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The Saview 55F (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 Diopter that does not interfere with visual acuity.

The Saview 55F(methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

The provided text is an FDA 510(k) clearance letter for the "Saview 55 (methafilcon A) Soft hydrophilic Contact Lens for Daily Wear." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

Specifically, the document does not provide any of the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human reader improvement with AI.
6. Information about a standalone (algorithm only) performance study.
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.

This letter solely states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The substantial equivalence determination means that the FDA believes the new device is as safe and effective as a previously cleared device. The specific performance data and acceptance criteria that led to this determination are typically found in the 510(k) submission itself, which is not provided in this public clearance letter.

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