(62 days)
The 3-Mirror Lens is an ophthalmic device used for the examination of the ocular fundus.
The 3-Mirror Lens is an optical device, which by the intermidiary of the mirrors, allows the ophthalmologist to observe different parts of the posterior chamber of the eye, in particular, the retina. The ophthalmologist holds the 3-Mirror Lens with his hand on the eye of the patient and he observes the images from the mirrors with a slit-lamp.
The provided text is a 510(k) premarket notification letter from the FDA to Luneau S.A. regarding their Luneau 3-Mirror Lens. This document does not contain any information about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a study proving the device meets acceptance criteria.
The letter is an FDA determination of substantial equivalence to a legally marketed predicate device, allowing Luneau S.A. to market the device. It outlines the regulatory classification, general controls, and other applicable regulations. It describes the device and its indications for use but does not present any efficacy or performance study data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study as the necessary information is not present in the provided text.
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.