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SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate)and PMMA contact lenses as recommended by your eye care practitioner.

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution used in the care contact lenses and is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal. storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner. It may also be uses as a diluent for enzymatic cleaning tablets, which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablet. The solution is contains in a plastic bottle and consists of a sterile isotonic solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate and polyhexanide 0.0001%. Each bottle is supplied sterile and is labeled with a lot number and expiration date.

The provided document is limited to the 510(k) Summary of Safety and Effectiveness for SOLO-Care™ Brand Multi-Purpose Solution. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. As such, it does not contain the detailed acceptance criteria and study information typically associated with performance evaluations of AI/ML-driven medical devices.

The document describes a contact lens solution, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

However, I can extract the relevant information regarding the "study" mentioned and acceptance criteria within the context of a contact lens solution:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "a series of microbiological testing" and "a compatibility study" but does not provide the number of samples or lenses used in these tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). However, the studies were "pre-clinical studies" and "all studies have previously been submitted under P940042, K 982168, and under K983291," indicating they were conducted as part of previous regulatory submissions. These are retrospective in the context of this submission, as they were prior submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is a chemical solution, not an AI/ML diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as this is a chemical solution, not an AI/ML diagnostic device requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is a chemical solution, not an AI/ML diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is a chemical solution and does not involve an algorithm.

7. The type of ground truth used

For the microbiological testing, the "ground truth" would be established by standard microbiological methods (e.g., colony counts to determine microbial reduction). For the compatibility study, the "ground truth" would be established by observed physical or chemical integrity and performance of the PMMA lenses after exposure to the solution. These are laboratory-based scientific measurements, not expert consensus or pathology in the clinical sense.

8. The sample size for the training set

This information is not applicable as this is a chemical solution and does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

This information is not applicable as this is a chemical solution and does not involve a training set for an AI/ML algorithm.

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