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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.

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The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) Contact Lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% methafilcon A and 55% water. A light blue color tinted with "reactive Blue 246" is for handling visibility purpose. Benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.53% (

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a soft (hydrophilic) contact lens, specifically the "Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (CooperVision's Frequency 55 series) based on physical, chemical, and optical properties, and manufacturing process.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document. If you have a different document related to an AI/ML medical device, please provide it.

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The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, Methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and Methacrylic acid (MAA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.

The provided text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.

Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.

However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.

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The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.

The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.

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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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The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280~315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.

The provided 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).

The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.

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EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 ~ - 12.00D. The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.

EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) contact lens is available as a single vision aspherical lens. The lens material, methafilcon A is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) cross-linked with ethylene glycol dimethacrylate (EGDMA) . The lens with visible tint is tinted blue using reactive blue 4K to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing buffered saline solution.

The provided 510(k) summary for the "EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear" focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria with detailed metrics in a table.

However, based on the nonclinical studies section, we can infer some "acceptance criteria" through the reported device properties and comparability to the predicate. The "study" proving these are the nonclinical performance tests.

Here's an attempt to structure the information as requested, though some sections will highlight the lack of detailed quantification regarding "performance" against explicit "acceptance criteria" as would be seen in an AI/software device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device (contact lens), the "acceptance criteria" are largely derived from established standards for contact lens properties and biocompatibility, and by demonstrating equivalence to a legally marketed predicate device. Specific numerical acceptance thresholds beyond what is shown are often found in the detailed test protocols which are not included in this summary.

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

• Clinical Study: At least 30 evaluable subjects' eyes were tested separately for 1 month.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the submitter's location (Jiangsu, China), it is highly probable the clinical study was conducted in China. The "summary of clinical study" describes an evaluation over a month, suggesting a prospective study.
• Nonclinical Studies: No explicit sample sizes are provided for individual nonclinical tests (e.g., irritation, cytotoxicity). For technological characteristics, it is implied that representative samples of the manufactured lenses were tested.

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

• Clinical Study: Not applicable in the sense of expert consensus for ground truth as would be used for diagnostic imaging devices. The study assessed patient-reported outcomes (satisfaction) and vision correction, likely measured by optometrists or ophthalmologists, but their number or specific qualifications are not detailed.
• Nonclinical Studies: Not applicable. These involve laboratory testing against established physical, chemical, and biological standards, not expert consensus on findings.

4. Adjudication Method for the Test Set

• Clinical Study: Not applicable for adjudication in the context of diagnostic ground truth. Clinical outcomes (vision correction, satisfaction) were likely recorded directly.
• Nonclinical Studies: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not conducted. This type of study is typical for diagnostic algorithms (e.g., AI in radiology) where human readers interpret cases with and without AI assistance. This submission pertains to a medical device (contact lens), not a diagnostic algorithm.

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

• No, a standalone (algorithm only) performance study was not done. This category is not relevant for a contact lens.

7. The Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study was based on:
  • Patient outcomes: Corrected vision (measured objectively).
  • Patient satisfaction: Subjective feedback on lens wearing and care.
  • General safety: Observation for adverse events or complications.
• Nonclinical Studies: The "ground truth" (or reference) for these tests involved:
  • Industry standards and guidelines: For properties like oxygen permeability, light transmittance, water content, sterility, etc.
  • Reference materials/controls: In biocompatibility and leachability testing.
  • Predicate device characteristics: For comparison of technological characteristics.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical product (contact lens), not an AI algorithm, so there is no "training set" in the computational sense.

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

• Not applicable, as there is no training set for this device.

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The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wcar for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive am etropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) the correction of refractive ametropia Contact Lens is indicated for daily wear for (myopia and hyperopia) and presbyopia in aphakic or or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.

The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate, and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 55 UV (methafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 87.630 in the UVA range of 316 nm to 380 nm and 98.975 % in the UVB range of 315 % nm to 280 nm. The lens contains 55% water by weight and each lens is supplied sterile in a blister container containing 0.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted using Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.

The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.

The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.

The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Saview-Aqua 55 UV contact lenses:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily demonstrates substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the Saview-Aqua 55 UV lenses against numerical targets. Instead, the "acceptance criteria" are implicitly understood to be meeting or exceeding the performance characteristics of the predicate devices. The study compares key physicochemical properties.

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

The document describes "pre-clinical tests" and "physicochemical testing" but does not specify numerical sample sizes for these tests. It indicates the data comes from tests performed by St. Shine Optical Co., Ltd. in Taiwan, R.O.C. (the submitter). The data is generated prospectively for the purpose of this submission, but not in the context of a clinical trial on human subjects for device performance. It focuses on material properties and safety.

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

This information is not applicable and not provided. The "ground truth" for these tests relates to the inherent physical and chemical properties of the lenses and their biological safety as tested in vitro or in animal models, not human diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or adjudication process described for the physicochemical and biocompatibility testing.

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 is a contact lens submission, not an AI-powered diagnostic device.

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

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

7. The Type of Ground Truth Used:

The ground truth used for this type of submission is based on:

• Physicochemical Measurements: Standardized laboratory tests to determine properties like water content, transmittance, Dk, refractive index, etc.
• Biocompatibility Standards: Results from tests showing non-toxicity, non-irritation, and absence of unsafe residues, typically assessed against established biological safety standards for medical devices (ISO 10993 series, though not explicitly cited, is standard practice).
• Sterility Testing: Ensuring the product remains sterile until the expiration date.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for this device.

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The Safi-gel Daily Disposable (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.

The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.

The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA), crosslinked with ethylene glycol dimethacrylate (45%). The hydrated lens contains 55% water by weight with a hyaluropolymer. The lens is tinted using a UV absorbing compound (RUVA-93) incorporated into the polymer and Pigment Blue 15 (copper phthalocyanine). The lens acts as a refracting lens to focus light rays on the retina.

The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is available as a single vision lens, which incorporates a bi-curve reduced optic front surface. The peripheral curve is tangential at the back optic zone.

The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens design incorporates a cylinder and base curve, and a bi-curve reduced optic front surface. The peripheral curve is tangential at the back surface. This makes both sides thicker at the upper and lower half of the front surface to keep the axis stable.

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.

The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.2 mm
Center Thickness: 0.08 mm (-3.00D) dry
Base Curves: 8.70 mm and 8.30 mm
Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps)

The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.5 mm
Center Thickness: 0.08 mm (-3.00D) dry
Base Curves: 8.70 mm
Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps)
Cylinder Power: -0.50DC to -2.50D
Axis: Full circle (in 10°steps)

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.0mm to 15.0mm
Center Thickness: 0.06mm to 0.40mm
Base Curve: 8.40mm to 9.30mm
Powers: +12.00 Diopters to -20.00 Diopters
Add Powers: Continuous add power to +3.25
Zone Sizes: 1.5, 1.9 mm

The physical/optical properties of the lens are:
Refractive Index: 1.410 (wet)
Light Transmittance: 90.3%
UV Transmittance: 9.3%
Water Content: 55%

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
  "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)": null,
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
  "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": null,
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
  "8. The sample size for the training set": null,
  "9. How the ground truth for the training set was established": null,
  "acceptance_criteria_and_performance_table": {
    "title": "Physical/Optical Properties and Performance of Safi-gel Daily Disposable Lenses",
    "headers": ["Property", "Reported Performance"],
    "data": [
      ["Refractive Index", "1.410 (wet)"],
      ["Light Transmittance", "90.3%"],
      ["UV Transmittance", "9.3%"],
      ["Water Content", "55%"]
    ]
  },
  "study_information": {
    "study_type": "Substantial Equivalence (via physicochemical and toxicological testing)",
    "test_set_sample_size": "Not specified, as clinical testing was not required. Testing was done on lens extracts.",
    "data_provenance": "Not specified beyond laboratory testing of the lenses themselves.",
    "number_of_experts_ground_truth": "N/A (No clinical ground truth established during this type of study)",
    "adjudication_method": "N/A (No clinical ground truth established during this type of study)",
    "mrmc_comparative_effectiveness_study": false,
    "standalone_performance_study": true,
    "ground_truth_type": "Physicochemical measurements and toxicological assays against established biological reactivity standards (e.g., ISO for cytotoxicity, systemic toxicity, ocular irritation).",
    "training_set_sample_size": "N/A (No machine learning algorithm or training set for this type of device submission)",
    "training_set_ground_truth_establishment": "N/A (No machine learning algorithm or training set for this type of device submission)"
  },
  "additional_notes": "Clinical testing was not required for these lenses because their physical/chemical properties are considered equivalent to the predicate device (cleared in [K051095](https://510k.innolitics.com/search/K051095)). Similarly, microbiological testing was not required because the manufacturing and packaging processes are the same as those for the predicate device. The submission focused on establishing substantial equivalence through physicochemical testing (water content, oxygen transmissibility, light transmission (visible and UV), and refractive index) and toxicological testing (non-cytotoxicity, no systemic toxicity, no ocular irritation). The reported performance values are intrinsic properties of the device material and design, not derived from a clinical test set with patient outcomes. The acceptance criteria for these properties would have been implicitly met by demonstrating substantial equivalence to the predicate device, which would have had its own established performance standards."
}

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The Sauflon New Day® (methafilcon A) Soft (hydrophilic) Visibility tinted contact lens is a daily disposable lens indicated for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

The SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lenses are available in an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the lens consists of 45% HEMA and 55% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with weight of summe inimelod in his meller on the well and one UV absorbing monomer is used to block UV radiation. Sauflon New Day lenses are daily disposable lenses. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380nm. The SAUFLON New Day Daily Disposable Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

This 510(k) summary describes a contact lens, the SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lens, and aims to establish its substantial equivalence to a predicate device, the SAUFLON 55UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649).

The acceptance criteria relate to demonstrating that the new device is as safe and effective as the predicate device. The study presented is a comparison of physical, optical, and chemical properties, as well as manufacturing processes and safety tests, between the two contact lenses. No clinical effectiveness study with human readers or AI assistance is mentioned as this is a medical device approval for a contact lens.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implicitly that the new device (SAUFLON New Day) demonstrates properties, materials, and manufacturing processes that are identical or equivalent to the legally marketed predicate device (SAUFLON 55UV), and where differences exist (e.g., lens design or modality), these differences do not affect safety or efficacy.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of tested units for each property. The "test set" here refers to the SAUFLON New Day lens, for which various properties were measured and compared. The data provenance is from Sauflon Pharmaceuticals Ltd., United Kingdom. The studies appear to be prospective in that new measurements were taken for the subject device to compare against the known predicate device. For some aspects (e.g., stability, leachability, toxicology), the data from the predicate device's prior approval (K013649) was deemed applicable due to identical materials and processes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable for this submission. The "ground truth" for contact lens properties like water content, transmittance, Dk, etc., is established through standardized physical, optical, and chemical testing methods, not through expert consensus on interpretation. Toxicology and leachability tests also follow established laboratory protocols.

4. Adjudication method for the test set

Not Applicable. As mentioned above, the "ground truth" is derived from objective physical, optical, and chemical measurements and standard laboratory tests, not from subjective expert 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

No. This is a submission for a medical device (contact lens), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

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

No. This is not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

The "ground truth" for the comparison is based on:

• Standardized physical, optical, and chemical measurements: For properties like water content, transmittance, Dk, refractive index, tensile strength, etc.
• Laboratory test results: For toxicology (cytotoxicity, systemic toxicity, ocular irritation), residual monomers, and color leachability studies.
• Manufacturing process documentation: To confirm identical processes.
• Reference to prior FDA clearance (K013649): For established safety and efficacy of the predicate device's materials and processes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set for this type of device. The ground truth for the comparison was established through objective, standardized testing and the documented equivalence to a previously cleared device.

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