Digital Prism Correction Feature (DPCF)

The Digital Prism Correction Feature (DPCF) is software for Apple Vision Pro that provides digital image adjustments to correct prism prescriptions. It is available over-the-counter for users with prism correction needs up to 7.75 Prism Diopters in horizontal and/or vertical dimensions, and works alongside optical inserts that correct other prescription components like sphere and cylinder.

The subject device and predicate device are technologically identical, both using digital image adjustment in accordance with a prism prescription to provide a prismatic effect. Both meet standardized prism tolerance requirements and operate within Apple Vision Pro. The only difference is the subject device is indicated for over-the-counter use while the predicate was prescription-only.

ISO 8980-1:2017 specifies the prism tolerance requirements that the device meets. Human factors testing with 30 subjects was conducted to assess self-selection and use-related risks for over-the-counter use.

Apple argues that changing from prescription-only to over-the-counter use does not constitute a different intended use that raises different safety or effectiveness questions. Since both devices have identical technological characteristics, the same intended function (providing prismatic correction), and perform equivalently against the same standards, the OTC designation alone does not create a safety concern that would defeat substantial equivalence. Human factors testing demonstrated acceptable use-related risks for OTC users to self-select and use the device appropriately.