(119 days)
ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.
The ZQuiet-SA oral appliance consists 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 multiple models allowing the dentist to recommend different degrees of mandibular advancement and preference of anterior posts.
The provided 510(k) summary for the ZQuiet-SA device does not contain acceptance criteria or a study proving that the device meets such criteria in the traditional sense of a performance study with defined metrics. This submission relies on demonstrating substantial equivalence to predicate devices. Therefore, the information requested in some categories cannot be extracted or is not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics Identical to Predicate Devices | The ZQuiet-SA has identical technological characteristics as the predicate devices (ZQuiet K090503, ZQuiet K093407, TOMED SomnoGuard K061688) in terms of basic design (one-piece upper and lower tray, flexible hinge), materials (thermoplastic elastomer compound), and differential mandibular advancement capabilities. The ZQuiet-SA offers more advancement options (0mm, 2mm, 4mm, 6mm) compared to the predicate ZQuiet devices (6mm) and is comparable to SomnoGuard (0-5mm). |
| Intended Use Identical to Predicate Devices | The ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults, which aligns with the intended use of comparable predicate devices. |
| Biocompatibility Established by Predicate Devices | Materials and manufacturing methods are identical to predicate devices K093407 and K090503, thus biocompatibility is considered established. |
| Risk Analysis Conducted | A Risk Analysis was conducted to demonstrate that product risks have been identified and appropriately accounted for. (No specific performance metrics are provided for the risk analysis itself beyond its completion). |
Detailed breakdown of requested information:
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A table of acceptance criteria and the reported device performance: See table above. It frames "acceptance criteria" as meeting the criteria for substantial equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set (clinical or performance) was used for this submission. The submission relies on substantial equivalence to predicate devices, which means no new clinical or non-clinical performance data was generated for this specific device to demonstrate its safety and effectiveness.
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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. No clinical or performance test set was used that required expert ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used.
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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. The ZQuiet-SA is a medical device (an intraoral appliance), not an AI/imaging diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ZQuiet-SA is an intraoral appliance; it is not an algorithm and does not operate in a "standalone" or "human-in-the-loop" context in the way AI algorithms do.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth determination was made for this submission, as it relied on substantial equivalence. The "ground truth" for the predicate devices' effectiveness would have been established through clinical trials (e.g., outcomes data related to snoring and AHI reduction), but these studies were not conducted for the ZQuiet-SA as part of this 510(k) submission.
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The sample size for the training set:
- Not applicable. No training set was used as this is not an algorithm-based device.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of the K140777 Submission:
This 510(k) submission for the ZQuiet-SA device is a direct demonstration of substantial equivalence. The manufacturer asserts that the ZQuiet-SA possesses "identical technological characteristics" and "identical materials and methods of manufacture" to its previously cleared ZQuiet devices (K093407 and K090503) and also compares it to another predicate, TOMED SomnoGuard (K061688).
The "study" that proves the device meets the acceptance criteria is the comparison of its technical characteristics and intended use to those of legally marketed predicate devices. The acceptance criteria are, implicitly, that these characteristics and intended use are sufficiently similar to deem it substantially equivalent, thereby implying comparable safety and effectiveness without the need for new clinical data.
Specifically, the document states:
- "No additional non-clinical testing was performed for this submission."
- "No additional biocompatibility testing was conducted" because materials and manufacturing are identical to predicate devices.
- "No clinical testing was performed in association with this submission."
The FDA's letter concurs with the substantial equivalence determination, allowing the device to be marketed.
§ 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.”