(150 days)
Zyppah® is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
The Zyppah Anti-Snoring Appliance is a single piece tray system for intraoral use. The 'boil-and-bite' device is customized to each patient. It features an elastic strap that spans the device that is designed to keep the tongue in place during sleep, instead of blocking the airway and contributing to snoring. The product is non-sterile and provided in a sealed box with directions for use.
This 510(k) summary (K182312) describes the Zyppah® Anti-Snoring Appliance. It's important to note that the document does not describe a study that proves the device meets specific acceptance criteria in terms of clinical performance. Instead, it relies on substantial equivalence to predicate devices and non-clinical bench testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria for clinical performance that the device was tested against. The acceptance is based on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics, materials, and non-clinical testing.
The key "performance" reported is related to structural integrity:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile strength of strap | 14% increase in force withstood compared to predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable for clinical performance. The only "test set" mentioned relates to non-clinical bench testing of the strap. No specific sample size for this bench test is provided in the summary.
- Data Provenance: The device performance data (tensile strength) is from non-clinical bench testing. The country of origin and whether it was retrospective or prospective is not specified, but it would be prospective for this type of bench test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the tensile strength test is objective physical measurement, not expert assessment.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication was involved for the non-clinical tensile strength testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states: "No clinical testing was performed in association with this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, no clinical testing (standalone or otherwise) was performed. This device is a physical appliance, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tensile strength test, the "ground truth" is the physical measurement of the force required to break the strap.
- The overall "ground truth" for marketing clearance is the substantial equivalence to predicate devices that have prior FDA clearance and a history of safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is a physical anti-snoring appliance, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.”