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The C-1805M is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution

The C-1805M is a pressurized bottle system capable of supplying a solution to the dental unit water lines or pressurized air. The system is used with solutions to clean the dental unit waterlines by air purging the waterlines or injecting a solution. The system can be used to supply water to the dental unit if necessary.

The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a dental device called "C-1805M." This documentation asserts equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI or diagnostic performance.

The device described, the C-1805M, is a "Pressurized bottle system" for cleaning dental unit water lines. It is a Class I medical device (Dental Operative Unit and Accessories) and its function is mechanical/fluid handling, not diagnostic or AI-driven.

Therefore, the requested information cannot be extracted from this document. The concepts of "acceptance criteria," "device performance," "sample size," "experts," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI effectiveness studies are not applicable to the content provided.

Summary of why the requested information cannot be provided:

The provided text describes a mechanical dental device and its FDA clearance process, which relies on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or AI performance through a detailed study with acceptance criteria. Therefore, the information requested in the prompt, which is relevant to AI/diagnostic device performance studies, is not present in the given document.

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