Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With Mobili Knee (a Powered Microprocessor-controlled Knee Prosthesis)
Conditions: Prosthesis User, Amputation
Sponsor: Össur Iceland ehf



 
 
© 2025 
 
CONFIDENTIAL DOCUMENT  
 
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Table of Contents 
How to Refer to This Document ...................................................................... 4 
 
Summary .................................................................................................. 4 
 
Changes from Previous Revision .......................................................... 6 
 
Changes for Revision 1.00 ......................................................................................... 6 
Changes for Revision 2.00 ................................................................................................... 6 
Abbreviations ................................................................................................... 7 
 
Investigational Device ............................................................................. 8 
 
Objectives and Hypotheses .................................................................. 13 
 
Design of the Clinical Investigation ..................................................... 16 
 
General .................................................................................................................... 16 
 
Investigational Device(s) and Comparator(s) ........................................................... 17 
 
Subjects ................................................................................................................... 17 
 
Procedures............................................................................................................... 18 
i) 
Test procedure......................................................................................................................... 18 
 
Statistical Considerations .................................................................... 20 
 
Statistical design and procedures ............................................................................ 20 
 
Sample size calculation ........................................................................................... 20 
 
Ethical Considerations ......................................................................... 21 
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References ............................................................................................. 24 
 
 
 

 
 
© 2025 
 
CONFIDENTIAL DOCUMENT  
 
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Build device in prosthetic system 
Align device in prosthetic system 
Configure device parameters 
Check Battery Status 
Turn ON and Turn OFF 
Recognize feedback from the device 
Charging 
Battery Pack Swap 
 
 Changes from Previous Revision 
 Changes for Revision 1.00 
Initial release. 
Changes for Revision 2.00 
Activity level changed to include K1 and K2 users.