A Single-Arm, Open Label Clinical Study to Collect Safety Data on the Osteoprobe System When Used as a Measurement Tool
Phase: NA
Conditions: Adverse Effects in the Use of the OsteoProbe System
Sponsor: Active Life Scientific, Inc.

 
 
TITLE PAGE 
A SINGLE-ARM, OPEN LABEL CLINICAL STUDY TO COLLECT SAFETY 
DATA ON THE OSTEOPROBE SYSTEM WHEN USED AS A 
MEASUREMENT TOOL 
 
 
Protocol Number: OP2020 
Version: 4.0 
Date: 21-SEP-2020 
 
 
 
Sponsor: 
Active Life Scientific, Inc. 
1027 Garden Street, Santa Barbara, CA 93101 
Phone: 805-770-2600 
Fax (Optional): 805-770-2606 
 
Sponsor Contact: 
Dr. Peter Burks 
Chief Executive Officer 
Email: peter@activelifescientific.com 
Phone: 805-770-2600 x106 
 
 
 
 
 
 
 
 
 
 
 
 
This document contains confidential information for use only by Investigators participating in the clinical 
investigation. This document should be maintained in a secure location and should not be copied or made 
available for review by unauthorized personnel. 

Clinical Study Protocol 
 
ii 
REVISION HISTORY 
 
Version 
Date 
Summary of Changes 
1.0 
07-MAY-2020 
Original Version 
2.0 
17-JUL-2020 
• 
Update protocol version number and date on title page, footer, 
Protocol Approval Page and Investigator Protocol 
Signature Page.  
• 
Revise List of Abbreviations to add BMSi. 
• 
Revise section 1 Study Summary including 1.1 Schedule of 
Events to reflect changes made in the body of the protocol and 
add the name and address of the Investigator and CRO. 
• 
Revise section 3.7 Device Traceability to include detailed 
information on tip assembly labeling and device accountability. 
• 
Revise section 3.8 Supply and Accountability of 
Investigational Devices to indicate that device storage 
instructions are documented in the User Guide. 
• 
Revise section 4.0 Benefit-Risk Analysis to correct the 
number of peer reviewed articles from 41 to 40. 
• 
Revise section 4.2 Risk Mitigation to correct the name of the 
product documentation and add a bullet to indicate that subject 
IDs will be used to mitigate risk. 
• 
Revise section 4.3 Anticipated Benefits to make it clear that 
there are no anticipated benefits to study subjects 
• 
Revise section 4.4 Risk to Benefit Ratio to indicate that the 
Investigator will be trained on the protocol. 
• 
Revise section 5.2 Secondary Objectives to indicate that 
safety events will be characterized. 
• 
Revise section 6.1 Study Duration to specify that AEs will be 
followed until no further resolution is expected. 
• 
Revise section 7.4 Exclusion Criteria to add clarity to existing 
exclusions, specify exactly how conditions such as allergies and 
infections will be determined and documented, specify that only 
topical antibiotics used at the procedure site are exclusionary, 
specify that only infections at the procedure site are 
exclusionary and exclude patients with needle phobia and 
additional conditions listed in exclusion criteria #14 
• 
Revise section 7.6 Informed Consent to refer to IRB 
guidelines. 
• 
Revise section 7.8 Screen Failures to indicate that Screen 
Failures will be captured on a log and re-screens require 
sponsor approval. 
• 
Revise sections 7.10 Subject Enrollment and 7.11 Treated 
Subjects to clarify when patients are considered enrolled and 
treated and that treated subjects will be followed for 30 days. 
• 
Revise section 8 Study Visit Procedures to clarify steps and 
order, list vitals to be captured, allow for screening procedures 
to be completed over a seven day period, and specify that 

Clinical Study Protocol 
 
iii 
follow ups may be in person or over video (telehealth) with body 
temperature measurements to help detect possible infections. 
• 
Revise section 9 Description of Study Procedures to clarify 
how the medical history will be captured, specify the vitals to be 
captured and document how pregnancy will be evaluated and 
tested. 
• 
Revise section 10.2 Subject Withdrawals to clarify that 
patients who withdraw consent prior to treatment will be 
considered screen failures. 
• 
Revise section 14.1 Definitions to add the definition of a device 
deficiency and revise the definition of an SAE to match FDA’s 
definition,  
• 
Revise section 14.2.2 Relationship to provide detail on how AE 
relationship to the investigational device will be determined. 
• 
Revise section 14.3 AE Reporting Procedures to clarify when 
AE collection begins and requirements for AE reporting, study 
termination and updating AE status. 
• 
Revise section 14.4 Treatment of AEs to clarify that AEs will be 
followed until resolved or no further improvement is expected. 
• 
Revise section 14.5 Clinical Events Committee to clarify the 
role of the CEC. 
• 
 Revise section 15 Study Monitoring to include the name and 
address of the CRO. 
• 
Revise section 18 Regulatory Considerations and Ethical 
Review to list all accurate regulatory requirements. 
• 
Revise section 18.4 Insurance to clarify who is insured and 
what they are insured for. 
• 
Revise section 19.1 Data Handling and Record Keeping to 
clarify roles and responsibilities. 
• 
Revise section 19.2 Record Keeping to include accurate 
regulatory requirements for retention of study records. 
• 
Revise section 19.4 Publication and Data Sharing Policy to 
indicate that the study will be registered on clinicaltrials.gov and 
results posted. 
• 
Minor administrative changes involving grammar, wordsmithing, 
punctuation, page numbers and other editorial changes have 
been made throughout the document. All are clearly identified in 
the track-changes version of the amendment. 
3.0 
08-SEP-2020 
• 
Revise sections 1, 1.1, 7.4, 8 and 9 to add x-rays for screening 
and adverse event evaluation. 
• 
Revise section 7.9 to clarify that subject IDs are not generated by 
the investigational device 
• 
Revise section 7.10 and 14.3.1 to clarify the point of enrollment 
4,0 
21-SEP-2020 
• 
Revise section 3.8 to reflect how Tip Assemblies will be tracked. 
• 
Make administrative change to footer to fix page numbering 
• 
Add section (New section 15) to describe study source 
documentation 

Clinical Study Protocol 
 
iv 
PROTOCOL APPROVAL SIGNATURE PAGE 
 
Protocol Number: OP2020 
 
Protocol Name: A Single-arm, Open Label Clinical Study to Collect Safety Data on the OsteoProbe 
System when used as a Measurement Tool 
 
Protocol Version: 4.0 
 
Protocol Date: 21-SEP-2020 
 
 
This protocol has been read and approved by: 
 
SPONSOR: 
 
 
 
 
 
 
 
Peter Burks 
CEO 
Active Life Scientific, Inc. 
 
Date (dd/mmm/yyyy) 
 
 
 
 
CRO: 
 
 
 
 
 
 
 
Iman Ahmad 
Director, Clinical Affairs 
MCRA, LLC 
 
Date (dd/mmm/yyyy) 
 
 
 
 
 
 
 
Dave McGurl 
Director, Regulatory Affairs 
MCRA, LLC 
 
Date (dd/mmm/yyyy) 
 
 
 
 
 
 
 
 
Chris Lotter 
Sr. Director, Data Management & Biostatistics 
MCRA, LLC 
 
Date (dd/mmm/yyyy) 

Clinical Study Protocol 
 
v 
INVESTIGATOR PROTOCOL SIGNATURE PAGE 
 
I have read and understand this protocol and will conduct the study in accordance with this protocol, all 
attachments and amendments, applicable Food and Drug Administration regulations, HIPAA, IRB 
requirements, and the policies of the institutions where the study will take place.  
 
In my formal capacity as Investigator, my duties include ensuring the safety of the study subjects enrolled 
under my supervision and providing Active Life Scientific, Inc. with complete and timely information, as 
outlined in the protocol. It is understood that all information pertaining to the study will be held strictly 
confidential and that this confidentiality requirement applies to all study staff at this site. 
 
Protocol Number: OP2020 
 
Protocol Title: A Single-arm, Open Label Clinical Study to Collect Safety Data on the OsteoProbe System 
when used as a Measurement Tool 
 
Protocol Version: 4.0 
 
Protocol Date: 21-SEP-2020 
 
 
 
Investigator: 
 
 
 
 
(Print Name) 
 
 
 
 
 
(Signature) 
Date (dd/mmm/yyyy) 
 
 
 
 
Upon signing, send a copy of this page to activelife@mcra.com.com and retain a copy for your files. 

Clinical Study Protocol 
 
vi 
TABLE OF CONTENTS 
 
TITLE PAGE ............................................................................................................................................ i 
PROTOCOL APPROVAL SIGNATURE PAGE........................................................................................ iv 
INVESTIGATOR PROTOCOL SIGNATURE PAGE ................................................................................. v 
LIST OF ABBREVIATIONS ..................................................................................................................... 1 
1. 
Study Summary ................................................................................................................................ 2 
1.1 
Schedule of Events .................................................................................................................. 5 
2. 
Introduction ...................................................................................................................................... 6 
2.1 
Background .............................................................................................................................. 6 
2.1.1 
OsteoProbe® System ........................................................................................................... 6 
2.1.2 
Diagnosis and Current Treatment Options ............................................................................ 6 
3. 
Investigational Device ....................................................................................................................... 6 
3.1 
Investigational Device Overview ............................................................................................... 6 
3.1.1 
Technological Characteristics ............................................................................................... 7 
3.2 
OsteoProbe Device Component Description ............................................................................. 8 
3.2.1 
Tip Assembly ........................................................................................................................ 8 
3.2.2 
Stylus ................................................................................................................................... 8 
3.2.3 
Holder & Reference Materials ............................................................................................... 8 
3.2.4 
Power Controller (Electronics) .............................................................................................. 9 
3.2.5 
Operator Interface ................................................................................................................ 9 
3.3 
Technical Specifications ......................................................................................................... 10 
3.4 
Device Sterilization ................................................................................................................. 11 
3.5 
Device Packaging and Labeling .............................................................................................. 11 
3.6 
Indications for Use.................................................................................................................. 11 
3.7 
Device Traceability ................................................................................................................. 12 
3.8 
Supply and Accountability of Investigational Devices .............................................................. 12 
3.9 
Device Use Experience and Training ...................................................................................... 12 
4. 
Benefit-Risk Analysis ...................................................................................................................... 12 
4.1 
Risks ...................................................................................................................................... 13 
4.2 
Risk Mitigation ........................................................................................................................ 13 
4.3 
Anticipated Benefits ................................................................................................................ 14 
4.4 
Risk-to-Benefit Ratio .............................................................................................................. 14 
5. 
Study Objectives............................................................................................................................. 14 
5.1 
Primary Objectives ................................................................................................................. 14 
5.2 
Secondary Objectives............................................................................................................. 14 
6. 
Study Design .................................................................................................................................. 15 
6.1 
Study Duration ....................................................................................................................... 15 

Clinical Study Protocol 
 
vii 
6.2 
Treatment/Control Group ........................................................................................................ 15 
6.3 
Primary Endpoints .................................................................................................................. 15 
6.4 
Secondary Endpoints ............................................................................................................. 15 
6.5 
Treatment/Control Groups and Blinding .................................................................................. 15 
7. 
Selection of Study Population ......................................................................................................... 16 
7.1 
Subject Recruitment ............................................................................................................... 16 
7.2 
Number of Subjects and Investigational Sites ......................................................................... 16 
7.3 
Inclusion Criteria .................................................................................................................... 16 
7.4 
Exclusion Criteria ................................................................................................................... 16 
7.5 
Screening ............................................................................................................................... 17 
7.6 
Informed Consent ................................................................................................................... 17 
7.7 
Subject Eligibility .................................................................................................................... 17 
7.8 
Screen Failures ...................................................................................................................... 17 
7.9 
Subject Identification .............................................................................................................. 18 
7.10 
Subject Enrollment ................................................................................................................. 18 
7.11 
Treated Subjects .................................................................................................................... 18 
8. 
Study Visit Procedures.................................................................................................................... 18 
8.1 
Visit 1:  Screening/Procedure Visit .......................................................................................... 18 
8.2 
Visit 2: 1-Day Follow-Up (+2 days).......................................................................................... 19 
8.3 
Visit 3: 7-Day Follow-Up (± 3 days) ......................................................................................... 19 
8.4 
Visit 4: 30-Day Follow-Up (± 10 days) ..................................................................................... 20 
8.5 
Out Of Window and Missed Visits ........................................................................................... 20 
8.6 
Unscheduled Visits ................................................................................................................. 20 
8.7 
Study Completion/Discontinuation .......................................................................................... 21 
9. 
Description of Study Procedures ..................................................................................................... 21 
10. 
Early Discontinuation Subjects ................................................................................................... 22 
10.1 
Lost to Follow-Up (LTFU) ....................................................................................................... 22 
10.2 
Subject Withdrawals ............................................................................................................... 22 
10.3 
Documentation of Early Discontinuation.................................................................................. 22 
10.4 
Use of Data from Early Discontinuation Cases ........................................................................ 23 
10.5 
Ongoing Treatment for Early Discontinuation Cases ............................................................... 23 
11. 
Early Discontinuation: Study ....................................................................................................... 23 
11.1 
Procedure for Suspension or Early Termination ...................................................................... 23 
11.2 
Procedure for Resuming the Clinical Investigation After Temporary Suspension ..................... 23 
11.3 
Routine Close-Out .................................................................................................................. 24 
12. 
Protocol Deviations .................................................................................................................... 24 
13. 
Concomitant Medications ........................................................................................................... 24 

Clinical Study Protocol 
 
viii 
14. 
Adverse Event and Device Deficiency Reporting ........................................................................ 24 
14.1 
Definitions .............................................................................................................................. 24 
14.2 
Classification of an AE............................................................................................................ 25 
14.2.1 
Severity .......................................................................................................................... 25 
14.2.2 
Relationship.................................................................................................................... 25 
14.3 
AE Reporting Procedures ....................................................................................................... 26 
14.3.1 
AE Reporting .................................................................................................................. 26 
14.3.2 
SAE Reporting ................................................................................................................ 26 
14.3.3 
Unanticipated Adverse Device Effect Reporting .............................................................. 27 
14.3.4 
Study Termination due to an Unanticipated Adverse Device Effect (UADE) ..................... 27 
14.4 
Treatment of AEs ................................................................................................................... 27 
14.5 
Clinical Events Committee (CEC) ........................................................................................... 27 
15. 
Study Monitoring ........................................................................................................................ 28 
15.1 
Site Monitoring ....................................................................................................................... 28 
15.2 
Monitoring Activities ............................................................................................................... 28 
15.3 
Frequency of Visits ................................................................................................................. 29 
16. 
Audits and Inspections ............................................................................................................... 29 
17. 
Statistical Analysis Plan ............................................................................................................. 30 
17.1 
Study Hypothesis ................................................................................................................... 30 
17.2 
Sample Size Analysis ............................................................................................................. 30 
17.3 
Study Populations .................................................................................................................. 32 
17.3.1 
Primary Analysis Set ....................................................................................................... 32 
17.3.2 
Per Protocol Analysis Set ............................................................................................... 32 
17.3.3 
Training Cases ............................................................................................................... 32 
17.4 
Testing of Primary Safety Hypotheses .................................................................................... 32 
17.5 
Missing Data/Sensitivity Analysis ............................................................................................ 32 
17.6 
Secondary Effectiveness Endpoints ........................................................................................ 32 
17.7 
Safety Analyses ..................................................................................................................... 33 
17.8 
Evalulation of Poolabitiy ......................................................................................................... 33 
17.9 
Changes to the Statistical Analysis Plan ................................................................................. 33 
17.10 
Software ............................................................................................................................. 34 
18. 
Regulatory Considerations and Ethical Review ........................................................................... 34 
18.1 
Ethical Review........................................................................................................................ 34 
18.2 
Regulatory Considerations ..................................................................................................... 34 
18.3 
Study Amendments ................................................................................................................ 34 
18.4 
Insurance ............................................................................................................................... 34 
19. 
Data Handling and Recordkeeping ............................................................................................. 34 

Clinical Study Protocol 
 
ix 
19.1 
Data Management .................................................................................................................. 34 
19.2 
Record Keeping ..................................................................................................................... 35 
19.3 
Data Protection and Subject Confidentiality ............................................................................ 36 
19.4 
Publication and Data Sharing Policy ....................................................................................... 36 
19.5 
Investigator Reports ............................................................................................................... 37 
 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 1 of 37 
LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
BMI 
Body Mass Index 
BMSi 
Bone Material Strength Index 
CDRH 
Center for Devices and Radiological Health 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRO 
Contract Research Organization 
DMP 
Data Management Plan 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
LTFU 
Lost to Follow-Up 
NRS 
Numeric Rating Scale 
OHRP 
U.S. Office of Human Research Protections 
PI 
Principal Investigator 
PP 
Per-Protocol 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOC 
Standard of Care 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
 
 
 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 2 of 37 
1. STUDY SUMMARY 
Study Full Title 
A Single-arm, Open Label Clinical Study to Collect Safety Data on 
the OsteoProbe System when used as a Measurement Tool 
Study Sponsor 
Active Life Scientific, Inc. 
Study Number 
OP2020 
Protocol Date 
17-JUL-2020 
STUDY OVERVIEW 
Study Design 
Prospective, Single Center, Open Label Clinical Study 
Purpose 
Collect safety data associated with the use of the OsteoProbe 
System. 
Expected Study Duration 
The study is expected to take approximately 3 months from first 
subject enrolled to the last follow-up visit. 
• 
2 months enrollment period (estimation) 
• 
1 month follow-up 
Evaluation Schedule 
Each subject will be evaluated at: 
• 
Screening/Procedure 
• 
1-Day (+2 days) 
• 
7-Day ((±3 days) 
• 
30-Day (±10 days) 
ELIGIBILITY CRITERIA 
Intended Subject Population 
A total of 40 subjects will be enrolled at 1 site. 
Main Inclusion Criteria 
In order to be eligible to participate in this study, subjects must 
meet all of the following inclusion criteria: 
 
1. Be greater than or equal to 22 years of age; 
2. Be able to give voluntary, written informed consent to 
participate and have signed an Informed Consent Form 
specific to this study 
3. If female and of child-bearing potential, must have a 
negative pregnancy status. 
Main Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded 
from participating in this study: 
 
1. Active skin infection at the procedure site as identified 
during a SOC physical examination. 
2. Subject-reported or known systemic infection; 
3. Subject-reported or known allergy to local anesthetic; 
4. Subject-reported or known allergy to stainless steel or 
nickel materials; 
5. Subject-reported or known current use of systemic 
antibiotics, or topical antibiotics administered to the 
procedure site; 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 3 of 37 
6. Subject-reported or known history of needle phobia; 
7. Significant soft tissue at the procedure site which would 
preclude use of the OsteoProbe in the judgement of the 
Investigator; 
8. Known instance of hardware in the tibia that is intended to 
be measured based on radiographic imaging; 
9. Known instance of a previous or current fracture in the tibia 
that is intended to be measured based on radiographic 
imaging; 
10. Are known to be actively participating or known to have 
participated in another clinical investigation for which they 
received an investigational product (including but not 
limited to a drug or vaccine) within the last 90 days, or 
reports that they intend to participate in another clinical 
investigation during the course of the study; 
11. Are known to be currently abusing drugs or alcohol or have 
a known history of the same within the last 12 months; 
12. Have any known or subject reported mental or 
psychological disorders that, in the judgement of the 
Investigator, would impair their ability to accurately 
complete the NRS Pain Score surveys; 
13. Are currently a prisoner; 
14. Have a condition which, in the judgement of the 
Investigator, would preclude adequate evaluation of the 
device’s safety and performance. Conditions include but 
are not limited to: 
a) Regional or systemic pain syndromes 
b) Radicular pain syndromes  
c) Chronic or intermittent leg pain 
d) Migraine headaches  
 
STUDY ENDPOINTS 
Primary Endpoint 
The incidence of device-related serious adverse events (SAEs) in 
subjects evaluated with the OsteoProbe System.  
Secondary Endpoints 
The secondary endpoints of this study, following evaluation with the 
OsteoProbe System, are: 
1. NRS Pain scores at Procedure, 1-day, 7-day and 30-day 
follow up visits; 
2. BMSi scores after the OsteoProbe procedure; 
3. Adverse event rates through Day 30; 
4. Device-related adverse events through Day 30; 
5. Serious adverse events through Day 30; and 
6. Unanticipated adverse device effects (UADE) through Day 
30. 
STATISTICAL CONSIDERATIONS 
Sample Size 
40 IDE Subjects 
 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 4 of 37 
A literature review was performed by the Sponsor who identified six 
studies with clinically relevant data to serve as an informative prior. 
These six studies contain 215 subjects with zero subjects 
experiencing device-related serious adverse events. Given there is 
no variability between these studies, the data are pooled together 
and collectively constitute the informative prior. The informative 
prior was constructed as Jeffries prior plus the data from the 
literature, that is, Beta(.5 + data, .5 + data).  
When there are zero device-related SAEs in 40 prospective 
subjects, the posterior probability will be .9765 and the device will 
have been shown to meet the performance goal. Therefore, only if 
there are zero device-related SAE’s will the alternative hypothesis 
be accepted. 
Statistical Plan 
The primary hypothesis is that the probability of experiencing 
device-related Serious Adverse Events (SAE) for subjects treated 
with the investigational device is smaller than the performance goal 
of 1%. Formally, the hypothesis to be tested is: 
H0: The expected proportion of subjects with device-related SAE up 
to Day 30 (pT) is greater than or equal to the performance goal (PG) 
of 1.0%. 
HA: The expected proportion of subjects with device-related SAE up 
to Day 30 (pT) is less than the performance goal (PG) of 1.0%. 
These hypotheses may be symbolically represented as: 
H0: pT ≥ PG = 1.0% 
Ha: pT < PG = 1.0% 
Where pT is the device-related SAE rate for subjects treated with 
the investigational device. 
If the Bayesian Posterior Probability that pT < PG is greater than or 
equal to .975, the alternative hypothesis will be accepted, and it will 
be concluded that the device meets the performance goal.  
 
STUDY MANAGEMENT  
Principal Investigator 
Brandon James Essink MD 
Meridian Clinical Research, LLC,  
3319 North 107th Street, Omaha, Nebraska 68134 
Clinical Research Organization 
(CRO) 
MCRA, LLC 
1050 K Street NW, Suite 1000 
Washington DC 20001 
 
 
 

Clinical Study Protocol 
 
 
 
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  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 5 of 37 
1.1 
SCHEDULE OF EVENTS 
 
Activity 
Visit 1 
Screening/
Procedure1 
Visit 2 
1-Day2,3 
(+ 2 days) 
Visit 3 
7-Day2,3 
(±3 days) 
Visit 4 
30-Day2 
(±10 days)  
Unscheduled 
Informed Consent 
X 
- 
- 
- 
- 
Inclusion/Exclusion Criteria Review 
X 
- 
- 
- 
- 
Demographics 
X 
- 
- 
- 
- 
Medical History 
X 
- 
- 
- 
- 
Physical Examination (including vitals) 
X 
- 
- 
- 
- 
X-Rays (AP & Lateral) 
X 
- 
- 
- 
- 
Pregnancy Evaluation/Test4 
X 
- 
- 
- 
- 
OsteoProbe Test Procedure 
X 
- 
- 
- 
- 
NRS Pain Score 
X5 
X 
X 
X 
X 
Record BMSi Score 
X 
- 
- 
- 
- 
Body Temperature 
 
X 
X 
X 
X 
Record/Review Concomitant Medications 
X 
X 
X 
X 
X 
Record/Review Adverse Events 
X6 
X6 
X6 
X6 
X6 
Record/Review Device Deficiencies 
X 
- 
- 
- 
- 
Work status 
X 
X 
X 
X 
X 
1 The Screening/Procedure visit may take place over multiple days, but the OsteoProbe procedure must be completed 
within 7 days of signing the ICF.  
2 To be conducted as telehealth visits with video interviews; option of in-person visits is acceptable if that is preferred by 
a subject or the Investigator. 
3 Measured from the date of the OsteoProbe procedure. 
4 Female subjects of child-bearing potential only. Negative pregnancy status can be based on self-reported sexual 
history and contraception use. An in-clinic test must be performed using urine dipstick when the subject thinks there is a 
potential that they might be pregnant.  
5 The NRS Survey must be completed once prior to the OsteoProbe procedure (baseline) and again following completion 
of the procedure. 
6 X-rays will be ordered by the Investigator to evaluate any adverse event that may be related to a potential tibial fracture 
based on clinical exam and/or adverse event details provided by the subject.  
 
 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 6 of 37 
2. INTRODUCTION 
2.1 
BACKGROUND 
2.1.1 
OsteoProbe® System  
The OsteoProbe® System (“OsteoProbe”) is a bone microindentation measurement tool. 
 
2.1.2 
Diagnosis and Current Treatment Options 
The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. 
There are no other available measurement tools for clinical assessment of bone’s resistance to 
microindentation. 
 
3. INVESTIGATIONAL DEVICE 
3.1 
INVESTIGATIONAL DEVICE OVERVIEW 
OsteoProbe is a bone microindentation measurement tool. It is intended to measure bone tissue’s resistance 
to microindentation on the left or right tibia in adults. It is a prescription device per 21 CFR Part 801.109. The 
device consists of five (5) components: 1) Stylus, 2) Power Controller (Electronics), 3) Holder and Reference 
Materials, 4) Tip Assembly, and 5) Operator Interface (Figure 1). The OsteoProbe includes a single-use 
disposable component (Tip Assembly) and reusable components (Stylus, Power Controller, and Holder).  
 
Figure 1: OsteoProbe Device 
 
 

Clinical Study Protocol 
 
 
 
Active Life Scientific, Inc. OP2020 
  CONFIDENTIAL            
Version 4.0, 21 SEP 2020  
 
 
    Page 7 of 37 
Table 1: OsteoProbe Device Components 
Component Part 
Number 
Component 
Representative Image 
1 
OPA-900 
Stylus 
2 
OPB-900 
Power Controller 
(Electronics) 
3 
OPC-900 
Holder and Reference 
Materials 
4 
OPD-900 
Tip Assembly 
5 
OPH-900 
Operator Interface 
N/A 
 
3.1.1 
Technological Characteristics 
Microindentation is a way of quantifying mechanical properties of materials. There are no devices on the 
market that can perform microindentation on bone in subjects. Microindentation involves a hard indenter that 
is pressed into a softer test material (i.e., bone) with a known force. Traditional microindentation testing has 
specific ASTM defined methods for calculating mechanical properties, like hardness. ASTM defined methods 
use specific shape indenters and measure indentation depth to calculate an arbitrary hardness number (e.g. 
Rockwell, Vickers). OsteoProbe operates according to the same principles and calculates a unique 
parameter: resistance to microindentation. The system software reports a simple numerical score with no 
reference to clinical utility or other information regarding the health status of the subject. 
 

Clinical Study Protocol 
 
 
 
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Version 4.0, 21 SEP 2020  
 
 
    Page 8 of 37 
3.2 
OSTEOPROBE DEVICE COMPONENT DESCRIPTION 
3.2.1 
Tip Assembly 
The Tip Assembly is attached to the Stylus in order to perform a measurement. The Tip Assembly is 
composed of two sub-components, the Tip and a Guide (Figure 2). The Guide retains the Tip and seals via a 
luer lock fitting to the Stylus. The Tip Assembly is the only component that directly contacts the subject. 
 
 
Figure 2: OsteoProbe Tip Assembly 
 
 
The Tip Assembly component is single-use and disposable. The Tip Assembly is packaged and shipped 
non-sterile. Sterilization instructions are provided to the end user.  
 
3.2.2 
Stylus 
The Stylus component consists of an outer Handle and an internal Body (Figure 3). The Stylus contains an 
actuation mechanism and sensor that measures the indentation depth of a Tip.  
Figure 3: OsteoProbe Stylus 
 
3.2.3 
Holder & Reference Materials 
The Holder consists of an enclosure/box that secures Reference Materials. There are two Reference 
Materials. The Reference Block, which is made from polymethylmethacrylate, is used after each 
measurement on a subject and is discarded after use. The Performance Check Block, which is made from 
epoxy resin (aka Noryl), is utilized during performance checks. These periodic verifications only ensure 
system is functioning as expected and are not used to calibrate the device. Both blocks are 1” x 1” x 0.5” (L x 
W x H) and are disposed of after a single use. 
Figure 4: OsteoProbe Holder 
 
 
Tip 
Guide 

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Specifications of the OsteoProbe Holder and Reference Materials are summarized in Table 2 below. 
Table 2: OsteoProbe Holder and Reference Materials Specifications 
Parameter 
Value 
Reproducibility 
Reference Block: 
Performance Check Block: 
± 1% 
± 1% 
Dimensions 
Reference Block: 
Performance Check Block: 
Holder: 
1” x 1” x 0.5” 
1” x 1” x 0.5” 
3.5” x 3.5” x 1.6” 
Weight 
Holder: 
5 lb 
 
3.2.4 
Power Controller (Electronics) 
The Power Controller consists of electronics that provide power and convert the analog signal from the 
Stylus into a digital signal which is processed by software on the personal computer terminal. No processing 
takes place in the power controller. 
Figure 5: OsteoProbe Power Controller (Electronics) 
 
 
Specifications of the OsteoProbe Power Controller are summarized in Table 3 below. 
Table 3: OsteoProbe Stylus Specifications 
Parameter 
Value 
Power Input Requirements 
Voltage: 
Frequency: 
Current: 
100 – 240 V~ 
50 – 60 Hz 
1.5 A 
Case Dimensions 
Approximately:  
46 x 34 x 17 cm 
Case Weight 
Approximately:  
8 kg 
Transport Conditions 
Ambient Temperature: 
Relative Humidity: 
Atmospheric Pressure: 
-20°C to 50°C 
10% to 90%, non-condensing 
28k Pa to 110 kPa 
Operating & Storage Conditions 
Ambient Temperature: 
Relative Humidity: 
Atmospheric Pressure: 
10°C to 30°C 
20% to 80%, non-condensing 
71 kPa to 101 kPa 
 
3.2.5 
Operator Interface 
The OsteoProbe Power Controller interfaces with a personal computer terminal via a USB port. The 
OsteoProbe Operator Interface consists of a software program that runs on a Windows 10 operating system 

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and processes the digital signal sent by the power controller. The Operator Interface provides the user 
control of the OsteoProbe to initiate a measurement. The Operator Interface will then store and display the 
measurement data as a simple numerical score. 
Figure 6: OsteoProbe Operator Interface Running on a Laptop 
  
 
Specifications of the OsteoProbe Operator Interface and Personal Computer specifications are summarized 
in Table 4 below. 
Table 4: OsteoProbe Operator Interface and Personal Computer Specifications 
Parameter 
Value 
Internet Connectivity 
Wireless: 
Ethernet: 
802.11b/g/n 
RJ-45 (100/1000 Mbps) 
Operating System 
Windows 10 Professional 
 
Interface Port 
USB A 
 
 
3.3 
TECHNICAL SPECIFICATIONS 
A summary of the system technical specifications is provided below (Table 5). 
Table 5: OsteoProbe General Technical Specifications 
Parameter 
Parameter Value 
System Classification 
FDA Class 
CAUTION: limited by Federal law to 
Investigational use only. 
EU Class 
Class IIa 
Safety Certifications 
U.S.A. Certification 
IEC 60601-1: 2012  
EU Certification 
IEC 60601-1: 2012 
EMC Certifications 
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: 
General requirements for basic safety and essential performance - 

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Parameter 
Parameter Value 
Collateral standard: Electromagnetic compatibility – Requirements 
and tests 
• CISPR 11:2015+A1:2016 - Limits and methods of measurement 
of radio disturbance, Characteristics of industrial, scientific and 
medical radio frequency equipment 
• IEC 61000-4-2:2008 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 2: Electrostatic 
discharge immunity test 
• IEC 61000-4-3:2010 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 3: Radiated, 
radio-frequency, electromagnetic field immunity test 
• IEC 61000-4-4:2012 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 4: Electrical fast 
transient/burst immunity test 
• IEC 61000-4-5:2005 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 5: Surge 
immunity test 
• IEC 61000-4-6:2013 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 6: Conducted 
immunity test 
• IEC 61000-4-8:2009 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 8: Power 
frequency magnetic field immunity test 
• IEC 61000-4-11:2004 - Electromagnetic Compatibility-Part 4: 
Testing and measurement techniques – Section 11: Voltage dips 
and interruptions immunity test 
IEC 61000-3-2:2014 - Electromagnetic compatibility (EMC) -Part 
3-2: Limits - Limits for harmonic current emissions (equipment 
input current < 16A per phase) 
IEC 61000-3-3:2013 - Electromagnetic compatibility (EMC) -Part 
3-3: Limits – Limitation of voltage changes, voltage fluctuations 
and flicker in public low-voltage supply systems, for equipment 
with rated current < 16A per phase and not subject to conditional 
connection 
CE Marking 
CE Marking for MDD 93/42/EEC 
 
3.4 
DEVICE STERILIZATION 
The tip is provided non-sterile for end user steam sterilization. All other components are reusable 
components, have a Spaulding classification of non-critical and must be reprocessed (cleaned and 
intermediate level disinfected) between each use. 
 
3.5 
DEVICE PACKAGING AND LABELING 
Device packaging and labeling are described in the User Manual. 
 
3.6 
INDICATIONS FOR USE 
The OsteoProbe System is indicated for use as a measurement tool to measure bone tissue’s resistance to 
microindentation on the left or right tibia in adults. It is not intended to make a clinical diagnosis. 
 

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3.7 
DEVICE TRACEABILITY 
Each device label includes a unique serial number that is associated with a device history record within the 
Company quality management system. The Tip Assembly of the device is single-use and disposable. The 
Tip Assembly components (tip and guide) are not individually serialized.  Unique Tip-ID labels are provided 
which are affixed to each sterilization pouch allowing for accountability of each Tip Assembly and traceability 
to manufactured lot. 
 
All devices will be shipped via commercial shipper with a tracking number. 
 
3.8 
SUPPLY AND ACCOUNTABILITY OF INVESTIGATIONAL DEVICES 
Tracking of the investigational product used in this study will be consistent with 21 CFR Part 821 and ISO 
14155:2011, and in accordance with local regulations. Devices will be stored in a secure location at the 
investigational site per the specifications in the User Manual which is only accessible to the Investigator and 
delegated site staff. OsteoProbe devices, labeled for Investigational Use Only, will be shipped directly to the 
clinical study site from: Active Life Scientific, Inc. 
 
The Investigator or delegate will maintain a Device Accountability Log to document the date of receipt, Tip 
ID, date of use, and final disposition of each device and Assembly Tip that they utilize during the course of 
the study. The log will be filed in the site’s ISF and will be available for review during monitoring visits. 
 
3.9 
DEVICE USE EXPERIENCE AND TRAINING 
The study Sponsor will ensure appropriate training for each Investigator prior to initiation of the study at the 
investigational site. This training will address topics such as the indications and contraindications for the use 
of the device, device handling, and the procedure.  
 
In addition, the Sponsor will provide training on the protocol, subject eligibility criteria, AE management, post-
operative care and follow-up for the Investigator and all delegated site staff. 
 
4. BENEFIT-RISK ANALYSIS 
There are 40 peer-reviewed articles that have been published that include discussion of OsteoProbe. Thirty 
of these 40 publications were clinical studies. None of these published clinical studies were sponsored by the 
Company. A complete list of published literature can be found in the Report of Prior Investigations.  
 
Active Life Scientific, Inc. has implemented a risk management process in conformance with EN ISO 14971. 
This risk management process includes risk management plan, risk analysis, risk evaluation, and risk 
control. The application of this risk management process is documented in a risk management file with a risk 
management plan. Documentation for the OsteoProbe risk management file will include: 
 
• 
OsteoProbe device-related risks 
• 
Clinical risks 
• 
Risk mitigation 
• 
Anticipated clinical benefits 
• 
Risk-to-benefit rationale 
• 
Conclusions from pre-clinical risk evaluation and justification for clinical investigation. 

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4.1 
RISKS 
The potential device- and procedure-related risks associated with the OsteoProbe device were identified as: 
• 
Allergic reaction to anesthetic or device materials 
• 
Mechanical failure or breakage of device 
• 
Discomfort 
• 
Pain 
• 
Bruising 
• 
Bleeding 
• 
Soft tissue infection 
• 
Bone infection 
• 
Bone fracture 
The probability of risks associated with the use of the OsteoProbe device are expected to be low. All adverse 
events will be captured and assessed by the Investigator.  
 
The subjects in this study will be exposed to the potential risks associated with the OsteoProbe device. 
There is clinical data on the device which help to understand that the risks associated with participation in 
the study to be relatively low.   
 
Trial-specific risks include the risks associated with study-related assessments, data collection and loss of 
confidentiality. 
 
Clinical investigations performed in this trial include non-invasive clinical evaluations and interview 
questionnaires. Questionnaires applied to this investigation are standard research instruments and have 
been applied in a large number of studies. 
 
As a result of participating in the study, there could be a risk of loss of protected subject information 
confidentiality. 
4.2 
RISK MITIGATION 
Appropriate designs and testing have been performed to minimize all risks as far as possible. Clinical 
monitoring, standard of care, and following the instructions for use ensure risks are minimized. An evaluation 
of the potential risks associated with use of the OsteoProbe System has been performed to minimize the 
risks associated with the device. Following are some of the ways in which risks have been or will be 
minimized. 
• 
Study Design 
• 
Subject monitoring 
• 
Subject selection 
• 
Anonymization of subjects’ identities via the use of Subject IDs on all study records 
• 
Device design 
• 
Procedure Guide & User Manual 
• 
Operator training 
• 
Mechanical testing 
• 
Software Validation 
• 
Cybersecurity 
• 
Sterilization and Cleaning Validation 
• 
Electrical Safety and EMC 
• 
Biocompatibility 

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All subject-associated risks pertaining to the device and procedure have been mitigated or minimized 
through design, labeling, training and validation/verification according to ISO 14971. 
 
4.3 
ANTICIPATED BENEFITS 
Although some of the noted risks are potentially significant, they are expected to have low probability of 
occurrence based on previous device use history. The subject will not directly benefit from the procedure 
since the device is not therapeutic nor diagnostic. No claims are being made in the trial regarding any 
potential benefits for the subjects. Since this is an investigational study designed to test the safety of the 
OsteoProbe®, the potential benefits would be for patients in the future.  
 
4.4 
RISK-TO-BENEFIT RATIO 
Based on the potential benefits listed above, and the anticipated risks, Active Life Scientific believes this 
study is justified for the following reasons: 
• 
OsteoProbe device is designed and constructed based on the principles of performing a 
measurement without causing pain or harm to the subject. 
• 
Robust testing has been performed supporting safety of the OsteoProbe device as designed for its 
intended use. 
• 
Biocompatibility analyses and material history provide a reasonable assurance of material safety. 
• 
The clinical protocol is designed to yield valid scientific evidence to support an FDA de novo 
submission. 
• 
The subjects will be screened and closely monitored for any potential adverse events. 
• 
The Investigator has been carefully selected and will be trained on the use of this device and the 
execution of this clinical protocol. 
• 
Study subjects will be selected according to specific inclusion/exclusion criteria and evaluated 
frequently. 
• 
The Sponsor will closely monitor the study, and adverse events will be recorded and reported 
promptly to the Sponsor. 
• 
A Clinical Events Committee (CEC) will be convened to independently review adverse events. 
The risks identified above have been minimized to the furthest extent possible, through pre-clinical bench 
testing, subject and Investigator selection, and proper labeling. In addition, all subjects will be informed of the 
potential risks during the informed consent discussion.  
 
Therefore, given the information provided throughout this submission, Active Life Scientific has adequately 
evaluated the safety of the device and put into place adequate clinical controls to initiate the start of an IDE 
study. 
 
5. STUDY OBJECTIVES 
5.1 
PRIMARY OBJECTIVES 
Collect and characterize safety data associated with the use of the OsteoProbe System. 
 
5.2 
SECONDARY OBJECTIVES 
Obtain information on pain regarding the procedure and characterize all safety events.  
 

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6. STUDY DESIGN 
The study is a prospective, single center, open label clinical study. 
 
6.1 
STUDY DURATION 
The study is expected to take approximately three (3) months from first subject enrolled to the last follow-up 
visit. 
• 
2 month enrollment period (estimation) 
• 
1 month follow-up 
The duration of the study follow-up period was selected to allow sufficient time to identify and assess 
adverse events that may be related to the use of the investigational device. Subjects who have a adverse 
event that has not resolved at their 30-day visit will be followed until the event is resolved or no further 
improvement is expected, or the subject is lost to follow-up. 
 
6.2 
TREATMENT/CONTROL GROUP 
The study will be a single arm study with no control group.  
 
6.3 
PRIMARY ENDPOINTS 
The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe 
System. 
 
6.4 
SECONDARY ENDPOINTS 
The secondary endpoints of this study, following evaluation with the OsteoProbe System, are: 
1. 
NRS Pain scores at Procedure, 1-day, 7-day and 30-day follow up visits; 
2. 
BMSi scores after the OsteoProbe procedure; 
3. 
Adverse event rates through Day 30; 
4. 
Device-related adverse events through Day 30; 
5. 
Serious adverse events through Day 30; and 
6. 
Unanticipated adverse device effects (UADE) through Day 30. 
6.5 
TREATMENT/CONTROL GROUPS AND BLINDING 
A total of forty (40) subjects will be enrolled in a single-arm investigational “OsteoProbe” group. In this 
investigation, neither the Investigator nor the subject can be blinded to the investigation group assignment 
after undergoing the measurement with the investigational device. 
 
 

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7. SELECTION OF STUDY POPULATION 
7.1 
SUBJECT RECRUITMENT 
Subjects participating in this study will be recruited from the Investigators’ standard patient populations. All 
subjects will be evaluated for study participation based on the inclusion/exclusion criteria listed below. 
Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. The Investigator 
maintains exclusive responsibility assessing the eligibility of all potential study participants. 
 
7.2 
NUMBER OF SUBJECTS AND INVESTIGATIONAL SITES 
A total of forty (40) subjects will be enrolled at a single US site. 
 
7.3 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, subjects must meet all of the following inclusion criteria: 
1. 
Be greater than or equal to 22 years of age; 
2. 
Be able to give voluntary, written informed consent to participate and have signed an Informed 
Consent Form specific to this study; 
3. 
If female and of child-bearing potential, must have a negative pregnancy status.  
7.4 
EXCLUSION CRITERIA 
Subjects who meet any of the following criteria will be excluded from participating in this study: 
1. Active skin infection at the procedure site as identified during a SOC physical examination. 
2. Subject reported or known systemic infection; 
3. Subject reported or known allergy to local anesthetic; 
4. Subject reported or known allergy to stainless steel or nickel materials; 
5. Subject reported or known current use of systemic antibiotics, or topical antibiotics administered to 
the procedure site; 
6. Subject reported or known history of needle phobia; 
7. Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the 
judgement of the Investigator; 
8. Known instance of hardware in the tibia that is intended to be measured based on radiographic 
imaging; 
9. Known instance of a previous or current fracture in the tibia that is intended to be measured based 
on radiographic imaging; 
10. Are known to be actively participating or known to have participated in another clinical investigation 
for which they received an investigational product (including but not limited to a drug or vaccine) 
within the last 90 days, or reports that they intend to participate in another clinical investigation 
during the course of the study; 
11. Are known to be currently abusing drugs or alcohol or have a known history of the same within the 
last 12 months; 
12. Have any known or subject reported mental or psychological disorders that, in the judgement of the 
Investigator, would impair their ability to accurately complete the NRS Pain Score surveys; 
13. Are currently a prisoner; 
14. Have a condition which, in the judgement of the Investigator, would preclude adequate evaluation of 
the device’s safety and performance. Conditions include but are not limited to: 
a) Regional or systemic pain syndromes 
b) Radicular pain syndromes  
c) Chronic or intermittent leg pain 

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d) Migraine headaches 
7.5 
SCREENING 
All subjects will be pre-screened for eligibility based on the inclusion and exclusion criteria described in 
Sections 7.3 and 7.4. Subjects will be consented prior to initiating any study-specific screening procedures 
that are not considered routine SOC.  
 
7.6 
INFORMED CONSENT 
The Principal Investigator or a site representative who is appropriately qualified under national law and who 
has been trained on the protocol will approach subjects who are potential candidates for participation. They 
will explain and verify that the subject understands the nature and scope of the study, the procedures to be 
performed as part of the study, the potential risks and benefits of participation, implications, expected 
duration, possible treatment alternatives, and follow-up measures if the participation of the subject in the 
clinical investigation is discontinued; his/her rights; the applicable damage compensation system and will 
answer any questions that the subject has. The study will be explained to the subject in lay terms and 
adequate time will be allowed for the subject to ask questions. Interested subjects will be invited to 
participate in the study and will be asked to provide written informed consent prior to initiation of any study-
related procedures. Subjects will be assured that they may withdraw from the study at any time and for any 
reason, without repercussion. If the subject agrees to participate, the informed consent form (ICF) must be 
signed and dated by the subject and by the person who obtained informed consent. The informed consent 
process shall be documented in the subject’s medical file.  
 
The informed consent form that is used must be approved by the EC/IRB. A dated and signed copy of the 
informed consent form will be given to the subject and the original dated and signed consent will be placed in 
the subject’s research file. 
 
If new information becomes available that can significantly affect a subject's future health and medical care 
that information shall be provided to the subjects affected in written format. If relevant, all affected subjects 
shall be asked to confirm their continuing informed consent in writing. 
 
A signed ICF must be obtained from every subject before any study-related procedures beyond SOC 
are performed. 
 
Failure to obtain a signed and dated informed consent form prior to performing study-related procedures 
constitutes a protocol violation, which must be reported to the IRB in accordance with their reporting 
guidelines. 
 
7.7 
SUBJECT ELIGIBILITY 
Once written informed consent has been obtained per the procedures outlined in 7.6, the Investigator will 
proceed to assess whether the subject meets all inclusion and exclusion criteria. The screening process will 
include, but will not be limited to, a review of the subject’s demographics, medical history, physical 
examination and current medications and therapies. 
 
7.8 
SCREEN FAILURES 
A screen failure subject is a consented subject that did not have the procedure either due to withdrawing 
consent or being withdrawn from the study by the Investigator due to not meeting eligibility requirements for 
treatment.  
 

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If a subject signs the ICF but is found ineligible for inclusion in the study prior to or during the procedure, the 
subject will not be advanced any further in this clinical investigation. The subject’s signed ICF and completed 
inclusion/exclusion criteria will be retained by the Investigator, and the subject will be notified. 
 
Screening data, including the reason for exclusion, will be collected but may not be complete in cases where 
the subject is determined to be a screen failure early in the screening process. A record of all screened 
subjects will be maintained in a Screening & Enrollment Log. The subject’s exclusion from the study and 
reason for ineligibility will be documented on the Screening & Enrollment Log. 
 
NOTE: If a subject does not meet the eligibility criteria during their Screening Visit, the subject may be re-
evaluated for entry into the study at a later time if deemed appropriate by the Investigator. These subjects 
will require formal written Sponsor approval, and the subject will need to be re-consented, sign a new 
informed consent form, and undergo a full review of the inclusion/exclusion criteria by the Investigator. 
 
7.9 
SUBJECT IDENTIFICATION 
Subjects who consent to participate shall be assigned a unique Subject Identification Number to de-identify 
their information. This Subject Identification Number will be captured on the Screening & Enrollment Log and 
used to identify them on all source documents and eCRFs thereafter. 
 
7.10 SUBJECT ENROLLMENT 
The point of enrollment occurs when the Investigator delivers the local anesthetic. All enrolled subjects, 
including those found to be ineligible after consent, will be followed for the next 30 days in accordance with 
the Schedule of Assessments. 
 
 
7.11 TREATED SUBJECTS 
A treated subject is an enrolled subject who has had the OsteoProbe measurement procedure completed 
and a BMSi measurement was recorded. All treated subjects, including those found to be ineligible after 
enrollment, will be followed for the next 30 days in accordance with the Schedule of Assessments. 
 
8. STUDY VISIT PROCEDURES 
8.1 
VISIT 1:  SCREENING/PROCEDURE VISIT 
Note: The Screening/Procedure visit may take place over multiple days, but the OsteoProbe procedure must 
be completed within 7 days of signing the ICF. 
 
Upon successful documentation of informed consent, the subject will be screened to confirm subject 
eligibility. The screening will include a documentation of demographics, medical history, physical exam with 
vitals (temperature, blood pressure, pulse and respiratory rate), x-rays to rule out tibial fractures or implants, 
pregnancy evaluation (for women of childbearing potential only), work status, and concomitant medications.  
 
Upon successful confirmation of subject eligibility, the subject will undergo the following: 
 
Baseline NRS Survey 
• 
The subject will complete a baseline Numerical Rating Scale (NRS) Survey right before initiating the 
OsteoProbe test procedure 
 

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OsteoProbe Test Procedure 
• 
The Investigator will clean the test site and apply a local anesthetic agent prior to performing the 
OsteoProbe procedure, as outlined in the Procedure Guide, with the assigned device. The 
Investigator will note the anesthetic agent used, time of delivery and the volume administered in the 
subject’s study records.  
• 
The procedure start time will be recorded as the time of first insertion of the Tip to the bone surface 
• 
The procedure stop time will be recorded as the time the Tip is removed from the skin following the 
final indentation  
• 
The Investigator will consider the procedure to be successful once the OsteoProbe software displays 
the BMSi 
• 
If the Investigator cannot complete the procedure for any reason, they should stop the use of the 
device on this subject and treat the subject per SOC 
Post-Procedure (< 60 Minutes) 
• 
The Investigator or delegate will apply a dressing to the test site per SOC 
• 
The Investigator or delegate will record the BMSi Score 
• 
The subject will complete the post-procedure Numerical Rating Scale (NRS) Survey– this pain 
survey must be administered prior to performing any adverse event or device deficiency evaluations 
to prevent information from these assessments biasing the subject’s responses. 
• 
The Investigator or delegate will record adverse events and device deficiencies, if applicable  
• 
The Investigator or delegate will review the suggested post-procedure regimen with the subject per 
the User Manual  
• 
The Investigator or delegate will perform a review of concomitant medications with the subject 
 
8.2 
VISIT 2: 1-DAY FOLLOW-UP (+2 DAYS) 
To allow the Investigator’s assessment of the subject’s progress, the subject will be contacted by the 
Investigator for a telehealth appointment and interviewed/examined to assess the following: 
 
• 
The subject’s Numerical Rating Scale (NRS) pain score – this pain survey must be administered 
prior to performing the other visit assessments to prevent information from these assessments 
biasing the subject’s responses. 
• 
New or updated adverse events, if applicable 
• 
Current work status  
• 
Review of concomitant medications 
• 
Current body temperature (for telehealth visits, the patient will take their temperature during the visit 
while being observed and display thermometer reading for the Investigator to confirm and record) 
 
8.3 
VISIT 3: 7-DAY FOLLOW-UP (± 3 DAYS) 
To allow the Investigator’s assessment of the subject’s progress, the subject will be contacted by the 
Investigator for a telehealth appointment and interviewed/examined to assess the following: 
 

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• 
Numerical Rating Scale (NRS) pain score – this pain survey must be administered prior to 
performing the other visit assessments to prevent information from these assessments biasing the 
subject’s responses. 
• 
New or updated adverse events, if applicable 
• 
Current work status  
• 
Review of concomitant medications 
• 
Current body temperature (for telehealth visits, the patient will take their temperature during the visit 
while being observed and display thermometer reading for the Investigator to confirm and record) 
 
8.4 
VISIT 4: 30-DAY FOLLOW-UP (± 10 DAYS) 
To allow the Investigator’s assessment of the subject’s progress, the subject will be contacted by the 
Investigator for a telehealth appointment and interviewed/examined to assess the following: 
 
• 
Numerical Rating Scale (NRS) pain score – this pain survey must be administered prior to 
performing the other visit assessments to prevent information from these assessments biasing the 
subject’s responses. 
• 
New or updated adverse events, if applicable 
• 
Current work status  
• 
Review of concomitant medications 
• 
Current body temperature (for telehealth visits, the patient will take their temperature during the visit 
while being observed and display thermometer reading for the Investigator to confirm and record) 
 
8.5 
OUT OF WINDOW AND MISSED VISITS 
If a subject fails to participate in a scheduled study visit within the visit window defined in the study protocol 
but completes the visit prior to the beginning of the next visit window, that visit is considered to have been 
completed out of window. A protocol deviation must be documented on the appropriate eCRF. 
 
If a subject fails to participate in a scheduled study visit within the visit window defined in the study protocol 
and the next scheduled study visit window opens, that visit is considered to have been missed. A protocol 
deviation should be documented on the appropriate eCRF. 
 
All attempts should be made to schedule the subject for the study follow-up as soon as possible so that it is 
captured late rather than missed completely. 
 
8.6 
UNSCHEDULED VISITS 
Subjects may be evaluated at unscheduled post-procedure visits by the Investigator or delegated staff as 
needed. During unscheduled in person or remote visits with the Investigator or delegated staff, the 
Investigator or delegate will assess the subject’s progress and perform/record the following: 
 
• 
Numerical Rating Scale (NRS) pain score – this pain survey must be administered prior to 
performing the other visit assessments to prevent information from these assessments biasing the 
subject’s responses. 

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• 
New or updated adverse events, if applicable. Adverse events must be reviewed and assessed by 
the Investigator. 
• 
Current work status  
• 
Review of concomitant medications 
• 
Current body temperature (for telehealth visits, the patient will take their temperature during the visit 
while being observed and display thermometer reading for the Investigator to confirm and record) 
 
8.7 
STUDY COMPLETION/DISCONTINUATION 
The Primary Endpoints will be evaluated after all subjects reach their 30-Day follow-up visit. Subjects will 
complete study participation after their 30-Day follow-up visit.  
 
 
9. DESCRIPTION OF STUDY PROCEDURES 
DEMOGRAPHICS 
At screening, subject baseline characteristics including, age, gender, BMI, and race/ethnicity will be 
recorded.  
 
PAST MEDICAL HISTORY 
At screening, each subject’s medical/surgical history will be reviewed with the subject and updated if needed. 
Once up to date, this medical/surgical history will be used as the basis for eligibility determination. 
 
PHYSICAL EXAMINATION 
A standard physical examination will be conducted according to the site’s SOC, and eligibility criteria 
reviewed to assess subject’s suitability for study participation. The physical exam will include a review of 
vitals (temperature, blood pressure, pulse and respiratory rate).  
 
PREGNANCY EVALUATION & TEST 
A pregnancy evaluation will be performed on female subjects of childbearing potential prior to procedure to 
ensure that the subject is not pregnant. Negative pregnancy status can be based on self-reported sexual 
history and contraception use. An in-clinic test must be performed using urine dipstick testing when the 
subject thinks there is a potential that they might be pregnant.  
 
X-RAYS 
Subjects will have AP and lateral x-rays collected at the Screening Visit to rule out the possibility of a 
previous or existing tibial fracture. X-rays will also be ordered by the Investigator to evaluate any adverse 
event that may be related to a potential tibial fracture based on clinical exam and/or adverse event details 
provided by the subject. 
 
NUMERICAL RATING SCALE - PAIN 
The Numerical Rating Scale (NRS) is a subjective measure in which individuals rate their pain on an eleven-
point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been 
shown that a composite scoring system including best, worst, and current level of pain over the last 24 hours 
was sufficient to pick up changes in pain intensity with maximal reliability. 
 
WORK STATUS 

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A self-reported work status evaluation will be performed to determine the subject’s current work status 
throughout the trial.   
 
10. EARLY DISCONTINUATION SUBJECTS 
10.1 LOST TO FOLLOW-UP (LTFU) 
Subjects who miss the final, 30-day study follow-up will be regarded as Lost to Follow-Up. Site staff should 
perform and document a minimum of three attempts to contact them via phone, and one attempt to reach 
them via certified mail to bring them in for the final study visit prior to considering the subject LTFU. The staff 
should document the date and type of attempted communication. 
 
All efforts should be made to have subjects complete all follow-up visits but only subjects that miss the 30-
day follow-up will be considered LTFU. 
 
10.2 SUBJECT WITHDRAWALS 
Subjects have the right to withdraw from the clinical investigation at any time and for any reason without 
prejudice to their future medical care by the investigation team or investigational site. The Investigator will 
ask reason for their withdrawal and will record all information regarding the subject discontinuation. Per 
Section 7.8, subjects who withdraw consent prior to treatment will be regarded as screen failures.  
 
A Subject may be withdrawn from the clinical investigation for reasons including but not limited to the 
following:  
 
• 
Subjects may choose to withdraw from the clinical investigation under the terms of the Declaration of 
Helsinki and their consent documentation without having to give a reason;  
• 
Any adverse event which, in the opinion of the Investigator, is related to the treatment and will 
endanger the well-being of the subject if treatment is continued;  
• 
Development of any intercurrent illness(es), infection or condition(s) that might interfere with the 
clinical investigation;  
• 
Non-compliance with the clinical investigation procedures deemed by the Investigator to be sufficient 
to cause discontinuation;  
• 
Any problem deemed by the Investigator to be sufficient to cause discontinuation.  
 
Regardless of the reason for withdrawal, data available for the subject at the time of withdrawal, including the 
reason for withdrawal, will be documented in the subject’s study records. The Investigator will treat all 
subjects discontinued from the investigation due to an adverse event until the event resolves. A subject that 
has been withdrawn from the study after treatment will not be replaced. 
 
10.3 DOCUMENTATION OF EARLY DISCONTINUATION 
In every instance where a subject does not complete the study, the Investigator will document the primary 
reason for discontinuation in the subject’s records.  
 
All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and 
without prejudice. However, if a subject expresses a desire to withdraw their consent for the study, the site 
should attempt to obtain written documentation for their study records.  
 

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For subjects that are discontinued by the Investigator, the Investigator must notify them of their 
discontinuation from the study in writing. 
 
10.4 USE OF DATA FROM EARLY DISCONTINUATION CASES 
Study data collected previously for subjects who withdraw from the study, are discontinued from the study by 
the Investigator or LTFU will be included in the data analysis and clinical study report. 
 
10.5 ONGOING TREATMENT FOR EARLY DISCONTINUATION CASES 
Subjects who withdraw voluntarily or are discontinued by the Investigator will remain eligible for SOC 
treatment by the Investigator and study staff. 
 
11. EARLY DISCONTINUATION: STUDY 
11.1 PROCEDURE FOR SUSPENSION OR EARLY TERMINATION 
The Sponsor may suspend or prematurely terminate this clinical investigation either at the investigational site 
An Investigator, IRB, or regulatory authority may suspend or prematurely terminate participation in this 
clinical investigation at the investigational site for which they are responsible. 
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation, or when so instructed 
by the IRB or regulatory authorities, the Sponsor will suspend the clinical investigation while the risk is 
assessed. If an unacceptable risk is confirmed, the Sponsor will terminate the clinical investigation. 
 
The Sponsor will consider terminating or temporarily suspending the participation of the investigational site 
or Investigator if monitoring or auditing identifies serious or repeated deviations on the part of an 
Investigator. 
 
If suspension or premature termination occurs, the terminating party will justify its decision in writing and 
promptly inform the other party. 
 
If suspension or premature termination occurs: 
 
The Sponsor will remain responsible for providing resources to fulfill the obligations from this protocol and 
existing agreements for following the subjects enrolled in the clinical investigation, and the Investigator or 
authorized delegate will promptly inform the enrolled subjects at his/her investigational site. 
 
If the study is terminated, Active Life Scientific, Inc. must comply with all applicable government regulations 
and the protocol-required subject follow-up. If discontinuation of the study should occur, the Investigator 
must return all clinical investigation materials (including devices) to the Sponsor, and provide a written 
statement to the IRB explaining the reasons for the premature termination. All applicable clinical investigation 
documents shall be subject to the same retention policies, as detailed in Section 19. 
 
11.2 PROCEDURE FOR RESUMING THE CLINICAL INVESTIGATION AFTER TEMPORARY 
SUSPENSION 
When the Sponsor concludes an analysis of the reason(s) for the suspension, implements the necessary 
corrective actions, and decides to lift the temporary suspension, the Sponsor will inform the relevant parties 
of the rationale and provide them with the relevant data supporting this decision. Concurrence will be 
obtained from the IRBs and, where appropriate, regulatory authorities before the clinical investigation 

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resumes. If subjects have been informed of the suspension, the Investigator or authorized delegate will 
inform them of the reasons for resumption. 
 
11.3 ROUTINE CLOSE-OUT 
Routine close-out activities will be conducted to ensure that the Investigator's records are complete, all 
documents needed for the Sponsor's files are retrieved, remaining clinical investigation materials are 
disposed of, previously identified issues have been resolved, and all parties are notified. 
 
12. PROTOCOL DEVIATIONS 
A protocol deviation is an event whereby the clinical Investigator or site personnel did not conduct the study 
according to the protocol. Conformance to the protocol is essential to the quality and integrity of the clinical 
study. Every effort should be made to avoid any deviation from the clinical protocol.  
 
Under emergency circumstances, deviations from the protocol to protect the rights, safety and well-being of 
human subjects may proceed without prior approval of the Sponsor and the IRB. Such deviations shall be 
documented and reported to the Sponsor within 5 days of knowledge. The IRB should be notified of the 
deviation as required by IRB reporting guidance.  
 
The Sponsor is responsible to assess protocol deviations in an ongoing manner and determine their impact 
on the conduct of the study. After evaluation of each deviation, the Sponsor will determine if corrective and 
preventive actions need to occur.  
 
The Sponsor reserves the right to disqualify Investigator on the basis of repeated or serious deviations at their 
site. 
 
13. CONCOMITANT MEDICATIONS 
For the purposes of this clinical study, only current medications being taken or administered for the following 
will be recorded: 
 
• 
Pain (any type); 
• 
Inflammation (any type); 
• 
Muscle relaxation; 
• 
Numbness and/or tingling; 
• 
Hormonal replacement therapy; and 
• 
Medications prescribed for treatment of AEs/SAEs  
 
14. ADVERSE EVENT AND DEVICE DEFICIENCY REPORTING 
14.1 DEFINITIONS 
Device Deficiency (DD) - A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequate labelling.  
 

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Adverse Event (AE) – An adverse event is any untoward medical occurrence, disease, injury, or untoward 
clinical signs (including abnormal laboratory findings, surgical complications, etc.), whether related or 
unrelated to the investigational device or its use.  
 
Serious Adverse Event (SAE) – A Serious Adverse Event is an AE which: 
1. Led to a death, 
2. Led to serious deterioration in the health of the subject that either resulted in:  
a) A life-threatening illness or injury, or  
b) A permanent impairment of a body structure or a body function, or  
c) In-patient hospitalization or prolonged hospitalization, or  
d) Medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function.  
3. Led to fetal distress, fetal death or a congenital abnormality or birth defect (not anticipated in this 
study as pregnant women are excluded from the study).  
4. Other Serious (Important Medical Events) 
 
NOTE: Planned hospitalization including for any pre-existing condition, without a serious deterioration in 
health, is not considered a serious adverse event. 
 
Unanticipated Adverse Device Effect (UADE) – An Unanticipated Adverse Device Effect is: 
• 
Any serious adverse effect on health or safety or any life threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death is not previously identified in nature, 
severity, or degree of incidence in the IDE application; or  
• 
Any other unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of the subjects. 
 
14.2 CLASSIFICATION OF AN AE 
14.2.1 Severity 
The Investigator will assess the severity of the AE and classify it according to the following definitions: 
 
MILD: Event/symptom is transient and well-tolerated by the subject. 
MODERATE: Event/symptom causes discomfort and interferes with routine activities of the subject. 
SEVERE: Event/symptom interferes considerably with the routine activities of the subject or causes inability to 
work. 
 
These definitions are for descriptive purposes only and are independent of the judgment of whether an event 
is classified as an AE or an SAE. 
 
14.2.2 Relationship 
The relationship between the use of the medical device (including the medical procedure) and the 
occurrence of each adverse event shall be assessed and categorized. During causality assessment, clinical 
judgment shall be used, and the Clinical Protocol shall be consulted, as all the foreseeable potential risks are 
listed here. The presence of confounding factors, such as concomitant medication/treatment, other 
concurrent illness or risk factors shall also be considered.  
 
The Investigator will assess the potential relationship of the AE or SAE to the use of the investigational 
device/procedure and classify the causality of the event according to the following definitions. 
 

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DEFINITELY RELATED: An AE that has a strong causal relationship. An AE that follows a strong temporal 
relationship, follows a known response pattern, and cannot reasonably be explained by known 
characteristics of the subject’s clinical state or other therapies. 
 
PROBABLY RELATED: An AE that potentially has a causal relationship. The AE has a reasonable temporal 
relationship and alternative etiology is less likely compared to the potential relationship to the use of the 
investigational device/procedure. 
 
POSSIBLY RELATED: An AE that potentially has a causal relationship. The AE has a reasonable temporal 
relationship to the use of the investigational device/procedure but alternative etiology is equally likely 
compared to the potential relationship to the use of the investigational device/procedure.  
 
NOT RELATED: An AE without any apparent causal relationship. The AE is due to the underlying disease state 
or is due to concomitant medication or therapy not related to the use of the investigational device/procedure. 
 
UNKNOWN RELATIONSHIP: If the AE cannot be determined to have a causal relationship, it will be classified as 
unknown. 
 
NOTE: Where the Investigator or Sponsor remains uncertain about how to classify the event, this should not 
cause them to exclude any possible relatedness, and the Investigator should consider classifying the event 
as “Possibly Related”. 
 
14.3 AE REPORTING PROCEDURES 
14.3.1 AE Reporting 
An AE is any undesirable clinical occurrence in a subject (including abnormal laboratory findings) whether or 
not it is related to the investigational device. Any condition at baseline that is recorded as a preexisting 
condition is not an AE unless it worsens in intensity or duration.  
 
The collection of AEs will begin in the exam room once the patient is enrolled, i.e. the Investigator delivers 
the local anesthetic. All AEs that occur through completion of the final follow-up visit for each subject (day 
30), whether observed by the Investigator or by the subject, and whether or not thought to be device-related, 
should be reported in detail and followed to resolution.  
 
The description of the AE will include the date and time of onset, severity, causal relationship to the 
investigational device, if any treatment was required, and the outcome of the event. Significant new 
information and updates should continue to be captured in the subject’s records and in the EDC as they 
become available and the adverse event should be followed until it is resolved or no further improvement is 
expected, or the subject is lost to follow-up. 
 
14.3.2 SAE Reporting 
Using the contact information below, the Sponsor should be notified of all SAEs within one (1) business day 
of the site becoming aware of the event by entering SAE information in the EDC. In the event the EDC is 
unavailable for any reason, notification to Active Life should be made via email or phone as follows: 
 
Sponsor Contact: Peter Burks 
E-mail: peter@activelifescientific.com 
Phone: +1-805-770-2600 x106 
 

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The Investigator will provide additional information on the SAE by updating the information in the EDC as 
updates become available. The Sponsor may also ask for additional clinical reports including redacted 
source documents to be provided by the Investigator to assist in the assessment of the event. Significant 
new information and updates should continue to be submitted promptly to the Sponsor and entered in the 
EDC as they become available, and the adverse event should be followed until it is resolved or no further 
improvement is expected, or the subject is lost to follow-up. 
 
The Sponsor shall ensure that the Investigator submits safety event notifications to the governing IRB within 
the timeframe specified by the IRB, when applicable. Acceptable means of confirming that the IRB 
requirements have been met include forwarding a copy of the written, signed report that was sent to the IRB 
to the Sponsor. Copies of this report should be filed in the Investigator’s site files and the Sponsor’s Trial 
Master File. 
 
New SAEs will only be documented for each subject until the last study related subject visit (day 30).  
 
14.3.3 Unanticipated Adverse Device Effect Reporting 
The Sponsor shall review all reported SAEs to evaluate whether they meet the criteria for an Unanticipated 
Adverse Device Effect. For AEs that are determined to be UADEs, the Sponsor will submit an expedited 
safety report to the FDA’s Center for Devices and Radiological Health (CDRH). The expedited safety report 
will be submitted to the FDA and governing IRB as soon as possible and, in no event, later than ten (10) 
business days after this is determined.  
 
If, following receipt and investigation of follow-up information regarding an AE that was previously 
determined not to be a UADE, the Sponsor determines that the event does meet the requirements for 
expedited reporting, the Sponsor will notify the FDA as soon as possible, but in no event later than ten (10) 
business days after this is determined. 
 
14.3.4 Study Termination due to an Unanticipated Adverse Device Effect (UADE) 
Active Life Scientific, Inc., in consultation with the Investigators, shall determine if the reported event 
presents an unreasonable risk to study subjects. If the event is determined to pose an unreasonable risk, the 
Sponsor may terminate the investigation, or the parts of the investigation presenting that risk, within 5 
business days after Sponsor makes an “unreasonable risk” determination or within 15 business days after 
Active Life Scientific, Inc. first received notice. 
 
14.4 TREATMENT OF AES 
The Investigator will ensure that all subjects who experience an adverse event are treated per Standard of 
Care until the event is resolved or no further clinical improvement is expected, or (if applicable) the subject is 
LTFU. 
 
14.5 CLINICAL EVENTS COMMITTEE (CEC) 
An independent Clinical Events Committee (CEC) comprising of three physicians who are familiar with the 
study indication will review and adjudicate all adverse events and protocol deviations to remove 
Investigator-based bias in AE/PD classification and allow for the poolability of data. The CEC will consist of 
physician(s) who are not affiliated with the Sponsor and are not participating in the study. The 
recommendations of the CEC override the Investigator’s classification and become part of the clinical trial data 
set. 
 

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The CEC will adjudicate all AEs and potentially reclassify the severity, seriousness, anticipatedness, and 
relationship to the device/procedure. The CEC will also adjudicate all PDs and potentially reclassify the 
deviations in terms of whether they are minor or major deviations.  
 
15.  SOURCE DOCUMENTATION 
The Investigator will be supplied with one physical binder per subject. The binder will contain paper Case 
Report Forms(CRFs) for collection of study data. It is expected that these CRFs will be the source of all 
study data. It is possible that additional supplemental source may be captured once the study is underway, 
but the primary source of all study data is expected to be the paper CRFs. 
 
16. STUDY MONITORING 
16.1 SITE MONITORING 
The study will be monitored to ensure that it is conducted in conformance with the monitoring plan by an 
independent CRO to assess continued compliance with the protocol, recognized Good Clinical Practices, 
FDA’s IDE guidance documents, and federal regulations outlined in 21 CFR 812.43(d) and 21 CFR 812.46. 
In addition, monitoring verifies that study records are adequately maintained, that data are reported in a 
satisfactory manner with respect to timeliness, adequacy, and accuracy, and that the Investigator continues 
to have sufficient staff and facilities to conduct the study safely and effectively.  
 
The study may also be subject to a quality assurance audit by the Sponsor or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and relevant study 
personnel are available during on-site monitoring visits or audits and that sufficient time is devoted to the 
process. 
 
The organization responsible for monitoring the study is: 
 
MCRA, LLC  
1050 K Street NW, Suite 1000 
Washington DC 20001 
 
In addition to ensuring adequate communication between the Investigators and the Sponsor, the CRO’s 
duties may include on-site visits and review of study documents and reported data per the Clinical Monitoring 
Plan. The CRO study representatives will be provided with appropriate device and protocol training prior to 
the study and will follow a Monitoring Plan for all study-related monitoring activities. 
 
16.2 MONITORING ACTIVITIES 
On-site monitoring visits may include, but are not limited to a pre-study Site Initiation Visit, periodic Interim 
Monitoring Visits, and a Close-Out Visit at the end of the site’s participation in the study. 
 
The Investigator will allocate adequate time for monitoring activities. The Investigator will also ensure that the 
monitor or other compliance or quality assurance reviewer is given access to the study-related documents 
and study-related facilities and has adequate space to conduct the monitoring visit. 
 
Monitoring visits will be documented on monitoring visit reports. On-site and remote monitoring will aim to 
verify that:  
 
• 
Compliance with the clinical protocol and applicable regulations is being maintained 

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• 
Source data is verified and signed-off upon as accurate 
• 
Subject files are accurate and complete 
• 
Subject withdrawal has been documented (if applicable) 
• 
Subject non-compliance has been documented (if applicable) 
• 
The Investigator and site staff are informed and knowledgeable of all relevant document updates 
concerning the clinical investigation 
• 
Only authorized individuals are performing study-related functions 
• 
The investigational device is being used according to the protocol and instructions for use 
• 
Adequacy of staffing and facilities 
• 
Signed and dated ICFs have been obtained from each subject 
• 
CRFs and queries are complete 
• 
All adverse events are reported to the Sponsor 
• 
All serious and unanticipated adverse device events are reported to the Sponsor and the IRB 
• 
All other required IRB reports, notifications, applications, submissions, and correspondence are 
maintained in the Investigator’s files and are accurate 
• 
Corrective and preventive actions have been implemented (if applicable) 
 
16.3 FREQUENCY OF VISITS 
To ensure that the study is conducted in accordance with the terms of the clinical protocol, study monitors 
may visit each investigational site throughout the duration of the study per the Clinical Monitoring Plan. The 
exact frequency of visits shall be determined shall depend upon factors such as but not limited to the 
following:  
 
• 
Rate of subject enrollment 
• 
Experience of the Investigator in conducting clinical studies 
• 
Record of previous site compliance 
 
17. AUDITS AND INSPECTIONS 
Participation as an Investigator in this study implies acceptance of potential inspection by government 
regulatory authorities. The Investigator must also be prepared to permit study-related audits and inspections 
by the Sponsor, CRO, IRB and the site’s institutional compliance and quality assurance groups. The 
Investigator will ensure the capability for inspections of applicable study-related facilities, records and 
reports. 
 

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18. STATISTICAL ANALYSIS PLAN 
18.1 STUDY HYPOTHESIS 
The primary hypothesis is that the probability of experiencing device-related Serious Adverse Events (SAE) 
for subjects treated with the investigational device is smaller than the performance goal of 1%. Formally, that 
hypothesis to be tested are: 
H0:  
The expected proportion of subjects with device-related SAE up to Day 30 (pT) is greater than or 
equal to the performance goal (PG) of 1.0%. 
HA:  
The expected proportion of subjects with device-related SAE up to Day 30 (pT) is less than the 
performance goal (PG) of 1.0%. 
These hypotheses may be symbolically represented as: 
H0: pT ≥ PG = 1.0% 
Ha: pT < PG = 1.0% 
Where pT is the device-related SAE rate for subjects treated with the investigational device. 
If the Bayesian Posterior Probability that pT < PG is greater than or equal to .975, the alternative hypothesis 
will be accepted, and it will be concluded that the device meets the performance goal.  
18.2 SAMPLE SIZE ANALYSIS 
A review was performed on all the published and unpublished clinical data on the OsteoProbe device. In 
order to systematically review and identify potential data sources for the informative prior initial criteria was 
established. In order for the data to be included as an informative prior the following criteria needed to be 
met:  
 
1. a minimum of 30 days follow-up on patients; 
2. the OsteoProbe procedure was administered in a manner consistent with the IDE; 
3. the data commented on safety around serious adverse events. 
 
First, a total of 40 published articles were reviewed. Of the published literature, and four published studies 
met criteria “1” (Patient Follow-up) and “2” (OsteoProbe Procedure) outlined in Section 2, above. The 
following are the four literature articles: 
(1) Sundh D, et al. [JBMR. 2018;33(7):1242-1251],  
(2) Pérez-Sáez MJ et al. [Bone. 2018;116:290-294],  
(3) Robert Guerri-Fernandez, et al [AIDS 2018, 32:913–920], and  
(4) Mellibovsky L, et al. [JBMR 2015;30(9):1651-1656].  
  
However, two (Sundh et al and Pérez-Sáez et al) of the four did not explicitly state the safety outcomes in 
the study. Given the articles did not explicitly state the safety result, the two articles were excluded from the 
informative prior. Only two studies met all three criteria, Robert Guerri-Fernandez et al and Mellibovsky L et 
al.  
  
Table 6. Literature Data Evaluation 
Study 
Criterion 1: >30 
day follow up 
Criterion 2: 
Procedure with 
OsteoProbe 
Criterion 3: 
Language 
explicitly 
Informative 
Prior Inclusion 

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stating safety 
results 
Sundh D, et al 
X 
X 
 
No 
Pérez-Sáez MJ et al 
X 
X 
 
No 
Robert Guerri-Fernandez, et 
al 
X 
X 
X 
Yes 
Mellibovsky L, et al 
X 
X 
X 
Yes 
 
Additionally, a review was performed on all unpublished and ongoing studies with the OsteoProbe device. 
The same criteria were applied in evaluation of these potential datasets. A total one unpublished or two 
ongoing studies were found meet the three criteria for inclusion as an informative prior. The table below 
summarizes the evaluation and inclusion of this information. Each of the included clinical data is further 
summarized below.   
 
Table 7. Unpublished or Ongoing Clinical Data Evaluation 
Study 
Criterion 1: >30 
day follow up 
Criterion 2: 
Procedure with 
OsteoProbe 
Criterion 3: 
Language 
explicitly 
stating safety 
results 
Informative 
Prior Inclusion 
OHSU (unpublished) 
X 
X 
X 
Yes 
LUMC (ongoing) 
X 
X 
X 
Yes 
BARWON (ongoing) 
X 
X 
X 
Yes 
 
The summary findings are shown belowTable 8.  
Table 8: Informative Prior Data 
Study 
# Subjects 
Device 
Related SAEs 
Robert Guerri-Fernandez (2018) 40 
0 
Mellibovsky L, et al (2015) 
52 
0 
OHSU 
18 
0 
LUMC (ongoing) 
110* 
0* 
BARWON (ongoing) 
50* 
0* 
Total 
270* 
0* 
 
 
*Anticipated at the time of De Novo submission 
 
These five studies contain or will contain 270 subjects with an anticipated rate of zero subjects experiencing 
a device-related Serious adverse events. Given there is no variability between these studies, the data are 
pooled together and collectively constitute the informative prior. To be conservative, the initial assumption 
will only consider 215 subjects with zero device-related adverse events. The informative prior was 
constructed as Jeffries prior plus the data in Table 8, that is, Beta(.5 + data, .5 + data).  
When there are zero device-related SAEs in 40 prospective subjects, the posterior probability will be .9765 
and the device will have been shown to meet the performance goal. Therefore, only if there are zero device-
related SAE’s will the alternative hypothesis be accepted. 

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18.3 STUDY POPULATIONS 
18.3.1 Primary Analysis Set 
All subjects with a time of procedure start recorded will be included in the Primary Analysis Set. The Primary 
Analysis Set will be utilized in testing of the primary safety endpoint. 
18.3.2 Per Protocol Analysis Set 
A per protocol (PP) analysis may be performed excluding enrolled subjects that are subsequently found to 
not meet the inclusion or exclusion criteria based objective criteria or that experience an intercurrent event 
during follow-up that makes the device-related SAE endpoint uninterpretable.  
18.3.3 Training Cases 
There are no training cases for this protocol. 
18.4 TESTING OF PRIMARY SAFETY HYPOTHESES 
The primary safety hypothesis will be tested by determining the Bayesian posterior probability that the 
device-related SAE rate is less (i.e., better) than the performance goal. The Bayesian posterior probability 
will be calculated by updating historical data with prospective trial data. The Bayesian posterior probability 
will be calculated through numerical integration with regards to the performance goal of .01. When the 
Bayesian posterior probability of the conditional device-related SAE rate is higher than .975, the alternative 
hypothesis will be accepted, and it will be concluded that the device has met the specified performance goal 
of 1%. As stated above, this will only occur when there are zero out of 40 events. 
Supporting analyses will summarize the Bayesian posterior probabilities that the device-related SAE rate is 
lower than varying reference margins.  
95% credible intervals of the device-related SAE rate will also be reported without using an informative prior 
distribution. 
18.5 MISSING DATA/SENSITIVITY ANALYSIS 
Given the short follow-up, there is not expected to be a large amount of missing data. Detailed descriptions 
of the reason(s) for missingness will be provided for every missing subject and timepoint. Subjects missing 
data will be multiply imputed using the posterior distribution of the observed data only. Bayesian posterior 
summarizes will characterize best- and worst-case scenarios as sensitivity to MAR assumption necessary for 
the imputation model. There will be no imputation for secondary effectiveness endpoints.  
 
18.6 SECONDARY EFFECTIVENESS ENDPOINTS 
The secondary endpoints of this study, following evaluation with the OsteoProbe System, are: 
• 
Follow-up NRS Pain scores take at Procedure, 1-day, and 7-day follow up visits 
• 
BMSi scores at Procedure 
• 
Adverse event through day 30. 
• 
All device-related adverse events through day 30. 
• 
Serious adverse events through day 30; and 
• 
Unanticipated adverse device effects (UADE) through day 30. 
Secondary endpoints are described in the Clinical Protocol. Continuous variables will be described by the 
number of observations, the number of missing observations, means, standard deviations, medians, 

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minimums, and maximum. Responder variables will be described by the number of observations, the number 
of missing observations, and percentages. Secondary endpoints may be further described through credible 
intervals or other posterior distribution summaries.  
18.7 SAFETY ANALYSES 
Assessment of the safety of the investigational device will include an evaluation of the incidence and severity 
of complications and adverse reactions associated with the treatment. 
Adverse event rates will be summarized by type of AE and for specific AEs in two ways: 1) per subject 
incidence of specific AEs and classes of AEs and 2) by event, summarizing event counts by visit interval 
over time and in accordance with FDA Guidance (CDRH 2004).1 device-related events will be summarized 
by severity and relatedness.  
Event listings that include details such as relatedness, severity, onset, and resolution status will be provided 
for all events and relevant subsets of events such as serious events and related events. Safety evaluations 
will be performed using the Primary Analysis Set. 
The summary tables will show the adverse events (in coded terms), the total number of events, and the 
number and the percentage of subjects affected (“subject wise evaluation”) and stratified by relation to 
device or procedure and severity. Data of dropouts will not be presented separately, but possible bias will be 
discussed in the final report. 
All AEs will be summarized in listings for the Primary Analysis Set. The following AE listings will be provided: 
1. AE Listing 1 All AEs Sorted by Event Type 
2. AE Listing 2 All AEs Sorted by Subject 
3. AE Listing 3 Serious AEs 
4. AE Listing 4 Severe AEs 
5. AE Listing 5 Device-related AEs 
6. AE Listing 6 Serious device-related AEs 
7. AE Listing 8 Other AEs 
8. AE Listing 9 AEs among subjects discontinued early 
9. AE Listing 10 AEs among subjects who died 
18.8 EVALULATION OF POOLABITIY 
Descriptive summarizes of the selected secondary endpoints will be provided stratifying by clinically relevant 
baseline variables in order to provide evidence that justifies poolability. Clinically relevant baseline variables 
include: 
• 
Age category (>=50 vs < 50 years old) 
• 
Sex 
• 
Site 
18.9 CHANGES TO THE STATISTICAL ANALYSIS PLAN  
Any changes to the statistical analysis plan will be fully documented in the Clinical Study Report.  
 
1 CDRH. Guidance for Industry and FDA Staff: Clinical Data Presentations for Orthopedic Device 
Applications, December 2, 2004.  

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18.10 SOFTWARE 
All statistical analyses will be performed with SAS version 9.4 or above software (SAS Institute Inc., Cary, 
North Carolina) or R version 3.6.3 or above (The R Foundation for Statistical Computing Platform). 
 
19. REGULATORY CONSIDERATIONS AND ETHICAL REVIEW 
19.1 ETHICAL REVIEW 
The clinical investigational plan, informed consent form, any other study specific documents as required by 
regulations and all amendments to these study documents will be reviewed and approved by the FDA and 
appropriate IRB, before enrollment of any subject. In addition, the Sponsor will keep the regulatory 
authorities informed of any UADEs throughout the study course, if applicable. 
 
19.2 REGULATORY CONSIDERATIONS 
This study will be conducted in accordance with the Good Clinical Practice (GCP) guidelines and other 
applicable regulatory requirements including, but not limited to: 
 
• 
FDA Regulations on Investigational Device Exemption (21 CFR 812) 
• 
FDA Regulations on research with human subjects (21 CFR 50, 54 and 56) 
• 
Health and Human Services (DHHS) Regulations on research with human subjects (45 CFR 46 
Subparts A, B, C, and D)  
• 
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry 
• 
The Declaration of Helsinki 
 
19.3 STUDY AMENDMENTS 
All changes to this protocol, that impact validity of data, scientific soundness, the rights safety or welfare of 
the subjects, must be documented in the format of an amendment with justification statements in the cover 
letter to the IRB and FDA. All amendments must be submitted to the IRB and regulatory authority for review 
and approval. Following approval, the protocol amendment will be distributed to all protocol recipients at the 
investigational site. 
 
19.4 INSURANCE 
The Sponsor will have clinical trial insurance in place during the study, with appropriate coverage for the 
duration of the entire study. Subjects who participate in this study will be insured against study-related injury 
according to local regulation requirements. 
 
 
20. DATA HANDLING AND RECORDKEEPING 
20.1 DATA MANAGEMENT 
All required data for this study will be collected on standardized eCRFs. The Investigator or investigational 
site will maintain, at the investigational site, in original format, all essential study documents and source 
documentation that support the data collected on the study subjects in compliance with International 
Conference on Harmonization (ICH)/Good Clinical Practice (GCP) and any local regulatory guidelines. 

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eCRFs will be completed in a 21 CFR Part 11 compliant electronic data capture (EDC) system for each 
subject enrolled into the clinical study. The Investigator or delegated site staff will enter the source data into 
the eCRFs and study monitors will perform a source document verification process. 
 
The Investigator will be responsible for the review and sign off on the Eligibility Criteria, Adverse Event, 
Protocol Deviation and Study Completion eCRFs and will sign each subject’s casebook once the subject 
completes the study to attest that all data entered on the eCRFs are complete and accurate. All of the above 
signatures will be completed digitally within the EDC system using the system’s Part 11 compliant digital 
signature system function. 
 
Any required data clarifications will be handled within the EDC system’s query management system. The 
EDC will be programmed to automatically place data clarification queries on missing values and values out 
of acceptable ranges. Study monitors and data managers will also be able to add data clarification queries to 
data points within the system. Study coordinators will have the opportunity to correct data and/or respond to 
the query for review by monitors and data managers. 
 
All procedures for the handling and analysis of data will be conducted using good clinical data management 
practices within systems meeting FDA guidelines for the handling, storage, and analysis of data for clinical 
studies. 
 
The CRO study representatives will follow a Data Management Plan for all study-related data 
management activities. 
20.2 RECORD KEEPING 
The Investigator and the Sponsor will maintain accurate, complete, and current records relating to participation 
in this clinical investigation. If the Investigator wishes to assign the responsibility of maintaining the study files 
to someone else or move them to another location, he/she should consult with the study sponsor in writing 
regarding the change. The Investigator will take measures to ensure that these essential documents are not 
accidentally damaged or destroyed. If for any reason the Investigator withdraws responsibility for maintaining 
these essential documents, custody must be transferred to an individual who will assume responsibility and 
the Sponsor must receive written notification of this custodial change.  
 
 
The sponsor and Investigators will retain the specified records and reports for up to two years after the 
marketing application is approved for the investigational device; or, if a marketing application is not submitted 
or approved for the investigational device, until two years after investigations under the IDE have been 
discontinued and the FDA so notified.  
 
The Investigator and Sponsor will maintain records in accordance with 21 CFR 812, Subpart G, to include: 
 
• 
Current and past versions of the IRB-approved clinical protocol and amendments and corresponding 
IRB-approved consent form(s) and, if applicable, subject recruitment advertisements 
• 
FDA correspondence related to the IDE application; including supplemental IDE applications, current 
Investigator lists, progress reports 
• 
IRB correspondence (including submissions and approval notifications) including safety and protocol 
deviation reports, and annual or interim reports 
• 
Signed Clinical Trial Agreement 

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• 
Signed Investigator Agreements and financial disclosure forms for the participating Investigator 
• 
Curriculum vitae (Investigator and Sub-Investigators) 
• 
Certificates of required training for the Investigator and any Sub-Investigators, including human 
subject protection and Good Clinical Practice 
• 
Instructions for handling the investigational device and other study-related materials 
• 
Device tracking logs 
• 
Signed ICFs 
• 
eCRF and Source Documents  
• 
Monitoring visit confirmation and follow-up letters  
• 
Copies of relevant Sponsor-Investigator correspondence, including notifications of adverse event 
information 
• 
Screening and Enrollment Log 
• 
Signed informed consent forms 
• 
Final clinical study report 
 
20.3 DATA PROTECTION AND SUBJECT CONFIDENTIALITY 
Subject confidentiality will be maintained throughout the study in a way that ensures that data can always be 
tracked back to the source data. For this purpose, a unique subject identification code (two digit site 
identification number and three digit subject name identification number code assigned sequentially) will be 
used that allows identification of all data reported for each subject without traceability back to the actual 
subject. 
 
The Investigator shall provide direct access to source data during and after the clinical investigation for 
monitoring, auditing, IRB review and regulatory authority inspections.  
 
“Protected Health Information” will be treated and maintained in compliance with the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) Privacy rule.  
 
The duration of storage time of personal data at the investigational site will be in accordance with national 
regulations (see section 19.2). 
 
Information obtained in the course of executing this study may be presented for regulatory, clinical or 
educational purposes as long as no subject is identified. The data collected is the property of Active Life 
Scientific, Inc. 
 
20.4 PUBLICATION AND DATA SHARING POLICY 
Data generated from the conduct of this study is intended be used to support an application by Active Life 
Scientific, Inc. as a de novo submission for FDA. Publication of the results of the study will follow Active Life 
Scientific, Inc.’s Publication and Presentation Policy.  
 
The study will be registered on Clinicaltrials.gov in compliance with 42 CFR Part 11. Results of the study, 
including an unanticipated early termination of the study, will be posted to the Clinicaltrials.gov database at 

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the conclusion of the study. In the event that the study is terminated early, the posting of these results will be 
completed within 30 days of completion of data analysis. 
 
 
20.5 INVESTIGATOR REPORTS 
The Investigator is responsible for the timely preparation and submission of the reports cited below. 
 
Table 9: Investigator Reports 
Report 
Sent To 
Timing of Report 
Unanticipated 
adverse device 
effect (UADE) 
Active Life 
Scientific, IRB 
UADE must be reported as soon as possible, but in no 
event later than 10 business days after the Investigator 
first learns of the event 
Withdrawal of 
IRB approval 
Active Life 
Scientific 
Reported within 5 business days 
Progress 
reports 
Active Life 
Scientific, IRB 
Reported as requested by Active Life Scientific or the 
reviewing IRB, but at least yearly 
Deviations 
from the 
investigational 
plan 
Active Life 
Scientific, IRB 
(FDA) 
A deviation to protect the life or physical well-being of a 
subject in an emergency must be reported as soon as 
possible but no later than 5 business days after the 
emergency occurred.  Deviations that may affect the 
scientific soundness of the investigational plan or the 
rights, safety, or welfare of the subject (and are not an 
emergency) must receive prior approval by Active Life 
Scientific and be reported to the FDA and IRBs. 
Device use 
without 
informed 
consent 
Active Life 
Scientific, IRB 
This deviation must be reported within 5 business days 
after the use occurs. 
Final Report 
Active Life 
Scientific, IRB 
This report must be submitted within 3 months after 
termination or completion of the investigation or the 
Investigator’s part of the investigation. 
Other 
FDA, IRB 
Upon request, accurate, complete, and current 
information about any aspect of the investigation must 
be reported.