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510(k) Data Aggregation
(222 days)
For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, 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 (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.
The provided text describes the Alcon Multi-Purpose Disinfecting Solution (MPDS) and its clearance through a 510(k) premarket notification. It outlines the safety and effectiveness studies conducted, but does not present acceptance criteria in a table format with numerical performance metrics for the device. The term "acceptance criteria" is used in a general sense, referring to compliance with guidelines.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance Study for Alcon Multi-Purpose Disinfecting Solution (MPDS)
The Alcon Multi-Purpose Disinfecting Solution (MPDS) was evaluated against guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, as well as relevant ANSI and EN ISO standards for microbiological requirements (EN ISO 14729:2001) and antimicrobial preservative efficacy (EN ISO 14730:2000).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table. Instead, it refers to meeting established guidelines and demonstrating clinical equivalence or superiority. The reported performance is qualitative.
| Category | Acceptance Criteria (Implied based on guidance/standards) | Reported Device Performance |
|---|---|---|
| Cleaning Efficacy | Effective removal of protein deposits and reduction of lipid deposition from contact lenses. Surfactant concentrations above Critical Micelle Concentration (CMC). | Alcon MPDS is "effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses." Studies "also demonstrated cleaning activity." Surfactant concentrations are "well above the CMC." |
| Compatibility | Compatibility with soft (hydrophilic) and silicone hydrogel lenses, ensuring no adverse effects on lens material or performance. | "The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses." |
| Microbiology | Meeting or exceeding criteria for disinfection and preservative efficacy as defined by FDA guidance (May 1, 1997), ANSI Z80, EN ISO 14729:2001, and EN ISO 14730:2000. This typically involves specific log reductions for various microorganisms and maintenance of antimicrobial activity over time. | "Alcon MPDS exceeds the criteria for disinfection and preservative efficacy." |
| Biocompatibility | Compliance with guidelines set forth in FDA's May 1, 1997 Guidance, ensuring safety for consumer under recommended and reasonably foreseeable misuse conditions. This typically involves cytotoxicity, sensitization, irritation, and other systemic toxicity tests. | "Based on the results of the comprehensive preclinical evaluations, Alcon MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse." |
| Clinical Efficacy | Clinically acceptable safety and efficacy in silicone hydrogel and soft contact lens wearers, comparable to or better than a legally marketed predicate device (Bausch & Lomb™ renu® fresh™). Outcomes on comfort and moisture from insertion to removal should be adequate. | "The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control." "The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal." |
2. Sample Size and Data Provenance (for test set/clinical study)
- Sample Size: Not explicitly stated for the clinical study. The text only mentions "a clinical study was conducted" with "silicone hydrogel and soft (hydrophilic) contact lens wearers."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and is prospective in nature, as it evaluates the safety and efficacy of the new Alcon MPDS in lens wearers.
3. Number of Experts and Qualifications (for ground truth)
- This information is not provided in the given text. For a medical device like a contact lens solution, ground truth regarding safety and efficacy in a clinical setting would typically be established by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed.
4. Adjudication Method (for test set)
- This information is not provided in the given text. While a clinical study was performed, the method of adjudicating outcomes (e.g., adverse events, comfort scores) is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for diagnostic imaging AI devices, not for a contact lens care solution. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. Standalone Performance (Algorithm only)
- No, a standalone (algorithm only) performance study was not conducted. This device is a chemical solution, not an AI algorithm. Its performance is inherent to its chemical formulation and interaction with biological and material components.
7. Type of Ground Truth Used (for test set)
- The ground truth for the clinical study would be based on clinical assessments and patient reports of outcomes (e.g., safety events, comfort levels, visual acuity where relevant) in comparison to the control product. For microbiological studies, ground truth is established by standard laboratory culture methods. For cleaning and compatibility, it's based on laboratory analytical methods.
8. Sample Size for the Training Set
- This concept is not applicable as the device is a chemical solution, not an AI algorithm that requires a training set. The development of the solution involved chemical formulation and in-vitro testing.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable for a chemical solution. The "ground truth" during development would be based on scientific principles, chemical analysis, and iterative testing in vitro to optimize the formulation for its intended functions (cleaning, disinfection, compatibility).
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