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The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism.

The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens helps 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 (see "Wearing Schedule").

When prescribed for single-use disposable wear (see "Wearing Schedule") the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required. When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).

The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is an extended depth-of-focus (EDOF) contact lens for the daily wear correction of distance, intermediate and near vision in presbyopic persons.

The lens material, etafilcon A. is a random co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were cross-linked with ethylene qlycol dimethacrylate (EGDMA) and 1,1,1 -trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using color additive Reactive Blue No. 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UVB range of 280-315 nm and less than 30% in the UVA range of 315-380 nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

The document does not contain all the requested information for acceptance criteria and specific study details. The provided text is a 510(k) summary for the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with acceptance criteria for device performance.

However, based on the available information, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document mentions that the BHV VIVID contact lens is substantially equivalent to predicate devices and that "Successful results from chemical/physical, stability, and toxicology tests further confirmed the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment."

However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for properties like visual acuity, comfort, or complications typically found in clinical trials for contact lenses. The comparison table (Table 8.1) focuses on material and physical characteristics for substantial equivalence, not clinical performance metrics.

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

The document states under "VIII. Clinical Testing" that "The technological characteristics, formulation, manufacturing and sterilization processes are substantially equivalent to the predicate devices, therefore no clinical data is required." This means there was no specific clinical test set for this device to prove its performance in human subjects, as its equivalence was based on non-clinical data and comparison to existing devices.

The non-clinical tests mentioned ("Bench Testing", "Biocompatibility", "Microbiology", "Bacteriostatic Validation", "Leachables") would have involved laboratory samples rather than human subjects. The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it would have been generated in a controlled laboratory setting.

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 test set requiring expert ground truth establishment was conducted for this 510(k) submission. The evaluation was primarily based on non-clinical testing and comparison to predicate devices, adhering to recognized consensus standards.

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

Not applicable, as no clinical test set was conducted.

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 is a contact lens, not an AI-powered diagnostic device, and no MRMC study was performed or mentioned.

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

Not applicable. This is a contact lens.

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

For the non-clinical tests, the "ground truth" would be established by validated laboratory methods and adherence to the recognized consensus standards listed (e.g., ISO, ASTM). For example:

• Biocompatibility: Adherence to ISO 10993 series standards.
• Material properties: Measured values compared to specifications and predicate device data.
• UV blocking: Spectrophotometry results demonstrating compliance with specified transmittance percentages.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable.

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