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The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The subject device, Clearcolor 1- Day (hioxifilcon A) Daily Disposable Device Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Description Daily Disposable Soft (hydrophilic) Contact Lens is a Soft Hydrophilic Daily Disposable Color Soft Contact Lens. The subject device is made of a nonionic lens material, hioxifilcon A, which is a random co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and glycerol methacrylate (HEMA/GMA) cross-linked with ethylene glycol dimethacrylate. The copolymer consists of 42% hioxifilcon A and 58% water by weight when immersed in normal buffered saline solution. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN). The subject device is a cosmetically tinted contact lens and contains a pigmented area that will mask or enhance the color of the natural iris. The cosmetically tinted lenses contain one or more of the following US FDA approved colorants for contact lenses: D&C Yellow, No. 10, D&C Green, D&C Red No. 17, Phthalocyanine-2-Copper, Carbazole Violet, Titanium dioxides, reactive Black 5, C.I. Vat Orange 1, C.I. Vat yellow 3, C.I. Pigment Green, C.I. Vat Orange 5, C.I. Vat Brown 1, C.I. Vat Green 1, Pigment Blue 36, and Iron Oxides. These colorants will be used to make 1-tone, 2-tone and 3-tone color patterns on contact lenses. The cosmetically tinted lens is available in variety of opaque colors including: Gray, Brown, Tan Brown, Black, Green, and Blue.

The provided document is a 510(k) premarket notification for a contact lens, and as such, it does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria and studies for an "AI device" is not applicable.

The document focuses on demonstrating the substantial equivalence of the "Clearcolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens" to a legally marketed predicate device (clearlab (hioxifilcon A) 1-day soft (hydrophilic) contact lens, clear and visibility tinted for spherical, single use daily wear contact lens, cleared under K080632).

The "acceptance criteria" presented in the document are primarily the characteristic specifications of the contact lens. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed to show the equivalence of the subject device to the predicate device, not the performance of an AI algorithm.

Below is a breakdown of the requested information, adapted to the context of this contact lens submission:

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

The document lists various characteristics of the subject device (Clearcolor 1-Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens) and states they are identical to the predicate device (clearlab (hioxifilcon A) 1-day). Therefore, the "acceptance criteria" are implied to be these specifications, and the "reported device performance" is that the subject device meets these specifications, as evidenced by non-clinical testing and comparison to the predicate.

"Study that proves the device meets the acceptance criteria":

The document explicitly states: "Toxicology, physical, chemical and stability testing confirm the subject device [...] is safe and effective." It also mentions specific tests conducted as recommended by the US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, 12 May 1984:

• Toxicology Testing:
  • Cytotoxicity testing using the Argose Overlay method
  • ISO Ocular Irritation Study
  • USP & ISO Systemic Toxicity in Mice
• Leachable Testing
• Physical & Chemical Testing
• Stability Testing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the document for the non-clinical tests. The tests are mentioned generally (e.g., "Cytotoxicity testing"), without details on the number of samples or the experimental setup. Data provenance for such lab-based material testing is typically internal to the manufacturer and not specified in the 510(k) summary beyond the type of test.

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 the document describes non-clinical testing of a physical product (contact lens materials and characteristics), not an AI algorithm requiring expert ground truth labeling.

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

This is not applicable for the same reason as point 3.

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 is not applicable. This document is for a contact lens, not an AI medical device.

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

This is not applicable. This document is for a contact lens, not an AI medical device.

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

For the non-clinical tests, the "ground truth" is typically established by physical and chemical standards, validated protocols (e.g., ISO standards, USP standards), and material properties, rather than expert consensus on medical images or pathology. For example, water content is a direct measurement, and biocompatibility is assessed against established toxicological benchmarks.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" involved in this submission.

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

This is not applicable for the same reason as point 8.

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The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index at 21ºC: 1.4011(wet)
Light Transmission: > 95%
Surface Character: Hydrophilic
Water Content at 21ºC: 59.77 %
Specific Gravity at 21ºC: 1.086(wet)
Oxygen Permeability at 34-36°C: 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).

The provided text describes a 510(k) summary for a soft contact lens and does not contain information about a study that tests the device against acceptance criteria in the context of AI/medical imaging performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a device performance study.

The document is a regulatory submission for a contact lens, which is a physical medical device, not an AI or imaging diagnostic tool. The "acceptance criteria" discussed in such a submission would typically relate to manufacturing specifications, material properties, and clinical safety/performance in human trials (bio-compatibility, visual acuity achieved, adverse event rates), rather than statistical metrics like sensitivity, specificity, or F1-scores derived from an AI model's output compared to ground truth.

Specifically, the document states:

• "The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices: Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. and Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd."
• The comparison is made on "Technological Characteristics" such as intended use, functionality, indications, production method, FDA group #, USAN name, water uptake (%), oxygen permeability (Dk), and specific gravity (wet).

These are not acceptance criteria or performance metrics related to an AI device's diagnostic accuracy.

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