(177 days)
For use in the daily cleaning, conditioning, rinsing, removing protein deposits, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
ALCON® Multi-Purpose Disinfecting Solution can also be used with OPTI-FREE® SUPRACLENS® Daily Protein Remover.
ALCON® Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, sodium borate, propylene glycol, a proprietary dual action conditioning system (Tetronic® 1304t, nonanoyl ethylenediaminetriacetic acid) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0005% as preservatives.
The provided text describes the Alcon Multi-Purpose Disinfecting Solution, a contact lens care product, and its submission for 510(k) premarket notification. The document details safety and effectiveness studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information, specifically focusing on what can be extracted from the provided text for a device performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in a quantitative, pass/fail format with specific performance metrics defined beforehand. Instead, it refers to meeting "guidelines" and "standards" and then reports study results. However, we can infer acceptance criteria based on the standards cited and the reported outcomes.
| Acceptance Criteria (Inferred from Standards/Guidelines) | Reported Device Performance |
|---|---|
| Cleaning Effectiveness: Effective passive cleaning for silicone hydrogel and soft contact lenses. | Effective at passively cleaning all soft contact lenses, including silicone hydrogel lenses. Improved cleaning efficacy with OPTI-FREE® SUPRACLENS®. Surfactant concentration well above Critical Micelle Concentration (CMC). |
| Compatibility: Compatible with silicone hydrogel and FDA Groups I and IV contact lenses. | Compatible with all soft contact lenses, including silicone hydrogels. |
| Wettability (In vitro & Ex vivo): Show excellent wettability (significantly lower wetting angles) compared to predicate. | Showed significantly lower wetting angles (excellent wettability) in in vitro and ex vivo studies compared to Bausch & Lomb ReNu MultiPlus. Statistically significant difference (p ≤ 0.0001) in favor of ALCON® Multi-Purpose Disinfecting Solution after wear. |
| Microbiological Efficacy (Stand Alone Test): Meet Stand Alone Antimicrobial Activity criteria (FDA Guidance, EN ISO 14729, ANSI Standard, EN ISO 14730) in presence and absence of organic soil. | Meets Stand Alone Antimicrobial Activity in presence and absence of organic soil. |
| Microbiological Efficacy (Regimen Test): Pass Regimen Criteria in the presence of soil when tested according to directions for use. | Passes Regimen Criteria in the presence of soil when tested according to the directions for use. |
| Microbiological Efficacy (with SUPRACLENS®): Meet primary criteria of Stand Alone test with OPTI-FREE® SUPRACLENS®. | Combination with OPTI-FREE® SUPRACLENS® meets primary criteria of the Stand Alone test. |
| Biocompatibility: Meet FDA guidelines for contact lens care products; safe for consumers under recommended use and foreseeable misuse. | Meets FDA guidelines; safe based on comprehensive preclinical evaluations. |
| Clinical Safety & Efficacy: Clinically acceptable and similar to marketed comparator regimens. (Inferring no significant adverse events, similar comfort, and acceptable lens condition). | Clinically acceptable and similar to marketed comparator regimens (Bausch & Lomb ReNu MultiPlus and AMO Complete MoisturePLUS). |
| Clinical Lens Deposits: Demonstrate statistically lower levels of lens deposits compared to control regimens. | Statistically lower levels of lens deposits than control regimens. |
| Clinical Corneal Staining: Demonstrate statistically lower corneal staining compared to predicate. | In at least one study, subjects had statistically lower corneal staining compared to one of the predicate product regimens. |
| Clinical Comfort: Demonstrate significantly improved comfort on some measures compared to predicate. | In at least one study, subjects had significantly improved comfort (on some measures) compared to one of the predicate product regimens. |
2. Sample Size Used for the Test Set and the Data Provenance
The document provides information on clinical studies but does not explicitly define a "test set" in the context of an algorithm's performance evaluation as might be expected for an AI device. Instead, it describes clinical trials.
- Clinical Studies (Safety and Efficacy):
- One three-month clinical study with asymptomatic soft (hydrophilic) lens wearers.
- One one-month study with silicone hydrogel lens wearers.
- One one-month study with symptomatic soft (hydrophilic) lens wearers.
- An additional clinical study for wettability evaluation (also cited in wettability studies section).
- Sample Size: The exact number of subjects in each clinical study is not provided.
- Data Provenance: The document does not specify the country of origin for the clinical study data or explicitly state whether they were retrospective or prospective. Given they are described as "clinical studies" and compare "regimens," they are inherently prospective.
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 document. The studies described are clinical trials evaluating the product's performance in human subjects, not a diagnostic algorithm where expert consensus might establish a "ground truth" for a specific condition. Evaluations would likely be conducted by optometrists or ophthalmologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. As detailed above, the context is not an algorithm performance evaluation where expert adjudication of results would be typical. Clinical trial outcomes would be assessed based on established clinical endpoints and measurements.
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 Multi-Reader Multi-Case (MRMC) Study was done. The device is a contact lens care solution, not an AI-powered diagnostic tool.
- No AI assistance is involved. Therefore, there is no effect size related to human reader improvement with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance was done. The device is a physical product (contact lens solution), not an algorithm.
7. The Type of Ground Truth Used
For this type of device (contact lens solution):
- Clinical Ground Truth: Clinical studies assessed various parameters like comfort levels, lens deposits, corneal staining, and wettability. These are direct measurements of physiological responses or visual assessments made by clinicians.
- Microbiological Ground Truth: For efficacy, laboratory standards (e.g., FDA Guidance, EN ISO 14729) define target log reductions for specific microorganisms, which serve as the "ground truth" for antimicrobial activity.
- Chemical/Physical Ground Truth: Cleaning efficacy (CMC), compatibility, and wettability studies use scientific measurements and established physical/chemical principles.
8. The Sample Size for the Training Set
- Not applicable. The device is a contact lens solution, not an AI model. Therefore, there is no "training set." The product's formulation and associated laboratory testing could be considered its developmental "training," but not in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question does not apply. The "ground truth" for the product's development and pre-clinical testing would be established through established scientific methods, chemical analysis, in vitro microbiological assays, and compatibility testing with known lens materials.
§ 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.”