(53 days)
The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
The Menicon SF-P (melafocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate, siloxanylmethacrylate and methacrylic acid with water absorbance of less than 0.5% by weight. The lens is available in blue tint. The blue tinted lens contains D&C Green No. 6 as the color additive.
The Menicon Z (tisilfocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. Lens colors available are light blue and violet. The blue lens is tinted with color additive D & C Green No. 6 and the violet lens contains the color additives D & C Green No. 6 and D & C Violet No. 2. Also, UV absorber is added.
Solution used for packaging the Menicon RGP lenses:
BARNES-HIND® ComfortCare® GP WETTING & SOAKING SOLUTION, which contains edetate disodium and chlorhexidine gluconate as preservatives.
The provided document is a 510(k) summary for Menicon Rigid Gas Permeable Contact Lenses and discusses their substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
This document describes a process change for contact lenses (wet storage vs. dry storage) and focuses on non-clinical stability, microbiology, and toxicology testing to support substantial equivalence. It does not involve a study with a test set, ground truth established by experts, or any performance evaluation against numerical acceptance criteria for a diagnostic or AI-driven device.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details on sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.
§ 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.