MAIA (AHMACME001)

MAIA is a non-mydriatic retinal imaging device that captures digital images of the human retina without requiring pupil dilation. It operates as a standalone unit with a multitouch display and incorporates confocal imaging technology using white and infrared light for image acquisition, focusing, and retinal tracking.

MAIA uses confocal illumination with white light to acquire sharp, naturally colored retinal images. It incorporates pupil tracking via dual cameras to enable automatic alignment with the eye position. The device has a 60° field of view, 5 megapixel sensor, 17 µm retinal resolution, and requires a minimum 3 mm pupil. It also includes an exempt perimetry function with automated retinal tracking at 25 Hz.

ISO 15004-1, ANSI Z80.36, ISO 12866, IEC 60601-1, IEC 62304, and biocompatibility testing per ISO standards. Electromagnetic compatibility and basic safety evaluations were performed according to applicable standards.

MAIA is technologically identical to the predicate COMPASS (K150320) — both employ fundus perimetry using continuous infrared retinal imaging with eye-movement compensation. Although MAIA's indications for use are narrower (omitting perimetry-related language), this difference reflects exclusion of non-premarket-review functions rather than a technological change. Bench testing demonstrates equivalent performance and safety; the same consensus standards used for COMPASS validation apply to MAIA.