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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.

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