(83 days)
For the daily cleaning, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use in chemical (not heat) disinfection.
Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Alcon Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, tetronic 1304, with edetate disodium 0.05%, Polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.
The provided text describes the regulatory submission for a contact lens care product, "Alcon Multi-Purpose Disinfecting Solution ID 90746," and its approval based on substantial equivalence to existing devices. The document outlines microbiological studies, preclinical toxicology tests, and a clinical study to demonstrate safety and efficacy.
Here's an analysis of the acceptance criteria and study information, extracting what is available and noting what is not explicitly stated in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Reference/Standard) | Reported Device Performance |
|---|---|---|
| Microbiological Studies | Meets FDA Guidelines for contact lens solutions; Stand-Alone criteria for disinfection against bacteria, yeast, and mold. | The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold. |
| Preclinical Toxicology (Safety) | Substantives the safety of the product combination for use with all soft (hydrophilic) contact lenses (Group I, II, III, and IV). | Toxicological tests were conducted, including cytotoxicity (agar overlay) and ocular safety (irritation) evaluations, to substantiate safety. (Specific metrics not quantified beyond "safety"). |
| Compatibility/ Cleaning Efficacy | Compatibility with soft contact lenses and ability to clean laboratory-deposited lenses. | Studies demonstrated the compatibility and cleaning efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen. (Specific metrics not quantified beyond "compatibility and cleaning efficacy"). |
| Clinical Safety & Efficacy | Demonstrate safety and efficacy for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses. | The clinical study demonstrated the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses. (Specific metrics not quantified beyond "safe and effective"). |
2. Sample size used for the test set and the data provenance
- Clinical Study Test Set: "65 patients/130 eyes - 3 months".
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical," implying prospective data collection for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The clinical study evaluated safety and efficacy; however, it doesn't describe an "expert ground truth" for a classification task in the way a diagnostic device might. The outcome measures would be related to clinical observations by medical professionals involved in the study, but their specific roles or number for establishing a ground truth are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the text.
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
- This is not applicable. The device is a contact lens care solution, not an AI-assisted diagnostic or imaging tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. The device is a contact lens care solution and does not involve an algorithm with standalone performance. Its effectiveness is based on chemical and physical properties and their interaction with lenses and biological systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the Microbiological Studies: The ground truth was based on the "FDA Guidelines for contact lens solutions" and "Stand-Alone criteria for disinfection." These are established regulatory and industry standards for germicidal efficacy.
- For Preclinical Toxicology: Ground truth for safety was established through standardized toxicology tests like "cytotoxicity (agar overlay)" and "ocular safety (irritation) evaluations."
- For Compatibility/Cleaning Efficacy: Ground truth for compatibility and cleaning efficacy was established through laboratory studies evaluating interaction with lenses and removal of deposited materials.
- For the Clinical Study: The ground truth for safety and efficacy would have been based on clinical observations and assessments by ophthalmologists or optometrists involved in the study, measuring parameters related to lens comfort, ocular health, and cleaning performance over the 3-month period. The text does not specify exact outcome measures beyond "safe and effective."
8. The sample size for the training set
- This is not applicable as the device is not an AI/ML algorithm that requires a "training set." The development of the solution would involve formulation and laboratory testing, but not in the context of a machine learning training set.
9. How the ground truth for the training set was established
- This is not applicable for the reasons stated in point 8.
§ 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.”