(57 days)
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with nondiseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eves who may have 10.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The etafilcon A contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
When prescribed for single-use disposable wear (See "Wearing Schedule") the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be discarded after each removal.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is available as a spherical lens, a bifocal lens, a toric lens, and a toric bifocal lens. The lens material (etafilcon A) is a copolymer of 2hydroxyethyl methacrylate and methacrylic acid cross-linked with 1, 1, 1 -trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Visibility Tinted with UV Blocker, for Daily Wear is tinted blue using Reactive Blue Dye #4 to make the lenses more visible for handling. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will mask or enhance the color of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phytalocyanine green, vat orange 1 and Reactive Blue Dye #4. The cosmetically tinted lens is available in the following opaque colors: Blue, Gray, Green, Honey, Chestnut, Hazel and Sapphire. They are also available in the following enhancer colors: Blue, Green and Aqua.
In the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear, a benzotriazole UV absorbing monomer is used to block UV radiation. The UV Blocking for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear averages 97% in the UVB range of 280 nm to 315 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Wear averages 82% in the UVA range of 316 nm to 380 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Cosmetically Tinted with UV Blocker for Daily Wear averages 81% in the UVA range of 316 nm to 380 nm.
The provided text describes a Special 510(k) submission for a VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens. This submission is for modifications to an existing device, and therefore, the primary method of demonstrating acceptance criteria is through comparison to a predicate device and non-clinical testing, rather than a de novo clinical study with specific performance metrics for the modified device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission concerning modifications to an existing device, "acceptance criteria" are generally focused on demonstrating that the modified device performs equivalently to the predicate device for specified properties, and meets established safety and performance standards through non-clinical testing.
| Property | Acceptance Criteria (Predicate Device Label Claim) | Reported Device Performance (Subject Device Label Claim) |
|---|---|---|
| Water Content, % | 58 | 58 |
| Refractive Index @ 20° C | 1.40 | 1.40 |
| Dk-Fatt method, non-edge corrected (cm²/sec)* (ml O₂/ml*mmHg) | 28.0 x 10⁻¹¹ | 28.0 x 10⁻¹¹ |
| Specific Gravity, (calc.) | 0.98 - 1.13 | 0.98 - 1.13 |
| Light Transmission | Minimum 85% | Minimum 85% |
| Base Curve Radius, mm | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm |
| Diameter, mm | 12.0 mm to 15.0 mm | 12.0 mm to 15.0 mm |
| Power, Diopters | Varies with power: 0.06 mm to 1.00 mm | Varies with power: 0.06 mm to 1.00 mm |
| Center Thickness, mm | -20.0 D to +20.0 D | -20.0 D to +20.0 D |
| UV Blocker (UVB range 280 nm to 315 nm) | (Implicitly similar to predicate based on statement "UV absorbing monomer is used to block UV radiation") | Averages 97% |
| UV Blocker (UVA range 316 nm to 380 nm - Clear & Visibility Tinted) | (Implicitly similar to predicate) | Averages 82% |
| UV Blocker (UVA range 316 nm to 380 nm - Cosmetically Tinted) | (Implicitly similar to predicate) | Averages 81% |
| Toxicology Testing (Cytotoxicity, Ocular Irritation, Systemic Toxicity, Leachables) | Compliance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact lenses, May 12, 1984 standards. | "Non-toxic and biocompatible with the ocular environment" |
| Physical/Chemical Testing | Within established finished product specifications. | "Within established finished product specifications" |
| Stability Testing | Remains stable. | "Remain stable" |
| Solution Compatibility Testing | Compatibility with disinfection systems. | (Implied by nature of test) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device, therefore no clinical data is required." This indicates that there was no separate "test set" of patient data for a new clinical study. The data provenance would be derived from the non-clinical tests and the established equivalence to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical data was required or provided, there was no "test set" requiring ground truth established by experts in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical data or test set requiring adjudication was conducted for this 510(k) submission.
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 device is a contact lens, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned (Toxicology, Physical/Chemical, Stability, Solution Compatibility), the "ground truth" would be established by validated laboratory testing methods and accepted industry standards, as referenced by the FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact lenses, May 12, 1984. For the comparative properties shown in the table, the ground truth is the predicate device's label claims.
8. The sample size for the training set
Not applicable. This device is a modified contact lens, not an AI model, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
§ 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.