(88 days)
ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.
Not Found
This document is a 510(k) clearance letter from the FDA for a multi-purpose contact lens solution called ContaClair®. It does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/ML medical device) meets acceptance criteria. The product is a chemical solution, not a software or hardware device that would typically involve acceptance criteria and a study as requested.
Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory approval for a contact lens care product, not a description of a device's performance study.
§ 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.”