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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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SOLO-Care ™ Brand Multi-Purpose Solution Is Indicated for use in daily cleaning, ninsing, chemical (not haat) disinfecting, protein removal and storing of soft (hydrophilic) or rigld gas permeable (fluoro sillcone acrylate and sillcone acrylate) lenses as recommended by your eye care precitioner.

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

This document is a 510(k) Summary for the SOLO-Care™ Brand Multi-Purpose Solution, which is a contact lens solution. It describes the device's indications for use, its substantial equivalence to a predicate device, and outlines the studies conducted to demonstrate its safety and effectiveness.

Here's the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative or tabular format for specific performance metrics (e.g., microbial kill rates, protein removal percentages with thresholds). Instead, it states that various studies were conducted to confirm safety and effectiveness, and that the product is shown to be "substantially equivalent" to a predicate device.

However, we can infer the intent of the acceptance criteria based on the described functions and comparative claims. The performance is reported in terms of its ability to perform these functions effectively and its compatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "A series of preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness..." However, no specific sample sizes for clinical or preclinical test sets are provided within this document.

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the studies would typically be prospective for clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The evaluation of contact lens solutions typically involves laboratory testing for microbial reduction, cytotoxicity, and clinical trials for safety and comfort, which are assessed by various medical professionals and technicians, but "experts" establishing ground truth in the sense of image interpretation is not directly applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where there's subjectivity and disagreement among readers. This is not directly relevant to the testing of a contact lens solution.

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

No MRMC comparative effectiveness study was done, as this device is a contact lens solution, not an AI-powered diagnostic tool. Therefore, there is no effect size related to human readers improving with or without AI assistance.

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

No standalone algorithm performance study was done, as this device is a chemical solution, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a contact lens solution, "ground truth" generally refers to:

• Laboratory-based measurements: e.g., microbial kill rates using standardized organisms, protein removal efficacy, cleaning efficacy using simulated soiling, lens compatibility assessments.
• Clinical outcomes data: e.g., slit lamp examinations for ocular health, patient reported comfort, adverse event rates, visual acuity.
• Comparison to predicate device performance benchmarks.

The document generically states "preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness." It implies that standard test methods applicable to contact lens solutions were used to establish the "ground truth" for these various performance parameters.

8. The sample size for the training set

This information is not provided and is not applicable in the context of a chemical contact lens solution. "Training set" refers to data used to train machine learning models, which are not involved in this device's development or evaluation.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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