(68 days)
The O2Vent W is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.
The provided text does not contain information about the acceptance criteria or a study proving that the O2Vent W device meets specific performance criteria. Instead, it is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's what can be extracted from the document regarding testing, and why it doesn't align with the detailed request:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document focuses on comparing the O2Vent W to predicate devices based on design features, intended use, and materials.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical study with a test set is described. Non-clinical testing was performed, but sample sizes for these tests are not mentioned.
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)
Not applicable, as no ground truth for a test set is described in the context of a clinical study for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is an oral appliance, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document states that "Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent W".
8. The sample size for the training set
Not applicable, as no training set for an algorithm is discussed.
9. How the ground truth for the training set was established
Not applicable.
Information that is present regarding testing:
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Summary of Non-Clinical Tests (Page 8):
- Scope: Risk assessment of physical properties and ability to achieve intended use.
- Preliminary Testing: Performed to confirm design can withstand forces during normal use and reasonable abuse (e.g., bruxing).
- Results: The O2Vent W "met the specifications set." (Specific specifications are not detailed).
- Materials: New materials (adjustment screws) are made of special grade stainless steel, have prior 510(k) approval, and are widely used in dental appliances, matching those in the predicate SOMNODENT CLASSIC device.
- Biocompatibility: An assessment was performed. No new materials were used; all materials are already in predicate devices (O2Vent T & OVENT). Biocompatibility testing of the adjustment screws was deemed not warranted due to their source, nature, and long history of safe use in the intraoral environment. The device is considered biocompatible based on similar materials to predicate devices (O2Vent T, OVENT & SOMNODENT CLASSIC).
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Summary of Clinical Tests (Page 8):
- Conclusion: Human clinical studies were not deemed necessary for substantial equivalence due to:
- Designs not dissimilar from predicate devices.
- No new technologies different from legally-marketed intra-mandibular repositioning devices.
- No deviation from indications for use of predicate devices (O2Vent T, OVENT, SOMNODENT CLASSIC).
- Risk Management: Risks and mitigating controls (e.g., potential for soreness) are addressed by advising patients and dentists in the "Instructions for Use," covering contraindications, warnings, precautions, storage, fitting, and adjustment.
- Conclusion: Human clinical studies were not deemed necessary for substantial equivalence due to:
In essence, the document confirms that the O2Vent W underwent non-clinical testing for usability and material safety, met its internal specifications for these tests, and was deemed not to require clinical studies for its 510(k) submission based on its substantial equivalence to existing devices. Specific quantitative acceptance criteria and detailed performance data from a clinical study are not provided.
§ 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.”