The loss of an arm is a devastating event; medical technology in the realm of prosthetic arms has come a long way from days of yore when the limb was replaced with a hook. A high-tech device is now available that is much superior to currently available prosthetic arms. On May 9, the Food and Drug Administration (FDA) approved a robotic arm for amputees that is named for the “Star Wars” character Luke Skywalker
The DEKA Arm System is the same shape and weight as an adult arm; it is the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. The electrodes detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. The electrodes send the electrical signals to a computer processor in the prosthesis that translates them to a specific movement or movements. Electrical signals are converted into up to 10 powered movements, and it. In addition to the EMG electrodes, the prosthesis contains a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.
“This innovative prosthesis provides a new option for people with certain kinds of arm amputations,” explained Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. She added, “The DEKA Arm System may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm.”
The FDA evaluated the device by reviewing clinical information regarding it. The evaluation include a four-site Department of Veterans Affairs study in which 36 DEKA Arm System study participants provided data on how the arm performed in common household and self-care tasks. It found that approximately 905 of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair.
The DEKA Arm System is versatile; it can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. However, it cannot be configured for limb loss at the elbow or wrist joint. The FDA review included testing of software as well as the electrical and battery systems. The ability to prevent or stop unintended movements of the arm and hand mechanisms was evaluated. Impact and durability testing was also conducted. The durability testing entailed the device’s ability to withstand exposure to common environmental factors such as dust and light rain.
The FDA’s review process was done via the agency’s de novo classification process, which is a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind. The prosthesis is manufactured by DEKA Integrated Solutions in Manchester, New Hampshire.