1. Clinical Review by CAPT Marie A. Schroeder

2. OVERVIEW Background Background Indications for Use Indications for Use Assessments and Training Assessments and Training Pivotal Trial Summary Pivotal Trial Summary Safety Analyses Safety Analyses Effectiveness Analyses Effectiveness Analyses Human Factors Human Factors

3. BACKGROUND Original premarket approval (PMA) application Original premarket approval (PMA) application Expedited review Expedited review Pilot studies Pilot studies 1999 -- 1 Study 1999 -- 1 Study 2001 – 2 Studies 2001 – 2 Studies

4. BACKGROUND (continued) Pivotal study - February to May, 2002 Pivotal study - February to May, 2002 Assessed marketing version of the iBOT™ Assessed marketing version of the iBOT™ Used marketing versions of the assessment and training methods and materials Used marketing versions of the assessment and training methods and materials

5. Indications for Use The INDEPENDENCE™ iBOT™ 3000 Mobility System is a powered mobility device for individuals who have mobility impairments and the use of at least one upper extremity. The INDEPENDENCE™ iBOT™ 3000 Mobility System is a powered mobility device for individuals who have mobility impairments and the use of at least one upper extremity. To provide indoor and outdoor mobility in confined spaces, at an elevated height, to climb curbs, ascend/descend stairs, traverse obstacles, travel over a wide variety of terrain and negotiate uneven/inclined surfaces. To provide indoor and outdoor mobility in confined spaces, at an elevated height, to climb curbs, ascend/descend stairs, traverse obstacles, travel over a wide variety of terrain and negotiate uneven/inclined surfaces.

6. Indications for Use (continued) Prescription device Prescription device Clinicians require certification Clinicians require certification

7. PIVOTAL TRIAL SUMMARY Study of the INDEPENDENCE™ IBOT™ 3000 Mobility System During Real World Use

8. ASSESSMENTS and TRAINING Clinician Certification Clinician Certification User Training User Training

9. CLINICIAN CERTIFICATION 1)Drive/operate the iBOT™ 1)Drive/operate the iBOT™ 2)Assess device user 2)Assess device user 3)Deliver the iBOT™ training to a user 3)Deliver the iBOT™ training to a user 4)Observation in the field 4)Observation in the field

10. CLINICIAN CERTIFICATION (continued) 1) Drive/operate the iBOT™ User Manual User Manual Quick Reference Cards Quick Reference Cards Delivery Guidebook Delivery Guidebook Safe usage videos Safe usage videos 2)Assess device user Medical Interface Manual Medical Interface Manual Assessment Guidebook Assessment Guidebook

11. CLINICIAN CERTIFICATION (continued) 3) Deliver the iBOT™ training to a user Delivery Guidebook Delivery Guidebook Delivery Interface Manual Delivery Interface Manual Clinician Observation Test Video Clinician Observation Test Video 4)Observation in the field

12. USER ASSESSMENT and TRAINING 1)Screening 2)Mailings 3)Clinic Assessment (Prior to device delivery) 4)Materials delivered prior to receipt of device and final training 5) Clinic Training and Assessment

13. USER ASSESSMENT and TRAINING (continued) 1) Screening Telephone Screening Form/Product Qualification Survey Telephone Screening Form/Product Qualification Survey 2) Mailings Home/Transportation Assessment Survey Home/Transportation Assessment Survey Cardiac, Pulmonary and Fracture Risk Forms Cardiac, Pulmonary and Fracture Risk Forms 3) Clinic Assessment (Prior to device delivery) Verification Survey Verification Survey Medical Interface Manual Medical Interface Manual Assessment Guidebook Assessment Guidebook

14. USER ASSESSMENT and TRAINING (continued) 4) Materials delivered prior to receipt of device User Manual (If deemed appropriate to continue) User Manual (If deemed appropriate to continue) Quick Reference Cards Quick Reference Cards 5) Clinic Training and Assessment Delivery Interface Manual Delivery Interface Manual Delivery Guidebook Delivery Guidebook Safe Usage Videos Safe Usage Videos

15. STUDY RESULTS Safety Analyses Safety Analyses Effectiveness Analyses Effectiveness Analyses

16. SAFETY ANALYSES

17. ADVERSE EVENTS Bruises - 2 / 20 subjects (10%) Pinched mid-forearm between the iBOT™ UCP and the armrest - received treatment (forearm pad applied) Pinched mid-forearm between the iBOT™ UCP and the armrest - received treatment (forearm pad applied) Bruised leg due to the iBOT™ falling over - no treatment required Bruised leg due to the iBOT™ falling over - no treatment required Falls – 5 / 20 subjects (25%) iBOT™ ………..3 / 20 subjects (15%) iBOT™ ………..3 / 20 subjects (15%) Own device …...2 / 20 subjects (10%) Own device …...2 / 20 subjects (10%) Other – 4 / 20 subjects (20%) experienced adverse events not related to the iBOT™

18. DEVICE FAILURES Twelve of the 20 subjects experienced a total of 22 events that resulted in device replacement or one or more component replacements: Twelve of the 20 subjects experienced a total of 22 events that resulted in device replacement or one or more component replacements: Device# Events Own device 9 events iBOT™13 events None of the above device failures resulted in injury to the subjects. None of the above device failures resulted in injury to the subjects.

19. iBOT™ REPLACEMENTS 3 Total devices 3 Total devices -- One subject had the iBOT™ replaced twice -- One other patient also had the iBOT™ replaced 1 Powerbase 1 Powerbase 2 Wheel assemblies 2 Wheel assemblies 3 Caster assemblies 3 Caster assemblies 1 Seat assembly 1 Seat assembly 2 Modems 2 Modems 3 Modem cables 3 Modem cables 1 Modem card 1 Modem card 1 Backrest shroud 1 Backrest shroud 1 Non-UCP armrest 1 Non-UCP armrest 1 Non-UCP armrest cover 1 Non-UCP armrest cover

20. Problems Prompting Total iBOT™ Replacement Bent charger port pin Bent charger port pin Seat height unable to adjust Seat height unable to adjust UCP backlight failed to function UCP backlight failed to function during stair training

21. Replacements to Own Mobility Devices 1 Spring loaded piece in wheel hub 1 Bearings on casters 1 Armrests 1 Lever cable 1 Bolt on caster 3 Tires (Note: 3 events report replacement of tires, but the number of tires is not specified) 1 Wheels (Note: 1 event reports replacement of wheels, but the number of wheels is not specified) 1 Bolt on backrest 1 Bolt (not specified)

22. Computerized Alert and Failure Identification Data Alert / FailureTotal (count) Controller Failure 5 Controller Auto 4-Wheel 22 Controller Alert Balance42 Controller Alert 4-Wheel 3 Controller Alert Stair80 4-Wheel Off Top of Stair62 Wheel Motor Hot 4 Cluster Motor Hot89 Security Password 0 Service Trigger 17

23. EFFECTIVENESS ANALYSES Primary - Community Driving Test Primary - Community Driving Test Secondary - Subject Specific Function Scale Secondary - Subject Specific Function Scale

24. Community Driving Test Limitations The 2-rail stair climbing technique was not included. The 2-rail stair climbing technique was not included. Balance function was tested by 1 task Balance function was tested by 1 task (“Retrieves book off high shelf”) Remote function was not tested. Remote function was not tested. Speed templates assigned: Speed templates assigned:  Slow 0 subjects  Medium18 subjects  Fast 2 subjects

25. Solo versus Assist Stair Climbing  Twelve subjects achieved “solo” status for stair climbing.  Four solo subjects also had a trained assistant for the “assist” stair climbing.  Two solo plus assist subjects were cleared for solo stair climbing with 2 rails only (not for 1 rail).  Eight subjects required the “assist” stair configuration.

26. SUBJECT SPECIFIC FUNCTION SCALE Assessment limitations Not all patients identified the same tasks Not all patients identified the same tasks Assessment focused on tasks that subjects are unable to perform or perform with difficulty with current devices; it is expected that scores with the current devices would be low. Assessment focused on tasks that subjects are unable to perform or perform with difficulty with current devices; it is expected that scores with the current devices would be low.

27. ADDITIONAL EFFECTIVENESS DATA Data Logger Distributions Data Logger Distributions Device Failures and Replacements Device Failures and Replacements Accessibility Problems Accessibility Problems Mechanical /Operational Difficulties Mechanical /Operational Difficulties Home and Community Maneuvering Summary Home and Community Maneuvering Summary

28. Mechanical /Operational Difficulties Mechanical/Operational Difficulty iBOT™ Own Device Assist Handle/Backrest 11 Battery183 Brakes10 Cluster/Wheels/Casters76 CPU Fault 20 Footrest/Armrest32 Modem Cable 30 Seating/Seat Height 42 Tires37 User Control Panel 50 User Technique 112 Other12

29. HUMAN FACTORS Joystick Joystick Can be disabled but is re-enabled with pushing any control panel button (except for the backlight button) Can be disabled but is re-enabled with pushing any control panel button (except for the backlight button) Subject accidentally re-enabled the joystick and a person reaching across caused unexpected movement of the device. Subject accidentally re-enabled the joystick and a person reaching across caused unexpected movement of the device. Pinch points Pinch points The User Manual describes a number of device features where a user can get pinched The User Manual describes a number of device features where a user can get pinched

30. HUMAN FACTORS User Control Panel (UCP) User Control Panel (UCP) Difficult to detach from armrest and user may get hurt or might not be able to remove for using Remote Function Difficult to detach from armrest and user may get hurt or might not be able to remove for using Remote Function Subject experienced this problem Subject experienced this problem UCP Display UCP Display Difficult to see due to glare and when operating joystick (hand covers the display) Difficult to see due to glare and when operating joystick (hand covers the display) Subject experienced this problem Subject experienced this problem

31. CONCLUDING REMARKS