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SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.

SilentZPro 2.0 is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against set acceptance criteria.

Specifically, the document states:

• "No clinical performance testing was conducted." This directly indicates that there was no study performed to evaluate the device's performance against specific clinical metrics or acceptance criteria.
• The comparison section (F. Comparison of Technological Characteristics) focuses on matching the proposed device's attributes (e.g., intended use, population, mechanism of action, materials, design) to those of the predicate and reference devices.
• The "Performance Testing" section (G.) only details non-clinical testing for biocompatibility (cytotoxicity, sensitization, irritation) and physical properties, concluding that the device "meets the applicable requirements of ISO 10993." This is about material safety, not device efficacy/performance.
• Risk analysis was conducted in accordance with ISO 14971:2007, but this is a process for identifying and mitigating risks, not a study proving functional performance.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text. The submission relies on substantial equivalence based on technological similarities and non-clinical biocompatibility testing rather than clinical performance data against pre-defined acceptance criteria.

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