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

Device Description

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.

AI/ML Overview

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:

Similarities in technological characteristics to existing predicate devices (intended use, operating principle, technology, manufacturing process).
Existing medical literature supporting the efficacy of oral appliances for snoring and obstructive sleep apnea.
"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."

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (as stated or implied by reference)
Substantial Equivalence to Predicate Devices:	Device is deemed substantially equivalent.
- Same intended use	Yes, for reducing snoring and mild to moderate OSA.
- Same operating principle	Yes, mandibular repositioner.
- Same technology	Yes, intraoral appliance.
- Same manufacturing process	Yes.
Safety (Risk Assessment)	No new safety concerns raised.
Effectiveness (supported by literature & reference to internal data)	Literature supports oral appliances' efficacy (52% chance of control for mild-severe OSA, better accepted than CPAP). "Clinical data provided (Jonathan Greenburg's Sleep Study Table) illustrates patients can improve their sleep apnea disease significantly." (Specific metrics/data not provided in this document).

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.

Summary

{0}------------------------------------------------

K111 680

Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 jgreenburg(@earthlink.net

DEC 2 3 2011

510(k) SUMMARY

Summary Prepared on 9-5-2011

Contact Person:

Jonathan Greenburg DDS President Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 4144817 jgreenburg@earthlink.net

Name of Device: Dr Greenburg's Hybrid

Common or Usual Name: Anti-Snoring and Apnea Device

Classification Name: Anti-Snoring Device (21CFR872.5570)

Product Code: LRK

Predicate Devices:

NoRad (K020893), Vital Sleep (092942), SomnoGuard (K061688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794)

{1}------------------------------------------------

Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 jgreenburg@earthlink.net

Description of the Device:

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.

{2}------------------------------------------------

Always More Marketing Inc 4535 W. Sahara Ave. Ste. 200 Las Vegas, Nevada 89102 818 414 4817 jgreenburg@earthlink.net

Indications for Use: Dr Greenburg's Hybrid Anti-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.

Technological Characteristics: Dr Greenburg's Hybrid device has the following similarities to the previously cleared predicate devices: Same intended use. Same operating principle. Same technology. Same manufacturing process.

All of the predicates and the Dr Greenburg's Hybrid act as mandibular repositioners for the treatment of snoring and mild to moderate Obstructive Sleep Apnea.

Dr Greenburg's Hybrid and the Full Breath (K091035), both have tongue retaining components.

Dr Greenburg's Hybrid, the Silent Nite (K972424), and EMA (K971794) use straps/bands held onto button attachments.

Substantial Equivalence is based on non-clinical data. In addition the literature supports the historical significance of oral devices that reposition the jaw and reduce and manage snoring as well as sleep apnea.

The Abstract Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review from SLEEP. Vol. 29, No. 2, 2006 Page 259 states... "Overall, those with mild to severe OSA have a 52% chance of being able to control their sleep apnea using an appliance. OAs are on the whole less effective than CPAP but may be better accepted by patients than nasal CPAP in studies where subjects used both treatments." Also, "They are well tolerated by most patients" and "Published literature now provides evidence for the efficacy of OAs in the treatment of patients with mild to moderate OSA"

Based on clinical data, it is demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring and sleep apnea, oral appliance therapy is an effective means by which these conditions can be managed. This effectiveness is embraced from a variety of aspects including safety, convenience and cost.

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 with a tongue retaining component during sleep.

{3}------------------------------------------------

Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 jgreenburg@earthlink.net

A risk assessment concluded that there were no new safety concerns raised by the design of Dr Greenburg's Hybrid.

In conclusion, a number of studies have shown improvement of the airway during sleep utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), aid in the management and reduction of snoring and sleep apnea. In addition the clinical data that was provided (Jonathan Greenburg's Sleep Study Table) illustrates patients can improve their sleep apnea disease significantly if they use an intraoral anti-snoring device with a tongue retaining component during sleep.

In summary, the device described in this submission is substantially equivalent to the predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEC 2 3 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Jonathan Greenburg President Always More Marketing Incorporated 4535 W. Sahara Avenue, Suite 200 Las Vegas, Nevada 89102

Re: K111680

Trade/Device Name: Dr. Greenburg's Hybrid Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: December 19, 2011 Received: December 20, 2011

Dear Dr. Greenburg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Greenburg

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K111680

Device Name: Dr Greenburg's Hybrid

Indications For Use:

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

Image /page/6/Picture/7 description: The image shows the words "Prescription Use (Part 21 CFR 801 Subpart D)" on the left side of the image. To the right of the text is a box with a check mark inside of it. The box is underlined.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suen Pane

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of _

510(k) Number: KJ) (087

Regulation Number and Section

§ 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.”