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Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.

These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lens may be disinfected using a chemical disinfection system.

The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.

Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:
• Diameter: 14.2mm to 15.0mm
• Base curve: 8.0mm to 9.5mm
• Center Thickness: 0.15mm to 0.96mm varies with power
• Powers: -20.00 to +20.00 D
• Add powers: +0.50 to +4.00 D

The physical properties of the lens are:

• . Refractive Index: 1.38
• Light Transmittance . 62%
• Surface Character: Hydrophilic . ・
• Water Content ● ሬቶਅ the power of
• Oxygen Permeability . 27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)

The provided text is a 510(k) summary for a medical device (Proclear Compatibles Multifocal contact lenses). It outlines the device description, indications for use, and regulatory information, but it does not contain any information about acceptance criteria, study design, or device performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting detailed clinical study results and performance metrics.

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