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The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and 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 1.00 diopter or less that does not interfere with visual acuity.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal design is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal-toric design is indicated for daily wear for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement, or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is for daily wear and is fully molded in the sphere, toric, multifocal-toric design configurations. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from senofilcon C, which contains silicone hydrogel material and other hydrophilic monomers. The lens consists of 59.0% senofilcon C and 41.0% water by weight when immersed in saline solution. The senofilcon C name has been adopted by the United States Adopted Names Council (USAN).

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens contains Reactive Blue 246 (21 CFR Part 73.3106) for visibility and handling. The Lucens 41 (senofileon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315nm - 380mm).

This looks like a 510(k) summary for a contact lens, not a software device that would typically have the kind of acceptance criteria and study details you're asking about (e.g., AI performance metrics, expert consensus, MRMC studies, ground truth establishment methods for training sets).

The document details the Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens and its substantial equivalence to a predicate device (ACUVUE (senofilcon C) Soft Contact Lens).

Therefore, answering your request using this document for the specified criteria (e.g., "effect size of how much human readers improve with AI vs without AI assistance") is not possible because this is not an AI/software device.

However, I can extract the closest analogous information from this document regarding its "acceptance criteria" through performance testing and the "study" (non-clinical performance testing and substantial equivalence argument) used to prove it meets them.

Here's a breakdown of the available information, addressing what can be, and explaining why other points cannot be, derived from this specific document:

Acceptance Criteria and Device Performance (Analogous for a Contact Lens)

For a contact lens, "acceptance criteria" are typically related to its physical, chemical, and biological properties, and meeting the performance characteristics of a legally marketed predicate device. "Device performance" would be the results from their testing.

Study Details (Analogous for a Contact Lens)

1. Sample size used for the test set and the data provenance:

   • The document primarily relies on non-clinical performance testing (toxicology, shelf life, bench tests). It does not specify "sample sizes" in the context of patient data or test sets like AI studies would.
   • Data Provenance: The studies were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying a controlled laboratory environment, rather than clinical patient data from a specific country. This is retrospective/bench data for device characterization, not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept is not applicable here. Ground truth, in the context of a medical device like a contact lens, relates to established scientific methods and standards for material properties, biocompatibility, and physical dimensions. There are no "experts" establishing ground truth in the way a radiologist might for an image-based diagnosis. The "ground truth" is determined by validated laboratory test methods and established international standards (e.g., ISO, FDA guidance).

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

   • This is not applicable for non-clinical performance testing of a contact lens. Adjudication methods are used in clinical studies, particularly in AI or diagnostic settings where human interpretation differences need to be resolved.

4. 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:

   • No. This is a contact lens. There are no human "readers" or AI assistance involved in evaluating its performance in this context.
   • The study focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

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

   • Not applicable. This is not a software algorithm.

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

   • For this device, the "ground truth" is based on:
     • Standardized physicochemical measurements: (e.g., refractive index, water content, oxygen permeability) conducted in a laboratory setting using validated equipment and methods.
     • Biological safety standards: (e.g., ISO 10993 for biocompatibility/toxicology) which define acceptable limits for cytotoxicity, systemic toxicity, and ocular irritation.
     • Product specifications and tolerances: (e.g., sphere power, diameter, base curve) that must be met during manufacturing.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth established for it in this context.

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