Search Results

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated 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 4.00D of ADD power and have 0.75D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Timed, is also indicated for daily wear to enhance or alter the appearance of the eye.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the ACUVUE® (etafficon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.

When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal-toric design. 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 dimethacrylate. The composition of the lens is 42% etafilcon A and 58% water by weight when hydrated and stored in buffered saline solution with or without povidone. The lens is supplied in a sterile state.

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Visibility Tinted with UV Blocker for Daily Wear, 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 UV Blocking for ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lenses for Presbyopia, Visibility Tinted with UV Blocker averages 97% in the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm.

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will enhance or alter the appearance of the eye. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green, vat orange 1, and Reactive Blue Dye #4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia:

Based on the provided FDA 510(k) summary, the device being described is a soft contact lens, and the submission is for a new multifocal design (ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear).

Crucially, the document states that clinical performance data was NOT required because the device is substantially equivalent to predicate devices. This means that there wasn't a new clinical study specifically designed to establish the performance of this particular new multifocal design against specific acceptance criteria. Instead, the substantial equivalence relies on the material, manufacturing process, and indications being similar to previously cleared devices, and on non-clinical testing to ensure the modified design meets specifications.

Therefore, many of the questions regarding a study proving acceptance criteria cannot be directly answered from this document because such a study was not conducted for this 510(k) submission.

Here's a breakdown of what information can be extracted:

1. A table of acceptance criteria and the reported device performance

Since a dedicated clinical study for this specific multifocal design was not performed to establish new acceptance criteria or performance metrics, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices and through non-clinical verification of specifications.

The document provides the following technical specifications for the device, which serve as performance characteristics that were verified non-clinically:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as a specific clinical study for this device's performance against clinical acceptance criteria was deemed unnecessary due to substantial equivalence. Non-clinical testing was conducted to verify that the finished products meet specification tolerances, but sample sizes for this internal verification are not detailed.

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)

This information is not provided as a clinical study with expert-established ground truth was not conducted for this 510(k) submission.

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

This information is not provided for the same reason as point 3.

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

This is not applicable. The 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

This is not applicable. The device is a contact lens, not an algorithm.

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

This information is not provided as a clinical study was not required. The "ground truth" for the non-clinical verification would be the established engineering and material specifications.

8. The sample size for the training set

This information is not provided as a clinical study with training and test sets in the typical sense (for algorithm development or performance evaluation) was not performed.

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

This information is not provided for the same reason as point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The pivotal information regarding the device meeting acceptance criteria is found under the sections "Nonclinical Performance Data" and "Clinical Performance Data."

• Nonclinical Performance Data: The submission states that the device is made from the same material and uses the same manufacturing process as a predicate device (VISTAKON® (etafilcon A) cleared under K062614). Therefore, all nonclinical testing supporting that predicate device is considered representative. Additionally, "finished product testing for verification of the modified design was conducted to demonstrate that lenses meet specification tolerances." This refers to internal quality control and verification that the physical dimensions and material properties (as listed in the table above) are within the acceptable ranges.
• Clinical Performance Data: The document explicitly states: "clinical performance data to demonstrate substantial equivalence are not required." This is because the new ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia has the same indications, uses the same etafilcon A material, and shares the same manufacturing and sterilization processes as predicate devices (K062614 for material and manufacturing, and K073459 for the multifocal design type). The "demonstration of the physical and chemical equivalency of the subject device to the predicate devices support the safety and effectiveness of the subject device for an alternate multifocal lens design configuration."

Conclusion:

The device did not undergo an independent clinical study to establish new acceptance criteria or prove its performance against such criteria. Instead, its acceptance is based on demonstrating substantial equivalence to already legally marketed predicate devices through:

1. Sharing the same core material (etafilcon A).
2. Utilizing the same manufacturing and sterilization processes.
3. Having comparable technological characteristics (e.g., water content, Dk, UV blocking, physical parameters).
4. Having similar indications for use.
5. Performing non-clinical finished product testing to verify the modified design meets established specifications.

Ask a specific question about this device