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The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.

The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).

The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:

Chord diameter: 12.5 to 17.0mm
Center thickness: 0.13 to 0.73; varies with power
Base curve: 7.0 to 10.5mm
Powers: -20.00 to +20.00 diopters
ADD powers (multifocal): Up to +3.00 diopters
Cylinder (toric): Up to 4.00 diopters
Axis (toric): 0° to 180° in 1° steps
Optical zone diameters: 5.0 to 10.0mm

The physical/ootical properties of the lens are:

Refractive Index 1.408 (hydrated)
Light Transmission - tinted greater than 90%
Water Content 54%
Specific Gravity 1.299 (dry)
Oxygen Permeability (Dk Value) 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects

The provided text is a 510(k) summary for the C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/ML medical devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a contact lens. The "study" mentioned is the established safety profile and manufacturing/chemistry data, which were deemed equivalent to the predicate device.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies) are not applicable to this type of submission.

Here's a breakdown of the available information:

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

No explicit acceptance criteria in terms of accuracy, sensitivity, or specificity are provided for this medical device submission. The substantial equivalence argument relies on the inherent properties of the contact lens material and design being comparable to already approved devices.

The "performance" is implicitly demonstrated through the device's physical/optical properties and the claim of 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)

Not applicable. This submission relies on substantial equivalence to predicate devices, not a new clinical performance study with a test set in the conventional AI/ML sense. The "safety profile (pre-clinical toxicology and manufacturing/chemistry data)" of the device is stated to be equivalent to the predicate device (BENZ-G 4X (hioxifilcon D), 510(k) K062854). This implies that previous data collected for the predicate device forms the basis of comparison, but specific sample sizes and data provenance for that data are not detailed in this document.

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. Ground truth establishment with experts is not relevant for this type of substantial equivalence submission for a contact lens.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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. An MRMC study is not relevant for a contact lens submission focused on substantial equivalence. There is no AI component mentioned.

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

Not applicable. This device is a physical contact lens, not an algorithm.

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

Not applicable. The concept of "ground truth" as typically applied to performance studies (like for AI/ML devices) is not directly addressed here. The "truth" is established by the known physical, chemical, and optical properties of the material and the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML device.

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

Not applicable. There is no "training set" or "ground truth for a training set" in this context.

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