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Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eve, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia an extreme photophobia.

When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.

When prescribed for Disposable Wear, the wearing time prescribed by the eve care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic lenses. The lens material, methafilcon A, is a random co-polymer of hydroxyethylmethacrylate and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. The lenses are made by modifying the uncolored methafilcon A base lens by affixing colorants on that portion of the front surface that corresponds to the iris. The colorants Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 are listed in 21 CFR Part 73.

The provided 510(k) summary for the "Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses" explicitly states that clinical studies were not deemed necessary to establish the safety and efficacy of the device. This determination was based on the device's substantial equivalence to two predicate devices:

1. Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164 and K973063)
2. Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lens (K001090)

As a result, no specific acceptance criteria or performance numbers for the device itself are described in the context of a dedicated study. Instead, the focus is on demonstrating equivalence to already approved devices.

However, the document does describe preclinical testing to support safety.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was conducted for the subject device to establish specific performance metrics, there's no direct "acceptance criteria" table with performance numbers. Instead, the acceptance criteria were met by demonstrating equivalence in material, physical, optical, and chemical properties, and acceptable preclinical safety.

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