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The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the above lenses 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 disinfecting system.

The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear. visibility-tinted, and decorative) are hemispherical shells with molded spherical base curves and lathe-cut front surfaces and are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eves.

The non-ionic lens material, polymacon, is a hydrophilic copolymer of 2hydroxyethyl methacrylate (2-HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. It consists of consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for dayto-day cosmetic or occasional theatrical purposes. These decorative designs may be distributed under a unique or "private label" trade name such as See Clear, See Clear Color, and Fierce Contact Lenses. Lenses are tinted only with FDAapproved ("listed") listed color additives for which FDA has previously reviewed the toxicology / biocompatibility profiles. Tinted lenses contain only the amount of color additive needed to accomplish the intended decorative effect.

In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. When placed on the cornea, the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear acts as a refracting medium to focus light rays on the retina.

The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped, however it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

The provided text describes a 510(k) submission for the "See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear." This submission aims to demonstrate substantial equivalence to a predicate device, the "MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lens for Daily Wear."

Based on the provided information, there is NO study described that details acceptance criteria and device performance in the way typically expected for a medical device that improves human performance (e.g., AI assistance, diagnostic tools).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a contact lens. The "acceptance criteria" are implied by the comparison to the existing, legally marketed predicate device, rather than specific performance metrics against a defined standard. The "study" here refers to the collection of non-clinical performance data to show that the new device has similar characteristics to the predicate.

Here's an analysis based on the request, interpreting "acceptance criteria" and "study" within the context of a 510(k) for a contact lens:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission aiming for substantial equivalence, the "acceptance criteria" are generally that the new device's technical characteristics and intended use are sufficiently similar to the predicate device and do not raise new questions of safety or effectiveness. The "performance" is therefore a comparison against the predicate.

Note regarding "Acceptance Criteria": For a 510(k), acceptance criteria are not typically expressed as strict pass/fail thresholds for quantitative performance values in the same way a direct efficacy or diagnostic performance study might. Instead, the submission argues that the new device's parameters are similar enough to the predicate device, or differences do not raise new questions of safety or effectiveness. For example, the oxygen permeability of the subject lens is higher than the predicate, which would generally be seen as a positive or at least not a negative safety concern. The elongation at break is lower, but the tensile strength and breaking force are similar. The submission asserts overall "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)

The document lists "Non-Clinical Performance Data" which includes:

• Chemical composition of finished lenses
• Purity of initial monomers
• Shelf Life
• Leachability of Residual Monomers
• Leachability of Color Additives
• Biocompatibility testing
• Sterilization Validation
• Color and light transmittance
• Refractive index
• Water content
• Oxygen permeability
• Specific gravity
• Mechanical Testing

Sample Size: The document does not specify the sample sizes used for any of these non-clinical tests.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that testing "has been performed."

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 type of information is not relevant or included in the provided 510(k) summary for a contact lens. The "ground truth" for non-clinical performance data is derived from standard laboratory testing methods (e.g., revised Fatt method for oxygen permeability). There is no "test set" and "ground truth" established by human experts in the context of diagnostic interpretation as implied by the question.

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

Not applicable. There is no human adjudication process described for the non-clinical performance data of a contact lens.

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 device is a contact lens, not a diagnostic or AI-assisted device for human readers. No MRMC study was performed.

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

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

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

For the non-clinical performance data, the "ground truth" is established by direct physical, chemical, and biological measurements and tests performed according to recognized standards and methods (e.g., revised Fatt method for oxygen permeability, standard mechanical testing). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is a physical product (contact lens), not an AI algorithm requiring a training set.

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

Not applicable. No training set is involved.

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