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UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:

• in the power range of -20.00 to +20.00 diopters for sphere,
• with center thickness from 0.16 mm to 0.39 mm
• with base curves of 5.5 mm to 9.00 mm
• with diameter of 14.50mm

When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material.

The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.

This document describes the premarket notification for UltraHealth™ SiH and UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses. It details the device, its intended use, and its substantial equivalence to previously approved devices.

Here's a breakdown of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already been proven safe and effective. The "reported device performance" is essentially that the new lenses are equivalent in design and material to previously cleared safe and effective lenses. The table below summarizes the characteristics of the new lenses compared to predicate and reference lenses, implying that similarity to the predicate is the primary criterion for acceptance.

The key "performance" is that the new lenses are made of materials and have designs that match, or are substantially equivalent to, previously cleared devices.

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 refers to "[c]linical studies submitted in K052675 and K060102" which "were shown to be safe and effective." These predicate devices' studies were conducted "per the FDA Contact Lens Daily Wear Guidance Document, May 1994."

• Sample size: Not explicitly stated in this document. It refers to the clinical studies of predicate devices (K052675 and K060102) without detailing their sample sizes.
• Data provenance: Not explicitly stated in this document. Details would be in the original submissions for K052675 and K060102. It's safe to assume they were prospective clinical studies, given the nature of a medical device approval process and the reference to FDA guidance for contact lens clinical trials.

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 this is a contact lens submission, not an AI or diagnostic imaging device submission. Safety and effectiveness are determined through clinical trials and material biocompatibility, not by expert interpretation of data for ground truth establishment in a diagnostic context.

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

Not applicable for this type of medical device submission. Clinical trial outcomes are typically assessed by investigators and monitored for adverse events and visual acuity changes, not through an adjudication method like those used for diagnostic device ground truth.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device (contact lens).

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

For the predicate devices, safety and effectiveness were established through outcomes data from clinical studies. This would typically include:

• Visual acuity measurements with the lenses.
• Assessment of ocular health (e.g., absence of adverse events like corneal staining, infections, edema) by optometrists/ophthalmologists.
• Patient comfort and satisfaction.

8. The sample size for the training set

Not applicable. This is a contact lens submission, not an AI/machine learning device. The "training set" conceptually for a physical device would be the product development and testing phases, which do not involve a "training set" in the AI sense.

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

Not applicable. See point 8.

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