Clinical Investigation (Beta) of Power Knee
Phase: NA
Conditions: Prosthesis User, Amputation
Sponsor: Össur Iceland ehf



 
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Sponsor 
Coordinating Investigator 
Össur Iceland ehf 
Grjótháls 3-5 
110 Reykjavík  Iceland 
Kurt N Gruben  
Sponsor’s Statement: I have reviewed and approved this CIP in its entirety and agree to sponsor its 
implementation 
 

 
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Investigational sites: 
Investigational Site #1: 
 
 
 
MCOP, 
Silver 
Spring 
Prosthetic Clinic 
2421 linden lane 
Silver spring 
Md, 20910 
 
Local Principal Investigator: 
Ian Fothergill 
 
Investigational site #2: 
 
 
Medical Center, Boston, MA 
Prosthetic Clinic 
 
500 
Lincoln 
Stree
Allston, MA 02134 
Local Principal Investigator: 
John Warren 
 
Investigational site #3: 
 
 
Motus Research 
975 W. Walnut Street 
Indianapolis, 
IN 
46202 
Local Principal Investigator: 
Jeffrey A. Denune 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
1 
How to Refer to This Document ............................................................. 6 
2 
Summary .................................................................................................. 6 
3 
Changes from Previous Revision .......................................................... 8 
3.1 
Changes for Revision 1.00 ......................................................................................... 8 
4 
Abbreviations .......................................................................................... 9 
5 
Investigational Device ........................................................................... 10 
6 
Justification for the Design of the Clinical Investigation ................... 16 
7 
Objectives and Hypotheses .................................................................. 17 
8 
Design of the Clinical Investigation ..................................................... 21 
8.1 
General .................................................................................................................... 21 
8.2 
Investigational Device(s) and Comparator(s) ........................................................... 22 
8.3 
Subjects ................................................................................................................... 23 
8.4 
Procedures............................................................................................................... 25 
i) 
Recruitment ............................................................................................................................. 25 
ii) 
Test procedure......................................................................................................................... 25 
iii) 
Measurements and data collection .......................................................................................... 26 
8.5 
Compensation .......................................................................................................... 27 
iv) 
Subject ..................................................................................................................................... 27 
8.6 
Responsibilities ........................................................................................................ 27 
8.7 
Study monitoring and Oversight ............................................................................... 27 
9 
Investigational Device Accountability ................................................. 28 
10 
Statistical Considerations .................................................................... 29 
10.1 
Statistical design and procedures ............................................................................ 29 
10.2 
Sample size calculation ........................................................................................... 29 
10.3 
Additional statistical matters..................................................................................... 29 
11 
Amendments and Deviations from the Protocol (CIP) ........................ 30 
11.1 
Amendments ............................................................................................................ 30 
11.2 
Deviations ................................................................................................................ 30 
12 
Statement of Compliance ..................................................................... 30 
13 
Ethical Considerations ......................................................................... 31 
13.1 
Anticipated clinical benefits ...................................................................................... 31 
13.2 
Device related risk ................................................................................................... 31 
13.3 
Risk of Study (To Patient) ........................................................................................ 31 
13.4 
Risk Mitigation .......................................................................................................... 32 
13.5 
Risk-to-Benefit Rationale ......................................................................................... 32 
13.6 
IRB Review and Communications ............................................................................ 32 
13.7 
Vulnerable populations ............................................................................................ 32 
13.8 
Informed Consent .................................................................................................... 32 
13.9 
Participant confidentiality – Data management ........................................................ 32 
14 
Evaluation of Adverse Events and Device Deficiencies ..................... 34 
14.1 
Definitions of adverse events, effects and deficiencies ............................................ 34 
14.2 
Reporting procedures .............................................................................................. 34 

 
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14.3 
Suspension or premature termination of the clinical investigation............................ 35 
15 
Publication Policy ................................................................................. 35 
16 
References ............................................................................................. 35 
17 
Appendix 1 – Informed consent forms ................................................ 37 
18 
Appendix 2 – Questionnaire User ........................................................ 45 
1. 
PMQ ......................................................................................................................... 45 
2. 
PLUS-M: .................................................................................................................. 46 
3. 
PEQ – Comfort in standing ...................................................................................... 47 
4. 
PEQ – Safety in stair and hill descent ...................................................................... 47 
5. 
PEQ – Safe and stable stance phase ...................................................................... 47 
6. 
PEQ - Noise ............................................................................................................. 48 
7. 
Walking speed ......................................................................................................... 48 
8. 
Side effects .............................................................................................................. 49 
9. 
Usability of POWER KNEE MAINSTREAM ............................................................. 50 
10. 
Falls questionnaire ................................................................................................... 51 
19 
Appendix 2 – Questionnaire CPO ........................................................ 52 
20 
Annex ..................................................................................................... 54 
 
Tables 
Table 1 Summary of procedures and visits ......................................................................................................... 7 
Table 2 Identification and Description of the Investigational Device .............................................................. 10 
Table 3 Technical and functional features ......................................................................................................... 15 
Table 4 Endpoints, test methods and hypotheses ............................................................................................ 19 
Table 5 Inclusion/Exclusion criteria ................................................................................................................... 24 
Table 6 Visit schedule and procedures .............................................................................................................. 26 
 
 
 

 
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4 Abbreviations 
6MWT 
Six Minute Walk test 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AMPRO 
Amputee Mobility Predictor (prosthesis users) 
BL 
Baseline 
CA 
Competent Authority 
CEP 
Clinical Evaluation Plan 
CER 
Clinical Evaluation Report 
CI 
Co-Investigator 
CIB 
Clinical Investigator´s Brochure 
CIP 
 
Clinical Investigation Plan 
CIR 
 
Clinical Investigation Report 
CRF 
Case Report Form 
CT 
Clinical Trial 
EC 
Ethics Committee (see IEC, IRB, REB and REC) 
FU 
Follow-Up 
ICF 
Informed Consent Form 
IDMF 
Investigational Device Management Form 
IEC 
Independent Ethics Committee 
IFU 
Instructions For Use 
IRB 
Independent/Institutional Review Board 
LCI 
Local Co-Investigator 
LPI 
Local Principal Investigator 
LRA 
Local Research Assistant 
PEQ 
Prosthesis Evaluation Questionnaire 
PI 
Principle Investigator 
PIS 
Participant Information Sheet 
PKM 
Power Knee Mainstream 
REB 
Research Ethics Board 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Event 
SOP 
Standard Operating Procedure 
SOTA 
State-Of-The-Art 
SRA 
Sponsor Research Assistant 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

 
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5 Investigational Device 
See Table 2 for details on the investigational device. 
Table 2 Identification and Description of the Investigational Device 
Summary description of 
the investigational 
device and its intended 
purpose: 
The investigational device is a motor driven microprocessor-controlled prosthetic 
knee, intended for moderate to high active transfemoral or knee disarticulation 
amputees. It provides support in locomotion tasks as well as non-cyclical tasks 
through powered flexion and extension. 
The investigational device is used with a smart app to adjust and interact with the 
knee.  
Manufacturer of the 
investigational device: 
Össur ehf. 
Grjothals 1-5 
110 Reykjavik 
Iceland 
Name or number of the 
model/type, including 
software version and 
accessories, if any, to 
permit full identification: 
POWER KNEE MAINSTREAM – Dynamic (No product number yet, software version 
not available yet) 
Accessories: Lithium Ion Battery pack (no product number yet) 
Össur Logic is an iOS smart app and it is required to adjust and interact with the 
knee. It is a standalone software as a medical device, used with other bionic devices 
as well, the app is documented separately, see [1].  
Traceability during and 
after the investigation:  
Investigation Device Management Form (IDMF) will be used to track the use of each 
device within the clinical investigation using the device serial number. 
Intended purpose of the 
investigational device in 
the proposed clinical 
investigation: 
Intended purpose of the investigational device in the proposed clinical investigation is 
within the intended use as described below. 
See following chapters on the intended purpose of the investigational device in the 
proposed clinical investigation for details. 
The populations and 
indications for which the 
investigational device is 
intended: 
 
Unilateral transfemoral / knee disarticulation amputation 
Bi lateral transfemoral /knee disarticulation amputation 
 
Targeted Medical Indications: 
Any medical reasons resulting in amputation at or above the knee level. 
 
Description of the 
investigational device: 
POWER KNEE MAINSTREAM - Dynamic is composed of a motorized knee 
prosthesis, which forms the core of the system, as well as other devices used to 
sustain operation on a daily basis. More specifically, POWER KNEE MAINSTREAM – 
Dynamic is composed of four devices. Operation of the motorized knee prosthesis 
relies on a detachable battery pack, which provides system power, and a Prosthesis 
Configuration Device (software application) that allows adjustment of the knee 
parameters to optimize its performance with respect to the user physiological 
characteristics, activity level, gait style and personal preferences. Furthermore, the 
battery pack is provided and an off-the-shelf power supply, allowing conveniently 
recharging the battery pack when not used in the knee prosthesis. POWER KNEE 
MAINSTREAM - Dynamic is intended for moderately and highly active amputees (K3 
to K4) of moderate/high impact levels, building on established powered knee 
technology and utilizing the clinical benefits associated with powered prosthetics. The 
system should not impose any activity limitations and should be designed for ease of 
use of K3 and K4 users.  
The device is a non-invasive, single patient, reusable system. The system is not used 
in direct contact with the body. It should be noted that the aspect of the prosthesis 

 
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that is in direct physical contact with the amputee is the liner/socket, to which the 
POWER KNEE MAINSTREAM - Dynamic is connected to. In other words, the 
POWER KNEE MAINSTREAM - Dynamic is not in direct physical contact with the 
amputee. An amputee typically wears prosthesis and thereby utilizes the POWER 
KNEE MAINSTREAM - Dynamic, for up to 18 hours a day over duration of multiple 
years. 
The device will be supplied in a hard-plastic case with custom made foam cut-outs to 
protect the product and all relevant documents and accessories. 
The devices will be labelled according to regulations concerning non-CE marked 
investigational devices. R&D engineers will be responsible for identification of 
devices: on the required label for each device will be a serial number, same format as 
those used for CE-marked Össur devices of a similar type. 
Investigation Device Management Form (IDMF) will be used to track the use of each 
device within the clinical investigation using the device serial number. 
 
 
Intended Use: 
The POWER KNEE MAINSTREAM - Dynamic is intended to fulfil the requirements 
associated with daily ambulation of individuals showing an average to high activity 
level. The product targets an amputee population that are trans- femoral unilateral 
amputees showing good control over their residual limb with respect to the locomotion 
task range that they intend to address. Based on the user activity level, stump 
capacity and personal preferences, the product can be configured as a walking-only 
product or support the complete range of locomotion tasks introduced below. While 
being optimized for average users, the product can be used by amputees with a body 
mass ranging from 50kg to 116kg, as long as the maximum assistance and support 
levels provided by the motorized prosthesis are shown sufficient to sustain the safe 
product usage. 
The following paragraphs provide more details on the product intended typical use for 
the various supported locomotion tasks. 
 
Locomotion Tasks: 
POWER KNEE MAINSTREAM - Dynamic provides complete support of the most 
commonly encountered locomotion tasks in daily living. Moreover, in order to properly 
address the requirements of a wide range of user activity levels, residual limb control 
and strength, the product allows the user-specific configuration of the product 
features, such that optimal performance and safety can be achieved on a user-
specific basis. The following paragraphs provide more details on the supported 
locomotion tasks. 
Walking: The POWER KNEE MAINSTREAM - Dynamic sustains typical level walking 
through stance-phase flexion control and swing phase kinematics restoring, while 
contributing to the overall user forward progression. Automatic cadence adjustment, 
as well as heel rise control, is provided in order to optimize the product performance 
with respect to the user needs and personal preferences. 
Stairs Ascent: The POWER KNEE MAINSTREAM - Dynamic sustains step-over-step 
stairs ascent for intended users by providing mechanical assistance in the push-off 
phase and swing phase kinematics in order to favour proper and timely foot 
placement. For users showing limited residual limb control and strength, it is possible 
to block this locomotion task. 
Stairs Descent: The POWER KNEE MAINSTREAM - Dynamic sustains step-over-
step stairs descent for intended users by providing mechanical support in the 
controlled lowering phase of the gait cycle, while again focusing on kinematics and 
foot placement during the swing phase. 
Inclined Planes: The POWER KNEE MAINSTREAM - Dynamic can be used on 
inclined planes ascent and descent for intended users. Again, the product provides 
assistance and/or support as per configured for each specific task, while proper 

 
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kinematics and foot placement represent the focus of the swing phase. 
Non-cyclical Tasks: The POWER KNEE MAINSTREAM - Dynamic provides either 
support, assistance, or remains passive for tasks such as standing, sitting, sit-to-
stand transfer, stand-to-sit transfer, and kneeling. 
Operational Environment 
POWER KNEE MAINSTREAM – Dynamic device is intended for use in indoor and 
outdoor environments, in common daily living environments, like home, office, and 
public location. POWER KNEE MAINSTREAM – Dynamic device is intended to 
support typical use in commonly encountered weather conditions, like rain, fog, cold, 
etc. 
Product Configuration 
The product is intended to be used with Ossur’s standard prosthetic components. It is 
configured with standard proximal and distal connectors, allowing use with most 
commonly encountered socket technologies and shank replacement products. 
Foreseen ankle-foot products to be used with this product are Ossur’s Pro-Flex pivot, 
Pro Flex XC and/or Pro-Flex LP. 
The device does not incorporate, as an integral part, a substance or human blood 
derivative referred to in Section 7.4 of Annex I of 93/42/EEC, amended by 
2005/50/EEC. It is manufactured without utilizing tissues of animal origin as referred to 
in Directive 2003/32/EC. Training requirements for subjects and procedures relating to 
fitting and use of a device will for all general purposes be similar to the training and 
procedures required for using a CE- marked device of a similar type. 
POWER KNEE MAINSTREAM - Dynamic is a microprocessor controlled prosthetic 
knee. It is used exclusively for exo- prosthetic fitting of transfemoral and knee 
disarticulation amputees. It is utilized as part of prosthetic limb system, in other words 
an amputee requires additional components, such as a foot, to use the POWER 
KNEE MAINSTREAM - Dynamic in a functioning prosthesis. The POWER KNEE 
MAINSTREAM - Dynamic requires a certified prosthetist to set-up and fit the device to 
an amputee. The certified prosthetist uses software called “OssurLOGIC” running on 
a computer to communicate to the POWER KNEE MAINSTREAM - Dynamic, such 
that parameters can be optimized for an amputee. As the POWER KNEE 
MAINSTREAM - Dynamic is battery powered (rechargeable lithium ion) a charger is 
required. 
The device is classified as ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL 
according to Title 21 §890.3500, bearing the product code ISW: “External assembled 
lower limb prosthesis.”. It is 510(k) and GPM exempt, except for general 
requirements. 
 

 
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Figure 1, Knee center height 
 

 
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6 Justification for the Design of the Clinical Investigation  
The introduction of microprocessor controlled prosthetic knee in 1997 was a major leap in prosthetics in restoring 
function and increase safety of individuals with a lower limb amputation. Countless studies showed the benefits 
of such devices, e.g. Hafner et al.1 and Bellmann et al.2. However, such devices are still passive with a major 
shortcoming, which is that they cannot provide positive power to support the user. In other words, they are unable 
to generate concentric moments to support the user in situations in which such moments are needed. Standing up 
and step over step stair climbing are two examples where concentric moments are in principal needed, in order to 
fulfil these tasks. Although recent passive microprocessor controlled prosthetic knees have been introduced that 
offer modes which facilitate step over step stair climbing, the power needed still has to be generated by the proximal 
hip joint of the user. Especially in individuals with a trans-femoral amputation, who may have reduced all over 
physical capabilities, such modes cannot be used, due to the physical limitations of the user. This fact is for 
example substantiated by the inclusion criteria in Bellmann et al., who investigated step by step stair climbing in 
K-Level 3-4 subjects with a passive microprocessor controlled prosthetic knee. Beside in these rather complex 
movement patterns, knee power is also needed for knee flexion in the swing phase while walking. Although the 
magnitude of the power needed in this state is rather small, providing power has a pronounced clinical impact, 
since a reduced clearance in swing is associated with a higher risk of falls. 
Several studies have provided evidence for the clinical performance of previous versions of the Power knee 
(PK), which has the same function and intended use, those are detailed in the Literature review device report [3].  
Results of studies on previous versions of the Power knee indicate that the PK provides support in the sit to 
stand and stand to sit activity, provides stance phase flexion in level ground walking, support in ascending and 
descending ramps and stairs and that it does provide active flexion and extension during walking which leads to 
users being able to walk further and feel less tired. In addition, Pasquina et al.3 tested the Power Knee as an 
initial knee prosthesis after combat-related TF amputation or knee disarticulation and found indications that the 
Power Knee can be helpful as initial prosthesis after TF/KD amputation, participants reached mobility milestones 
faster than norms identified by expert panel. Shortening the rehabilitation time after amputation has the potential 
for great savings in healthcare expenditure and large benefits for the patients, e.g. with earlier mobilization and 
independence. Creylman et al.4 compared the Power knee and the Rheo knee (passive MPK), their results 
indicated more symmetric gait with the PK compared to passive MPK.  
As the literature shows, a powered prosthetic knee which is able to generate concentric moments is of high 
interest, to better counterbalance the disability of individuals with a lower limb amputation.  
Preclinical testing 
Variety of tests and activities have been carried out to verify the safety and performance of the 
investigational device. Structural test summary is presented in 20 Annex. 
Based on the intended use of the device, as it is not intended to be used directly on skin, the outcome of 
the risk analysis and that vendors have supplied verification that the device contains no Materials of 
Concern, biocompatibility testing was not necessitated. 
Based on the results of these tests, calculations, specifications, and design verification and validation 
activities it is considered justifiable to use the device in human subjects. 
Existing clinical data 
No clinical data exists for the investigational device.  

 
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Table 4 Endpoints, test methods and hypotheses 
 
Hypothesis 
Test Method 
Endpoint 
Acceptance 
Criteria 
A 
Subjects 
reduced 
exertion performing 
6MWT compared to 
previous 
prosthesis 
(primary outcome) 
BORG scale  
Mean difference 
in BORG score 
pre and post 
6MWT 
compared to 
comparator 
𝐻0: 𝜇1 ≤𝜇2 
𝐻1: 𝜇1 > 𝜇2 
p<0.05 
 
B 
Subjects 
improved 
performance 
in 
6MWT compared to 
previous prosthesis. 
6MWT (meters) 
Average 
distance walked 
in 6MWT 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 
𝐻1: 𝜇1 < 𝜇2 
p<0.05 
C 
Subjects report on 
average 
no 
worse 
support in sit to 
stand and stand to 
sit than with previous 
prosthesis.  
Self-report:  
PMQ (Questions 9 and 10) 
Likert scale 0-4 
 
 
Total score of 
PMQ questions 
9 and 10 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
D 
Subjects 
perceived 
safety 
in 
hill 
descent is no worse 
than with previous 
prosthesis. 
Self-report: 
Modified PEQ 14F (rate your safety 
when walking down a steep hill using 
the prosthesis) 
Likert Scale 1-10 
Average score 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
E 
Subjects 
perceived 
safety 
in 
stair 
descent is no worse 
than with previous 
prosthesis. 
Self-report: 
Modified PEQ 13D (rate your safety 
when walking downstairs using the 
prosthesis) 
Likert Scale 1-10 
Average score 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
F 
Subjects perceive no 
speed 
limitation 
while 
walking 
with 
the 
investigational 
device.  
Self-report(yes/no): 
„Are you satisfied with your walking 
speed 
using 
your 
prosthesis/test 
prosthesis?” 
Support question: 
 “Do you feel that your walking speed 
is limited by your prosthesis/test 
prosthesis?”  
Proportion 
of 
subjects 
(p) 
reporting 
satisfaction with 
walking 
speed 
on 
investigational 
device.  
𝐻0: 𝑝< 80% 
𝐻1: 𝑝≥80% 
p<0.05 
 
G 
Subjects 
reported 
ability to ambulate 
over 
typical 
environmental 
obstacles with the 
investigational device 
is no worse than with 
previous prosthesis. 
Self-report: 
PMQ (Question 2-7) 
Likert scale 0-4 
PLUS M  
 
 
Total score of 
PMQ questions 
2-7 and PLUS 
M T-score 
compared to 
comparator.  
For PLUS-M: 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 10𝑇  
For PMQ questions: 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 

 
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|𝑀𝑁𝐼| = 3 
p<0.05 
H 
Subjects 
safe 
and 
stable stance phase 
perception no worse 
than 
previous 
prosthesis. 
Self-report: 
Modified PEQ 13A (rate your safety 
(during stance phase) when walking 
with your prosthesis/test prosthesis) 
Likert Scale 1-10 
Average score 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
I 
Provides comfort in 
standing no worse 
than 
previous 
prosthesis. 
Self-report: 
PEQ-Question 1D 
“Rate your comfort while standing 
when 
using 
your 
prosthesis/test 
prosthesis” 
Likert Scale 1-10 
Average score 
compared to 
comparator 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
J 
The 
investigational 
device 
provides 
easier 
setup 
for 
CPO compared to 
previous version of 
power knee 
Self-report: 
Likert Scale 1-10 
Average score 
compared to 
previous 
versions of PK  
𝐻0: 𝜇1 ≥𝜇2 
𝐻1: 𝜇1 < 𝜇2 
p<0.05 
K 
The 
investigational 
device provides no 
worse ease of setup 
for CPO compared 
to 
SOTA 
passive 
MPKs 
Self-report: 
Likert Scale 1-10 
Average score 
compared to 
SOTA MPKs 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 1 
p<0.05 
M 
The 
investigational 
device 
provides 
acceptable 
noise 
level  
Self-report: 
PEQ- Questions 3K, 3L 
Likert Scale 1-10 
Support question (yes/no) 
“Would the noise from the test device 
prevent you from preferring it as your 
usual prosthesis?” 
Proportion of 
participants (p) 
with average 
score of PEQ 
3K & 3L over 5 
with 
investigational 
device. 
𝐻0: 𝑝< 80% 
𝐻1: 𝑝≥80% 
p<0.05 
L 
The 
investigational 
device provides ease 
of 
use 
of 
gait 
functions no worse 
than 
previous 
device 
 
Self-report: 
PMQ (Questions 1 and 3-6) 
Likert scale 0-4 
 
Objective measure 
L-test 
Total score of 
PMQ 
questions1, 3-6. 
 
Proportion of 
subjects (p) 
successfully 
completing the 
L-test using gait 
functions. 
For PMQ score: 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 2,5 
p<0.05 
For L-test: 
𝐻0: 𝑝< 80% 
𝐻1: 𝑝≥80% 
p<0.05 
M 
Side effects N/A 
Side effects 
Occurrence of 
side effects  
N/A 

 
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N 
Mobility using the 
investigational device 
is no worse than 
with the comparator 
PMQ total score (0-48) 
Average total 
score of the 
PMQ 
𝐻0: 𝜇1 ≥𝜇2 + |𝑀𝑁𝐼| 
𝐻1: 𝜇1 < 𝜇2 + |𝑀𝑁𝐼| 
|𝑀𝑁𝐼| = 5,5 
p<0.05 
O 
Activity 
level 
increases with longer 
adaptation period on 
the 
investigational 
device 
Activity reports from the knee (daily 
steps, use time) 
Activity level 
after 8-12w 
follow up 
compared to 2w 
follow up on 
investigational 
device 
𝐻0: 𝜇2 ≥𝜇3 
𝐻1: 𝜇2 < 𝜇3 
p<0.05 
 
 
Informative endpoint: In house usability questionnaire (Perceived weight, size, look, ergonomics, fit w/clothes, 
battery life, preference, falls questionnaire) 
8 Design of the Clinical Investigation 
8.1 General 
The test will be a two group prospective cross-over design, within subject comparison. Amputees are a small 
proportion of the general population. The population group specified in the inclusion/exclusion criteria is a further 
subsample of amputees. For practical reasons, i.e. to achieve statistical power, it is therefore more feasible to 
use within-subject comparison rather than creating study arms to compare. Furthermore, as mobile amputees 
generally have and use a prosthetic device for their daily activities, within-comparison is feasible comparing to 
the subject’s previous device. 
All investigational activities will be conducted at MCOP Silver Spring Prosthetic Clinic (2421 linden lane, Silver 
spring Md, 20910), Medical Center Boston, MA Prosthetic Clinic (500 Lincoln Street, Allston, MA 02134) and 
Motus Research (975 W. Walnut Street Indianapolis, IN 46202). 
As stated above the primary endpoint is the perceived exertion during walking measured by the Borg scale 
before and after 6MWT, see table 4, and the secondary endpoints are focused on the general mobility 
performance and efficacy of the investigational device, as well as performance of gait functions and ease of set 
up for average to highly active transfemoral/knee disarticulation amputees and CPOs. See previous chapter on 
objectives and hypothesis and Table 4 for rationale. 
Drop-outs and withdrawals may be replaced if deemed necessary to fulfil the methodological standards of the 
study. 
Instruments for data collection will include the following:  
The Six Minute Walk test (6MWT) is simply a record of the distance traveled by a given patient at his or her self-
selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or 
track of known distance5,6.  
The Borg Scale of Perceived Exertion7 is a subjective rating scale on which people indicate their perceived 
exertion and has been used with people with lower-limb amputation8.  
The Amputee mobility predictor (AMPro) is a 20-item scale that was originally developed to provide a more 
objective approach to the assignment of Medicare K-levels. The scale includes tasks intended to assess sitting 
balance, transfers, standing balance, gait, and obstacle negotiation and takes around 15 minutes to administer6.  
The Prosthetic Mobility questionnaire (PMQ) is a measure of perceived ability to perform a range of ambulation 
and transfer tasks with a lower limb prosthesis. PMQ has been reported to have high internal consistency, great 
test-retest reliability, and good convergent construct validity in people with lower limb amputation. PMQ will be 
administered as recommended by Franchignoni et al.9 PMQ is scored from 0 to 4; higher scores indicate higher 
perceived ability. 

 
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The Prosthesis Evaluation Questionnaire (PEQ) measures prosthetic-related quality of life. It consists of 82 items 
grouped into nine subscales. In addition, there are individual questions not contained in the subscales regarding 
satisfaction, pain, transfers, prosthetic care, self-efficacy, and importance10. 
L-test of functional mobility is a modified version of the Timed up and go test (TUG) developed for more active 
lower limb amputees. The patient begins the test seated in a chair, ideally positioned in an exam room and facing 
the entrance to the hallway. The patient rises from the chair, walks three meters into the hallway, turns 90 
degrees and then walks an additional seven meters down the hallway. Upon completing seven meters, he turns 
180 degrees, returns down the hallway, turns 90 degrees to face the exam room, and returns the three meters to 
his chair, where he retakes his seat11 
The Plus-M is a self-report instrument for measuring mobility of adults (age 18+) with lower limb amputation who 
have experience of using a prosthesis. PLUS-M measures prosthetis users’ mobility (i.e., their ability to move 
intentionally and independently from one place to another). The questions assess respondents’ perceived ability 
to carry out specific activities that require use of both limbs. PLUS-M questions cover movements that range 
from basic ambulation such as walking a short distance indoors to more complex outdoor activities such as 
hiking for long distances12,13. 
Video 
Data logging by Össur Logic 
See chapter 10.2 Sample size calculation and Table 4 for analysis of variables. 
 
Equipment required for each amputee subject: 
• 
Pen/pencil 
• 
Detailed protocol  
• 
Printed out instruments and instructions (Case report forms, PEQ, PMQ, AMPro, PLUS-M, Borg scale, 
in-house questionnaire) 
• 
Logbook/Notebook 
• 
Stopwatch/phone for 6MWT 
• 
Markers and a measured corridor/course of known distance for 6MWT and L-test 
• 
Chair for L-test and AMPro 
• 
Measuring tape 
• 
10cm obstacle for AMPro 
• 
Investigational device: Power Knee Mainstream (along with test foot and components as applicable).  
• 
Tools for fitting 
 
The equipment used does not require specific monitoring, maintenance or calibration procedures.  
8.2 Investigational Device(s) and Comparator(s) 
The investigational device is a powered microprocessor controlled prosthetic knee, with the same intended use 
as the previous version of the device (POWER KNEE II, a CE- marked device). See full details on the 
investigational device in Clinical investigators brochure [3]. 
When the investigational device is on the market the device will be a single user device, with a typical use time of 
5 years. Due to supply shortage, for clinical testing purposes the same investigational device may be used 
iteratively for periods of up to 3 weeks, maximum 3 times. Before refitting of a device, a reset to manufacturer 
settings will be performed as well as inspection for damage or malfunction. This supply shortage only refers to 

 
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visits 1 and 2 in the test procedure due to time limitations. For visit 3, investigational devices will be available for 
all users. 
The subjects will be asked to use the investigational device as their primary prosthesis for 2-3 weeks. Individual 
exposure will differ between subjects. Subjects are expected to use the investigational device for their daily living 
activities as they would with any other prosthesis, for up to 18 hours a day depending on the individual. The 
comparator device will not be used within the timeframe of the intervention period of the study. Subjects will 
evaluate and provide feedback on their exposure of the comparator at baseline and prior to them being fitted to 
the investigational device or after, depending on the group they are assigned to. The investigational device is 
used with a smart app to adjust and interact with the knee. Össur Logic is an iOS smart app and it is required to 
adjust and interact with the knee. It is a standalone software as a medical device, used with other bionic devices 
as well, the app is documented separately, see [1].  
The comparator device is the users current prosthesis, it may be any passive MPK or a previous version of the 
Power Knee (AMPK), depending on the subject. Both have the same intended use and population as the 
investigational device.   
The subject will be using the remaining part of their current prosthetic system with the investigational device, as it 
was used with the comparator device. If this is not possible, an advanced ESAR foot will be used and provided 
by Össur.  
No other device, medication or intervention will be used. Aside from the Össur Logic app which is used to 
interact with the knee.  
15-18 subjects are to be enrolled and therefore 15-18 investigational devices will be used, as the devices are 
intended to be used by a single patient; one for each subject.  
8.3 Subjects  
All subjects will be dispositioned as follows: 
• 
Screen Failure: Subject did not pass screening procedures, not called in for clinical visit; 
• 
Candidate for enrollment: Passed screening procedures, accepts to come in for clinical visit; 
• 
Enrolled: Subject signs informed consent; 
• 
Fitted: Subject leaves the clinic on the investigational device; 
• 
Discontinued: Candidate for enrollment or Enrolled subject whose participation ended because they 
withdrew consent, were withdrawn by the Investigator, were lost to follow up, or died;] 
 
 

 
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8.4 Procedures  
i) Recruitment 
Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). The LPI 
evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is 
cognitively capable. If a potential participant fits the inclusion and exclusion criteria the PI will contact them via 
telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest 
is expressed at this point they will answer some screening questions and questions relating to the duration of the 
study, number of clinical visits required, and the investigational device will be answered and if the eligibility 
criteria are met they will be invited for the 1st visit.  
ii) Test procedure 
There are three scheduled and one optional study event, all testing procedures will be conducted at the study 
site. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will 
seat the subject and proceed as described in chapter 13.8 Informed consent. 
Procedure for resetting and inspection of investigational devices between users:  
In Ossur Logic App, default parameters of the knee will be restored using the default profile.  
An activity report is generated in order to record the number of steps performed on the device before the next 
user starts using the device.  
Visual inspection of the device condition performed to identify any signs of wear or damaged parts. If damaged 
parts or sign of wear are observed, the knee shall be segregated and not fitted to a new user. 
Following the instructions provided in the Instruction for Use, the knee exterior surface and the battery pack 
complete outer surfaces will be cleaned.  
Visit 1: 
The subject will be consented and enrolled after verification of the inclusion/exclusion criteria. Potential risk of 
participating in the investigation will be explained to the subject. 
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion 
criteria and are willing to participate. 
Subjects will be randomized into 2 groups, using a random number generator. Half of the subjects (Group 1) will 
then be fitted with the investigational device. Prior to fitting the subjects of Group 1 will be asked to provide 
feedback on the current prosthesis, by filling in a set of questionnaires and performing the AMPro, L-test and 
6MWT with Borg scale, to obtain baseline data. Subjects may be videotaped during fitting and while performing 
functional tests, care will be taken to blur out faces and other personally identifiable markers such as tattoos and 
birthmarks. 
Users will be fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking 
on various terrain. After being fitted with the investigational device subjects will receive functional training on the 
investigational device prior to going home and using it as their usual prosthesis for approximately 2-3 weeks. 
They will be given an appointment for the follow up visit prior to leaving the testing site.  
The other half (Group 2) will stay on their prescribed prosthesis until the next visit in 2-3 weeks. 
CPO subjects will provide feedback on the ease of setup and fitting, they will also be videotaped during setup. 
Care will be taken to blur out faces and other personally identifiable markers such as tattoos and birthmarks. 
Visit 2: 
During the second visit subjects in Group 1 will perform the same functional tests as in the first visit (6MWT, L-
test, Borg scale) on the investigational device and answer questionnaires on the performance of the 
investigational device, and then be fitted back to their prescribed prosthesis. Subjects in Group 2 will perform the 
tests/questionnaires on their prescribed prosthesis and then be fitted with the investigational device. A new 
appointment is made after approximately 2-3 weeks.  
CPO subjects will provide feedback on the ease of setup and fitting. 
Visit 3: 

 
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The study monitor(s) and LPI will maintain communication on a minimum biweekly basis, via telephone and 
email. The LPI will provide the study monitor(s) with information of all scheduled study visits. The study monitor 
will visit the investigational site at least once while a study visit takes place. 
9 Investigational Device Accountability 
The investigational device will be provided as needed for the study population.  Devices will not be packaged but 
will be labeled according to FDA regulatory requirements. Subjects will not be blinded. 
The LPI will keep records documenting the receipt, use and return of the investigational device in the 
Investigational Device Management Form, including: 
• 
Date of receipt 
• 
ID of each investigational device 
• 
Date of use 
• 
Subject ID 
• 
Date of device return 
• 
Date of return of unused, expired or malfunctioning investigational devices, as applicable 
 
 
 

 
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10 Statistical Considerations 
10.1 Statistical design and procedures 
Outcomes at each timepoint will be visually inspected for normality using histograms and qq-plots. If the data are 
deemed to be normal the hypotheses will be tested using a two-tailed, paired, student’s t-test. Non-normal data 
will be tested using the Wilcoxon signed-rank test.  
Acceptance criteria for the data, as applicable, is defined in Table 4 Endpoints, test methods and hypotheses. 
Subgroup analysis will not be performed as no subgroups are defined. 
Repeated measures analysis has the advantage of increased power vis-à-vis group allocations and reduction in 
error variance associated with induvial difference, as each subject acts as its own control. This is important for 
studying amputees as the group is a small proportion of the total population, and with specific inclusion/exclusion 
criteria the total eligible population becomes very small, making it difficult to find and recruit subjects to attain an 
acceptable level of power. This limited population pool often results in slightly heterogeneous sample, as the 
amputees available are few and far between, in every sense. Furthermore, no single amputation procedure and 
therefore amputated stump is exactly the same, making the experience of each amputee a bit unique. The 
within-subject design significantly reduces the individual differences when comparing the two conditions. 
The drawback of the design is the potential of “carryover effects”, i.e. experience from one condition can affect 
outcome or performance in the other condition, creating a confounding extraneous variable that varies with the 
independent variable. Such effects are: practice, positive carryover effect to the latter condition; and fatigue, 
negative carryover effect to the latter condition. 
10.2 Sample size calculation 
Power analysis for the estimated required sample size was conducted using G*Power.  See protocol below: 
t tests - Means: Wilcoxon signed-rank test (matched pairs) 
Options: 
A.R.E. method 
Analysis: 
A priori: Compute required sample size  
Input: 
Tail(s) 
= One 
 
Parent distribution 
= Normal 
 
Effect size dz 
= 0.7084529 
 
α err prob 
= 0.05 
 
Power (1-β err prob) 
= 0.8 
Output: 
Noncentrality parameter δ 
= 2.6812808 
 
Critical t 
= 1.7676466 
 
Df 
= 13.3239449 
 
Total sample size 
= 15 
 
        Actual power 
 
        = 0.8150214 
 
It is therefore expected that at least 15 subjects are required to complete the protocol with a power of 0,8 and 
significance at 0,05. Effect size was estimated for the primary endpoint based on a previous in-house study of 
the RHEO KNEE, a passive microprocessor controlled prosthetic knee.  
Given a drop-out rate of 20%, up to 18 subjects may be recruited. 
For pass/fail criteria, see Table 4 Endpoints, test methods and hypotheses. 
10.3 Additional statistical matters 
There is no provision for interim analysis and no criteria for early termination of the clinical investigation on 
statistical grounds.  
Any deviations from the statistical plan provided in this protocol will have to be approved by the sponsor and the 
reasons for the deviation reported in the clinical investigational report. Dropouts and withdrawn participants will 

 
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be included in the data analysis for the procedures that they completed. They will be grouped together and 
compared to the group that finished the protocol. Any statistical differences of the two groups will be reported. If 
the participants have not provided any data, they will not be included in the data analysis. No particular 
information will be excluded from the statistical analysis and tests, as described above. 
11 Amendments and Deviations from the Protocol (CIP) 
11.1 Amendments 
Any amendments to this protocol must be first approved by the sponsor and PI for single site studies, and then 
be evaluated by the IRB and, where appropriate regulatory authorities, before being implemented. 
For non-substantial changes (e.g. minor logistical or administrative changes, change of monitor(s), telephone 
numbers, renewal of insurance) not affecting the rights, safety and well-being of human subjects or not related to 
the clinical investigation objectives or endpoints, a simple notification to the IRB and, where appropriate, 
regulatory authorities can be sufficient. 
11.2 Deviations 
Investigators are not allowed to deviate from this protocol without a formal approval from the IRB, if the deviation 
affects subject's rights, safety and wellbeing, or the scientific integrity of the clinical investigation. Any such 
deviation from the protocol is to be documented in detail and the report sent to the IRB.  
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 and the IRB as soon as possible. 
Investigators can request for an approval from the sponsor for a deviation if the deviation does not affect 
subject's rights, safety and wellbeing, or the scientific integrity of the clinical investigation. 
In case of a deviation from this protocol taking place without prior approval from the sponsor, and IRB/REB/REC 
as applicable, it shall be reported to the sponsor within 24 hours of LPI knowledge of the deviation. The LPI 
responsible for the deviation is to send a report to the sponsor no later than five days after the deviation was 
reported. The report shall include: 
• 
Reason for deviation 
• 
When deviation took place 
• 
Circumstances of the event 
• 
Identification of all subjects affected by the deviation, if any 
o 
Details how each subject is affected, e.g. rights, safety or wellbeing 
• 
Details how this deviation might affect the scientific integrity of the clinical investigation 
The sponsor and the IRB/REB/REC will evaluate any deviations that take place without prior approval on a case-
by-case basis. If the deviation affects subject's rights, safety and wellbeing, and the scientific integrity of the 
clinical investigation the LPI shall be disqualified from further participation in the clinical investigation. 
12 Statement of Compliance 
The clinical investigation is sponsored by Össur Iceland ehf.  
It shall be conducted: 
• 
in accordance with the ethical principles that have their origin in the Declaration of Helsinki 
• 
in compliance with the ISO 14155 International Standard 
• 
in compliance with any regional or national legislations, as applicable 
The clinical investigation shall not commence until the required approval from the IRB, and regulatory authority 
as applicable, has been obtained. 
Any additional requirements imposed by the IRB or regulatory authority shall be followed, as applicable. 

 
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13.4 Risk Mitigation 
For each device designed by Össur risk mitigation is part of the design process according to ISO 14971 [3]. 
Furthermore, each participant fitted with a MPK prosthesis for the first time, or an upgraded/adjusted version 
of the device, will be trained by a fully qualified professional until the user can demonstrate sufficient 
understanding of the product operation and demonstrate minimum ability level in its operation. This process is 
the same as the usual training process deployed for normal fitting of a MPK prosthesis.  
As part of the training process, the participant will be informed on the risks inherent in using a MPK prosthesis 
in an uncontrolled environment. Moreover, the participant will be provided with the product literature (e.g. 
Information for User), as well as being informed and trained on how to use the product. 
13.5 Risk-to-Benefit Rationale 
The development of a MPK prosthesis is controlled by a multi-level verification and validation processes before 
being authorized for field testing and subsequent release. The Design & Verification process execution, coupled 
with the risk management and control strategy deployed for POWER KNEE MAINSTREAM – Dynamic ensure 
that the risks associated with use of the device in typical daily living conditions does not exceed risks level 
associated with the operation of any such device under similar conditions. 
The residual risks of the investigation and the investigational device are minimal and are significantly out 
weighted by the benefits of participating in the investigation. 
13.6 IRB Review and Communications 
The study protocol (CIP), informed consent form, and other study documentation forms require IRB review and 
approval. Communication to and from the IRB shall be directed from or to the primary Össur contact, Steinþóra 
Jónsdóttir, the Study Monitor. Continuous communication will be maintained between Össur and the IRB, as 
required. Moreover, communication will be maintained between the PI and the IRB, as required. 
13.7 Vulnerable populations 
No vulnerable populations will be enrolled.  
13.8 Informed Consent 
The Principal Investigator, or any researcher qualified, will obtain from the subject, written signed informed 
consent form to his/her inclusion in the study, after explaining the rationale for and the details of the study, the 
risks and benefits of alternative treatments, and the extent of the subject's involvement. The subject will receive a 
copy of the informed consent. 
The subjects will be informed that their participation is voluntary and that they can withdraw from participation at 
any time, at his/her discretion and this will not have any consequences for the participant’s treatment. 
In case the information on the ICF changes, and subjects need to be provided with new information, the PI will 
contact each subject by phone and explain the new information as required and participants will be reconsented 
as applicable. 
Subjects that for any reason are unable to provide informed consent will not be enrolled in the study. 
13.9 Participant confidentiality – Data management 
Subjects will be assigned a random study identification (ID) number and a random investigational device 
(identified by the study serial number). 
When recording video care will be taken not to include the face or other identifiable features, if they are 
accidentally captured they will be blurred or blackened.  
Confidentiality of all relevant subject feedback and information will be maintained through use of the identifying 
number only, in all documentation. The study sponsor, Össur, will remain the sole owner of the study data. A list 
connecting the ID to the subject´s name will be stored in a password secured file until the end of the study at 
which point it will be destroyed. Only investigators involved in the trial will have access to this information. 

 
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The screening form will be in paper format and will be stored by the PI in a locked container. All documents will 
be collected by Study Monitor and/or PI.  
A Clinical Investigation Report (CIR) will be generated by Medical Office. The report will be stored with the device 
technical file within Össur Quality Management System, along with the unlinked data and all accompanying 
investigational documents, according to the R&D and Quality documentation procedures. Subjects participating 
in the study can have access to the results, on demand, when the CIR is internally published. 
Study results, data, and documentation will be stored for a minimum of 5 years.  
 
 

 
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14 Evaluation of Adverse Events and Device Deficiencies 
For a list of foreseeable adverse events and anticipated adverse device effects, together with their likely 
incidence, mitigation or treatment see chapter 13.2 above and Hazard Analysis documentation [3]. 
14.1 Definitions of adverse events, effects and deficiencies 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device. 
An adverse device effect (ADE) is any adverse event related to the use of an investigational medical device, 
including events resulting from insufficient or inadequate instructions for use, operation, malfunction, etc. 
A serious/severe adverse event (SAE) is an AE that: 
• 
Is life-threatening or fatal 
• 
requires or prolongs hospitalization 
• 
results in permanent impairment of a body function 
• 
or results in permanent damage to a body structure. 
A serious/severe adverse device effect (SADE) is an adverse device effect that has resulted in any of the 
consequences characteristic of a SAE. 
An anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk management for the device.  
An unanticipated adverse device effect (UADE) is a serious adverse effect on health or safety of participants 
caused by the device if not previously identified in nature, severity, or degree of incidence in the protocol (CIP) or 
the risk analysis for the device.  
A device deficiency (DD) is the 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. 
A use error (UE) is an act or omission of an act that results in a different medical device response than intended 
by the manufacturer or expected by the user. 
See ISO 14155:2011 for details. 
14.2 Reporting procedures 
Adverse events and device deficiencies are recorded and reported to the competent authority in all countries in 
which the trial is being conducted according to national guidelines.  
All device related adverse events will be investigated. Adverse events that are serious, unanticipated and 
(possibly) device related shall be reported to the sponsor by telephone as soon as possible.  The complete 
adverse event investigation form shall be faxed to the sponsor within 24 hrs. Within ten days the Sponsor will 
report to the IRB and the FDA. Any serious device related adverse event will lead to the immediate termination of 
the trial.  
Participants will be provided the contact information of the investigator and told to call them in the event of an 
adverse event that may be connected to previous use of the device.  
The Principal investigator shall supply a copy of the complete adverse event investigation form, together with a 
cover letter to the IRB when events are judged to be serious, unanticipated and (possibly) device related.   
Contact in case of unexpected adverse event:  
Ian Fothergill mobile: 
 for Investigational site 1# and 2# 
Email: 
  
Jeffrey Denune mobile: 
 Investigational site 3#  
Email: