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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 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily 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 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. Then prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The 55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells, which cover the cornea and a portion of the adjacent sclera. The 55 UV Contact Lens is available in a single vision lens design, the 55 UV Toric Contact Lens is available in a double slab-off back surface design and the 55 UV Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound, 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]] ethyl methacrylate, has been incorporated into the lens polymer. Lenses are tinted using the color additive Pigment Blue 15, ([Phthalocyaninato(2-)] copper).

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for contact lenses, primarily comparing the proposed devices to predicate devices to establish substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study as this information is not present in the input.

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The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and 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 lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.

The provided text is a 510(k) summary for a medical device (contact lens) and does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (contact lenses) and its substantial equivalence to predicate devices based on physicochemical properties and manufacturing processes, not on an algorithm's performance. There is no mention of acceptance criteria or studies involving artificial intelligence, machine learning, or similar computational methods.

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The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective 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 Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IGEL Visioncare contact lenses, formulated to answer your specific questions.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed performance metrics and statistical analyses typically associated with novel device approvals. Therefore, some of your requested information (e.g., specific effect sizes, adjudication methods for clinical studies with human readers, specific training set details, or sample sizes for clinical trials if not explicitly mentioned) may not be present or directly inferable from this type of regulatory document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices. The performance criteria are the physicochemical properties that are compared directly to the predicate devices.

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LL-55 (methafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Biocompatibles Evecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses (LL-55):

This submission is a Parametric Release 510(k), which means it focuses on the sterility release mechanism rather than a new device design or clinical performance. The key point is that the lenses themselves remain unchanged from a previously approved 510(k) (K941877). Therefore, the "acceptance criteria" and "device performance" discussed here specifically pertain to the sterilization process validation for parametric release, not the clinical effectiveness or safety of the contact lens as a medical device in terms of vision correction or wear.

Acceptance Criteria and Reported Device Performance

Study Details (Focusing on Sterilization Validation)

1. Sample size used for the test set and the data provenance:

   • Steam Sterilization Validation: "Normal finished product lenses" were used, but a specific sample size for this part of the test is not explicitly stated. The validation demonstrated the process's capability.
   • Product Bioburden Monitoring: Bioburden results were obtained "monthly over a 5 month period" (July 1997 to November 1997). The number of product units sampled per month for bioburden is not specified, only the average CFU per unit.
   • Thermocouple Readings: 10 validation thermocouple readings were used for data logger calibration.
   • Data Provenance: Retrospective, based on internal validation and monitoring data from Biocompatibles Eyecare Inc. (USA). This is typical for process validation data.

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

   • Not applicable as this is a process validation study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical and microbiological measurements demonstrating sterility assurance.

3. Adjudication method for the test set:

   • Not applicable. This is a scientific and engineering validation of a sterilization process, relying on quantifiable measurements and established standards (e.g., SAL). There is no "adjudication" in the sense of resolving discrepancies between human readers.

4. 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 sterilization process validation for a contact lens, not a diagnostic AI device requiring human reader studies.

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

   • Not applicable. This submission is about the process of sterilization and its parametric release, not an algorithm's performance.

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

   • The ground truth is based on scientific and engineering measurements against established standards for sterilization (e.g., 10^-6 SAL, specific temperature, pressure, and time parameters), and microbiological assays to quantify bioburden.
   • It relies on calibrated equipment and validated microbiological testing methods.

7. The sample size for the training set:

   • Not applicable. This is a process validation, not a machine learning model's development. There is no "training set" in this context. The underlying principles for determining sterilization parameters are based on extensive scientific literature and regulatory guidelines, not a specific training dataset for this device.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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