(49 days)
The Contact Lens Case is a device intended for storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
The Contact lens case is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use. Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right), meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.
The provided document is a 510(k) premarket notification for a contact lens case, not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria, performance studies (like MRMC or standalone), ground truth establishment, or sample sizes related to AI/ML model development and validation.
The document focuses on demonstrating substantial equivalence to a predicate device by comparing:
- Intended Use: Both the proposed and predicate devices are for storing soft, rigid gas permeable, and/or hard contact lenses for chemical disinfection only, not heat disinfection.
- Design: Both have two adjoining wells with screw-down lids.
- Materials: While different (Polypropylene/Polyethylene vs. ABS), the proposed device's materials were tested for biocompatibility (cytotoxicity, irritation, systemic toxicity) and passed.
- Performance: Non-clinical tests were conducted for leakage and color fastness.
Since the request is specifically about AI/ML device validation, and this document is for a physical contact lens case, I cannot extract the requested information.
§ 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.”