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The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The eye care practitioners may prescribe the contact lens for single use daily disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily disposable single use and should be discard after removal.

The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a random copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% water by weight.

These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive.

The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing wetting agent.

This document describes the premarket notification for the "Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear".

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance metrics in a format directly mapping to typical AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device through physiochemical properties, non-clinical tests, and a clinical study. The acceptance criteria for the clinical study are primarily related to non-inferiority in effectiveness and safety.

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

• Sample Size (Clinical Study):
  • Screened: 151 subjects
  • Randomized and Enrolled: 144 subjects (73 in test group, 71 in control group)
  • Completed the study: 139 subjects (70 in test group, 69 in control group)
• Data Provenance: The clinical study was conducted in Taiwan. It was a prospective, randomized, double-blind, parallel, active-controlled clinical study.

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

This information is not provided in the document. The study involves visual acuity measurements and ocular examinations, which would typically be performed by trained medical professionals (e.g., ophthalmologists, optometrists), but the number and qualifications of these individuals are not specified as "experts establishing ground truth" in the context of an AI/ML device. For contact lenses, "ground truth" would relate to objective measurements of visual acuity and ocular health assessments, not typically expert consensus on interpretations.

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

This information is not explicitly provided. Clinical studies for contact lenses often involve masked evaluators, but a formal adjudication method like "2+1" for discrepancies is not mentioned.

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 was not a multi-reader multi-case (MRMC) comparative effectiveness study. This study is for a contact lens, which is a medical device, not an AI/ML algorithm that assists human readers.

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

This was not a standalone performance study. Again, this document refers to a contact lens, not an AI/ML algorithm.

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

For the clinical study, the ground truth for effectiveness was based on objective measurements of corrected visual acuity (≥ 1.0) with the contact lens. For safety, it was based on the incidence of adverse events and ocular health assessments. These are clinical outcomes and objective measurements.

8. The sample size for the training set:

This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" in that context. The document refers to the manufacturing process and material characteristics, which are developed and tested, but not in the framework of machine learning training data.

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

This information is not applicable as this is not an AI/ML device.

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