(223 days)
For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.
ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ALCON® Multi-Purpose Solution:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes general categories of studies and concludes that the device performed acceptably.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning Efficacy | "TETRONIC® 1304 concentration is well above the CMC, which ensures the effective cleaning function of the product. These findings are supported by results of clinical evaluations." |
| Lens Compatibility | "Lens compatibility studies performed show that ALCON® Multi-Purpose Solution is compatible with silicone hydrogel lenses." |
| Microbiological Efficacy (Disinfection & Preservative) | "These results indicate ALCON® Multi-Purpose Solution meets satisfactory levels of disinfection and preservative efficacy" based on EN ISO 14729:2001, ANSI Contact Lens Care Products Standard, and EN ISO 14730:2000. |
| Biocompatibility | "Based on the results of the preclinical evaluations, ALCON® Multi-Purpose Solution is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse." |
| Clinical Safety & Efficacy | "The safety and efficacy of the ALCON® Multi-Purpose Solution were clinically acceptable. Subjects assigned to the ALCON® Multi-Purpose Solution regimen had statistically less corneal staining compared to the control regimen with silicone hydrogel lenses." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Cleaning Studies: Not specified, but implied by "clinical evaluations."
- Compatibility Studies: Not specified.
- Microbiology Studies: Not specified beyond adherence to standards.
- Clinical Studies: The document mentions "Two clinical studies were conducted." The exact number of subjects in these studies is not specified.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Clinical studies are generally prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The studies performed are tests of the chemical solution itself (cleaning, microbiology, biocompatibility) and clinical outcomes in human subjects, not dependent on expert interpretation of images or other data that would require a "ground truth established by experts" in the traditional sense of AI/medical device studies.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided as the studies are focused on direct chemical/biological assays and clinical outcomes rather than expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document describes clinical studies where subjects were assigned to either the ALCON® Multi-Purpose Solution regimen or a control regimen (Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution). This is a direct comparison of solution performance, not a study involving multiple human readers interpreting results with and without AI assistance.**
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the device is a contact lens solution, not an AI algorithm. The performance evaluation is inherently "standalone" in that it's evaluating the product itself, not an algorithm's output.
7. The Type of Ground Truth Used:
- For Cleaning Studies: The "ground truth" was likely derived from the Critical Micelle Concentration (CMC) measurement and subsequently confirmed by clinical evaluations (which would involve direct observation of lens cleanliness or indirectly through patient comfort/health).
- For Compatibility Studies: The "ground truth" would be established by direct observation and measurement of lens material integrity after exposure to the solution.
- For Microbiology Studies: The "ground truth" was adherence to established international and ANSI standards (EN ISO 14729:2001, EN ISO 14730:2000) for disinfection and preservative efficacy, which involve quantitative microbial reduction targets.
- For Biocompatibility: The "ground truth" was likely established through preclinical tests designed to assess tissue irritation, cytotoxicity, and other adverse biological reactions, guided by recognized biocompatibility standards.
- For Clinical Studies: The "ground truth" for efficacy (e.g., corneal staining) was established through direct clinical observations and measurements by eye care professionals in the studies.
8. The Sample Size for the Training Set:
- This information is not applicable as the device is a physical solution, not an AI model 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 a physical solution, not an AI model.
§ 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.”