The DEKA Arm System®, which detects signals from an individual’s muscles and translates those signals into movements allowing for the completion of complex tasks, was approved for marketing according to an announcement by the FDA. This approval marks the first time the FDA has allowed a product to be marketed that can perform multiple and simultaneous movements, which has resulted in the completion of tasks including using keys and locks, preparing food, brushing hair, and using zippers by users. According to FDA officials, the DEKA Arm System allows for movement that is more advanced than what is allowed for using current available prosthetics and that more closely resembles natural arm movement.
DEKA Arm System
The DEKA Arm System utilizes electromyogram (EMG) electrodes that “detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached,” which are then sent to “a computer processor in the prosthesis that translates them to a specific movement or movements.” Moreover, the system contains other mechanisms such as switches, movement sensors, and force sensors that combine to make movements in the prosthetic. The prosthetic is able to use the entire process to convert signals from the electrodes into 10 different powered movements. The device has the same shape and weight of a natural arm and can be fit to those with limb loss that occurred at the shoulder joint, the mid-upper arm, or the mid-lower arm. It, however, cannot be configured to fit those that experienced loss at the elbow or wrist. The system is manufactured by DEKA Integrated Solutions, which operates out of Manchester, New Hampshire.
During the review process, which was the de novo classification process employed by the FDA for novel, first-of-a-kind devices that present low-to-moderate health risks, the FDA considered clinical testing results as well as software and electrical and battery systems testing. The clinical trial that was conducted for the DEKA Arm System revealed that 90 percent of the 36 participants were able to perform activities with the system that they were not able to perform using their current prosthetics. This trial was conducted as a 4-site Department of Veterans Affairs study. The software and other electrical testing that was reviewed included that which investigated mitigation of the unintended movements in the arm and hand mechanisms for the product as well as durability and impact testing.