§ 886.5500 Digital therapy device for amblyopia.

(a) Identification. A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use with labeled compatible visual display devices, including evaluation of all adverse events and device performance to improve measures of visual function. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include characterizations of the technical specifications of the software. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. All visual displays intended for use must undergo compatibility testing to ensure adequate display resolution, luminance, contrast, field of view, image quality, appropriate optical image distance, and verify their compatibility with the software and intended user (such as appropriate interpupillary distance). (4) Labeling must include the following: (i) The minimum hardware and operating system requirements that support the software of the device; (ii) The models of the visual displays validated to be compatible with this device; (iii) The length of treatment and/or retreatment supported by clinical performance testing; and (iv) A summary of the clinical performance testing conducted with the device. (5) Labeling comprehension testing with intended users must be performed.