COMPLETE CONTROL System Gen2

The COMPLETE CONTROL System Gen2 is engineered to offer upper extremity amputees intuitive and seamless control over their powered myoelectric prostheses through non-invasive means. It achieves this by utilizing pattern recognition algorithms to interpret EMG signals from cutaneous electrodes, simplifying user calibration via features like a mobile application, and enhancing overall system integration and efficiency.

The COMPLETE CONTROL System Gen2 is an advanced control solution specifically designed for upper extremity amputees using powered myoelectric prostheses. Its core methodology involves pattern recognition technology that non-invasively acquires and interprets user-specific muscle signals (EMG) from cutaneous electrodes, translating these signals into prosthesis movements. This system aims to provide users with intuitive control, eliminate the need for control switching, and allow for quick and powerful recalibration, simplifying electrode placement and enhancing interaction with industry-standard prostheses. Key components include the COMPLETE CONTROLLER main processor, device and EMG interface cables, a COMPLETE CALIBRATE button, a fabrication aid, a socket cut-out template, the COMPLETE CONTROLROOM Application (for PC and mobile), and a COMPLETE COMMUNICATOR Dongle. Compared to its predicate, the Gen2 system incorporates several enhancements, including the integration of signal amplification, filtering, and EMG transmission functions (previously in a separate CO-AMP unit) into the main COMPLETE CONTROLLER. This optimization, along with a change to cast Polyurethane for the enclosure material from Polyjet, contributes to a slightly smaller footprint and significantly reduced power consumption (less than half of the predicate), while also supporting an expanded operating voltage range (5.0-20.0 VDC). A significant usability improvement is the addition of a mobile application, allowing users to easily recalibrate their prosthesis without needing a computer. The system retains the same core algorithms and indications for use as its predecessor—exclusively for external prosthetic fittings of the upper limbs—and has successfully passed non-clinical performance testing for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and various internal validation tests covering cabling, power, connectivity, inputs/outputs, calibration, pattern recognition, and file saving.

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• Q1. How does the pattern recognition algorithm adapt to changes in muscle signals due to user fatigue or minor electrode shifts over prolonged daily use?; What is the typical learning curve for a new user to achieve proficient control with the COMPLETE CONTROL System Gen2, and how does the new mobile application specifically facilitate this learning and recalibration process?; Beyond the listed compatible prosthetic components in the user manual, what are the technical interface requirements or limitations for integrating the COMPLETE CONTROL System Gen2 with other third-party prosthetic hands, elbows, or wrists?; How does the performance of the cast Polyurethane enclosure, chosen for its production cost and finish, compare to the previous Polyjet material in terms of long-term durability, impact resistance, and stability within the prosthetic socket environment?; What specific advancements in the integrated signal amplification, filtering, and EMG signal transmission within the COMPLETE CONTROLLER contribute to the system's reduced power consumption and potentially improved signal-to-noise ratio compared to the predicate's separate Co-Amp unit?