(142 days)
The Dr Greenburgs Hybrid Vacuum Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
The Dr Greenburgs Hybrid Vacuum Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single patient multiple times at home or sleep laboratories. The Dr Greenburgs Hybrid Vacuum Device is a two piece, upper and lower arch tray system that includes an additional elastic component which impedes the tongue from falling back into the airway. The system is designed to posture the lower jaw forward with the intent to increase the airway passage opening, while the additional elastic component aids in keeping the tongue from falling back into the airway. The combined effect of the advancement of the lower jaw, and the elastic impeding the tongue from falling back into the airway reduces snoring and breathing arrests due to obstruction. Dr Greenburgs Hybrid Vacuum has a front area opening that is large enough for emergency breathing. Dr Greenburgs Hybrid Vacuum Snoring appliance consists of two independent trays (Top and Bottom), and an elastic that is connected between the trays located posteriorly. The trays consist of a clear, medical grade, copolyester that gives strength and support. The elastic consists of a non-allergenic, latex free silicone. The elastic stretches from molar to molar and is designed to impede the tongue from falling back into the airway. The flexibility of the elastic allows movement of the tongue, as well as assisting in swallowing. The elastic is held firmly onto the bottom tray via securing buttons and is locked securely between the top and bottom trays. The top and bottom trays alignment are determined by the length connecting bands that are attached via buttons on the sides of the top and bottom trays. This system moves the jaw forward to achieve the most effective position.
The provided text is a 510(k) summary for the "Dr. Greenburg's Hybrid Vacuum Anti-Snoring and Apnea Device." It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics.
The submission focuses on demonstrating substantial equivalence based on:
- Same intended use: Treatment of snoring and mild to moderate Obstructive Sleep Apnea.
- Same operating principle: Mandibular repositioning.
- Same technology: Intraoral device.
- Same manufacturing process.
The document mentions clinical data and literature support in a general sense, but does not present a controlled study with acceptance criteria, sample sizes, ground truth establishment, or specific performance outcomes for the Dr. Greenburg's Hybrid Vacuum device itself.
Here's a breakdown of what is mentioned or can be inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document. The 510(k) submission generally relies on demonstrating substantial equivalence to already cleared predicate devices, rather than presenting a performance study with specific acceptance criteria for the new device.
The closest to "reported performance" is a general statement: "Jonathan Greenburg's Sleep Study Table illustrates patients can improve their sleep apnea disease significantly if they use an intraoral anti-snoring device..." However, no specific metrics (e.g., AHI reduction percentage, snoring events reduction) or acceptance thresholds are given for this "significant improvement."
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided. The document refers to "clinical data provided (Jonathan Greenburg's Sleep Study Table)" but does not specify the sample size, design of the "sleep study," or its provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not mentioned. The document does not describe how ground truth was established for "Jonathan Greenburg's Sleep Study Table."
4. Adjudication Method
Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned. The document does not describe any study comparing human readers with and without AI assistance for this device. This type of study would not typically apply to an anti-snoring appliance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical intraoral appliance, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
For the "clinical data provided (Jonathan Greenburg's Sleep Study Table)," the specific type of ground truth (e.g., polysomnography (PSG) results for AHI, validated questionnaires for snoring) is not explicitly stated, though "sleep apnea disease" implies objective sleep study measurements.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI/ML algorithm.
In summary: The 510(k) submission for "Dr. Greenburgs Hybrid Vacuum Anti-Snoring and Apnea Device" relies on demonstrating substantial equivalence to existing predicate devices. While it references "clinical data" and "literature support," it does not provide a specific, detailed performance study with explicit acceptance criteria, sample sizes, ground truth methodology, or expert qualifications for the new device itself. The approval is based on the device's technological characteristics being similar to already cleared devices with the same intended use.
§ 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.”