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510(k) Data Aggregation
(53 days)
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that 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 eve.
The ILICON (ocufilcon D) TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that 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.
The ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eves that may exhibit astigmatism up to 5.0 diopters that 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 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) 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 ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere, toric, and multifocal design configurations.
The provided document is a 510(k) Summary for the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color). This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. It does not describe a clinical study of the type you are asking about, which typically involve AI/ML performance metrics, expert adjudication, or MRMC studies.
Instead, this submission focuses on demonstrating the safety and effectiveness of the contact lenses through non-clinical testing (toxicology, shelf-life, physicochemical, and mechanical properties). Clinical testing was not deemed necessary as the clinical performance of soft contact lenses made from ocufilcon D material has been previously established.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the specific information about acceptance criteria for an AI/ML device, a study proving device meets acceptance criteria as typically understood in AI/ML performance studies, sample sizes for test sets in an AI/ML context, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance with AI, or ground truth establishment for such a study.
However, I can extract the relevant information regarding the device's technical specifications and the non-clinical tests performed:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Parameter" and "Tolerance*" which can be considered acceptance criteria, and the "Range" or specific value as the reported performance, indicating the device meets these specifications.
| Parameter | Acceptance Criteria (Tolerance*) | Reported Device Performance (Range/Value) |
|---|---|---|
| Chord Diameter | ±0.20 mm | 11.00 mm to 15.00 mm |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | 0.05 mm to 0.15 mm |
| Base Curve | ±0.20 mm | 7.00 mm to 10.0 mm |
| Back Vertex Power (F'v) | When 0.00 1.50 D → ± 5° | 10° to 180° (in 10° steps) |
| Multifocal Add Power | ±0.37 D | +0.25D to +4.00D (0.50D steps) |
| Surface Appearance | Lenses should be clear with no surface defect | - |
| Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | ±20% | 19.6 |
| Light Transmission - Tinted (@ 380-780nm) | ±5% | 95% |
| Ultraviolet Radiation Transmittance | TUVB (280 to 315 nm) |
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