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The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.

With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

AI/ML Overview

The document provided is a 510(k) premarket notification for a soft contact lens. It aims to establish substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, and ground truth establishment for the training set) are not applicable to this type of submission.

However, I can extract the acceptance criteria as defined by the non-clinical testing performed and compare them to the device's reported performance as presented in the "Substantial Equivalence Determination" section.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear) is asserting substantial equivalence to the VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (K051900). The "acceptance criteria" here are effectively the performance characteristics of the predicate device, which the proposed device aims to match or demonstrate equivalency to.

Metric	Acceptance Criteria (Predicate Device K051900)	Reported Device Performance (UNICON K141917)
General Characteristics
Regulatory Number	886.5925	886.5925
Classification	II	II
Prescription Use	Yes	Yes
Single Use	Yes	Yes
Material	Etafilcon A	Etafilcon A
Manufacturing Method	Cast Molded	Cast Molded
Sterilization Method	Traditional moist heat	Traditional moist heat
Primary Packaging	PP container with aluminum foil sealing	PP container with aluminum foil sealing
Physical/Optical Properties
Base Curve	7.85mm to 10.0mm	7.85mm to 10.0mm
Diameter	12.0mm to 15.0mm	12.0mm to 15.0mm
Water Content	58%	58%
UV Transmittance @280~315 nm	Avg

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