(30 days)
For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
The two color AOCup Lens Case with AODisc is equivalent to the predicate device except modifications of colorants and minor modifications to basket geometry.
It is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize the strong oxidizing agent hydrogen peroxide to harmless water and oxygen gas.
The modifications of colorants and basket geometry do not change any indications for use nor the basic technical principle of the device functions.
The provided text is a 510(k) Premarket Notification from the FDA regarding a contact lens care product. It does not contain information about an AI-powered device or a study involving acceptance criteria, expert ground truth, multi-reader multi-case studies, or training/test set details as requested in your prompt.
Therefore, I cannot provide the information you asked for based on the input text. The document is a regulatory filing for a physical medical device (contact lens case and solution), not a software or AI-based device that would require the type of performance evaluation details you've described.
§ 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.”