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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 EZvue UV (ocufilcon D) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity.

The EZvue Colors (ocufilcon D) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 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 eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare 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.

Disposable Wear:

Eyecare 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 EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer 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% ocufilcon D and 55% water by weight when immersed in saline solution. A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19.

The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer 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% ocufilcon D and 55% water by weight when immersed in saline solution. EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives: C.I. Reactive Blue 19, C.I. Pigment Green 7, Iron oxides, C.I. Reactive Yellow 86, C.I. Reactive Black 5, C.I. Pigment Violet 23, Titanium dioxide. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm.

In the hydrated state, both lenses conform to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface.

This document describes the 510(k) premarket notification for EZvue UV and EZvue Colors Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices, thus avoiding the need for extensive new clinical studies.

Here's an analysis based on your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative benchmarks for device performance in a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical properties, material composition, and intended use. The "reported device performance" refers to these physical characteristics and the results of non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on non-clinical testing and the established performance of the ocufilcon D lens material of the predicate device (K082879).

• Non-clinical Testing: Conducted "in vitro and in vivo." Specific sample sizes for these tests (e.g., how many lenses tested for sterility, how many animals for biocompatibility) are not provided.
• Country of Origin: The applicant is "I-SEE VISION TECHNOLOGY INC." from Hsinchu, TAIWAN, R.O.C. The non-clinical toxicology tests were conducted "under Good Laboratory Practice regulations," but the specific location of these labs is not mentioned.
• Retrospective or Prospective: These non-clinical tests are prospective, meaning they were performed specifically for this submission. The reliance on the "previously established" clinical performance of the (polymacon - this appears to be a typo and likely refers to ocufilcon D based on the context) lens material is retrospective, as it refers to data gathered for the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This submission does not involve a clinical study requiring expert assessment for ground truth. The "ground truth" for non-clinical tests is based on objective laboratory measurements and standardized protocols (e.g., sterility tests, toxicity assays).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a contact lens, not an AI-powered diagnostic tool. MRMC studies are for evaluating diagnostic efficacy.

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

Not applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is based on:

• Objective Laboratory Measurements: e.g., chemical composition analysis, water content measurements, oxygen permeability, UV transmittance.
• Standardized Biological Assays: For sterility and biocompatibility, these would follow established protocols for detecting microbial growth or toxic responses.
• Reference Standards: For performance metrics compared against the predicate device.

For the clinical performance, the ground truth is based on the previously established "clinical performance" of the predicate lens material, which would have involved outcomes data from clinical trials.

8. The sample size for the training set

Not applicable. This is not an AI device requiring a training set. The "training" for the device's development would be analogous to product development and formulation.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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