On May 9, the U.S. Food and Drug Administration (FDA) announced that it allows marketing of the DEKA Arm System, DEKA Integrated Solutions, Manchester, New Hampshire. Dubbed the “Luke Skywalker” arm, it is the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
EMG electrodes detect electrical activity caused by muscle contractions close to where the prosthesis is attached and send the electrical signals to a computer processor in the prosthesis that translates them into up to ten powered movements. The DEKA arm, which is the same shape and weight as an adult arm, also contains a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.
The FDA reviewed clinical information relating to the device, including a four-site U.S. Department of Veterans Affairs study in which 36 DEKA arm study participants provided data on how the arm performed in common household and self-care tasks. The study found that about 90 percent of study participants were able to perform activities with the DEKA arm that they were not able to perform with their current prostheses, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair.
The DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. It cannot be configured for limb loss at the elbow or wrist joint.
The FDA also reviewed testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing (such as its ability to withstand exposure to common environmental factors such as dust and light rain), and impact testing.