(125 days)
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only, Not to be used with heat.
The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.
This document describes the regulatory submission for the "i-Promotions Contact Lens Case" and does not contain information about the acceptance criteria or a study that proves a device meets such criteria in the context of advanced medical technologies or AI/ML.
The provided text focuses on the device's classification, intended use, and summary of safety testing carried out for regulatory clearance. It benchmarks the device against predicate devices based on design and materials, rather than performance metrics.
Therefore, I cannot provide the information requested in your bullet points (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details) because the document does not discuss these aspects in the context of device performance or clinical studies. The "Summary of Safety Testing" section only mentions cytotoxicity testing to demonstrate the product is safe for its intended use, but doesn't provide specific performance acceptance criteria or detailed study results beyond a general statement of safety.
§ 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.”