(109 days)
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping.
The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.
The provided 510(k) summary for the MPowRx™ Snoring Solution (K081965) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The core of this 510(k) submission is a claim of substantial equivalence to predicate devices, rather than a presentation of new performance data or efficacy studies. Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify any performance-based acceptance criteria for the MPowRx™ Snoring Solution, nor does it report any specific device performance metrics from a study. The substantial equivalence argument relies on the predicate devices' established safety and effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or data provenance is mentioned as part of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of a test set, ground truth establishment, or experts for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This device is an oral appliance, not an AI-assisted diagnostic tool or imaging device that would typically involve MRMC studies or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided. This is not a software algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth establishment is described for this device, as no new clinical study data is presented.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
- Cannot be provided. This is not a machine learning or AI device.
Summary from the document:
The 510(k) for the MPowRx™ Snoring Solution (K081965) primarily asserts substantial equivalence to existing predicate devices (Snor-X Mouth Guard K954324, Tongue Stabilizer Device K993381, Nose Breathe Mouthpiece for Heavy Snorer K013687).
The argument for safety and effectiveness is based on:
- Having the same indications for use (treatment of mild to moderate snoring).
- No substantial differences in design or materials that would raise new questions of safety or effectiveness compared to the predicate devices.
- The device is described as a "simple one-piece, one-size-fits-all oral appliance" made from "a common oral appliance material," functioning similarly by comfortably retaining the tongue to keep air passages open.
Therefore, the submission does not include data from a new study demonstrating specific performance metrics against pre-defined acceptance criteria, but rather leverages the established safety and efficacy of the predicate devices.
§ 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.”