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Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are 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.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.

The lens may be disinfected using a chemical disinfection system only.

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

This 510(k) summary describes a rigid gas permeable contact lens, not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria, as well as several other elements of the prompt (such as number of experts, adjudication method, AI improvement, training set size, etc.), are not applicable to this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices.

However, based on the information provided, here's an attempt to answer the relevant aspects of your request regarding acceptance criteria and the "study" that proves the device meets them, interpreting "acceptance criteria" as meeting the chemical and physical properties of similar, already-approved devices, and "study" as the comparison of these properties:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices. The Menicon Z™ rigid gas permeable contact lens is considered to meet these criteria if its material properties are comparable to those of the predicate devices.

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