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For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.

Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.

This document describes a minor specification modification to a Multi-Purpose Disinfecting Solution. The submission focuses on demonstrating that the modified product remains substantially equivalent to the previously cleared version and meets safety guidelines. It is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Ocular Irritation Study: Not explicitly stated, but the study was conducted "in rabbits." {1}
• Data Provenance: The ocular irritation study was conducted on rabbits, a common animal model for ocular safety. The location/country of origin is not specified, but the submission is to the U.S. FDA, implying the study adheres to U.S. regulatory standards. The study appears to be prospective, designed specifically to evaluate the safety of the modified formulation.

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

• Not Applicable. This is a chemical solution for contact lens care, not an AI/ML device involving expert interpretation of images or other data. The "ground truth" for the safety study is the observed biological response in the rabbits.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML device, there's no adjudication in the sense of reconciling expert opinions for ground truth. The safety study involves direct observation and assessment of ocular irritation.

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

• Not Applicable. This is a chemical solution, not an AI/ML device.

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

• Not Applicable. This is a chemical solution, not an algorithm.

7. The Type of Ground Truth Used

• Biological Response/Observed Safety Outcomes: For the ocular irritation study, the ground truth is the observed physiological response in the rabbits to the application of the modified solution. This typically involves grading irritation (e.g., redness, swelling, discharge) according to established scales.

8. The Sample Size for the Training Set

• Not Applicable. This is a chemical solution, not an AI/ML device that requires a training set.

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

• Not Applicable. This is a chemical solution, not an AI/ML device.

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For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of chemical (not heat) disinfection soft (hydrophilic) contact lenses as recommended by your eye practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets.

For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746` can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner.

Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.

This document is a 510(k) summary for a contact lens care solution, Multi-Purpose Disinfecting Solution ID 90746. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study design in the format expected for a medical device AI/ML study.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size
• Standalone (algorithm only) performance study details
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

However, based on the provided text, I can infer the following about the study conducted to support the device's claims:

Study Description (Focusing on Protein Removal Claim):

The document mentions studies conducted to support the protein removal claim for Multi-Purpose Disinfecting Solution ID 90746.

• Objective: To compare the protein removal efficacy of Multi-Purpose Disinfecting Solution ID 90746 with a predicate device (ReNu MultiPlus™ Multi-Purpose Solution).
• Methodology:
  • Lenses Used: Group I and Group IV human-worn contact lenses and laboratory lenses.
  • Procedure: Lenses were soaked in either Multi-Purpose Disinfecting Solution ID 90746 or ReNu MultiPlus™ Multi-Purpose Solution.
  • Measurement: Protein removal was measured and compared between the two solutions.
  • Analysis: Statistical analysis was performed on the data.
• Key Finding: "Statistical analysis of the data showed that significantly more protein was removed from human-worn Group IV lenses by Multi-Puroose Disinfecting Solution ID 90746 than by ReNu MultiPlus™ Multi-Purpose Solution."
• Conclusion: These studies demonstrate that Multi-Purpose Disinfecting Solution ID 90746 continues to remove protein while lenses are stored.

Important Note: This document pertains to a chemical solution for contact lens care, not an AI/ML medical device. The concepts of "acceptance criteria," "test set," "training set," "ground truth," "experts," and "MRMC studies" are typically applied to the validation of AI/ML algorithms in medical imaging or diagnostics, which is a different regulatory and scientific context.

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