Intended Use & Principle of Operation - NeuroFlex
Intended Use
NeuroFlex is a software-based medical device that uses an off-the-shelf virtual reality (VR) device to acquire eye and head movement data during structured visual tasks.
The device provides objective, non-invasive quantitative measurements and visualisations of oculomotor and vestibulo-ocular performance parameters.
The outputs are intended for review by trained healthcare professionals and may be used for observational analysis and longitudinal comparison of measured parameters over time.
The device does not provide interpretation of results, clinical conclusions, recommendations, diagnosis, classification, monitoring of disease or condition, or clinical decision support. All clinical interpretation remains the responsibility of the healthcare professional.
Principle of Operation
NeuroFlex presents structured visual stimuli within a virtual reality environment, and records associated eye and head movement responses using integrated tracking technology.
The acquired data are processed using software algorithms to calculate quantitative oculomotor and vestibulo-ocular measurement parameters.
The resulting measurements and visualisations are presented through a secure dashboard interface for review by trained healthcare professionals.
The
software does not apply diagnostic classifications, determine clinical
significance, or generate clinical recommendations.
