Search Results

The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism.

The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, 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 or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.

When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the 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.

The subject device 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 for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.

This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.

In this case, the "device performance" is the reported property/parameter values.

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: "clinical performance data to demonstrate substantial equivalence are not required."
Therefore, there is no "test set" in the context of clinical performance data described in this document. The non-clinical performance data involved "finished product testing for verification of the modified design," but no specific sample sizes or data provenance are provided for these tests.

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 performance data requiring expert ground truth for a test set was conducted or reported in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical performance data requiring adjudication was conducted or reported in this document.

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 device. No MRMC study 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 AI-powered algorithm. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical performance data requiring ground truth was conducted or reported in this document. The "ground truth" for the non-clinical tests would be the established specifications and measurement standards for the material and design properties.

8. The sample size for the training set

Not applicable, as no AI/machine learning model was developed for this device. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device