(258 days)
The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
Altaire MPS#1 Multipurpose Contact Lens Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127, cremophor RH40and preserved with edetate disodium dehydrate 0.025% and polyhexanide 0.0001%
The provided text describes the 510(k) Premarket Notification for Altaire MPS#1 Multipurpose Contact Lens Solution. The submission focuses on demonstrating substantial equivalence to a predicate device (SOLO-Care Plus Multipurpose Solution, K012731) rather than a de novo study proving efficacy against specific acceptance criteria with detailed performance metrics.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The device's performance is not reported in terms of specific numerical values against quantitative acceptance criteria for each study type. Instead, the document states that the device "satisfies the requirements" or "met acceptance criteria" according to FDA guidance.
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Studies (Critical Micelle Concentration) | "satisfies the requirements for daily cleaner of lens care products as per the FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997)" | "Results of the study showed that Altaire MPS#1 Multipurpose Contact Lens Solution satisfies the requirements for daily cleaner." |
| Cytotoxicity | No specific numerical criteria are given, but implies "non-toxic and a non-irritant" is the acceptance criteria. | "Results of the testing demonstrated that Altaire MPS#1 Multipurpose Contact Lens Solution is non-toxic and a non-irritant." |
| Microbiological (Disinfection Properties - Standalone with and without soil) | Acceptance criteria are implied to be those for disinfection properties described in "FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997)". Specific numerical log reductions for various microorganisms are typically required but not stated in this summary. | "All three studies showed that the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria." |
| Microbiological (Disinfection Properties - No rub regime) | Acceptance criteria are implied to be those for disinfection properties described in "FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997)". Specific numerical log reductions for various microorganisms are typically required but not stated in this summary. | "All three studies showed that the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria." |
| Microbiological (Preservative Efficacy with 14-day re-challenge) | No specific numerical criteria are given, but implied to be "met acceptance criteria" based on relevant FDA guidance. | "the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria." |
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 sample sizes used for the various tests (Critical Micelle Concentration, Cytotoxicity, Microbiological studies).
The data provenance is also not specified (e.g., country of origin, retrospective or prospective). These details are typically found in the full study reports, not in the 510(k) 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 information is not applicable to this type of device and study. The testing for a contact lens solution involves laboratory-based chemical and microbiological evaluations, not assessments requiring expert interpretation of clinical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of laboratory testing conducted for a contact lens solution. Adjudication methods are typically used in clinical studies or image-based diagnostic studies where multiple readers' opinions need to be reconciled.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices often involving AI assistance and human interpretation, which is not the case for a contact lens solution. The submission explicitly states: "clinical performance data was not performed, nor is it a requirement for the purpose of this premarket notification" because the device is substantially equivalent to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device. A contact lens solution is not an algorithm, nor does it involve human-in-the-loop performance. The microbiological studies for disinfection were "standalone" in the sense that they evaluated the solution's efficacy against microbes without human intervention during the disinfection process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed can be inferred as:
- Cleaning Studies: Established scientific and regulatory standards (FDA Guidance document) for micelle concentration and cleaning effectiveness.
- Cytotoxicity: Established cell viability assays and irritation assessment protocols which determine what constitutes "non-toxic" and "non-irritant."
- Microbiological Studies: Established microbiological testing standards (e.g., ISO, USP, or FDA guidelines) that define specific log reduction requirements for various microorganisms or preservative efficacy.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML algorithm.
§ 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.”