(35 days)
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.
| Material Property | Predicate Device (Fluorex® 700) Performance | Acceptance Criteria (Implied) | Reported Device Performance (Fluorex® Ultra) |
|---|---|---|---|
| Material Description | Fluoro-silicate-acrylic-copolymers | Similar formulation | Fluoro-silicate-acrylic-copolymer (similar to predicate in component monomers, differing in proportions) |
| Gas Permeability (Dk) | 70.0 | Acceptable Dk for RGP lenses | 60.0 |
| Hardness (Shore D) | 85.5 | Comparable | 86.0 |
| Wetting Angle (Wilhelmy plate method) | 15.3° | Comparable | 13.9° |
| Water absorption | 70% (aqua) color variant | >70% (aqua) | |
| Cytotoxicity | (Implied safe from predicate) | Non-cytotoxic | Non-cytotoxic (agar overlay test) |
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.
§ 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.