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Spherical and Aspheric

Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric

Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

The lenses are intended for single-use disposable wear.

The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, GMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution. one is borate solution (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121.

This document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving it meets those criteria (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) is not present.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the standard pathway for many medical devices, including contact lenses. This involves showing similar technological characteristics and performance through non-clinical testing.

Here's an analysis of the provided text in relation to the requested information, highlighting why certain points cannot be addressed:

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

The document provides a comparative table of technological characteristics between the proposed device ("Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)") and a predicate device (K040303). This isn't strictly "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm, but rather a comparison for demonstrating substantial equivalence.

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 states: "Clinical studies for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) of the present device are not required for the premarket notification," because the USAN name and process are the same as previously cleared predicate devices.

Instead, non-clinical testing was performed. The document lists the types of non-clinical tests (e.g., Physicochemical Properties, Biocompatibility Testing, Shelf Life Test, Sterility Test), but does not provide sample sizes for these tests or data provenance (country of origin, retrospective/prospective). These types of details are usually found in the full submission, not the public 510(k) summary.

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 is not applicable as no clinical study or human expert review of "test sets" (in the AI/ML sense) was conducted or required for this 510(k) submission. The evaluation is based on material properties and non-clinical performance, and substantial equivalence to a predicate.

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

Not applicable, as no clinical test set requiring expert adjudication was part of this submission.

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 for an AI/ML device, not a contact lens.

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

Not applicable. This is for an AI/ML device.

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

For a contact lens, "ground truth" relates to material specifications and performance standards (e.g., ensuring water content is 59%, or that oxygen permeability meets a certain threshold). These are established physical and chemical properties, not clinical "ground truth" derived from patient data or expert consensus in the diagnostic sense. The document states that non-clinical performance tests were conducted "in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses." This guidance defines the expected methods and standards for these physical and chemical property assessments.

8. The sample size for the training set

Not applicable. This is for an AI/ML device.

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

Not applicable. This is for an AI/ML device.

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NaturalVue (etafilcon A) 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 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.

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/or 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.

NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or 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.

The lenses are intended for single-use disposable wear.

The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibilitytinted, containing a UV blocker and are available in a spheric, 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 316-380nm. Each lens is supplied sterile in a blister pack containing buffered saline solution with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol.

The provided text describes a 510(k) premarket notification for NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission asserts substantial equivalence to a predicate device (K150385) with the addition of a modified saline solution.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria presented are in the form of material properties and performance characteristics, demonstrating equivalence to the predicate device.

Additional Performance Tests (Qualitative/Binary):

• Biocompatibility: Negative responses for cytotoxicity, maximization, and ocular irritation tests. Validity of blister packaging demonstrated by passing extraction tests. (Applies to both proposed and predicate as they share the same material).
• Microbiology (Sterilization): Steam sterilization validated to deliver minimum SAL of 10⁻⁶. Shelf-life stability supports sterility through expiration.
• Bacteriostatic Validation: Steam sterilizer effectiveness confirmed. Microorganisms killed under tested conditions. Lenses remained sterilized with no microbial growth for 5 years (accelerated conditions). Package seal remained tight for 5 years (accelerated conditions).
• Leachability: No leachable monomers and additive residues at detected levels.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical performance tests for material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. It does not describe a "test set" in the context of an algorithm or diagnostic device. Instead, it refers to the product itself and its components undergoing various testing.

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many lenses were tested for water content, or how many individual cytotoxicity tests were conducted). It only states that "All tests were conducted in accordance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses."
• Data Provenance: The tests are described as being performed to demonstrate safety and effectiveness of the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The data originates from these non-clinical studies conducted by or for Visioneering Technologies, Inc. There is no mention of country of origin for the underlying data, but the submission is to the U.S. FDA. The data is implicitly prospective in the sense that these tests were performed on the device or its components to support this specific 510(k) submission, rather than re-analyzing existing data.

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

This question is not applicable to this submission. The device is a contact lens, not an AI/diagnostic algorithm that requires expert-established ground truth for its performance evaluation in the way a medical image analysis software would. The "ground truth" for contact lenses is established through standardized physical, chemical, and biological testing methods (e.g., measuring water content, oxygen permeability, cytotoxicity, sterility).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This question is not applicable as there is no "test set" in the context of human expert review and adjudication for an AI/diagnostic algorithm. The non-clinical tests described have quantifiable outcomes or pass/fail criteria based on established scientific methods.

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 question is not applicable. The device is a contact lens and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable. The device is a contact lens and does not involve an algorithm.

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

For the non-clinical tests performed, the "ground truth" is based on:

• Established scientific methodologies and standards: For material properties (e.g., water content, refractive index, oxygen permeability, transmittance), the ground truth is the measured physical/chemical properties.
• Validated biological tests: For biocompatibility (cytotoxicity, maximization, ocular irritation), the ground truth is the biological response observed in animal or in-vitro models according to recognized standards.
• Sterilization validation standards: For microbiology, the ground truth is the demonstration of a specific sterility assurance level (SAL).
• Analytical chemistry techniques: For leachability, the ground truth is the detection or non-detection of leachable substances.

8. The sample size for the training set

This question is not applicable. The device is a contact lens and does not involve a "training set" for an AI algorithm.

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

This question is not applicable. The device is a contact lens and does not involve a "training set" for an AI algorithm.

Summary of the Study and Conclusion:

The study presented is a non-clinical evaluation to demonstrate the substantial equivalence of the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses to a previously cleared predicate device (K150385). The central argument for substantial equivalence relies on:

• Identical material composition (etafilcon A): The USAN name, material classification (Group 4 high water ionic), water content (58%), refractive index (1.4023), oxygen permeability (19.73 x 10⁻¹¹), % T at 593nm (>95%), UVA transmittance (<30%), and UVB transmittance (<5%) are all identical to the predicate device.
• Identical production method: Cast-molded.
• Identical range of lens designs.
• Historical Clinical Use: The submission leverages the well-established safety and effectiveness of etafilcon A lenses, citing several predicate and reference devices, including the K150385.
• Non-Clinical Performance Tests: Comprehensive testing was conducted in accordance with FDA guidance for daily wear contact lenses, covering:
  • Material Properties: Confirmed the listed characteristics are equivalent to the predicate.
  • Biocompatibility: Demonstrated material safety based on negative responses in cytotoxicity, maximization, and ocular irritation tests.
  • Microbiology: Validated the steam sterilization process to achieve a minimum SAL of 10⁻⁶ and confirmed shelf-life sterility.
  • Bacteriostatic Validation: Confirmed sterilizer effectiveness and lens sterility/package integrity over time (accelerated conditions).
  • Leachability: Showed no detectable leachable monomers or additive residues.
• Modification: The only significant difference highlighted is the modified saline solution (addition of Tween 80, Sodium Hyaluronate, and Polyethylene Glycol), which was previously cleared under K161739, implying its safety and compatibility.

The conclusion is that based on these performance and manufacturing verification studies, the proposed device is equivalent to the predicate device with respect to intended use, principles of operation, and technological characteristics, especially given the prior clearance of the modified saline solution.

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