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The 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 Contact Lens 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 Contact Lens Solution is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

The provided text describes a 510(k) submission for the EYE SEE™ Multipurpose Contact Lens Solution, specifically for a change in Directions for Use from a 4-hour soak to a 10-minute express disinfection. The study and acceptance criteria mentioned primarily relate to the microbial efficacy of this new disinfection time.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that most data, including general indications, chemistry testing, preservative effectiveness, and toxicology, references the previously cleared 510(k) K051104. The focus of this 510(k) is specifically on the 10-minute express disinfection. Therefore, the table below focuses on the microbial efficacy for disinfection.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the microbial studies conducted for the 10-minute express disinfection.

• Sample Size (Test Set): Not specified in the provided text for the microbial studies.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies were conducted by Lapis Lazuli International NV.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies are described as "Microbial Testing" conducted by the manufacturer, rather than studies requiring expert medical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation of data (e.g., imaging studies). This type of information is not relevant or provided for the microbial testing described in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes microbial efficacy testing for a contact lens solution, not a multi-reader multi-case comparative effectiveness study. These studies are typically for evaluating the performance of diagnostic imaging devices interpreted by multiple human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The document states: "Microbiological studies were conducted to demonstrate the microbial efficacy of EYE SEE™ Multipurpose Contact Lens Solution for 10 Minute Express Disinfection. This testing concluded that the product met primary stand-alone criteria." This "stand-alone criteria" refers to the performance of the solution itself in disinfecting, without human intervention as part of the performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the microbial testing is intrinsic to the methodology of microbiological efficacy studies, where the reduction in microbial population (colony-forming units) after exposure to the solution is directly measured against established standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense. It relies on quantitative microbial counts.

8. The Sample Size for the Training Set

This concept (training set) is typically relevant for machine learning algorithms. The provided document describes laboratory-based microbial efficacy testing of a disinfectant solution, not an AI/ML device. Therefore, there is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device and study, this question is not applicable.

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