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The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are available tinted to enhance or alter the apparent color of the eye. The lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Reactive Blue 21, Reactive Blue 19, Reactive Yellow 86.

The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are available printed to enhance or alter the apparent color of the eye. The lenses are printed with one or a combination of one or more of the following 'listed' color additives: Red Iron Oxide, Violet 23, Titanium Dioxide, Chromium Oxide Green, Blue 36.

The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses include a tint (1,4-Bis[4-(2methacryloxyethyl)phenylamino]-9,10-anthraquinone) in the composition of the lens for ease of handling and visibility.

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >88% in the UVB range (280mm - 315nm), and >68% in the UVA range (316nm - 380nm).

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses will be manufactured in the spherical design configuration.

This document describes the pre-market notification (510(k)) for Gelflex Laboratories' Sofclear Enhance, Sofclear Colors, and Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses. The submission asserts substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical performance metric sense (e.g., sensitivity, specificity for a diagnostic device). Instead, it demonstrates performance by comparing physicochemical and mechanical properties to the predicate devices and by demonstrating safety through non-clinical testing. The "acceptance criteria" appear to be meeting established standards for contact lenses and comparability to predicates.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in the context of clinical studies for performance metrics. The non-clinical tests (toxicology, shelf life, physicochemical & mechanical properties) were performed on device samples, but the exact number of units per test is not detailed.
• Data Provenance: The studies were non-clinical and conducted in laboratories in accordance with GLP regulations. No patient data (retrospective or prospective) is mentioned as part of the performance testing for this 510(k) submission, as clinical testing was deemed not required.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable. The submission is for a medical device (contact lens) and directly compares its physical/chemical properties and non-clinical safety to predicates, not a diagnostic AI system requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This is not applicable. No expert adjudication of data for a "test set" was performed for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI Improvement

This is not applicable. This is not an AI/diagnostic device, and no MRMC study was conducted.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithm or AI device. The testing focused on the physical and biological characteristics of the contact lenses.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests (toxicology, shelf-life, physicochemical/mechanical properties) was established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and direct measurement against defined specifications and comparison to the predicate devices. For example:

• Biocompatibility: Demonstrated non-toxicity, no systemic toxicity, no ocular irritation as per ISO standards.
• Performance Characteristics: Direct measurements of parameters like Dk, water content, refractive index, and UV blocking and comparison against specified ranges and predicate values.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

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The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.

The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.

The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.

Soft (hydrophilic) Contact Lens

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets such criteria, nor does it include details about artificial intelligence, human readers, or ground truth establishment. Therefore, I cannot generate the requested table and information based on the given input.

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Ask a specific question about this device

Ask a specific question about this device