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Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuitv.

Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear or frequent replacement wear. Eye care practitioners may prescribe the lens for daily disposable wear, or for frequent replacement wear.

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:

• The lens designs include spherical, toric and multifocal lenses.
• UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
• Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
• The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not provided.

Understanding the Device:
The device in question is a Soft (Hydrophilic) Contact Lens (Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal) made of Senofilcon A, which is visibility tinted. It's classified as a Class II medical device.

Key Point: This document is a 510(k) premarket notification decision letter, which means the manufacturer is asserting substantial equivalence to already legally marketed predicate devices, rather than proving efficacy from scratch through entirely novel clinical trials. The focus here is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical performance data and material comparisons. Therefore, many of the typical "AI/ML validation" questions (like number of experts, adjudication, MRMC studies, training set details) will likely not apply directly to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting various ISO standards and FDA guidance documents for contact lenses. The comparison table provides specific performance data points of the subject device against its predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a separate, clinical performance study. The data provided refers to non-clinical testing of the device itself (e.g., physical, chemical, mechanical properties, biocompatibility, sterilization validation). These tests are typically performed on representative batches of the manufactured device according to established protocols and standards, but the specific number of lenses or samples tested for each property is not detailed in this summary.
• Data Provenance: The manufacturer is St. Shine Optical Co., Ltd. from New Taipei City, Taiwan. The non-clinical testing appears to have been conducted by the manufacturer or their designated labs. The information provided does not specify if any data for this device was from other countries, though the predicate device K051095's ownership was transferred to St. Shine Optical. The studies are non-clinical (laboratory/in-vitro) as opposed to retrospective or prospective patient studies.

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

• Not applicable / Not provided. This information is typically relevant for studies involving human interpretation (e.g., AI in radiology). For a contact lens 510(k) submission, "ground truth" and expert consensus would refer to established scientific and engineering principles, and validated test methods (e.g., ISO standards) for measuring physical, chemical, and biological properties, not human interpretative tasks. The "experts" involved are the individuals performing and overseeing the technical and scientific tests (e.g., chemists, material scientists, microbiologists), and the regulatory bodies (FDA) that review the compliance with standards.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication is relevant when multiple human readers/reviewers provide subjective opinions that need to be reconciled, particularly in imaging or clinical diagnostic studies. The non-clinical testing described here relies on objective measurements and standardized test methods, where results are compared against predetermined specifications and ISO standards, not subject to human adjudication in the same way.

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 or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to its regulatory pathway.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device does not involve an algorithm or AI. It is a physical medical device (contact lens).

7. The Type of Ground Truth Used

• The "ground truth" for this submission are the established physical, chemical, and biological performance specifications and safety profiles for contact lenses, as defined by:
  • Relevant ISO standards (e.g., ISO 11981, ISO 18369 series, ISO 17665-1, ISO 10993 series for biocompatibility).
  • FDA guidance documents (e.g., 1994 FDA Guidance Document for Daily Wear Contact Lenses, FDA Guidance for Color Additives).
  • Performance characteristics of the predicate devices (K042275 and K051095), which the subject device aims to be substantially equivalent to.
  • GLP regulations (21 CFR Part 58) for biocompatibility tests.

8. The Sample Size for the Training Set

• Not applicable / Not provided. There is no "training set" in the context of AI/machine learning for this device. The manufacturing process and quality control would involve internal development and validation data, but this is not a "training set" like in AI.

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

• Not applicable / Not provided. Since there is no "training set," this question does not apply. The "ground truth" for demonstrating safety and effectiveness relies on standard testing methodologies and comparison to known safe and effective predicate devices and regulatory standards, as described in point 7.

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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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