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For the reduction of night-time snoring or mild to moderate obstructive sleep apnea in adults 18 years of age or older. Prescription use only.

The LambergSleepWell-Smartrusion is used to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The LSW-S is a removable intraoral device consisting of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth by means of a protrusive element on the upper member relating to the protrusive element's mate on the lower member. This interface, and thus this device, productions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. Every device is pharying a open your of reach patient and is adjustable at the time of delivery and anytime thereafter.

The provided text is a 510(k) summary for a medical device (LambergSleepWell-Smartrusion, LSW-S) and a declaration of substantial equivalent to predicate devices. It describes the device, its intended use, and a comparison with predicate devices. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics on how ground truth was established.

The document is a regulatory submission demonstrating substantial equivalence to pre-existing devices, rather than a clinical study report proving specific performance metrics against acceptance criteria. The FDA's letter (frames 2-3) confirms the "substantial equivalence determination" based on the provided information, not an evaluation of device performance against pre-defined acceptance criteria from a clinical study.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor can I answer the questions regarding study specifics, as this information is not present in the provided text.

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