(264 days)
ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.
The ZQuiet Advance is an intraoral appliance designed to reduce snoring by advancing the lower jaw. The principal effect of mandibular advancement devices is the protrusion of the lower jaw, thereby widening the upper airway to decrease air turbulence, a causative factor in snoring. This device combines several essential functions: Separate upper and lower dental trays with thermal impression material to engage the upper and lower dentition, a mechanism to provide the forward positioning of the lower jaw relative to the upper jaw in 3 positions determined by the user's bite providing up to +6 mm of possible advancement. The design allows the maintenance of the forward positioning of the lower jaw while allowing minor sagittal and vertical movement. The ZQuiet Advance is a "Boil-and-Bite" device that uses thermal impression resin for device retention. The upper and lower trays are both constructed out of a rigid plastic outer tray to provide the device structure and attachment points for the connecting semi-rigid straps that provide the adjustability. Both the upper and lower trays are lined with material that is moldable when heated in a water bath and provides the ability to conform the device to the individual's teeth.
The provided text is a 510(k) summary for the ZQuiet Advance intraoral device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the details of a study with specific acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing rigorous clinical trials to prove efficacy.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The device in question is a physical intraoral device, not an AI/ML algorithm requiring such detailed performance characteristics.
The document explicitly states:
- "No clinical testing was performed in association with this submission." (Page 15, Section 3.13)
- The justification for clearance relies on "Substantial Equivalence" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics.
Instead of a study proving the device meets acceptance criteria in the sense of an AI/ML study, the non-clinical testing performed focuses on mechanical properties and human factors:
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Non-Clinical Testing (Page 15, Section 3.11):
- Strap compression testing (compared to similar designs).
- Physical properties testing (by material manufacturer).
- Human Factors Evaluation: Concluded that identified risks associated with critical tasks were adequately mitigated.
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Biocompatibility (Page 15, Section 3.12):
- Testing conducted by the device manufacturer.
- Met requirements of ISO 10993-1 for mucosal membrane contacting devices with prolonged duration (cytotoxicity, sensitization, irritation).
Conclusion based on the provided text:
This document is a regulatory submission for a physical medical device. It does not provide the type of performance study details requested for an AI/ML-based device. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and non-clinical testing (mechanical and human factors), rather than a clinical study with specific performance metrics against an established ground truth.
§ 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.”