(89 days)
For the daily cleaning, rinsing, disinfecting and storing of soft (hydrophilic) contact lenses. For use in chemical (not heat) disinfection. Alcon Multi-Purpose Solution ID 90746 can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner.
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%, Polyquad (polyquaternium-1) 0.0001% and AL-6289 0.0005% as preservatives.
The provided text describes the regulatory submission for the Alcon Multi-Purpose Disinfecting Solution ID 90746, a contact lens care product. As such, the "device" in question is a chemical solution, not a medical imaging or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components related to software-as-a-medical-device (SaMD) or AI product evaluations (like sample size for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context.
However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific product as provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Guideline | Reported Device Performance |
|---|---|---|
| Microbiological Safety & Effectiveness | FDA Guidelines for contact lens solutions | - Meets Stand-Alone criteria for disinfection of contact lenses against bacteria, yeast, and mold. |
- Finished product is effectively preserved by FDA standards.
- Finished product conforms to USP sterility requirements. |
| Preclinical Toxicology (Safety) | Substantiation of safety for cleaning, rinsing, chemical disinfection, and overnight storage of all soft (hydrophilic) contact lenses (Group I, II, III, and IV). | - Acute oral toxicity studies conducted. - Cytotoxicity (agar overlay) studies conducted.
- Mutagenicity (Ames test) studies conducted.
- Sensitization/allergic potential (guinea pig maximization test) studies conducted.
- Ophthalmic container safety studies conducted.
- Ocular safety (irritation) evaluations conducted.
- Conclusion: Should not present an ocular hazard to the consumer when used under recommended regimens. |
| Compatibility/Cleaning Efficacy | Determine product compatibility with soft contact lenses and its ability to clean laboratory-deposited lenses. | - Demonstrated compatibility with soft contact lenses. - Demonstrated cleaning efficacy for laboratory-deposited lenses. |
| Clinical Safety & Efficacy | Evaluate safety and efficacy for cleaning, rinsing, disinfection, and storage of all soft (hydrophilic) contact lenses. | - Demonstrated safety and efficacy in a clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
- Microbiological Studies: Not specified, but generally refers to standard in-vitro laboratory testing as per FDA guidelines.
- Preclinical Toxicology: Not specified for each test, but standard toxicology models (e.g., guinea pigs for sensitization, Ames test for mutagenicity) would have accepted sample sizes for each.
- Compatibility/Cleaning Efficacy: Not specified, generally laboratory-based testing using various lens types with deposited materials.
- Clinical Study:
- Sample Size: 249 patients (498 eyes) for 3 months; 121 patients (242 eyes) extending to 6 months.
- Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or under internationally recognized good clinical practice (GCP) guidelines. It's a prospective study given it's a clinical trial for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the product is a contact lens solution, not an AI or imaging device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" would be the direct measurement of microbiological kill, absence of toxicity, and clinical outcomes based on patient health.
4. Adjudication Method for the Test Set
- Not applicable as this is not an interpretive diagnostic device. Clinical outcomes would be assessed by clinical investigators, and lab results by trained technicians.
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
- Not applicable. This is not an AI diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a chemical solution, not an algorithm. The microbiological and preclinical tests can be considered "standalone" in the sense that they evaluate the product's inherent properties without user interaction beyond recommended usage.
7. The Type of Ground Truth Used
- Microbiological Studies: Direct measurements of microbial reduction/kill (e.g., colony-forming units), and adherence to USP sterility standards.
- Preclinical Toxicology: Histopathological examination, physiological measurements, and observation of adverse effects in animal models or cell cultures as per standard toxicology protocols.
- Compatibility/Cleaning Efficacy: Direct measurement of material effects on lenses and quantification of removed deposits.
- Clinical Study: Patient ocular health assessments (e.g., slit lamp examination, visual acuity), comfort ratings, and incidence of adverse events, assessed by ophthalmologists or optometrists.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- 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.”