(30 days)
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lens material (etafilcon A) is a copolymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1- trimethylol propane trimethacrylate and ethylene glycol trimethacrylate. The VISTAKON® Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm. The lens is a hemispherical shell.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate 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/mlmmHg) | 28.0 x 10⁻¹¹ | 28.0 x 10⁻¹¹ |
| Specific Gravity, (calc.) | 0.98 - 1.12 | 0.98 - 1.12 |
| 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: -20.0 D to + 20.0 D |
| Center Thickness, mm | -20.0 D to + 20.0 D | 0.06 mm to 1.00 mm |
Note on Power and Center Thickness: The table in the document has the Power and Center Thickness rows swapped in the "Subject Device Label Claim" column compared to the "Predicate Device Label Claim" column. I have listed them as they appear in the document for the subject device.
2. Sample Size Used for the Test Set and Data Provenance
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 implies that there was no separate "test set" in the context of a clinical study for the subject device. The equivalence was established based on non-clinical testing and comparison to the predicate device's established performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was performed for the subject device.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed.
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-assisted diagnostic tool.
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
The "ground truth" for the subject device's performance was established through:
- Non-clinical testing: This includes Toxicology Testing (Cytotoxicity, Ocular Irritation, Systemic Toxicity), Leachables, Physical/Chemical Testing, and Stability Testing.
- Comparison to a legally marketed predicate device: The predicate device, 1-DAY ACUVUE® Brand (etafilcon A) Contact Lens cleared via K013973, served as the established "ground truth" for acceptable performance and safety. The subject device demonstrated substantial equivalence based on identical technological characteristics and non-clinical test results.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device (contact lens), not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.