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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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