(394 days)
EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
The EYE SEE™ Multipurpose Solution is a sterile, isotonic, buffered, solution containing boric acid, sodium chloride, Hydroxypropyl Methylcellulose (HPMC) as a lubricant, poloxamer 407 as a surfactant, disodium edetate as chelating agent, purified water and preserved with polyhexanide.
The EYE SEE™ Multipurpose Solution is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the clinical study mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on non-clinical and clinical studies demonstrating the overall safety and efficacy for all intended uses. While specific quantitative acceptance criteria for each test are not explicitly detailed in the summary, the overall outcome of the clinical study is described.
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| All Indications | Demonstrate safety and efficacy for: daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses. | A series of non-clinical and clinical studies were completed, indicating the solution meets these requirements. Specific details on non-clinical test results (e.g., microbial, toxicology) were described as "satisfactory." |
| Clinical Performance | Non-inferiority to predicate devices. | Results indicate that the solution is non-inferior to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 60 subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was conducted "Following an approved FDA clinical protocol," suggesting it was likely conducted in the US or under US regulatory oversight. It is a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. The clinical study investigated effectiveness in subjects, likely relying on direct observations and patient-reported outcomes rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This information is not provided in the summary. For a clinical study involving subject outcomes, adjudication might involve blinded assessment of adverse events or efficacy endpoints by clinicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study, typically seen in imaging for diagnostic accuracy, was not performed. The study was a clinical trial comparing the new solution to predicate devices with human subjects.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted diagnostic device study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Not applicable. This device is a contact lens solution, not an algorithm, so a standalone algorithm performance study was not relevant. The "standalone" performance here refers to the device's inherent efficacy in its intended uses. Non-clinical tests like cleaning effectiveness, microbial testing, and toxicology could be considered "standalone" as they evaluate the solution itself.
7. Type of Ground Truth Used
For the clinical study: The "ground truth" would be established through clinical assessments, patient complaints/symptoms, and potentially objective measures relevant to soft contact lens wear (e.g., ocular health exams, comfort ratings, adverse event monitoring). The summary states "results indicate that the solution is non-inferior," implying a comparison of these clinical outcomes between the test and predicate solutions.
8. Sample Size for the Training Set
Not applicable. This is a contact lens solution, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical product, not an AI/ML algorithm.
§ 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.”