Search Results

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

The ZQuiet is an oral appliance comprised of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in varying protrusive sizes allowing the user to try different degrees of mandibular advancement to reduce snoring.

This document is a 510(k) Premarket Notification for the ZQuiet device, an intraoral device intended to reduce snoring. As such, the focus of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

The document states, "No clinical testing was performed in association with this submission." and "Non-clinical testing was not performed for this submission." This indicates that the manufacturer did not conduct a study with acceptance criteria and reported device performance metrics for this specific 510(k) submission (K180124) to directly prove the device meets acceptance criteria in the way a clinical trial would.

Instead, substantial equivalence is argued based on the similarity of the ZQuiet device (K180124) to its predicate devices (ZQuiet K093407, ZQuiet K090503, and SnoreRx K170825) in terms of:

• Intended Use: All devices are intended for reducing snoring in adults.
• Technological Characteristics / Mode of Action: All are mandibular advancement devices that widen the pharyngeal airway.
• Design Principle: The ZQuiet devices (proposed and predicates) share a similar one-piece design with an upper and lower tray joined by a flexible hinge. While SnoreRx has a different adjustable design, its end result (mandibular advancement) is the same.
• Materials: The proposed ZQuiet uses the same thermoplastic elastomer as its ZQuiet predicates.
• Prescription Status: The change to OTC for the proposed ZQuiet is justified by comparison to the OTC SnoreRx predicate and by revised labeling including a STOP-Bang questionnaire.

Therefore, the following points address your specific questions in the context of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

   • Not Applicable. This 510(k) notification does not present a table of acceptance criteria and reported device performance from a clinical study for the K180124 device. The submission's goal is to demonstrate substantial equivalence to predicate devices, not to meet specific performance criteria from a de novo study. The document explicitly states "No clinical testing was performed in association with this submission." and "Non-clinical testing was not performed for this submission."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. No test set or clinical data was generated for K180124 for this submission. The basis for substantial equivalence relies on the characteristics and established performance of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. As no new clinical testing was performed for this 510(k) submission, there was no test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. No test set was used in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. This device is an intraoral appliance, not an AI-powered diagnostic imaging device. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable. This is a physical medical device, not an algorithm. Standalone performance as an algorithm is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. No new ground truth was established for this submission. The "ground truth" for the device's safety and effectiveness is implicitly derived from the prior clearances and safe marketing history of the predicate devices.

8. The sample size for the training set

   • Not Applicable. This submission does not describe a training set for an algorithm or model.

9. How the ground truth for the training set was established

   • Not Applicable. This submission does not describe a training set or its ground truth establishment.

Ask a specific question about this device