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The EYEREVE (hioxifilcon 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 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.

The EYEREVE (hioxifilcon 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.

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 EYEREVE Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

A UV absorbing monomer-2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]|ethyl methacrylate-is incorporated in the EYEREVE contact lens material to block UV radiation. The UV blocking characteristics of the lens are as follows:

• o >95% in the UVB range of 280nm 315nm
• o >67% in the UVA range of 316nm 380mm.

EYEREVE Soft Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:

Titanium Dioxide 21 CFR § 73.3126
Phthalocyanine Green 21 CFR § 73.3124
Carbazole Violet 21 CFR § 73.3107
Reactive Blue 19 21 CFR § 73.3127
C.I. Reactive black 5 21 CFR § 73.3127

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index 1.40 (hydrated)
Light Transmission greater than 98%
Light Transmission (tinted) greater than 96% (at region corresponding to pupil); Opaque or 0-10% (at region corresponding to iris)
Water Content 54 % ± 2%
Oxygen Permeability 21.50 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C)

The EYEREVE soft contact lenses will be manufactured in the sphere and toric design configurations with the following features and properties:

Chord Diameter: 12.80 mm to 15.00 mm
Center Thickness: 0.050 mm to 0.210 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range

• Sphere Power: -20.00D to +20.00D in 0.25D steps
• Cylinder Power (toric): -0.25D to -4.00D in 0.25D steps
• Cylinder Axis (toric): 10° to 180° in 10° steps

The provided document is a 510(k) premarket notification for the EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear. This document describes the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical trial. Therefore, the information requested regarding a study with a test set, ground truth, expert adjudication, and MRMC effectiveness is not present in this submission, as these types of studies are typically for diagnostic or screening devices evaluated with AI algorithms.

However, the document does contain information about pre-clinical performance and physicochemical & mechanical properties, which serve as the acceptance criteria for the contact lens material's safety and fundamental characteristics.

Here’s a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated through a comparison with predicate devices and compliance with established standards. The acceptance criteria are implied by the ranges and properties shown in the tables and the successful completion of toxicology tests.

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

This information is not applicable in the context of this 510(k) submission for a contact lens. The "test set" here refers to the samples of the device material and finished product used for pre-clinical testing, not a dataset of patient images or clinical outcomes for an AI algorithm. The document does not specify exact sample sizes for each physicochemical or toxicology test, but it states that "A series of preclinical testing was performed," and "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." The applicant is Vision Science Co., Ltd. in Gyeongsan-si, Gyeongsangbuk-do, South Korea, implying the testing likely originated there or was contracted to relevant labs. The data is prospective for these lab tests.

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)

This information is not applicable. The "ground truth" for contact lens material properties is established through standardized laboratory testing (e.g., ISO standards, specific analytical methods like revised Fatt method for Dk). The "experts" are the technicians and scientists performing these tests, and their qualifications are adherence to GLP regulations and standard analytical procedures, rather than medical expertise in interpreting clinical images.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of clinical or imaging data in diagnostic AI studies. For contact lens material testing, the results are typically quantitative measurements from instruments or qualitative observations from standardized tests, which do not involve expert adjudication in that manner.

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

This information is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance to human readers. This document is for a medical device (contact lens) and does not involve AI or human reader interpretation in the context of a diagnostic task.

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

This information is not applicable. This document is for a physical medical device (contact lens), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

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

The "ground truth" for the contact lens refers to the objectively measured material properties (e.g., water content, oxygen permeability, refractive index, tensile strength) and the results of toxicology tests following recognized standards (ISO 10993). This is established through:

• Standardized laboratory methods and measurements: for physicochemical properties.
• Compliance with GLP regulations and ISO standards: for toxicology tests (cytotoxicity, systemic toxicity, acute ocular irritation).
• Comparison to established properties of predicate devices: demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable. This document is not about an AI algorithm, so there is no "training set."

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

This information is not applicable. As there is no AI algorithm or training set, this question is not relevant.

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