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The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The POLYVUE (polymacon) Soft (hydrophilic) Contact Lens is available clear or tinted for visibility using phthalocyanine blue. The POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens contains a unique tinted pattern to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Phthalocyanine blue, Phthalocyanine green, Titanium dioxide, Iron Oxide, Reactive black 5, Carbazole violet.

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material-in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured in an aspheric design configuration.

This document describes a 510(k) premarket notification for POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses. The information primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain the details typically associated with the acceptance criteria and study proving performance for an AI-powered medical device, such as a multi-reader multi-case (MRMC) study or ground truth establishment by experts.

Therefore, many of the requested sections about AI device performance metrics, expert adjudication, and large-scale clinical studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and how it relates to proving the device meets acceptance criteria, followed by a note on the information that is not present:

A. Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document primarily evaluates the contact lenses against established standards and predicate devices for their physical, chemical, and biological properties. The acceptance criteria are implicit in the "Performance Data" section, where "results support the claim that the ... Contact Lenses are substantially equivalent to the currently marketed predicate device."

B. Sample Size and Data Provenance for the Test Set:

• Sample Size: Not explicitly stated for each non-clinical test, but typically these tests involve a representative sample size to meet the statistical requirements of the relevant ISO standards (e.g., ISO 10993 series and ISO 18369-2:2017).
• Data Provenance: The submitter is INTEROJO INC. based in PYONGTAEK-CITY Gyeonggi, SOUTH KOREA. The testing was conducted in accordance with GLP (Good Laboratory Practice) regulations, implying established quality control over the testing process. The original source of the raw materials (polymacon) isn't specified, but the testing would have been on the finished product. The data is retrospective in the sense that it was collected as part of the submission process, not from an ongoing clinical trial.

C. Number of Experts and Qualifications for Ground Truth for the Test Set:

• Not Applicable. This document is for a contact lens, not an AI-powered diagnostic device. Ground truth for non-clinical testing of material properties, biocompatibility, and manufacturing tolerances is established through standardized laboratory procedures and measurements, not by human experts interpreting images or clinical data.

D. Adjudication Method for the Test Set:

• Not Applicable. As above, no human interpretation requiring adjudication is involved in the non-clinical tests described.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable. This is not an AI-powered device. The document explicitly states: "Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously."

F. Standalone (Algorithm Only) Performance:

• Not Applicable. This is not an AI-powered device.

G. Type of Ground Truth Used:

• Laboratory Measurements and Compliance with Standards/Predicate Devices: The "ground truth" for the non-clinical tests is established by adhering to validated methods described in ISO standards (e.g., ISO 10993 for biocompatibility, ISO 18369-2 for optical properties and specifications) and comparing results to the properties of the legally marketed predicate devices.

H. Sample Size for the Training Set:

• Not Applicable. This is not an AI-powered device requiring a training set.

I. How the Ground Truth for the Training Set was Established:

• Not Applicable. This is not an AI-powered device requiring a training set.

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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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The I-55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity 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.

The I-55 (methafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves 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.

The I-55 (methafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity 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.

The I-55 (methafilcon A) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. 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 I-55 soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material (methafilcon A) 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% 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).

I-55 lenses are available clear, visibility tinted (for handling), and 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:

[Phthalocyaninato(2-)] copper
D&C Green No.6
D&C Red No.17
D&C Violet No.2
D&C Yellow No.10
Titanium dioxide

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(s) on the front surface of the contact lens in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.5 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 transparent or colored optical surface. The (methafilcon 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 appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

Refractive Index: 1.415
Light Transmission (clear): greater than 90%
Light Transmission (tinted): greater than 90%
Surface Character: hydrophilic
Water Content: 55±2%
Specific Gravity: 1.039 (hydrated)
Oxygen Permeability: 19.01 x 10-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C)) (revised Fatt method)

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the sphere, toric, multifocal, and toric multifocal design configurations with the following features and properties:

Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness: 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range

• Sphere Power: -12.00D to +12.00D in 0.25D steps
• Cylinder Power (toric): -0.25D to -2.25D in 0.25D steps
• Cylinder Axis (toric): 10° to 180° in 10° steps
• Multifocal Power: +1.25 to +2.50 in 0.25D steps

The provided text describes the 510(k) premarket notification for "I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear." This document focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study to prove acceptance criteria for a new AI-powered diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this submission. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." (Page 0)

And throughout the "Pre-Clinical Performance Data" and "Substantial Equivalence" sections (Pages 7-9), it continuously refers to establishing equivalence with predicate devices and using their established safety profiles and manufacturing processes. It does not describe a new study to prove adherence to a fresh set of acceptance criteria for a novel device, especially not an AI-enabled one.

Instead, the document details the equivalence of the I-55 contact lenses to predicate devices based on:

• Intended Use: The I-55 lenses have the same intended use (correction of visual acuity in aphakic/not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or astigmatism, and/or presbyopia) as the primary predicate device (PolyVue Distribution, Inc. "I-55 (methafilcon A)" K080794). The tinted versions are also equivalent to the PolyVue Technologies, Inc. "HD/HDT, PV/PVT (polymacon)" K013220 for color enhancement.
• Functionality: Both the subject device and predicate devices act as refractive media to focus light on the retina.
• Indications: Daily wear, soft (hydrophilic) contact lens.
• Production Method: Fully-molded, identical to predicate devices.
• Material (USAN name): The subject device uses "methafilcon A," which is the same as the primary predicate device (K080794). The secondary predicate device (K013220) uses "polymacon."
• Physical Properties:
  • Water Content: 55±2% for the subject device and the primary predicate (K080794). The secondary predicate (K013220) has 38±2%.
  • Oxygen Permeability: 19.01 x 10-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C) (revised Fatt method) for the subject device and primary predicate (K080794). The secondary predicate (K013220) has 8.40 x 10-11.
  • Specific Gravity: 1.039 (hydrated) for the subject device and primary predicate (K080794).
• Pre-Clinical Performance Data: The submission relies on pre-clinical data from the predicate device (K080794) for "consistency of the physical and material properties," "sterility," and "biocompatibility." Additional testing was performed on the I-55 soft contact lenses regarding the stability of parameters, toxicity/irritation (including color additives), and ensuring finished lenses remained within original specifications (Page 7).
• Manufacturing and Sterilization: The subject device will use identical processes and a cGMP quality assurance program as the predicate device (K080794) for manufacturing and sterilization. The process for incorporating color additives is identical to the HD/HDT, PV/PVT (polymacon) predicate (K013220).

In summary, this document is a 510(k) submission demonstrating substantial equivalence to existing devices, not a study evaluating acceptance criteria for a novel device, especially an AI one. Therefore, the specific questions posed are not addressed in this type of regulatory filing.

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