(161 days)
The device is designed to detect and quantify the amount of aniseikonia of a patient. Aniseikonia is defined as a condition of binocular vision where there is a relative difference in the size and/or shape of the ocular image of the two eyes. If a significant amount of aniseikonia is detected in a patient, a new prescription (contact lenses and/or glasses) can be calculated to reduce the amount of aniseikonia.
This device is intended to assist in the detection and management of aniseikonia.
The device is based on an old technique called 'direct comparison eikonometry'. I.e. the two eyes are offered a different image and the subject needs to determine if there is a size imbalance between the two images. If there is an imbalance in size, the size 16 a one of the images is changed until the subject perceives the two images as equal in size. The extent in which one of the images needed to be changed in size is a measure for the amount of aniseikonia of the subject. In The Aniseikonia Inspector the separation between the two eyes is accomplished by holding a red and a green filter in front of the eyes. The images are created on a computer screen and they can be altered by using a computer periheral such as the keyboard.
The provided 510(k) summary does not contain information about acceptance criteria, device performance, study details, and related elements typically found in a clinical study report. The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it lacks the specific data requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, and performance metrics based solely on the provided text. The document is primarily a notification of intent to market and a confirmation of FDA's substantial equivalence determination, rather than a detailed report of a performance study.
§ 886.1340 Haploscope.
(a)
Identification. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.