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1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Toric
   Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
   Multifocal
   Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Toric
   Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
   Multifocal
   Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
   The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 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 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for most tests in quantitative terms (e.g., number of lenses, number of animals). The document indicates "All tests were conducted" and "Studies were conducted to determine leachable materials," implying standard testing protocols were followed, which would inherently involve specific sample sizes per test type (e.g., for cytotoxicity, sensitization, ocular irritation, material property measurements) but these numbers are not detailed in this summary.
• Data Provenance: The studies were conducted by Pegavision Corporation (Taiwan). The report implies that these were internal studies to support the 510(k) submission. Therefore, it is retrospective in the sense that the data was generated to support the application, but the tests themselves would have been conducted prospectively on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• This information is not provided in the summary. For non-clinical tests (biocompatibility, material characteristics, microbiology), "ground truth" is typically established by laboratory standards and validated methods rather than expert consensus on individual observations. For manufacturing verification, engineers and quality control personnel would assess against specifications.

4. Adjudication Method for the Test Set

• This information is not applicable in the context of these non-clinical, objective tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, patient-reported outcomes) from multiple readers or clinicians require reconciliation for ground truth establishment.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical medical device (contact lenses), not an AI/software device that assists human readers. Therefore, this type of study is completely irrelevant to this submission.

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

• No, a standalone performance study was not done.
• As established above, this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• For the non-clinical tests described:
  • Material properties: Measured values compared against established standards and values of predicate devices.
  • Biocompatibility: Negative responses (absence of toxicity, sensitization, irritation) based on standardized in vitro and in vivo models.
  • Microbiology/Sterility: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validation studies using microbiological indicators and established protocols.
  • Leachability: Absence of detectable levels of specific substances using analytical chemistry methods.
  • Manufacturing Verification: Conformance to engineering specifications and tolerances for physical dimensions (diameter, power, base curve).

8. The Sample Size for the Training Set

• Not applicable. This device is a manufactured product, not an AI model requiring a training set. The term "training set" is typically associated with machine learning and AI algorithms.

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

• Not applicable. See point 8.

Summary of the Study per the Document:

The study presented in this 510(k) summary is a series of non-clinical, laboratory-based tests designed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) contact lenses and their substantial equivalence to legally marketed predicate devices. The "study" encompasses:

• Technological Characteristics Comparison: Direct comparison of material properties and design specifications with three predicate devices (K120028, K962804, K991134). The current device largely matches the most relevant predicate (K120028) for key properties like oxygen permeability and percentage transmission, and is in acceptable ranges for others.
• Biocompatibility Testing: According to standard cytotoxicity, maximization sensitization, and ocular irritation tests.
• Microbiology and Sterilization Validation: Validation of the steam sterilization process to ensure a minimum SAL of 10⁻⁵ and demonstration of sterility throughout the shelf life.
• Bacteriostatic Validation: Testing of the steam sterilizer's effectiveness in killing microorganisms.
• Leachability Studies: To confirm the absence of leachable monomers and additive residues.
• Manufacturing Verification Studies: For the new toric and multifocal lens designs, ensuring they meet specified tolerances for key parameters like diameter, power, and base curve.

The overarching "study" proves adherence to the "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses" (May 1994) and establishes substantial equivalence based on these non-clinical tests. Clinical studies were deemed "not required" due to the well-documented safety and effectiveness of etafilcon A lenses and the similarity to predicate devices.

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NaturalVue (etafilcon A) Sphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses are intended for single-use disposable wear.

The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

The provided text is a 510(k) summary for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. This document does not describe a study that uses AI or machine learning to determine performance against acceptance criteria. Instead, it describes non-clinical tests to demonstrate the safety and effectiveness of the contact lenses.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as they relate to AI/ML device evaluations.

However, I can extract the acceptance criteria and reported device performance from the non-clinical studies described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are based on demonstrating substantial equivalence to a predicate device (K140025 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses) and compliance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses. Where specific numerical acceptance criteria are not explicitly stated, the equivalence to the predicate device serves as the implicit acceptance criterion.

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

The document does not specify a "test set" in the context of an AI/ML device. For non-clinical material property testing, the sample sizes are not explicitly stated. The biocompatibility, microbiology, and leachability studies were conducted on the predicate device (K140025) and applied to the current device due to substantial equivalence, so the specifics of their sample sizes are not in this document.

Data Provenance: The document refers to the predicate device (K140025), which was submitted by Pegavision Corporation, Taiwan. The current device is from Visioneering Technologies, Inc., and the non-clinical tests were performed to demonstrate equivalence. It's a non-clinical, retrospective comparison to previously established data and standards.

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

Not applicable. This is not an AI/ML device, and no "ground truth" established by experts for a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No test set requiring expert adjudication is described for this type of device and study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI/ML device, and thus, no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device or an algorithm.

7. The type of ground truth used

Not applicable in the context of AI/ML. For the non-clinical tests, "ground truth" would be the established scientific and regulatory standards for contact lens material properties, biocompatibility, sterility, and leachability. For example:

• Material Properties: Direct measurements using laboratory techniques.
• Biocompatibility: Standardized in vitro and in vivo (animal, if applicable, though not specified here) tests.
• Microbiology: Validation of sterilization processes and sterility testing.
• Leachability: Analytical chemistry techniques.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. No training set is described.

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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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