(267 days)
OPTI-FREE® EXPRESS® LENS DROPS may be used to lubricate and rewet daily, extended wear and disposable soft (hydrophilic) contact lenses as follows:
- Moistening lenses as needed during the day to reduce discomfort. .
- Moistening extended wear lenses prior to retiring at night and upon . awakening.
OPTI-FREE EXPRESS Lens Drops is a sterile, buffered, isotonic, aqueous solution that contains a citrate buffer and sodium chloride with edetate disodium 0.05% and Polyguad® (polyguaternium-1) 0.001% as preservatives and Clens® ~ 100.
The provided text describes a 510(k) submission for OPTI-FREE® EXPRESS® Lens Drops, which is a contact lens rewetting solution. The submission focuses on demonstrating substantial equivalence to a previously approved device. While it mentions safety and effectiveness studies, the level of detail provided is insufficient to fully answer all aspects of your request as it pertains to acceptance criteria and a structured study demonstrating all specifics.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or precise performance metrics in a readily table format. Instead, it refers to compliance with FDA guidelines for contact lens solutions and demonstration of "safety and effectiveness."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Microbiological Safety and Effectiveness: Compliance with FDA guidelines for contact lens solutions. | "Results of all tests were in compliance with the FDA testing guidelines." |
| Toxicological Safety: No hazard to consumers under recommended use or accidental/intentional misuse. | "OPTI-FREE EXPRESS Lens Drops has been shown to be safe in comprehensive toxicology studies. OPTI-FREE EXPRESS Lens Drops should not present a hazard to the consumer when used under the recommended treatment regimen for soft (hydrophilic) contact lenses, or under conditions of accidental or intentional misuse." |
| Clinical Safety and Efficacy: Safe and effective, and reduction in lens lysozyme levels. | "These clinical studies demonstrate that OPTI-FREE EXPRESS Lens Drops is safe and effective and also significantly reduce lens lysozyme levels on soft contact lenses when used as indicated." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document only states "Studies were conducted to clinically evaluate the safety and efficacy..." without giving numbers of participants or lenses.
- Data Provenance: Not explicitly stated. However, given it's an FDA submission, the studies would typically be conducted according to US regulatory standards. It's likely prospective for clinical studies, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This type of study is highly unlikely for a rewetting solution for contact lenses. MRMC studies are typically used for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated for its impact on their performance. The provided device is a liquid solution for lens care.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- This concept is not applicable to a contact lens rewetting solution. The device itself is the product, not an algorithm that operates independently. Its "performance" is assessed through its chemical and biological effects on lenses and eyes, and its clinical impact on users.
7. Type of Ground Truth Used:
Based on the nature of the studies mentioned:
- Microbiological tests: Likely laboratory assays and challenge tests with defined microbial strains.
- Toxicology studies: Likely animal models and/or in vitro cell culture tests, following established toxicology protocols.
- Clinical studies: Likely relied on patient-reported outcomes (e.g., discomfort, satisfaction) and potentially objective clinical assessments by ophthalmologists or optometrists (e.g., ocular health, lens deposition). The mention of "lens lysozyme levels" suggests quantitative biochemical analysis from lenses.
8. Sample Size for the Training Set:
- Not applicable/Not specified. For a chemical product like this, there isn't a "training set" in the context of an AI/machine learning algorithm. The "development" would involve formulation and laboratory testing leading to the product and subsequent clinical validation, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of AI. The "ground truth" for the product's development and validation would be derived from scientific principles, laboratory testing standards, and clinical study endpoints.
§ 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.”