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The AIRPERM (siflufocon A) Rigid Gas Permeable Spherical, Aspherical, Toric and Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

THE AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR is an aspheric type multifocal which contains an aspherical (conicoid) curve on either the front or back surface. The lens is manufactured by the same method, i.e., lathing, as that used for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR except that the eccentricity of the lens periphery is made higher in order to impart a multifocal effect into the contact lens. The eccentricity for the aspheric single vision lenses varies from 0 to 0.8 and for the multifocal lenses varies from 0.9 to 1.5. All parameters of the AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR are described and measured in exactly the same way as those for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR. The lenses have the following parameters: Chord Diameter Approximately 6.5 to 11.5 mm, Center Thickness for Low Minus Lens: 0.05 to 0.30 mm, for Plus Lens: 0.10 to 0.70 mm, Base Curve 6.50 to 9.00 mm, Powers -20.00 to +12.00 Diopters, Add Powers +1.00 to + 3.00, Eccentricity 0.1 to 1.5. The physical properties of the lens are: Specific Gravity 1.25, Refractive Index 1.43 (589 nm at 25°), Light Transmittance Clear > 92% (380-780 nm), Tinted >88.0% (380-780 nm), Wetting Angle (CLMA Method) 24.0 ± 2, Water Content

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria.

The document describes the:

• AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR including its physical properties and parameters.
• INDICATIONS (USES) and CONTRAINDICATIONS (REASONS NOT TO USE) for the contact lenses.
• PRECAUTIONS related to the lenses.
• SELECTION OF PATIENTS for whom these lenses are suitable.
• FITTING PROCEDURE OUTLINE detailing steps for pre-fitting examination, initial lens power and diameter selection, and initial base curve selection.
• Adjunct Solutions used with the lenses.

Therefore, I cannot extract the requested information regarding acceptance criteria and a corresponding study from this text.

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