Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

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Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ABSTRACT There is a pressing need to improve control of myoelectric prostheses for individuals with upper limb loss (ULL). To date, only two fundamental control methods have been made commercially available – Direct Control (DC, introduced in 1960) and Pattern Recognition (PR, introduced in 2016). Both have significant limitations, as outlined within the proposal. Thus, we propose a new control method called Glide. The Glide architecture does not use ‘triggers’ to switch between different grasps like DC systems, nor does it require frequent ‘recalibration’ like PR systems. Instead, it combines the simplicity of DC with the functionality of PR. It is based on effecting joystick-style motions of the residual limb to move a “Glide cursor” to specific locations within a circular region called the “Glide domain.” The Glide cursor position is determined by the resultant of the vector summation of two to eight EMG channels (depending on individual patient’s needs), where each of the electrode channels are spaced at equal angular distances apart from each other on the Glide domain. To date, we have 1) developed the controller hardware; 2) iteratively developed the control strategy and user interface with direct involvement of clinicians and individuals with ULL; and 3) evaluated a total of nine individuals with trans-radial ULL including seven who completed long-term in-home testing. Of note, our experience now includes one individual who has been using the system for two and half years and counting. We now propose to commercialize the novel Glide control strategy and enable accessibility to the widest group of patients possible. We propose two aims to accomplish these goals. The first aim is a regulatory aim, where we will complete the Verification and Validation of the system and submit a 510(k) for regulatory approval. The second aim is a scientific aim, where we will evaluate the hypothesis that use of Glide results in improved functional, satisfaction and usage metrics as compared to use of a standard DC prosthesis. An important benefit of this aim, presuming the results are favorable, is that it will provide strong support for reimbursement. If we are successful, we will have met our dual mandate – to improve usability of upper limb prostheses, while simultaneously increasing real-world access to advanced prosthetic technologies.