Search Results

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL is indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and may have 0.75D of astigmatism or less.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D of astigmatism or less.

These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see REPLACEMENT SCHEDULE). When prescribed for daily disposable wear, lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional.

The ACUVUE® (senofilcon C) Soft Contact Lens is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 59% senofilcon C and 41% water by weight when hydrated and stored in buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date, a 4-year shelf-life has been established.

The ACUVUE® (senofilcon C) Soft Contact Lens is made of a silicone hydrogel material containing an internal wetting agent. The lens 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 transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm to 380 nm for the entire power range.

This document is a 510(k) premarket notification for ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lenses. It details the safety and efficacy of the device by comparing it to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device in various safety and performance aspects. The reported device performance is outlined against these implicit criteria through direct comparison with the predicate device.

Note: Differences in specific values (e.g., water content, Dk, specific astigmatism limits) are presented and argued not to adversely affect safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Study):
  • Sample Size: 221 subjects total (109 for the test lens, 112 for the control lens).
  • Data Provenance: Conducted in the U.S. (United States), described as a prospective, randomized, parallel group design.

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 for the clinical test set beyond implying the involvement of "Eye Care Professionals" who would make clinical determinations (e.g., for visual acuity, slit lamp findings, etc.). It mentions "clinical evaluation" and "clinically relevant areas of vision and health," which implies expert assessment, but no explicit details on the number or their specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "prospective, randomized, parallel group design" clinical study, where data points like slit lamp findings and visual acuity were collected. This suggests standard clinical assessment by the study's optometrists/ophthalmologists, but no specific multi-reader adjudication process is detailed for reaching a "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study's design was a direct clinical comparison of the new contact lens to a predicate contact lens, focusing on physiological and performance equivalence, not on the improvement of human readers with AI assistance. The device is a contact lens, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established through standard clinical assessments and measurements performed by Eye Care Professionals during the study. This includes:

• Slit lamp findings
• Visual acuity measurements
• Keratometry changes
• Evaluations of problems, symptoms, and complaints
• Adverse reactions
• Reasons for discontinuation

This can be broadly categorized as expert clinical assessment and outcomes data as observed and recorded during the prospective clinical trial.

8. The Sample Size for the Training Set

This question is not applicable. The device is a contact lens and does not involve AI or machine learning that would require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device