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The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the ApneaRx Pro.

The document is a 510(k) summary for the ApneaRx Pro, which focuses on establishing substantial equivalence to a predicate device (ApneaRx). It describes the device, its intended use, and a comparison of technological features and materials between the new device and the predicate. Nonclinical testing for biocompatibility and physical properties of the materials is mentioned, stating that they met device specifications. However, there are no specific numerical acceptance criteria or details of a study designed to demonstrate performance against such criteria (e.g., clinical efficacy study for reduction of OSA or snoring, or a performance study with specific endpoints).

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and a performance study.

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