A Current Perspective. Ann Surg. 
2004;239(1):14-21.  
2. National Evidence-based Healthcare Collaborating Agency. A Health Technology Assessment of the 
Effectiveness And Safety Of Robot Surgery. 2011. 
3. Health Insurance Review and Assessment Service. Health Insurance Coverage for Robotic Assisted 
Surgery: A Case Study. 2019. 
4. National Evidence-based Healthcare Collaborating Agency. Clinical Effectiveness and Safety of Robotic 
Surgery. 2014. 
5. National Health Insurance Service. Main Surgery Statistical Yearbook for 2019. 2020. 
6. Guerra F, Di Marino M, Coratti A. Robotic Surgery of the Liver and Biliary Tract. J Laparoendosc Adv 
Surg Tech A. 2019;29(2):141-146. 
7. The Korean Urological Oncology Society. Korean Clinical Practice Guideline for the Treatment of 
Prostate Cancer. 2020. 
8. Devore J. Probability and Statistics for Engineering and the Sciences. 8th ed. Boston: Cengage 
Learning; 2015. 
9. Koh DH, Jang WS, Park JW, et al. Efficacy and Safety of Robotic Procedures Performed Using the da 
Vinci Robotic Surgical System at a Single Institute in Korea: Experience with 10000 Cases. Yonsei Med J. 
2018;59(8):975-981. 
10. Alemzadeh H, Raman J, Leveson N, et al. Adverse Events in Robotic Surgery: A Retrospective Study of 
14 Years of FDA Data. PLoS One. 2016;11(4):e0151470. 
11. Chang KD, Abdel Raheem A, Choi YD, Chung BH, Rha KH. Retzius-Sparing Robot-Assisted Radical 
Prostatectomy Using the Revo-I Robotic Surgical System: Surgical Technique and Results of the First 
Human Trial. BJU Int. 2018;122(3):441-448.  
12. Lim JH, Lee WJ, Choi SH, Kang CM. Cholecystectomy Using the Revo-i Robotic Surgical System From 
Korea: The First Clinical Study. Updates Surg. 2021;73(3):1029-1035. 
13. Saklad M. Grading of Patients for Surgical Procedures. Anesthesiology 1941;2:281-284. 
14. Epstein JI, Egevad L, Amin MB, et al. The 2014 International Society of Urological Pathology (ISUP) 
Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and 
Proposal for a New Grading System. Am J Surg Pathol. 2016;40(2):244-252. 
15. Amin MB, Edge SB, Greene FL, et al. AJCC Cancer Staging Manual. 8th ed. New York: Springer 
International Publishing; 2017. 
16. Dindo D, Demartines N, Clavien PA. Classification of Surgical Complications: A New Proposal with 
Evaluation in a Cohort of 6336 Patients and Results of a Survey. Ann Surg. 2004;240(2):205-213. 

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14. Appendices  
14.1. Investigator Agreement and Signature Page 
Provided under separate cover 
14.2. List of the Investigators and Study Staff 
Provided under separate cover 
14.3. Investigational Device and Compatible Components 
Provided under separate cover 
14.4. Instructions for Use/Labeling 
Provided under separate cover 
• 
Hugo™ RAS System Instructions for Use 
• 
Hugo™ RAS Wristed Instructions for Use 
• 
VersaOne™ Bladeless Positioning Trocar System and Universal Cannula Positioning Trocar 
System Instructions for Use 
• 
VersaOne™ Reusable Positioning Trocar System Instructions for Use 
• 
Setup Guide for Cholecystectomy 
• 
Setup Guide for Prostatectomy 
14.5. Sample Informed Consent Form 
Provided under separate cover 
14.6. Sample Case Report Form 
Provided under separate cover 
14.7. Foreseeable Adverse Event List 
Provided under separate cover 

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14.8. Precautions 
Provided under separate cover 
 

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15. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
New Document 
Eunkyung Jung, 
Clinical Research 
Specialist 
2.0 
Following amendments are made upon MFDS feedback on version 
1.0: 
- 
Study background: Provided summary of pre-clinical studies 
and cadaveric studies 
- 
Inclusion criteria: Added definition of clinically localized 
prostate cancer 
- 
Exclusion criteria: Added ECOG Performance Status ≥ 2 
- 
Removed selection criteria for surgeon 
- 
Investigational device: Provided comparison between the 
investigational device and locally commercialized devices, 
added appropriate action in case of cybersecurity incident 
- 
Study measurements 
• 
Added pre-operative test items 
• 
Provided key procedural steps including port placement 
and arm positioning 
• 
Added post-operative imaging for prostatectomy subjects 
• 
Added post-operative follow-up visits for prostatectomy 
subjects 
• 
Changed frequency of vital signs/laboratory assessments 
- 
Study endpoints: Combine the primary effectiveness endpoint 
and the primary safety endpoint into single composite 
endpoint 
- 
Statistical methods: Revised the definition of per-protocol set, 
provided the method of statistical testing 
- 
Removed Section 9. Risks and Benefits 
- 
Other minor corrections (e.g., typos) 
Eunkyung Jung, 
Clinical Research 
Specialist 
3.0 
- 
Moved the list of sub-investigators, investigational device 
managers, and sponsor representatives to Appendix 14.2 
- 
Changed port placement and arm positioning figures for 
cholecystectomy 
- 
Moved and added details on investigational device and 
components to Appendix 14.3 
- 
Updated amendment date of applicable local regulations 
Eunkyung Jung, 
Senior Clinical 
Research 
Specialist 
4.0 
Following amendments are made upon MFDS feedback on version 
3.0: 
- 
Study background: Removed the summary of risks and 
benefits 
Eunkyung Jung, 
Senior Clinical 
Research 
Specialist 

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- 
Investigational device: Added images of surgeon console, arm 
carts, and system tower, removed description on the 
comparison between the investigational device and locally 
commercialized devices, added a summary of the instructions 
for use 
- 
Inclusion criteria: Added detailed description for gallbladder 
polyps 
- 
Exclusion criteria: Removed BMI ≥ 35, ECOG Performance 
Status ≥ 2 
- 
Sample size: Revised according to previous research results 
and updated the target performance 
- 
Study measurements: Changed port placement and arm 
positioning figures for cholecystectomy 
- 
Study endpoints: Updated wording of primary endpoint 
definition (i.e., “any system-related major complication” to 
“any major complication”) 
- 
Statistical methods: Added details in the definition of full 
analysis set 
5.0 
Minor changes are made upon MFDS amendment request on version 
4.0: 
- 
Investigational device: Inserted a paragraph that the system 
does not support hospital network or other Ethernet 
connectivity 
- 
Statistical methods: Added details in the analysis set definition 
Eunkyung Jung, 
Senior Clinical 
Research 
Specialist 
6.0 
Updates made to align to the updated SOP template 056-F275, Rev E 
Following changes are made to clarify data collection requirements: 
- 
Study measurements: Added takedown time, changes to port 
placement, delay in robot setup time, and delay in total 
operative time; added definition of robot setup time, 
removed pre-operative test results (e.g., electrocardiography, 
chest X-ray, pulmonary function test, echocardiography, and 
some laboratory values including urine tests, coagulation, and 
serology) from data collection, clarified which concomitant 
medications should be collected, and added window period 
for Day 7 visit for prostatectomy patients (i.e., ±3 days), 
allowed data collection in case of an unscheduled visit  
- 
Investigational device: Removed optional storage requirement 
for study device 
- 
Safety reporting: Update Table 11 and Table 12 regarding 
reporting timeframe upon the country and site IRB reporting 
requirements and combine the two tables into one 
- 
Statistical methods: Add descriptive analyses for added 
measurement items during procedure 
Eunkyung Jung, 
Senior Clinical 
Research 
Specialist