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The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astiqmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Translating Bifocal and Trifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.50 diopters or less that does not interfere with visual acuity.

The UV blocking materials contain a UV-absorbing compound incorporated into the fluoro-silicate-acryliccopolymers (flusilfocon A, B, C). The Fluorex® UV (flusilfocon) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.

This is a 510(k) summary for a contact lens material, not an AI device. As such, the requested information regarding AI device acceptance criteria and study details (sample size, experts, ground truth, MRMC study, standalone performance, training set) is not applicable or available in the provided text.

The document describes the addition of a UV blocker to existing Fluorex® contact lens materials and seeks substantial equivalence to already approved predicate devices. The "study" here refers to the comparison of material properties between the new UV-blocking versions and the predicate devices.

Here's the relevant information that can be extracted, framed within the context of a medical device submission rather than an AI study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent if its properties are comparable to the predicate device. The acceptance criteria are implicit in the "Substantial Equivalence" table, where the new materials' properties are presented alongside the predicate's for direct comparison. Deviations are noted, but typically the values are expected to be very similar for substantial equivalence.

Note: The "->" in the table for Chord Diameter, Center thickness, Base Curve, and Powers implies that the values are the same as the predicate since the "Substantial Equivalence" column header covers all materials.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material characterization rather than a data-driven AI test. Material properties are measured according to established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are determined by standardized physical and chemical tests, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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 not an AI device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used: Material properties are established through direct measurement and testing according to industry standards (e.g., ANZI, ASTM). For example:
* Gas permeability (Dk) by polarographic method.
* Hardness by Shore D hardness (ANZI/ASTM).
* Wetting Angle by Wilhelmy plate method.
* Water content by ANZI Z80.6; 5.6.1.
* Refractive Index by ANZI/ASTM D542-20.
* Light Transmission by ANZI/ASTM 280.6.4.5.
* Toxicology was assessed via an agar overlay cytotoxicity test.

The "ground truth" for the new materials is their experimentally determined physical and chemical characteristics.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of the study that proves the device meets the acceptance criteria:

The study demonstrating the device meets acceptance criteria is a material characterization and comparison study. G. T. Laboratories, Inc. performed various physical, chemical, and biological tests on the new UV-blocking Fluorex® materials (Fluorex® 700-UV, 500-UV, 300-UV) to show their properties are substantially equivalent to the previously approved Fluorex® materials (Fluorex® 700, 500, 300).

The key findings indicating the "proof" are:

• Chemistry: The UV-blocking materials are described as "identical to the already approved Fluorex® (flusilfocon) materials in component monomers, with the only difference being the addition of the UV blocker." No monomers were found to be extracted.
• Toxicology: The UV-blocking material was found to be "noncytotoxic in an agar overlay cytotoxicity test."
• Microbiology and Clinical: No testing was required due to the similarity to the predicate device, indicating that the addition of the UV blocker was not expected to significantly alter these aspects based on existing data for the predicate.
• Material Property Comparison (Table): The provided table directly compares multiple physical properties (Gas permeability, Hardness, Wetting Angle, Water content, Refractive Index, Specific Gravity, Light Transmission) between the new UV-blocking materials and their non-UV predicate counterparts. The results show very similar values, with the primary difference being the intended 0.0% UV light transmission in the new UV-absorbing materials, which is the desired feature. The minor differences in Dk, Refractive Index, and Specific Gravity are deemed acceptable for substantial equivalence.

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The Fluorex® Ultra (flusilfocon E) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Fluorex® Ultra (flusilfocon E) Translating Bifocal and Trifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.50 diopters or less that does not interfere with visual acuity.

The Fluorex® Ultra (flusilfocon E) is a fluoro-silicate-acrylic-copolymer. The Fluorex® Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.

This 510(k) summary for the Fluorex® Ultra (flusilfocon E) Rigid Permeable Contact Lenses indicates that the device's acceptance criteria are based on achieving substantial equivalence to a predicate device, Fluorex® 700 (flusilfocon A) Rigid Gas Permeable Contact Lenses (PMA #P880001). The "study" proving the device met the acceptance criteria was primarily a comparison of material properties, with no clinical or traditional standalone studies performed for the Fluorex® Ultra itself.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Fluorex® Ultra were implicitly defined by demonstrating that its material properties were comparable to or acceptably different from the predicate device, Fluorex® 700.

Note: The physical dimensions (Chord Diameter, Center thickness, Base Curve, Powers) listed for Fluorex® 700 are provided as context for the type of lens, but Fluorex® Ultra is not explicitly stated to meet these exact dimensions; rather, it is presumed to be available in a similar range. The "Actions" are also a functional description that applies to both.

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

• Sample Size: Not applicable in the context of a traditional test set for performance evaluation. The "test" here refers to the material characterization of Fluorex® Ultra. The report does not specify the number of material samples used for each physical property measurement.
• Data Provenance: The data appears to be from internal laboratory testing of the Fluorex® Ultra material itself, likely performed by G.T. Laboratories, Inc. or a contracted lab. The document does not specify a country of origin for the data beyond the applicant's location in Illinois, USA. It is retrospective in the sense that the material was manufactured and then tested.

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

Not applicable. This device classification relies on substantial equivalence based on material properties, not on expert-adjudicated ground truth data for a diagnostic or imaging device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication was performed for the material property tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of results, which is not the case for a contact lens material.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. A "standalone" performance study in the context of AI or diagnostic algorithms is not applicable here. The performance evaluation was based on laboratory testing of the material properties of the contact lens itself (e.g., Dk, hardness, wetting angle), and toxicology/cytotoxicity.

7. The Type of Ground Truth Used

The "ground truth" for the Fluorex® Ultra material was established through laboratory measured physical and chemical properties and cytotoxicity testing. For example, the gas permeability (Dk) was determined by the polarographic method, hardness by Shore D hardness ANZI/ASTM, and so on. The "ground truth" for demonstrating substantial equivalence was the known properties of the predicate device, Fluorex® 700.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/machine learning model. The device is a material, not a data-driven algorithm.

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

Not applicable. As there was no training set, there was no ground truth for it. The comparison was against the established characteristics of the predicate device.

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