DEVICE: EndeavorRx™ (00850002639018)

Device Description: EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. The EndeavorRx program is software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home. EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili’s proprietary, patented, technology platform which is designed for the selective targeting and modulation of specific cognitive neural systems in the brain related to attention function. EndeavorRx uses Akili’s adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver the presentation of stimuli that are designed to engage targeted neural systems which play a key role in attention function. In a closed-loop system, the adaptive SSME algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient. EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.