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510(k) Data Aggregation
(93 days)
APNEA GUARD
The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights.
The Apnea Guard is a Mandibular Repositioning Device (MRD) which consists of interlocking upper and lower trays filled with silicone retention material fitted to the patient. The useful life of the retention material will limit the Apnea Guard's used to a temporary appliance, less than 30 days. The trays are locked into a position that advances the mandible for the treatment of snoring and / or obstructive sleep apnea. The one-size-fits-all appliance is able to accommodate the full range of dental etiologies, including wide and narrow arches, missing or compromised teeth and gums, etc.
This document describes the acceptance criteria and the study that demonstrates the Apnea Guard device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of "acceptance criteria" for the Apnea Guard in a quantitative manner that can be directly mapped to the study's performance results. Instead, it frames the performance in terms of "substantial equivalence" to a predicate device (Airway Management TAP III). The key performance indicator highlighted is the reduction in Apnea-Hypopnea Index (AHI).
Therefore, the table below reflects this comparative performance for the critical metric mentioned:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Apnea Guard) |
|---|---|
| Statistically significant reduction in overall and supine AHI (equivalent to predicate device). | Statistically significant reduction in overall and supine AHI, found to be equivalent to custom appliance. 56% showed > 50% reduction in overall AHI, and 63% showed > 50% reduction in supine AHI. |
| Reduce sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals. | Demonstrated equivalence to the predicate in reducing sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Eighteen patients.
- Data Provenance: The study was "prospective." The document does not explicitly state the country of origin, but given the FDA 510(k) submission, it is highly likely to be a study conducted within the United States or under international clinical trial standards acceptable to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts (e.g., sleep physicians, polysomnography technologists) involved in establishing the ground truth for the test set. It mentions that patients underwent a "two-night Qualification Home Sleep Test (HST)" and that "Measurement and recording of Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals was done." This implies that standard diagnostic procedures for sleep disorders, typically interpreted by trained professionals, were followed.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set data. The collection of AHI, hypoxemia, snoring, and sympathetic arousal data likely followed standard polysomnography scoring rules, which inherently involve a defined process for data interpretation, but not necessarily a multi-reader adjudication process as seen in some AI studies.
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?
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a clinical study comparing the Apnea Guard (the proposed device) against a predicate device (Airway Management TAP III) in terms of its effectiveness in reducing sleep-disordered breathing. It does not involve human readers interpreting data with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Apnea Guard is a physical mandibular repositioning device, not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study is not applicable. The device itself is the "standalone" intervention being tested.
7. The Type of Ground Truth Used
The ground truth for the clinical performance was established using physiological measurements and clinical assessments derived from sleep studies. Specifically, "Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals" were measured and recorded. These metrics are objective physiological indicators of sleep-disordered breathing.
8. The Sample Size for the Training Set
No training set is mentioned as the Apnea Guard is a physical medical device, not an AI/ML algorithm that requires a training phase.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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