(66 days)
The VISTAKON® (senofilcon A) Contact Lens is indicated for daily wear 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® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakit persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON® (senofilcon A) Toric Contact Lens 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 10.00 D of astigmatism or less.
The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens is indicated for daily wear for the correction of distance and near vision in presby opic phakic or apakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
• The VISTAKON® (senofilcon A) Contact Lens Clear and Visibility Tint with UV Blocker is available as a spherical lens, a multifocal lens, a toric lens and a multifocal-toric lens.
• The lenses are made of a silicone hydrogel material containing an internal wetting agent.
• The VISTAKON® (senofilcon A) Contact Lens may be 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 transmittance characteristics are less than 1% in the UVB range of 280 – 315nm and less than 10% in the UVA range of 316 – 380nm.
• The VISTAKON® (senofilcon A) Contact Lens is a hemispherical or hemitoric shell.
• The lens is supplied in a sterile state, packaged in a buffered saline solution with 0.005% methyl ether cellulose.
• The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution.
Here's a summary of the acceptance criteria and study information for the VISTAKON® (senofilcon A) Contact Lens, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device rather than setting specific numeric acceptance criteria for revolutionary performance. The "acceptance criteria" here are implied through comparative performance to the predicate and general safety/effectiveness.
| Characteristic / Study Outcome | Predicate Device (Focus® NIGHT AND DAY™ (lotrafilcon A) Contact Lens) | VISTAKON® (senofilcon A) Contact Lens | Acceptance Criteria (Implied) | Reported Performance (VISTAKON®) |
|---|---|---|---|---|
| Material Type | Group I | Group I | Matching predicate material group | Group I |
| Water Content (%) | Labeled: 24, Measured: 23 | Labeled: 38, Measured: 38 | Safe, effective, and similar in overall performance to predicate | 38% |
| Refractive Index @ 20°C | Labeled: 1.43, Measured: 1.43 | Labeled: 1.42, Measured: 1.42 | Safe, effective, and similar in overall performance to predicate | 1.42 |
| Dk (edge corrected) | Labeled: 140, Measured: 141 | Labeled: 103, Measured: 107 | Safe, effective, and similar in overall performance to predicate | 107 |
| Dk (non-edge corrected) | NA, Measured: 168 | NA, Measured: 126 | Safe, effective, and similar in overall performance to predicate | 126 |
| Base Curve (mm) | Labeled: 8.4, Measured: 8.47 | Labeled: 8.8, Measured: 8.81 | Safe, effective, and similar in overall performance to predicate | 8.81 |
| Diameter (mm) | Labeled: 13.8, Measured: 13.80 | Labeled: 14.6, Measured: 14.62 | Safe, effective, and similar in overall performance to predicate | 14.62 |
| Power (D) | Labeled: -1.00, Measured: -1.11 | Labeled: -0.50, Measured: -0.35 | Safe, effective, and similar in overall performance to predicate | -0.35 |
| Toxicology/Biocompatibility | N/A - Predicate established as safe | Not toxic, not irritating | Not toxic and not irritating | Confirmed non-toxic and non-irritating |
| Lens Physical/Material Properties | Consistent with currently marketed lenses | Consistent with currently marketed lenses | Consistent with currently marketed lenses | Confirmed consistent |
| Clinical Performance (Safety/Efficacy) | N/A - Predicate established as safe/effective | Similar overall performance to concurrent controls | Similar overall performance in vision, health, comfort, and fit compared to controls | Demonstrated similar overall performance |
2. Sample Size for Test Set and Data Provenance
- Sample Size: "at least 50 patients" were evaluated in the clinical study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was a prospective clinical study conducted over "three (3) months".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. The clinical study evaluated parameters like adverse reactions, keratometry changes, reasons for discontinuations, and unscheduled lens replacements, which would typically be assessed by eye care professionals.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data or outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC for AI assistance) is not applicable to this device, which is a contact lens and not an AI-powered diagnostic or assistive tool. The study was a clinical trial comparing the new contact lens to a predicate lens.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a contact lens and does not involve an algorithm.
7. Type of Ground Truth Used
The ground truth for the clinical study appears to be based on clinical assessments and observations by investigators during the study, evaluating parameters such as visual acuity, ocular health, comfort, and fit, as well as adverse reactions. For toxicology and biocompatibility, the ground truth was established through in vitro and in vivo preclinical toxicology and biocompatibility tests following GLP regulations.
8. Sample Size for the Training Set
Not applicable. This device is a contact lens and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm, there is no training set or ground truth for a 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.