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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.

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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.

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.

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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.

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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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