(136 days)
FP(hexafocon A) and ASP(hexafocon A) RGP Contact Lens are indicated for daily wear for the correction of refractive amptropia (myopia, lyperopia, astigmatism) in aphakic and not- aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.
The FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are is hemispherical shell of the following dimentions.
· Diameter: 8.00 to 10.00mm
· Center Thickness: 0.10 to 0.50mm
· Base Curve: 6.00 to 9.00mm
· Power: -20.0 to +20.0 diopter
The physical properties of the lens are
- · Specific Gravity 1.27
- · Refractive Index 1.415
- · Light Transmittance 92%
- · Surface Character Hydrophobic
- 490 · Wetting Angle
- · Water Content
The provided text does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
This document is a 510(k) Summary of Safety and Effectiveness for a rigid gas permeable contact lens, indicating that the device is substantially equivalent to previously cleared devices. It primarily focuses on the device's technical specifications, intended use, and its equivalence to predicate devices based on material properties and function.
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods 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.