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The Dr Greenburg's Hybrid 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 Greenburg's Hybrid Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single patient to use multiple times at home or sleep laboratories.

Dr Greenburg's Hybrid Anti-Snoring 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 tray system is designed to posture the lower jaw into several elective positions, with the intent to increase the airway passage opening, while the additional elastic component aids in keeping the airway open by impeding the tongue from falling back and blocking 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 obstructive sleep apnea.

Dr Greenburg's Hybrid has a front area opening that is large enough for emergency breathing.

Dr Greenburg's Hybrid Snoring appliance consists of two independent trays (Top and Bottom), and an elastic that is connected between the trays located posteriorly. Each tray contains a hard outer shell and a soft thermoplastic inner body. The inner body is comprised of medical grade, FDA approved Ethylene Vinyl Acetate. This thermoplastic material is the inner lining which accommodates the teeth and gives the device its characteristic "boil-&-bite" feature. The outer hard tray consists of a solid, medical grade, FDA approved Polypropylene that adds strength and structural support. The elastic consists of a non-allergenic, latex free silicone. The elastic stretches from molar to molar across the tongue. It applies slight pressure to impede the tongue from falling back into the airway. The flexibility of the elastic allows movement of the tongue, aiding in swallowing and comfort. The frictionless silicone helps to prevent any tongue irritation.

The Top and Bottom trays are locked together via a coupling protrusion mechanism. The coupling mechanism consist of buttons that are located on the lower tray and holes on the top tray. The buttons insert tightly into corresponding matching holes of the upper tray. The holes and buttons are precession made to allow the buttons to "Snap" into the corresponding holes. The strength of the polypropylene creates a tight, locking fit. The retaining elastic is held firmly on the buttons and is locked securely between the two trays via the coupling protrusion mechanism. An additional locking mechanism comes after the thermoplastic material is heated during the "Boil and Bite" phase. The thermoplastic material melts together creating a glue like structure that locks all the pieces together.

Here's an analysis based on the provided text, but it's important to note that the document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed primary study data with acceptance criteria and specific performance metrics for the Dr. Greenburg's Hybrid device itself.

The document makes its case for substantial equivalence based on:

1. Similarities in technological characteristics to existing predicate devices (intended use, operating principle, technology, manufacturing process).
2. Existing medical literature supporting the efficacy of oral appliances for snoring and obstructive sleep apnea.
3. "Clinical data provided (Jonathan Greenburg's Sleep Study Table)" which is mentioned but not included or described in detail in the provided text. This is a crucial missing piece for directly answering your request for specific device performance against acceptance criteria.

Therefore, the following answers are constructed based on what the document does state, and highlight what information is missing for a comprehensive response to some of your specific questions.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the device's acceptance criteria for market clearance (through 510(k)) were primarily based on its substantial equivalence to predicate devices and the general understanding of oral appliance efficacy as supported by existing literature. There are no explicit quantitative acceptance criteria or corresponding reported performance metrics for the Dr. Greenburg's Hybrid device itself presented in the document as a primary study.

The document references historical clinical data (Jonathan Greenburg's Sleep Study Table) but does not provide it, nor does it specify exact metrics used for "significant improvement."

Detailed Breakdown of Study Information (Based on the document):

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 does not specify a sample size for a test set for the Dr. Greenburg's Hybrid device.
• It references "Jonathan Greenburg's Sleep Study Table" in the context of clinical data but provides no further details about this study's design (sample size, provenance, retrospective/prospective nature).
• The argument for effectiveness primarily relies on existing literature about oral appliances in general.

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/Not mentioned. This document does not describe a study involving expert-established ground truth for the device's performance. The "ground truth" for the 510(k) submission appears to be regulatory equivalence and general medical consensus on the efficacy of the class of devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not mentioned. There is no description of a study design that would involve adjudication.

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 anti-snoring and apnea device, not an AI-assisted diagnostic imaging tool, so an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the argument of efficacy: The ground truth is largely based on published medical literature/clinical evidence regarding the effectiveness of oral appliances in general for snoring and OSA, which would derive from various types of clinical outcomes data (e.g., AHI reduction, snoring intensity reduction, patient satisfaction).
• The document also mentions "clinical data provided (Jonathan Greenburg's Sleep Study Table)" which implies outcomes data was used to show improvement for patients using their specific device, but the details of this data are not included.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established

• Not applicable. See #8.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and leveraging existing clinical knowledge about oral appliances. It refers to an internal "Sleep Study Table" for the Dr. Greenburg's Hybrid device but does not provide the details (methodology, sample size, specific outcomes, or how "ground truth" was established) of that study within this public summary document. Therefore, specific acceptance criteria and detailed device performance from a primary study on this particular device are not explicitly stated in the provided text.

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