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The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.

The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) soft hydrophilic contact lens has a spherical back surface. 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; 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 36% water by weight.

This document doesn't contain a study that demonstrates the device meets acceptance criteria. Instead, it's a 510(k) summary for a medical device (AL-47 Toric contact lens) seeking FDA clearance based on substantial equivalence to previously marketed predicate devices, not on new clinical performance data.

Therefore, most of the information requested about acceptance criteria and a detailed study (like sample sizes, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is presented as equivalence to these predicate characteristics.

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The AL-47 (isofilcon) Soft Contact Lens for daily wear are indicated for the correction of visual acuty in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AL-47 (isofilcon) Hydrophilic Daily Wear Contact Lens (clear, lathe-cut, parametric release)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a contact lens. It does not contain the information requested in your prompt regarding acceptance criteria and study details for device performance. It simply states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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