(93 days)
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.
AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.
Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.
The provided text is a 510(k) summary for the AIO Breathe device, an intraoral device intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA). Crucially, the document explicitly states: "No clinical studies were conducted on AIO Breathe."
Therefore, I cannot provide information regarding acceptance criteria or a study proving the device meets those criteria, as no such study was conducted according to this document. The submission relies on substantial equivalence to a predicate device (Slow Wave DS8 K191320), not on a direct clinical study of AIO Breathe's performance.
If there were a clinical study described, the following information would be extracted and organized as requested:
1. Table of acceptance criteria and reported device performance: This would list specific metrics (e.g., AHI reduction, snoring reduction percentage) with their predefined acceptance thresholds and the results achieved by the AIO Breathe device in the study.
2. Sample size used for the test set and the data provenance: This would state the number of patients/participants in the study and whether the data was collected specifically for this study (prospective) or from existing records (retrospective), and the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many independent experts were involved in evaluating patient outcomes and their professional backgrounds (e.g., Board-certified sleep physicians with X years of experience).
4. Adjudication method for the test set: This would describe how discrepancies among experts were resolved (e.g., a third expert reviewed discordant cases).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This would state if human readers were part of the study, and if so, how their performance was measured with and without AI assistance, including the effect size. (Likely not applicable for a physical intraoral device).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would indicate if the device's performance was evaluated purely by itself, without human intervention in its function or interpretation. (Likely not applicable for a physical intraoral device).
7. The type of ground truth used: This would specify the gold standard against which the device's performance was measured (e.g., polysomnography results, patient-reported outcomes).
8. The sample size for the training set: If machine learning was involved in the device's design or functionality, this would state the size of the dataset used to train any algorithms. (Likely not applicable for this type of device).
9. How the ground truth for the training set was established: This would describe the method used to label or categorize the data in the training set for any machine learning components. (Likely not applicable for this type of device).
In summary, based on the provided document, no clinical studies were performed on the AIO Breathe device, and therefore, no acceptance criteria or study results demonstrating its performance are available within this text. The clearance is based on its substantial equivalence to an existing predicate device.
§ 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.”