(100 days)
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
The provided text describes the 510(k) submission for the "Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses." However, it is not a study of a device that uses AI or machine learning. This submission relies on demonstrating substantial equivalence to a predicate device (Alcon RGP Multi-Purpose Solution ID 100136, K000148) by confirming that the new device has:
- The same formulation, ingredients, and intended use.
- Equivalence in chemical composition to the predicate device.
- Satisfactory biocompatibility and shelf-life stability.
Therefore, most of the requested information regarding AI/ML studies, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance, are not applicable to this document. The "Performance Data" section explicitly states that "there were no additional clinical studies required to establish the safety and efficacy of the new device" due to its equivalence to the previously cleared predicate.
However, I can extract the acceptance criteria and performance data as presented for the non-clinical aspects and the general claim of equivalence.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Chemical Composition: Equivalent to predicate device. | Chemical analysis of the Japanese product confirmed equivalence to the product manufactured by Alcon (the predicate device). The composition listed for the new device is identical to the predicate device. |
| Biocompatibility: Components meet ISO 10993 standard. | "Components used in this product have been evaluated in accordance with Part 10993 of the ISO standard for Biological Evaluation. Test results indicate the test articles meet the ISO standard." (This was done for the predicate and confirmed for the new device's container). |
| Shelf-life Stability: Satisfactory. | "Shelf life stability tests" were conducted on the new device (implicitly found satisfactory, as substantial equivalence was determined). |
| Safety and Efficacy: As safe and effective as the predicate. | "Based upon the test data presented, the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is as safe, as effective and performs as well as the predicate device." This is based on the new device having the "same formulation, are manufactured by equivalent manufacturing processes and meet the same product release specifications" as the predicate device. |
| Intended Use: Identical to predicate device. | The "Indications for Use" for the new device are word-for-word identical to those of the predicate device. |
Explanation: The "acceptance criteria" here are that the new device must be substantially equivalent to the predicate device across key characteristics. The "reported device performance" is the evidence presented to show this equivalence.
Non-Applicable Information for this type of Submission:
The following information is not present in the provided document because the submission relies on demonstrating substantial equivalence to an existing device rather than presenting a novel AI/ML device study:
- Sample size used for the test set and the data provenance: Not applicable as no new clinical study was conducted for this device. The non-clinical testing was comparative/confirmatory.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of an AI/ML study. The "ground truth" for this submission is the established safety and efficacy of the predicate device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”