(216 days)
The use of the SNOREX device is indicated for anyone who snores, has a desire to alleviate or eliminate snoring, and has sufficient natural upper and lower teeth to hold the appliance in place while sleeping.
The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.
The provided 510(k) summary for the SNOREX device does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria in the requested format. The document is a 510(k) premarket notification for a medical device submitted in 1997, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results against predefined acceptance criteria.
Here's why the requested information cannot be extracted from the given text:
- No Acceptance Criteria or Performance Data: The document states that "The SNOREX and the SILENCER are comparable in all aspects." This is a general statement of equivalency, not a presentation of specific acceptance criteria (e.g., reduction in AHI by X%, snoring loudness reduction by Y dB) or quantitative performance data (e.g., actual reduction in snoring instances, AHI improvement).
- No Study Details: There is no mention of a specific study design, methodology, sample size, or results of any clinical trial or performance evaluation. The document focuses on the device's description, intended use, and comparison to a predicate device.
- No Ground Truth Information: Since no performance study is described, there's no mention of how ground truth was established, the number or qualifications of experts, or adjudication methods.
- No MRMC or Standalone Study Information: The concepts of multi-reader multi-case studies or standalone algorithm performance are not relevant to this type of device (a physical anti-snoring appliance) and are not mentioned.
- No Training Data Information: The document is about a physical device, not an AI/algorithm, so there is no training data or how its ground truth was established.
In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a performance study report. Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details.
However, based on the information provided, I can infer the general approach to regulatory clearance at the time:
- Acceptance Criteria (Implied): The implied acceptance criterion is "substantial equivalence" to the predicate device, "THE SILENCER APPLIANCE," meaning it performs similarly in its intended use of maintaining open airways to reduce or eliminate snoring and sleep apnea.
- "Study" (Implied): The "study" is the comparison of technological characteristics to show that the SNOREX is "comparable in all aspects" to the predicate, with the exception of the "Halstrom Hinge," which the SNOREX achieves via its "manufacturing procedure without the use of a hinge." This is a technical comparison for substantial equivalence, not a clinical trial.
Without a detailed clinical or performance study report, the requested table and specific questions cannot be answered.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”