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The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

The BluePro® oral appliance design concept is based upon the use of a standard set of upper and lower trays, referred also as splints in documentation, that are then customized for fit by a dentist. The design is commonly referred to as a Mandibular Repositioning Device (MRD).

The provided text describes the regulatory clearance of a medical device, the BluePro®, by the FDA. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the typical sense of a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reduction in AHI.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (ApneaRx - K113569), which is a common pathway for FDA clearance for Class II devices. This means the device is being cleared because it is similar enough to an already legally marketed device, not necessarily because it has met specific, pre-defined performance thresholds in a clinical study presented in this document.

Here's an attempt to answer your questions based only on the provided text, acknowledging that many details you requested are not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of performance metrics (e.g., "device must achieve X accuracy"). Instead, the acceptance criteria for regulatory clearance appear to be based on demonstrating substantial equivalence to the predicate device in terms of indications for use, technology/principle of operation, environment of use, patient population, and safety (biocompatibility).

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