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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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