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Clinical Review

Clinical Review. by CAPT Marie A. Schroeder. OVERVIEW. Background Indications for Use Assessments and Training Pivotal Trial Summary Safety Analyses Effectiveness Analyses Human Factors. BACKGROUND . Original premarket approval (PMA) application Expedited review Pilot studies

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Clinical Review

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  1. Clinical Review byCAPT Marie A. Schroeder

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

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

  4. BACKGROUND(continued) • Pivotal study - February to May, 2002 • Assessed marketing version of the iBOT™ • 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. • 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 • 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 • User Training

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

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

  11. CLINICIAN CERTIFICATION(continued) 3) Deliver the iBOT™ training to a user • Delivery Guidebook • Delivery Interface Manual • 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 2) Mailings • Home/Transportation Assessment Survey • Cardiac, Pulmonary and Fracture Risk Forms 3) Clinic Assessment (Prior to device delivery) • Verification Survey • Medical Interface Manual • Assessment Guidebook

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

  15. STUDY RESULTS • Safety Analyses • Effectiveness Analyses

  16. SAFETYANALYSES

  17. ADVERSE EVENTS Bruises - 2 / 20 subjects (10%) • 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 Falls – 5 / 20 subjects (25%) • iBOT™ … …….. 3 / 20 subjects (15%) • 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: Device # Events Own device 9 events iBOT™ 13 events • None of the above device failures resulted in injury to the subjects.

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

  20. Problems Prompting Total iBOT™ Replacement • Bent charger port pin • Seat height unable to adjust • 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 / Failure Total (count) Controller Failure 5 Controller Auto 4-Wheel 22 Controller Alert Balance 42 Controller Alert 4-Wheel 3 Controller Alert Stair 80 4-Wheel Off Top of Stair 62 Wheel Motor Hot 4 Cluster Motor Hot 89 Security Password 0 Service Trigger 17

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

  24. Community Driving Test Limitations • The 2-rail stair climbing technique was not included. • Balance function was tested by 1 task (“Retrieves book off high shelf”) • Remote function was not tested. • Speed templates assigned: • Slow 0 subjects • Medium 18 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 • 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 • Device Failures and Replacements • Accessibility Problems • Mechanical /Operational Difficulties • Home and Community Maneuvering Summary

  28. Mechanical /Operational Difficulties

  29. HUMAN FACTORS • Joystick • 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. • Pinch points • The User Manual describes a number of device features where a user can get pinched

  30. HUMAN FACTORS • 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 • Subject experienced this problem • UCP Display • Difficult to see due to glare and when operating joystick (hand covers the display) • Subject experienced this problem

  31. CONCLUDING REMARKS

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