(87 days)
The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.00D) in aphakic or not-aphakic persons with nondiseased eyes. The lens may be disinfected using chemical disinfection only.
The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.
Not Found
This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for a contact lens. It does not contain information about acceptance criteria or a study proving device performance against such criteria.
Therefore, none of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for training set) can be extracted from this document.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.