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Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.

Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.

There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.

All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.

This document is a 510(k) premarket notification for a Contact Lens Case. It does not describe a study that uses a machine learning algorithm or AI. Therefore, I cannot provide the requested information about acceptance criteria for an AI device.

The document primarily focuses on establishing substantial equivalence to a predicate device (K071081) for a physical product (contact lens case). The "tests" mentioned are non-clinical leakage testing and biological evaluation for safety.

Here's a breakdown of why the requested information cannot be extracted:

• No AI/Machine Learning Device: The device in question is a "Contact Lens Case," a physical product for storing contact lenses. There is no mention of any AI or machine learning component.
• No Acceptance Criteria for AI Performance: Since it's a physical product, the acceptance criteria are related to its physical properties, safety, and functionality (e.g., lack of leakage, biocompatibility, sufficient capacity for lenses), not performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
• No Study for AI Performance: The document explicitly states, "The subject of this premarket submission, Contact lens case did not require clinical studies to support substantial equivalence." The "Summary of Non-Clinical Leakage Testing" is a performance test for the physical case, not an AI study.
• No Ground Truth, Training Set, Experts, etc.: These concepts are relevant to AI/machine learning studies, not to the approval process for a simple medical device like a contact lens case.

Therefore, I cannot populate the table or answer the specific questions related to AI studies.

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