(26 days)
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. These lenses may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. The lenses are made by modifying the uncolored methafilcon A cast molded lens by affixing a colored pigment on that the unoolorod from hamsee that corresponds to the iris. The colored pigments consist of portion on the from oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine phinalobyanino groom, we . These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power that is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
This 510(k) submission describes the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted). The submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo performance studies with separate acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission primarily demonstrating substantial equivalence to an existing predicate device, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) are not presented in the same way they would be for a novel device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new device's properties are equivalent to the predicate device, which is presumed to have already met necessary safety and effectiveness standards.
| Acceptance Criteria Category | Reported Device Performance (FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™) |
|---|---|
| Material Composition | Made of polymerized HEMA crosslinked with EGDMA; methafilcon A. Equivalent to predicate. |
| Physical Properties | Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear. |
| Optical Properties | Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear. |
| Chemical Properties | Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear. |
| Toxicology | Non-toxic (demonstrated by cytotoxicity, acute systemic toxicity, acute ocular irritation tests). |
| Leachability | Respective extracts did not contain leachable color or significant levels of residual monomers. |
| Indications for Use | Same indications for use as the predicate (K971164): correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes, up to 2.00 Diopters astigmatism that does not interfere with visual acuity. May enhance or alter eye color. Daily wear in a Frequent Replacement Program. Disinfection using chemical or hydrogen peroxide systems. |
| Parameters Available | +8.00 to -8.00D Powers, 0.12 mm Center Thickness, 14.2 mm Diameter, 8.8 mm Base Curve. (These are reported as descriptive parameters, not explicit acceptance criteria with thresholds, but they fall within expected ranges for contact lenses). |
| FDA Classification | Group 4, Ionic, high water content polymers, as established by FDA (Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance testing related to toxicology and leachability, but it doesn't specify a "test set sample size" in the context of comparative clinical performance against human readers or standalone diagnostic accuracy.
- Toxicology and Color Leachability: Lenses were loaded with eleven specified pigments and tested for cytotoxicity, acute systemic toxicity, acute ocular irritation, residual monomer, and color leachability.
- Sample Size: Not explicitly stated in terms of number of lenses or subjects. The phrasing "The results of toxicology testing...have demonstrated" and "the results of residual monomer and color leachability testing demonstrate" implies a study was conducted, but the specifics of the sample size are absent.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
For the claim of substantial equivalence regarding physical, optical, and chemical properties, the "sample" is essentially the design and manufacturing specifications of the new device being compared to the predicate. The document states: "The physical, optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd." This suggests an inherent equivalence due to shared manufacturing/supplier, rather than a separate, large-scale comparative study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable to this 510(k) submission. The device is a contact lens, not an AI diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for contact lens performance typically involves engineering specifications, material science testing, and clinical safety/tolerance studies.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" in the context of human interpretation or diagnostic decision-making to require adjudication.
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 for evaluating observer performance, particularly in diagnostic imaging, which is not relevant to a contact lens.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study in the context of an "algorithm" is not applicable. This device is a physical medical device (contact lens), not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Material Science and Engineering Specifications: The chemical composition (methafilcon A, HEMA, EGDMA), physical dimensions, optical power, water content, and other parameters that define the lens.
- Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is that the new device's properties (physical, optical, chemical) and indications for use are "substantially equivalent" to a legally marketed predicate device (Aspect Vision Care, Ltd.'s FREQUENCY 55).
- Toxicology and Leachability Testing: Lab-based tests demonstrating non-toxicity and non-leachability of color additives/monomers.
- FDA Guidance: Compliance with established FDA guidance for daily wear contact lenses (e.g., being a Group 4, ionic, high water content polymer).
8. The Sample Size for the Training Set
This information is not applicable. Contact lenses do not utilize "training sets" in the context of AI or machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.