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The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.

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The provided document is an FDA 510(k) clearance letter for the "Ultima Snoring Mike, Model 0540." This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria, as typically found in clinical study reports or detailed technical documentation.

Therefore, I cannot provide the requested information from the given text.

The document primarily states:

• The device name and model.
• Its classification (Class II, Product Code MNR).
• Its intended use: "provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system."
• Target population and environment of use.
• Concurrence of the FDA's Office of Device Evaluation.

This document serves as an authorization to market the device, not a detailed technical report of its performance against specific acceptance criteria.

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