(35 days)
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.
| Acceptance Criteria (Predicate Device Property) | Reported Device Performance (Fluorex® 700-UV) | Reported Device Performance (Fluorex® 500-UV) | Reported Device Performance (Fluorex® 300-UV) |
|---|---|---|---|
| Material Type: Fluoro-silicate-acrylic-copolymers, tinted with specific dyes. | Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416 | Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416 | Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416 |
| Actions: Corrective refracting medium on human cornea. | Same | Same | Same |
| Chord Diameter*: 7.00 to 10.50 mm | -> (Implies same range) | -> (Implies same range) | -> (Implies same range) |
| Center thickness*: 0.10mm to 1.00mm | -> (Implies same range) | -> (Implies same range) | -> (Implies same range) |
| Base Curve*: 6.00 to 9.00 mm | -> (Implies same range) | -> (Implies same range) | -> (Implies same range) |
| Powers*: -20.00 to +12.00 D | -> (Implies same range) | -> (Implies same range) | -> (Implies same range) |
| Gas permeability (Dk): 70.0 | 70.0 | 51.5 (Predicate: 50.0) | 29.3 (Predicate: 30.0) |
| Hardness (Shore D hardness): 85.5 | 85.5 | 86.5 | 87.0 |
| Wetting Angle (Wilhelmy plate method): 14.8° | 14.8° | 13.8° | 12.9° |
| Water content: All materials 90% | All materials >90% | All materials >90% | All materials >90% |
| Light Transmission, UV (250-350nm): Not specified (for predicate) | 0.0% (for UV absorbing materials) | 0.0% (for UV absorbing materials) | 0.0% (for UV absorbing materials) |
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.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.