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To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses

The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

This 510(k) premarket notification for the "Optimum™ Cleaning, Disinfecting and Storage Solution" does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The provided document, K014162, is a 510(k) summary and the FDA's clearance letter for a contact lens care solution. This type of submission primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Therefore, the document does not include the detailed study information you've requested regarding acceptance criteria, performance metrics, sample sizes, expert qualifications, or ground truth establishment. These types of details are more common in clinical study reports for devices undergoing Premarket Approval (PMA) or for devices where clinical data is explicitly required to establish substantial equivalence beyond technological characteristics.

Here's why the requested information is not present in this document and what one might typically find in a 510(k) for a contact lens solution:

• Acceptance Criteria and Device Performance Table: Not applicable in this context. Substantial equivalence is the primary criterion. For cleaning and disinfecting solutions, performance is generally assessed through microbiological and cleaning efficacy studies, often compared directly to the predicate device or against industry standards. The summary states, "The product formulation, solubility, cleaning effectiveness and disinfection properties are similar to the predicate product." This implies such tests were likely conducted and showed comparable results, but the detailed criteria and results are not in this public summary.
• Sample Size, Ground Truth, Expert Qualifications, Adjudication, MRMC, Standalone Performance, Training Set: These are concepts typically associated with imaging or diagnostic algorithms where human interpretation plays a role, or where a "ground truth" needs to be established for classification performance. For a contact lens solution, "ground truth" would relate to laboratory measurements of microbial kill rates, cleaning efficacy (e.g., protein removal), and lens compatibility, rather than expert interpretation of images or clinical outcomes in humans as described in your questions.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the performance of AI in assisting human readers, typically in interpreting medical images.
• Standalone performance: While the device itself has a standalone performance (how well it cleans and disinfects), the document doesn't detail this in the format you've requested, as its purpose is to show equivalence.
• Type of ground truth: For a contact lens solution, ground truth would be established through laboratory methods (e.g., standardized microbiological assays to count viable organisms after disinfection, optical density measurements for protein removal, and material compatibility tests).
• Sample size for training set, how ground truth for training set was established: These relate to AI/machine learning models and are not relevant to a contact lens cleaning solution.

In summary, the provided document (K014162) is a 510(k) notification for a contact lens solution. It establishes substantial equivalence to a predicate device and does not contain the detailed performance study information, acceptance criteria, or statistical details typically found in submissions for AI/ML-driven medical devices or those requiring extensive clinical trials for efficacy.

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