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The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.

The ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

Eye care practitioners may prescribe the lens for either single-use disposable wear or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. 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 ACUVUE Contact Lens with visibility tint 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 average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm.

The provided text describes a 510(k) submission for ACUVUE (etafilcon A) Contact Lenses, focusing on the substantial equivalence to a predicate device rather than a new medical device requiring extensive acceptance criteria and a standalone study for performance. Here's an analysis based on the provided information:

This submission is for a contact lens, which is a medical device, but the context indicates it's an update to an existing product (ACUVUE with UV blocker) seeking substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating this equivalence rather than establishing completely new performance benchmarks for a novel AI or diagnostic device.

Here's an attempt to extract and format the information as requested, acknowledging the limitations of applying these categories to a contact lens 510(k) submission:

Acceptance Criteria and Device Performance for ACUVUE (etafilcon A) Contact Lens (with UV blocker)

The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to the predicate device, ACUVUE (etafilcon A) Contact Lens clear and with visibility tint. Performance is largely assessed through a comparative analysis of physical and chemical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are the established specifications or performance of the predicate device, or general industry standards for contact lenses. The subject device demonstrates performance within these established ranges or meets the specific new UV blocking claims.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each characteristic measurement. The values "% Water Content", "Refractive Index", "Dk", "Base Curve Radius", "Diameter", and "Power" are reported as "Measured (avg)", suggesting measurements were taken on a sample of devices.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal or contracted by Vistakon, Johnson and Johnson Vision Products, Inc. The toxicology studies were conducted by a contract laboratory under Good Laboratory Practice Regulations.
• Retrospective or Prospective: The physical and chemical characterization data would be considered prospective in the sense that new samples of the subject device were manufactured and tested for these properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. For this type of device (contact lens) and submission (510(k) for substantial equivalence), "experts" are not typically used to establish a "ground truth" for the test set in the way they would be for an AI diagnostic device (e.g., radiologists for image interpretation). The "ground truth" is based on objective physical, chemical, and biological measurements and established safety standards.

4. Adjudication method for the test set

• N/A. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretation (e.g., image analysis by multiple readers). Here, the testing involves objective measurements of material properties, toxicology, and sterility, which do not require interpretive adjudication.

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

• N/A. This is not an AI-assisted device. The submission pertains to contact lenses, not diagnostic or interpretive software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is not an algorithm or software device. Performance is inherent to the physical product.

7. The type of ground truth used

For the various aspects of the device, the "ground truth" is established by:

• Physical and Chemical Measurements: Objective measurements using validated laboratory methods (e.g., for water content, refractive index, Dk, transmittance, dimensions, power).
• Toxicology Studies: In vivo and in vitro laboratory assays (e.g., ocular irritation, systemic toxicity, cytotoxicity, oral gavage toxicity, Ames test) with outcomes interpreted against pre-defined safety thresholds and regulatory standards.
• Microbiology Studies: Validation of sterilization processes to achieve a specified Sterility Assurance Level (SAL) and compatibility with approved lens care products.
• Material Property Data: Comparison of chemical compositions and properties to established standards and the predicate device.
• Leachable Studies: Laboratory analysis to detect leachable monomers or additives against detection limits.

8. The sample size for the training set

• N/A. This is not a machine learning or AI device that requires a "training set." The product's properties are determined by its manufacturing process and material composition, not by learning from a dataset.

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

• N/A. As there is no training set, this question is not applicable.

Summary of Non-Clinical Studies Mentioned (Acting as the "Study" for Acceptance Criteria Demonstration):

The document primarily relies on non-clinical studies to demonstrate safety and substantial equivalence:

• Toxicology Studies:
  • Ocular Irritation (on molded etafilcon A contact lenses)
  • USP Systemic Toxicity (on molded etafilcon A contact lenses)
  • Cytotoxicity (on molded etafilcon A contact lenses)
  • 4-week Oral Gavage Toxicity Study in Rats (on neat UV absorbing additive)
  • Ames Salmonella/Microsome Reverse Mutation Assay (on neat UV absorbing additive)
  • Conducted by a contract laboratory under Good Laboratory Practice Regulations.
• Microbiology Studies:
  • Validation of moist heat sterilization process (minimum SAL of 10⁻⁶).
  • Shelf-life stability data to support sterility claims.
• Chemistry Studies:
  • Material property data comparison between current and modified materials (showing no significant differences except for UV transmittance).
  • Compatibility with Group IV lens care products (relying on prior demonstrations).
  • Leachable materials studies from finished lenses (indicating no leachable monomers or additives at detection levels).
• Shelf-life Studies:
  • Protocols approved under N18-033, with initial shelf-life declared based on data, and a minimum of six months of real-time data collected.

Conclusion Drawn from Studies:
The studies support the safety and effectiveness of the device and its substantial equivalence to the predicate device, especially regarding the addition of a UV blocker. Clinical studies were explicitly not required for this Premarket notification because the USAN name and process are the same as the predicate device.

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