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The Clalen 54 (hioxifileon 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 for visibility and handling.

The Clalen 54 (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 for visibility and handling.

The Clalen 54 (hioxifilcon D) Multifocal 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 presbyopic persons requiring an add power ranging from +1.25D to +2.50D, and 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 for visibility and handling.

The Clalen 54 (hioxifilcon D) Toric-Multifocal 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, possesses refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling.

Daily wear replacement schedules may vary from patient to 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 Clalen 58 (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive r ror 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 for visibility and handling.

The Clalen 58 (hioxifilcon A) 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 for visibility and handling.

The Clalen 58 (hioxifilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of refractive rerror in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by presbyonic persons requiring an add power ranging from +1.25D to +2.50D, and 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 for visibility and handling.

The Clalen 58 (hioxifilcon A)) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling.

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 Clalen 54 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 lens is available with a blue visibility-handling tint, which includes [phthalocyaninato (2-)] copper and Reactive Blue 69. The hioxifilcon D name has been adopted by the U.S. Adopted Names Council (USAN).

A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the Clalen 58 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 >70% in the UVA range of 316nm 380nm.

In the hydrated state, the lens conforms to the curvature of the eve 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: 1.404 (hydrated)
Light Transmission: greater than 96%
Water Content: 54 % ± 2%
Oxygen Permeability: 18.42 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C)

The Clalen 58 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 A) 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 41% hioxifilcon A and 59% water by weight when immersed in saline solution. The lens is available with a blue visibility-handling tint, which includes Reactive Blue 69. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the Clalen 58 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 >85% in the UVA range of 316nm 380mm.

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 A) 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 59% water by weight. The physical properties of the lens are:

Refractive Index: 1.403 (hydrated)
Light Transmission: greater than 98%
Water Content: 59% ± 2%
Oxygen Permeability: 20.76 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35℃), (revised Fatt method).

This document describes the regulatory approval for the "Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens For Daily Wear" and the "Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens For Daily Wear." The submission highlights the device's substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a de novo study.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific acceptance criteria for a new device's performance metrics like sensitivity, specificity, or image-based diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices by comparing various physicochemical and mechanical properties, as well as general performance characteristics relevant to contact lenses.

The table below summarizes the comparison between the subject devices (Clalen 54 and Clalen 58) and the predicate devices (Extreme H2O 54% and Extreme H2O 59%), which serves as the "performance" data in this context.

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

The document describes pre-clinical testing and toxicology studies. These are material and biocompatibility tests, not clinical performance studies on human subjects as would be typical for an AI/algorithm-based diagnostic device.

• Toxicology: The toxicology tests (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation) are conducted on the lens material. While specific sample sizes for these tests are not explicitly stated in the summary, they would typically involve standard laboratory methodologies (e.g., cell cultures for cytotoxicity, animal models for systemic toxicity and ocular irritation) as per ISO 10993 standards.
• Physicochemical & Mechanical Properties: These tests are performed on the contact lenses themselves to compare material properties. No specific sample sizes are mentioned for these comparative tests in the provided text.
• Data Provenance: The document does not specify the country of origin for the data, but it mentions that Interojo, Inc. is located in South Korea. The predicate devices are from Hydrogel Vision Corporation, without specifying data origin.

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

This information is not applicable in the context of this 510(k) submission for contact lenses as described. The "ground truth" for contact lens regulatory approval of this type focuses on material properties, biocompatibility, and manufacturing consistency, not on interpretation by human experts of diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. There is no "test set" in the sense of a dataset requiring expert interpretation and adjudication for a diagnostic or AI device.

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. The device is a contact lens, not an AI-assisted diagnostic tool or an algorithm intended to improve human reader performance.

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

This information is not applicable. The device is a contact lens, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this submission is established through:

• Material Specifications: Defined properties (e.g., water content, oxygen permeability, refractive index) for the contact lens materials.
• Biocompatibility Standards: Compliance with ISO 10993 standards for toxicology, ensuring the material is safe for ocular contact.
• Manufacturing Standards: Verification of consistent manufacturing processes and adherence to engineering tolerances and lens specifications.
• Predicate Device Data: The established safety and effectiveness of the legally marketed predicate devices serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as the device is not an AI/machine learning model.

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

This information is not applicable. Since there is no training set, there's no ground truth established for one.

Summary of Acceptance Criteria and Study:

The "acceptance criteria" for the Clalen 54 and Clalen 58 contact lenses are primarily based on demonstrating substantial equivalence to predicate devices. This involves showing that the subject devices share the same intended use, fundamental technological characteristics (material, production method), and comparable performance data (physicochemical and mechanical properties, biocompatibility).

The "study" that proves the device meets these criteria consists of:

• Pre-clinical tests: Including toxicology studies (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation) conducted in accordance with GLP regulations and ISO 10993 standards. These tests confirm the biocompatibility and safety of the lens material.
• Physicochemical & Mechanical Properties Testing: Demonstrating that properties like water content, oxygen permeability, and refractive index are consistent with (and in some cases, superior to) the predicate devices.
• Manufacturing/Design Verification: Studies confirming the manufacturer's ability to produce the lenses consistently within specified tolerances.
• Shelf Life Data: Supporting the stability of the lenses over time (though specific data details are not provided in this summary, it's mentioned as part of the evidence).

The provided document is a 510(k) summary, which focuses on demonstrating equivalence to existing devices rather than exhaustive de novo clinical trials to establish new performance benchmarks. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the legally marketed predicate devices.

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