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MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated 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 -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.

The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.

When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

This document is an FDA 510(k) clearance letter for a contact lens, not a medical device that relies on AI or complex algorithms requiring extensive performance studies with human readers or AI-specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design for AI models (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable to this submission.

However, I can extract the relevant performance data and the conclusion regarding substantial equivalence for this specific device.

Device Name: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (with e-PL in the packaging solution)

Predicated Device: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (K131378)

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):

The submission aimed to demonstrate substantial equivalence to a predicate device, with the primary difference being the addition of 100 ppm Epsilon-Polylysine (e-PL) to the blister packing solution as a preservative. The acceptance criteria are implicitly met by demonstrating that the physical, mechanical, optical, and toxicological properties of the new device are equivalent to the predicate device and comply with relevant standards.

Here's a table summarizing the types of performance testing done and the overall conclusion:

Regarding the other requested information (which is not directly applicable to this non-AI device submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated as a distinct "test set" in the context of an AI model. The bench testing data would involve samples of the manufactured contact lenses. Data provenance is implied to be from laboratory testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a contact lens's physical properties is established by objective measurements based on specified standards, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Evaluation is done by standardized laboratory testing.
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 or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI or algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was established through adherence to recognized international and industry standards (ISO, ANSI, ASTM) for measuring physicochemical properties and conducting biocompatibility tests (e.g., specific gravity, refractive index, water content, cytotoxicity).
8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI/machine learning product.
9. How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the Submission:

"Conclusive evidence was provided to demonstrate that the subject device lens material is equivalent to the currently marketed predicate device lens material through the statistical analysis of the physical/mechanical/optical properties of the lens. Based on the performance testing and the fact that the subject device has the same manufacturing process as the marketed predicate device lens, clinical performance data was not required to be submitted in this 510(k). The performance testing demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device."

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