Search Results

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.

Device Description

• 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.

AI/ML Overview

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.

Ask a Question

Ask a specific question about this device

Page 1 of 1