(205 days)
Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) contact lenses as recommended by your eye care practitioner.
Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphoric acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.
Here's a breakdown of the provided information regarding the acceptance criteria and supporting studies for the Clear Care Cleaning and Disinfecting Solution.
Acceptance Criteria and Device Performance
The provided document describes studies aimed at demonstrating improved patient comfort and substantial equivalence to existing products, rather than defining explicit quantitative "acceptance criteria" in terms of specific performance metrics (e.g., minimum percent reduction in bacterial count). Instead, the acceptance is based on demonstrating statistically significant improvements in comfort symptoms and substantial equivalence in wearing time compared to control products.
The primary focus of this 510(k) submission is to add specific statements to the package insert regarding improved comfort. Therefore, the "acceptance criteria" are implicitly met by demonstrating these improvements through clinical trials.
Interpretation of Acceptance Criteria and Reported Performance
| Acceptance Criteria (Implied) | Reported Device Performance and Study Findings |
|---|---|
| 1. Improved Comfort (Specifically for prior MPS users) | A multicenter comparison of AOSept Clear Care and multipurpose contact lens care systems: Among previous multipurpose users, significant improvements were found after switching to AOSept Clear Care in: - Frequency of dryness - Intensity of dryness - During-the-day comfort - End-of-the-day comfort |
| 2. Lasting Comfort for All-Day Lens Wear | AOSept Clear Care multicenter study: The improvements in comfort were found in each measure of comfort in this study; frequency and intensity of dryness, during the day and end of the day comfort all showed significant improvements. (This supports the claim of lasting comfort). |
| 3. Substantial Equivalence to Control Products | AOSept Improved UKClinical Trial R-162-C-002: The data from this study demonstrated that Clear Care was substantially equivalent to the control multipurpose solution in terms of lens wearing time and hours of comfortable wearing time. |
| 4. Maintenance of existing safety and efficacy claims | Non-clinical tests: Solution remains unchanged from those cleared under Premarket 510(k) Notifications K003345 and K013521. This implies that the previous non-clinical safety parameters (e.g., disinfection efficacy, compatibility with lenses) are still met. (Specific performance metrics for these are not detailed in this document but are referenced as previously cleared). |
Study Information
Due to the nature of this submission (a 510(k) for revised labeling based on clinical comfort data), the typical structure of an AI/ML device study isn't directly applicable. However, I will describe the provided clinical studies in the requested format, interpreting "test set" as the enrolled patient population in the clinical trials, and "ground truth" as the patient-reported outcomes.
Clinical Study 1: A multicenter comparison of AOSept Clear Care and multipurpose contact lens care systems
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Sample size used for the test set and the data provenance:
- Sample Size: 148 patients were enrolled.
- Data Provenance: Prospective, multicenter study conducted at 18 eyecare offices throughout the United States.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study relies on patient-reported outcomes for comfort and dryness symptoms. Therefore, there were no external "experts" establishing a "ground truth" in the traditional sense of medical image interpretation. The patients themselves provided the subjective data based on their experience. The "experts" involved would be the eyecare practitioners (ophthalmologists, optometrists) at the 18 centers who conducted the evaluations, but their role was data collection rather than ground truth establishment of the primary endpoints.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the primary endpoints are patient-reported symptoms (subjective data directly from the participant). There's no external adjudication process for a patient's feeling of dryness or comfort.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this was not an MRMC study. It was a comparative effectiveness study comparing patient-reported outcomes with different contact lens care systems.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a contact lens solution, not an algorithm or AI device.
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The type of ground truth used:
- Patient-reported outcomes (subjective measures of dryness frequency, dryness intensity, comfort during the day, and end-of-day comfort).
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The sample size for the training set:
- Not applicable. This is a clinical trial, not an AI/ML development process with a distinct training set. The entire enrolled patient population serves as the "test set" for the study's conclusions.
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How the ground truth for the training set was established:
- Not applicable.
Clinical Study 2: AOSept Improved UKClinical Trial R-162-C-002
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Sample size used for the test set and the data provenance:
- Sample Size: 182 subjects.
- Data Provenance: Prospective, randomized, masked, contra-lateral with crossover clinical trial conducted in the UK.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Similar to Study 1, the primary endpoints (wearing time, comfortable wearing time) would likely be patient-reported or measured, not subject to expert "ground truth" establishment in a diagnostic sense. The eyecare professionals conducting the trial would be responsible for data collection.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as endpoints are objective measures (wearing time) or patient-reported (comfortable wearing time).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this was not an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens solution.
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The type of ground truth used:
- Measured (for lens wearing time) and patient-reported outcomes (for comfortable wearing time).
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The sample size for the training set:
- Not applicable.
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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.”