Sense System with IBT Electrodes

The Sense System with IBT Electrodes aims to provide intuitive and enhanced control of upper limb prostheses by detecting and interpreting muscular electrical signals from the user. It employs surface EMG sensing through specialized biocompatible titanium electrodes, advanced signal processing with pattern recognition algorithms, and a user-friendly interface with Bluetooth connectivity to translate user intent into precise prosthetic motion.

The Sense System with IBT Electrodes is an advanced surface electromyography (sEMG) system designed for controlling external upper limb prosthetic devices. It functions by detecting myoelectric signals from the user's residual limb via up to eight IBT Electrodes. These signals are then processed by a dedicated Signal Processing Box utilizing a pattern recognition algorithm, which translates the user's intended movements into standardized control signals. These output signals are compatible with a variety of commercially available prosthetic components such as hands, wrists, and elbows, allowing for intuitive operation without modifying the core functionality of the attached prosthetics. The system is intended for prescription use and requires installation by a trained prosthetist. Key technological features of the Sense System include Bluetooth communication between the Signal Processing Box and a User Interface software, which facilitates calibration of the pattern recognition classifier and allows for parameter adjustments. Users can calibrate specific movements and practice control pre-prosthetically with a virtual arm feature. The IBT Electrodes utilize biocompatible titanium contacts, minimizing skin irritation, and are designed for easy replacement and compatibility with suction seal sockets. The system accepts power from the FlexCell Battery system and has undergone comprehensive performance testing, including software and design verification and validation, usability studies, and adherence to relevant safety (IEC 60601-1, IEC 60601-1-11) and electromagnetic compatibility (IEC 60601-1-2) standards to ensure its operational integrity and safety.

AI Regulatory Concerns

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• Q1. What are the specific performance metrics (e.g., accuracy, latency, number of discernible movements) of the pattern recognition algorithm used in the Sense System across diverse user populations?; How does the long-term daily use of the IBT Electrodes affect skin integrity and signal quality, particularly in relation to the suction seal compatibility?; What quantifiable improvements in functional outcomes or user satisfaction does the Sense System's user interface and virtual arm training provide compared to systems without these features?; Can the Sense System's pattern recognition algorithm adapt over time to changes in a user's EMG signals due to muscle fatigue or physiological changes?; What is the range and reliability of the Bluetooth communication between the Signal Processing Box and the User Interface, especially in environments with potential RF interference?