(188 days)
AQuify® Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called Aquify® Multipurpose Solution. This document is related to regulatory approval for a contact lens care product and does not contain information about the performance of an AI/ML powered device, its acceptance criteria, or any associated studies.
Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”