(115 days)
The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.
The provided text is a 510(k) Summary for the ZQuiet® Pro-Plus oral appliance, seeking substantial equivalence to a predicate device. It defines the device, its intended use, and compares it to a legally marketed predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical outcomes.
Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on similar intended use, technological characteristics, and materials. The non-clinical testing mentioned is related to material properties rather than clinical performance for treating snoring or sleep apnea.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics and associated acceptance criteria related to reducing snoring or OSA, nor does it present results from a study designed to measure these.
- Sample size used for the test set and the data provenance: No clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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 oral appliance, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable as no clinical study is detailed.
- The sample size for the training set: Not applicable as there is no mention of a training set for a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
What the document does indicate regarding "study" and "proof":
- Non-Clinical Testing: The document mentions "Biocompatibility test results are known for this device as well as tests for tear resistance tear strength, tensile strength, elongation yield, and modulus of elasticity." These tests relate to the material properties and safety of the device, not its clinical efficacy in treating snoring or OSA.
- Proof of Substantial Equivalence: The primary "proof" presented in this 510(k) submission is the comparison to a predicate device, the SomnoMed MAS RxA (K050592). The conclusion states: "By comparing designs to the predicate device and the materials used it's concluded that the ZQuiet® Pro-Plus is as safe, as effective, and performs as well as the predicate device." This is a regulatory pathway that relies on the predicate device's established safety and effectiveness, rather than a new clinical study for the ZQuiet® Pro-Plus.
§ 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.”