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The Respire Clear is indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

The Respire Clear is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Clear is made out of dental industry standard 3D printed resins & metals, and is custom designed to fit each patients' unique oral anatomy.

The provided document is a 510(k) Premarket Notification for the Respire Clear device, an intraoral device for mild to moderate obstructive sleep apnea. It describes the device, its intended use, and comparative information with predicate devices, but it does not contain details about acceptance criteria, device performance results against specific criteria, or a comprehensive study report as requested in the prompt.

The document states:

• "bench testing was conducted on the device in order to ensure that it safely & effectively performs as intended. This testing included mechanical safety & performance validation, biocompatibility tests, and shipping validation tests. The results indicated that the Respire Clear performs as well as the predicate device." (page 8, section b(1)).
• "The mechanical safety, performance validation, and biocompatibility tests criteria were all evaluated thoroughly, and passed successfully." (page 9, section b(3)).
• Clinical testing was "not required" per FDA guidance because the device does not use dissimilar designs, new technology, or changes in indication for use compared to previously cleared devices (page 8, section b(2)).

Therefore, I cannot create the requested table of acceptance criteria and reported device performance, nor can I provide information about the specifics of the study (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details) because these details are not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a detailed performance study against explicit acceptance criteria.

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