(59 days)
The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
The Menicon Saline Rinse Solution is a sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution indicated for rinsing soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. This sterile, normal saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.
The provided document describes a 510(k) premarket notification for the "Menicon Saline Rinse Solution" and does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.
The document is for a contact lens care product, which is a saline solution, not an AI/ML device. Therefore, the requested information (table of acceptance criteria and reported device performance for AI/ML, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not applicable to this submission.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on composition, intended use, and existing regulatory standards for saline solutions.
Key information provided in the document related to its performance and regulatory approval includes:
- Non-Clinical Data: Biocompatibility tests were deemed "unnecessary" because "The solution is a 0.9 % saline solution that meets the requirements of USP saline." This implies that meeting USP standards for saline is the key acceptance factor, and the components are considered safe for intended use.
- Clinical Data: Clinical studies were "unnecessary" because "Lens care solutions used with this Saline Rinse Solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses." This indicates reliance on the known safety and efficacy of similar existing products and the established utility of saline.
- Conclusion: The device is considered "as safe, as effective and performs as well as the predicate devices" based on its composition and previous test data (presumably regarding the USP standards and predicate device data).
In summary, for this specific product (Menicon Saline Rinse Solution), the "acceptance criteria" are implied to be adherence to United States Pharmacopeia (USP) standards for saline and its similarity in composition and intended use to already cleared predicate devices. No detailed performance study with specific metrics (like sensitivity, specificity, or AUC) or human reader performance is presented because it's a sterile saline solution, not an AI/ML diagnostic or therapeutic device.
§ 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.”