Prismira

Prismira is a prescription digital therapeutic software application that runs on a mobile device to improve attention function in adults ages 22-55 with primarily inattentive or combined-type ADHD. The app presents structured games designed to challenge attention-related cognitive domains, with visual and optional auditory feedback, and includes an engagement system to promote compliance. Users engage in approximately 15 minutes of gameplay daily, with improvements measured by the Test of Variables of Attention (TOVA).

Prismira uses swiping and tapping interactions on a mobile device running iOS, compared to the predicate EndeavorRx which uses steering, tapping, and multi-tasking. Prismira implements an adaptive algorithm with an Engagement System for compliance promotion, whereas EndeavorRx uses the Selective Stimulus Management Engine (SSMETM). Both are prescription-use-only digital therapeutics with similar game-based structures and the same intended use for closed-loop treatment of cognitive dysfunction.

Software development followed IEC 62304 (Medical device software – Software life cycle processes). Non-clinical testing included software verification and validation in accordance with FDA Guidance for Software Contained in Medical Devices (June 2023) and cybersecurity testing based on FDA Guidance for Management of Cybersecurity in Medical Devices (September 2023). The document references international and FDA-recognized consensus standards but does not specify additional ISO or ASTM standards by designation.

Prismira is substantially equivalent because it shares the same intended use, similar indications for use, and comparable technological principles as the predicate EndeavorRx—both are digital therapeutics for ADHD attention improvement measured by TOVA. Although Prismira targets adults ages 22-55 versus EndeavorRx's 8-12 year-old children, the pivotal GAMES Study demonstrated statistically significant TOVA improvements (p=0.0149) in the adult population with a favorable safety profile matching the predicate (minimal adverse events, no serious events). The different age range and software algorithm differences do not raise new safety or effectiveness questions because clinical data shows the device performs substantially similarly in its intended adult population, and both devices comply with the same regulatory classification and special controls under 21 CFR 882.5803.