(234 days)
Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together.
The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).
The provided document describes the FDA 510(k) clearance for Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it states that tests were conducted according to established guidance and protocols, and the results "demonstrated" effectiveness or compatibility. The general acceptance criterion for most tests appears to be "similar to the predicate device" or "effective/compatible."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Lens Compatibility | Compatible with various commercially available hydrogel, silicone hydrogel, and RGP lenses. | "Results demonstrated that the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution was compatible with the test contact lenses." |
| Neutralization Profile | Similar neutralization profile to the predicate device; neutralizer catalyst disk stability. | "The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution showed a similar neutralization profile to the predicate device. In addition, stability of the neutralizer catalyst disk was confirmed for 90-cycles treatments." |
| Disinfecting Efficacy | Harmful microorganisms reduced to an ISO level at specified time points. | "Results demonstrated that harmful microorganisms were effectively reduced to an ISO level at 6 and 24 hours and 7 days after neutralization." |
| Preservative Efficacy | Ensure 3-month open bottle discard date. | "Preservative Efficacy test was conducted to ensure 3-month open bottle discard date of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution." |
| Cleaning Efficacy | Similar performance to the predicate device in protein and lipid removal. | "Results suggested that both solutions performed similarly in the removal of lens deposition." |
| Toxicology/Biocompatibility | Non-toxic and non-irritating for the neutralized solution, lens case, and catalyst. | "Results demonstrated that the neutralized solution, the lens case materials and the neutralizer catalyst were non-toxic and nonirritating under the experimental conditions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of lenses, microorganisms, or test runs) for each non-clinical test. It mentions testing with:
- Lens Compatibility: Six commercially available hydrogel/silicone hydrogel soft contact lenses and two commercially available RGP lenses.
- The data provenance (country of origin, retrospective/prospective) and specific details about the laboratories conducting these non-clinical tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a cleaning and disinfecting solution, not an AI or diagnostic imaging device that requires human expert review for "ground truth." The "ground truth" for its performance is established through objective laboratory tests and scientific protocols that measure chemical properties, microbiological reduction, and material compatibility. Therefore, the concept of "experts establishing ground truth" in the way it applies to AI diagnostic studies is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI diagnostic evaluations where human readers interpret data. This is a non-clinical, laboratory-based performance study for a chemical solution. Therefore, such adjudication methods are not applicable and not mentioned.
5. 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
No MRMC comparative effectiveness study was done. This is a chemical cleaning solution, not an AI-assisted diagnostic device, so comparison with human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance. As the device is a chemical solution, this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of this device is established through:
- Scientific Protocols and Laboratory Measurements: For lens compatibility, neutralization profiles (residual hydrogen peroxide levels), disinfecting efficacy (microbial reduction counts against ISO standards), preservative efficacy, cleaning efficacy (quantification of protein/lipid removal), and toxicology (in-vitro and in-vivo biocompatibility tests based on GLP regulations). This is essentially objective, measurable data generated by laboratory instruments and techniques following validated methods.
8. The sample size for the training set
This device is not an AI algorithm requiring a "training set." Therefore, the concept of a training set sample size is not applicable. The performance studies are validation tests, not machine learning model training.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this question is not applicable.
§ 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.”