(68 days)
The Paragon Lens Vial is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.
The Paragon Lens Vial is indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection.
Not Found
The provided text is a 510(k) summary for the Paragon Lens Vial, a contact lens case. It is for chemical disinfection and storage of rigid gas permeable and hard contact lenses. The submission refers to toxicology testing performed to support the premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the format requested.
The document is a regulatory approval letter and 510(k) summary, which typically outlines the device, its intended use, and its substantial equivalence to a predicate device. While toxicology testing is mentioned, the specifics of an "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes, expert involvement, and ground truth are not present.
Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not contained within the provided text.
§ 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.”