(128 days)
DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.
The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only.
The LISA Appliance is a one piece, non-adjustable design. The LISA II Appliance is a dynamic, adjustable design. The Dorsal Appliance is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. The adjustable Herbst Appliance is a one piece construction held together by two adjustment mechanisms on the buccal or outer are of the upper and lower appliance.
The provided text describes a 510(k) summary for DynaFlex® Anti-Snoring & Sleep Apnea Devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is largely not present in the provided text.
The document states: "It has been shown in this 510(k) submission that the differences between the DynaFlex® Anti-Snoring & Sleep Apnea Devices and the predicate devices do not raise any questions regarding their safety and effectiveness. DynaFlex® Anti-Snoring & Sleep Apnea Devices, as designed and manufactured, are therefore determined to be substantially equivalent to the referenced predicate devices."
This implies that the predicate devices have established safety and effectiveness, and the DynaFlex device is considered equivalent based on its similar intended use and technological characteristics (or differences that don't raise new questions). There is no standalone performance study described for the DynaFlex device with specific acceptance criteria.
However, based on the information provided, here's an attempt to answer the questions, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria in a dedicated study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. No specific test set or study data for the DynaFlex device is described.
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)
This information is not present in the provided text. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
This information is not present in the provided text. The device is a physical intraoral device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided text. The device is a physical intraoral device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text. As this is not an AI device, the concept of a "training set" in this context is not applicable.
9. How the ground truth for the training set was established
This information is not present in the provided text.
§ 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.”