(140 days)
The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.
The Snore Guard consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.
This device is cleared through the FDA's 510(k) pathway, which means it demonstrated "substantial equivalence" to a predicate device rather than undergoing a full clinical study to prove its own efficacy against specific acceptance criteria. Therefore, the provided text does not contain the detailed information you've requested regarding acceptance criteria and a study proving those criteria were met.
The submission states: "The Snore Guard has the same intended use and similar indications, principles of operation, and technological characteristics as Snore Guard. The minor differences in the Snore Guard's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard is substantially equivalent to its identified predicate devices."
This means the "study" for this device was a comparison to existing, already cleared devices (Snore Guard Advance (K102118) and SleepRight Original (K100545)). The acceptance criteria were effectively that the new device did not introduce new safety or effectiveness concerns compared to these predicates.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies because this type of information is not typically generated or required for a 510(k) substantial equivalence submission unless specific performance data is needed to demonstrate equivalence for particular features or changes.
Summary of what can be inferred from the provided text:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated as performance metrics. The implicit acceptance criterion was "substantial equivalence" to predicate devices, meaning it should perform comparably to them in its intended use for treating nighttime snoring and mild to moderate Obstructive Sleep Apnea. No specific performance data (e.g., reduction in AHI, snoring events) is reported for this device in the document.
- Study That Proves the Device Meets the Acceptance Criteria: The "study" was a substantial equivalence determination by the FDA, comparing the Snore Guard to the predicate devices. This is a regulatory review process, not a clinical trial with performance endpoints.
- All other questions (Sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set information): This information is not applicable or not provided within a 510(k) substantial equivalence submission unless specific performance testing was conducted to address a particular aspect of the device's design or claims, which is not detailed here.
§ 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.”