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The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and Toric Soft Contact Lenses For Daily Wear, are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or possess refractive astigmatism not exceeding 10 Diopters. They are available for either conventional wear or planned replacement modalities.

Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses

The provided document is a 510(k) premarket notification letter for soft contact lenses. It does not contain information about the acceptance criteria or a study proving that a device (in the context of AI/software as a medical device) meets acceptance criteria.

The document discusses the substantial equivalence of Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses to legally marketed predicate devices. The focus is on the regulatory pathway for these contact lenses, which fall under 21 CFR 886.5925, Soft (hydrophilic) contact lens, and are classified as Class II.

Therefore, I cannot extract the requested information about acceptance criteria and a study from this document, as it pertains to contact lenses and not a device that would typically have the kind of performance study details requested (e.g., sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance).

The information provided in the prompt is specific to a type of medical device (like an AI algorithm) that would undergo performance evaluation against explicit acceptance criteria, often involving clinical studies with human readers, ground truth, and statistical analysis. This document simply confirms the FDA's decision regarding the substantial equivalence of ophthalmic contact lenses based on their regulatory classification.

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