(142 days)
The Dr Greenburgs Hybrid Acrylic 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 Acrylic Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single an resure in Creatiourgs Hybrid Anti-Snoring Device is a removable intraoral device for muliple times at home or sleep laboratories. and theming the upper and lower jaw into and one multiple times at home or sleep laboratories.
The Dr Greenburgs Hybrid Azalea
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The provided text describes a 510(k) summary for the "Dr Greenburgs Hybrid Acrylic" anti-snoring and apnea device. This document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, some information requested might not be directly available or explicitly stated in the provided text.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of performance metrics in the way a clinical study report would. The primary "performance" discussed is the intended use of reducing snoring and mild to moderate obstructive sleep apnea. The submission relies on citing existing literature and presenting anecdotal "clinical data" to support its claims of efficacy.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: No new safety concerns | "A risk assessment concluded that there were no new safety concerns raised by the design of Dr Greenburgs Hybrid Acrylic." |
| Efficacy (reduce snoring & mild to moderate OSA): Equivalent to predicate devices & supported by literature/clinical data | "Overall, those with mild to severe OSA have a 22% chance of being able to control their sit of the sever Apres: A Review from SLE" (from cited literature) |
| "Clinical data provided (Jonathan Greenburg's Sleep Study Table) illustrates patients can improve their sleep apnea disease significantly if they use an intraoral anti-snoring device..." | |
| Technological Characteristics: Similar to predicate devices | "Same intended use. Same operating principle. Same technology. Same manufacturing process." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical data provided (Jonathan Greenburg's Sleep Study Table)" and refers to literature. However, it does not provide details about a specific test set, its sample size, or its provenance (e.g., country of origin, retrospective/prospective nature). The "Sleep Study Table" is mentioned as "provided" but its contents are not detailed.
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)
There is no information provided in the document about the number or qualifications of experts used to establish ground truth for any test set. The efficacy claims largely refer to general medical literature and an internal "Sleep Study Table," without describing the methodology for how "ground truth" was established within those contexts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There is no information provided regarding an adjudication method for a test set.
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 device is an intraoral anti-snoring and apnea device, not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance would not be applicable to this type of medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical intraoral appliance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" used for efficacy claims appears to be:
- Clinical Outcomes Data: The mention of "Jonathan Greenburg's Sleep Study Table" suggests some form of patient outcomes data (e.g., reduction in AHI, reported snoring). However, the specific metrics and how they were verified as "ground truth" are not detailed.
- Literature Review/Expert Opinion: The document heavily relies on existing scientific literature (e.g., "The Abstract Oral Appliances for Snoring and Observe Steep Apnea: A Reviews and Check Charact Crail States" from Sleep Vol. 2, 2006) which synthesizes existing clinical evidence and expert understanding of oral appliances.
8. The sample size for the training set
As this is a physical medical device and not a machine learning algorithm, the concept of a "training set" in this context is not applicable. The device's design is based on established biomechanical principles and comparisons to existing predicate devices.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this physical 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.”