The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights.

Device Description

The Apnea Guard is a Mandibular Repositioning Device (MRD) which consists of interlocking upper and lower trays filled with silicone retention material fitted to the patient. The useful life of the retention material will limit the Apnea Guard's used to a temporary appliance, less than 30 days. The trays are locked into a position that advances the mandible for the treatment of snoring and / or obstructive sleep apnea. The one-size-fits-all appliance is able to accommodate the full range of dental etiologies, including wide and narrow arches, missing or compromised teeth and gums, etc.

AI/ML Overview

This document describes the acceptance criteria and the study that demonstrates the Apnea Guard device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" for the Apnea Guard in a quantitative manner that can be directly mapped to the study's performance results. Instead, it frames the performance in terms of "substantial equivalence" to a predicate device (Airway Management TAP III). The key performance indicator highlighted is the reduction in Apnea-Hypopnea Index (AHI).

Therefore, the table below reflects this comparative performance for the critical metric mentioned:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Apnea Guard)
Statistically significant reduction in overall and supine AHI (equivalent to predicate device).	Statistically significant reduction in overall and supine AHI, found to be equivalent to custom appliance. 56% showed > 50% reduction in overall AHI, and 63% showed > 50% reduction in supine AHI.
Reduce sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals.	Demonstrated equivalence to the predicate in reducing sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Eighteen patients.
Data Provenance: The study was "prospective." The document does not explicitly state the country of origin, but given the FDA 510(k) submission, it is highly likely to be a study conducted within the United States or under international clinical trial standards acceptable to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts (e.g., sleep physicians, polysomnography technologists) involved in establishing the ground truth for the test set. It mentions that patients underwent a "two-night Qualification Home Sleep Test (HST)" and that "Measurement and recording of Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals was done." This implies that standard diagnostic procedures for sleep disorders, typically interpreted by trained professionals, were followed.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set data. The collection of AHI, hypoxemia, snoring, and sympathetic arousal data likely followed standard polysomnography scoring rules, which inherently involve a defined process for data interpretation, but not necessarily a multi-reader adjudication process as seen in some AI studies.

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?

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a clinical study comparing the Apnea Guard (the proposed device) against a predicate device (Airway Management TAP III) in terms of its effectiveness in reducing sleep-disordered breathing. It does not involve human readers interpreting data with or without AI assistance.

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

The Apnea Guard is a physical mandibular repositioning device, not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study is not applicable. The device itself is the "standalone" intervention being tested.

7. The Type of Ground Truth Used

The ground truth for the clinical performance was established using physiological measurements and clinical assessments derived from sleep studies. Specifically, "Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals" were measured and recorded. These metrics are objective physiological indicators of sleep-disordered breathing.

8. The Sample Size for the Training Set

No training set is mentioned as the Apnea Guard is a physical medical device, not an AI/ML algorithm that requires a training phase.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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111110

JUL 2 2 2011

510(k) SummaryPage 1 of 412-Jul-11		JUL 22 2011
Company	Advanced Brain Monitoring, Inc.2237 Faraday Avenue, Suite 100Carlsbad, CA 92008Tel - (760) 720-0099Fax - (760) 476-3620
Official Contact:	Daniel J. Levendowski
Proprietary or Trade Name:	Apnea Guard
Common/Usual Name:	Device, anti-snoringIntraoral devices for snoring and intraoral devices for snoringand obstructive sleep apnea
Classification / CFR:	LRK - CFR 872.5570
Device:	Apnea Guard
Predicate Devices:	K062951 - Airway Management – TAP III

Device Description:

Indications for Use:

Patient Population:

Patients 18 years or older who snore or have mild to moderate obstructive sleep apnea (OSA)

Environment of Use:

Home, dental and physician offices, sleep laboratories as well as hospitalized patients where the Apnea Guard may be appropriate.

Contraindications:

Missing. Loose, infected teeth, Temporary crowns or fillings, TMJ

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ge2of
12-Jul-11

Comparison of Proposed Device vs. Predicate
	Apnea Guard	Airway ManagementTAP III - K062951
Attributes
Indications for Use	The Apnea Guard is a mandibularrepositioning device intended to reduce oralleviate snoring and mild to moderateobstructive sleep apnea (OSA) in patients18 years and older. The Apnea Guard isintended to be fitted with assistance from ahealthcare professional, and used duringsleep for less than 30-nights.	To reduce or alleviate night time snoringand mild to moderate obstructive sleepapnea (OSA)
Environments of use	Home, dental and physician offices, sleeplaboratories as well as hospitalized patientswhere the Apnea Guard may be appropriate.	Home, Dental offices, Sleep laboratories
Patient Population	Patients 18 years and older	Adult patients 18 years and older
Contraindications	Missing, infected, loose teeth Temporary crowns or fillings Temporomadibular Joint (TMJ) dysfunction	Missing, infected, loose teeth Temporary crowns or fillings Temporomadibular Joint (TMJ) dysfunction
Prescription	Prescription use	Prescription use
Single patient, multi-use	Yes	Yes
Limitation of duration of use	< 30 days	No limitation
Design
Upper and lower trays fitted to the patient	Yes	Yes
Tray filled with impression material	Yes	Yes
Adjustment method for setting the amount ofprotrusion	YesManual and then held in place with a clip	YesScrew mechanism
Works by holding lower jaw forward	Yes	Yes
Cleaned by simple rinsing with water	Yes	Yes
Performance
Materials used	Silicone impression material	Acrylic for traysDental grade impression material
Biocompatibility	Testing according to ISO 10993-1
Sleep study performanceReduced AHI	Statistically significant reduction in overall andsupine position found to be equivalent tocustom appliance, 56% and 63% showed > 50%reduction in overall and supine AHI,respectively.	72%
Bench Testing	Environmental, Mechanical, Device specific

Comparison of Proposed Device vs. Predicate

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Discussion of Substantial Equivalence

The Apnea Guard is viewed as substantially equivalent to the predicate device because:

Indications -

Substantially equivalent to predicate -- K062951 -- Airway Management TAP III -- Indicated to reduce or alleviate night time snoring and treat mild to moderate obstructive sleep apnea (OSA).

Technology -

Substantially equivalent to predicate - K062951 - Airway Management TAP III - both devices use a separate tray design with a means to adjust the lower jaw. Each is filed with an impression material to assure a tight fit for the user.

Materials -

The materials in contact with the patient have been tested per ISO 10993.

Environment of Use -

Substantially equivalent to predicate - K062951 - Airway Management TAP III - except we have added the use in hospitals and sub-acute care settings which are all under supervised care and observation.

Patient Population -

Identical to predicate -Airway Management TAP III - 18 years and older

Performance Testing

Bench testing included:

Design performance was evaluated looking at tray design, strength, compression, . extension and collapse and Locking mechanism
Impression Material Retention .
Storage temperature at elevated and low temperatures .
User fit and comfort evaluation .

Clinical testing included:

A sleep study comparing the proposed vs. predicate device was performed. This study included eighteen patients who underwent a prospective IRB approved study. Patients were studied to assess outcomes when compared with the predicate device. Patients successfully complete a two-night Qualification Home Sleep Test (HST). Measurement and recording of Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals was done and compared to the predicate.

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1000 - 1000 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100

. .

Conclusions of Performance Testing

The bench demonstrated that the Apnea Guard design and performance meets is design requirements and was found to be equivalent in performance to the predicate for the intended use.

The clinical study with the Apnea Guard demonstrated that it was equivalent to the predicate in reducing sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals in patients with mild to moderate OSA

The Apnea Guard was found to be substantially equivalent and does not raise any new safety or efficacy issues.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Public Health Service

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

Advanced Brain Monitoring, Incorporated C/O Mr. Paul Dryden President, Regulatory Consultant Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

JUL 222 2011

Re: K111110

Trade/Device Name: Apnea Guard 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: June 28, 2011 Received: June 29, 2011

Dear Mr. Dryden:

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.

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Page 2 - Mr. Dryden

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 (OS) 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/CD RH/CDRHOffices/ucm1 l 5809.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.

Richard C. Chapman 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

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Indications for Use Statement

KI11110 510(k) Number:

Device Name:

Apnea Guard

Indications for Use:

The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and The Apnea Guard is intended to be fitted with assistance from a healthcare older. professional, and used during sleep for less than 30 nights.

Environment of Use:

Home, Dental and Physician offices, Sleep laboratories as well as hospitalized patients where the Apnea Guard may be appropriate.

Prescription Use XX_	or	Over-the-counter use_
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sinor Quare

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

510(k) Number: K111110

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.”