Snore-Aid®plus is indicated for use in patients with primary snoring A. or snoring and mild OSA (obstructive sleep apnea) where mandibular advancement and elevation of the tongue can increase a patient' s pharyngeal air space.

Snore-Aid®ø/us is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.

Device Description

Snore-Aid@plus is a single plate mandibular advancement and tongue positioning orthotic consisting of: (1) a flat mandibular occlusal bite plate, (2) an adjustable external maxillary lip shield, and (3) a wide occlusal surface. The occlusal bite plate provides dental stability, protects the TMJ from occlusal loading and prevents muscle soreness due It also actively elevates and positions the tongue anteriorly to bruxism. and dorsally against the palate, thereby increasing the patency of the airway.

AI/ML Overview

This 510(k) summary describes the Snore-Aid®plus device, an orthotic designed to treat snoring and mild obstructive sleep apnea (OSA) by advancing the mandible and positioning the tongue.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Snore-Aid®plus device were implicitly based on achieving a significant reduction in the Respiratory Disturbance Index (RDI) for patients with snoring and OSA. The study defined 'treatment success' as a 50% reduction in RDI and a post-treatment RDI ≤ 10.

Acceptance Criteria Definition	Reported Device Performance
Treatment success: 50% reduction in RDI AND post-treatment RDI ≤ 10	For RDI ≤ 30 patients (n=18): 100% (18 out of 18 patients) achieved treatment success.
	For RDI > 30 patients (n=7): All 7 achieved a reduction in RDI below the pretreatment index, but only 1 achieved a post-treatment RDI ≤ 10.
Absence of TMJ pain or muscle soreness	None of the subjects reported TMJ pain or muscle soreness.
Absence of bite changes upon awakening	None of the subjects reported bite changes upon awakening from sleep.
Absence of significant adverse events	Two patients reported nocturnal bruxism which caused temporary soreness of incisor teeth (considered minor compared to primary outcomes).

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

Sample Size for Test Set: 25 subjects.
Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The country of origin is not specified but is presumed to be the USA given the FDA submission.

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

The document does not explicitly state the number of experts or their qualifications who diagnosed the snoring and OSA conditions. However, it mentions that subjects "were diagnosed with snoring and mild to severe OSA," implying a clinical diagnosis by qualified medical professionals (e.g., sleep specialists, pulmonologists). The polysomnography was read and interpreted by healthcare professionals skilled in sleep medicine.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1, 3+1, or similar. The "12 channel polysomnography" suggests objective data collection, which typically relies on established scoring rules rather than subjective adjucation for raw data. The diagnosis of OSA and RDI calculation would follow recognized clinical guidelines.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This study focuses on the device's efficacy when used by patients.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical, prescribed medical device (orthotic), not an algorithm or AI. Therefore, the concept of an "algorithm only" or "standalone" performance study, as typically applied to AI/software, is not applicable here. The study assesses the device's effectiveness in patients.

7. Type of Ground Truth Used

The ground truth for the test set was established through clinical diagnosis and objective physiological measurements.

Diagnosis: Subjects were diagnosed with snoring and mild to severe OSA.
Outcome Measurement: 12-channel polysomnography (PSG) was used for full-night sleep studies, providing objective data (e.g., RDI, apnea-hypopnea index) to assess the severity of OSA and the effectiveness of the treatment.

8. Sample Size for the Training Set

This document describes a clinical study on the device's efficacy, not the development of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The 25 subjects constitute the clinical study population used to evaluate the device.

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

As noted in point 8, there is no training set in the AI/ML sense. The ground truth for the clinical study was established by diagnosing patients with snoring and OSA and then using pre- and post-treatment 12-channel polysomnography to objectively measure the RDI and other sleep-related parameters.

Summary

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JUL 22 1999

Concept, Development & Production of Specialized Dental Technology K99 1449

510(k) Summary

April 21,1999

William A. Belfer, D.M.D., M.Sc.D. c/o Dental Imagineers & Associates 804 West Park Avenue Ocean, New Jersey 07712

(732) 493-4747 phone: fax: (732) 493-4742

Snore-Aid@plus Device/Trade name: Mandibular Advancement and Tongue Positioning Descriptive name: Orthotic (MATPO) Anti-Snoring Device Common name: Device, Anti-Snoring Classification name:

Substantial Equivalence Device: The Snore-Aid®plus is substantially equivalent to the Snore Free® K955336 (also known as the Rest Assured® appliance) and the Snore Guard® K882303 appliances.

Description of Device:

Snore-Aid@plus is a single plate mandibular advancement and tongue positioning orthotic consisting of: (1) a flat mandibular occlusal bite

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plate, (2) an adjustable external maxillary lip shield, and (3) a wide occlusal surface. The occlusal bite plate provides dental stability, protects the TMJ from occlusal loading and prevents muscle soreness due It also actively elevates and positions the tongue anteriorly to bruxism. and dorsally against the palate, thereby increasing the patency of the airway.

The Snore Free® and Snore Guard® utilize a single unit maxillary plate and a mandibular guide plane to advance the lower jaw. The Snore-Aid®plus utilizes the mandibular occlusal bite plate to hold the lower jaw forward and buttresses against the maxillary lip via the use of a maxillary external lip shield.

The external lip shield is adjustable horizontally upon an anterior extension of the occlusal bite plate which extends between the lips.

Intended Use:

Snore-Aid®plus is a perscribed anti-snoring device.

Snore-Aid®ø/us is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.

Characteristics: Technological -

The Snore-Aid®plus, Snore Free®, and Snore Guard® appliances are similar in that they all are individually customized and they all advance the lower jaw and increase airway space. The predicate devices have no means of actively elevating the tongue. However, Snore-Aid®plus elevates the tongue against the palate even if the mandible is not fully advanced, and thereby efficacy is enhanced.

Snore-Aid@plus and Snore Free® have full occlusal coverage to prevent occlusal bite changes. Moreover, the occlusal bite plate of Snore-Aid®plus can be equilibrated as a splint to influence occlusal function

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and protect against parafunctional habits. SnoreGuard® has only partial occlusal coverage.

In the Snore Free® and Snore Guard® devices the maxillary plate and the mandibular guide plate provide the advancement function, but there is no protective mechanism for the TMJ. Snore-Aid®plus uses an external lip shield in lieu of the maxillary plate of the SnoreFree® and SnoreGuard®. It permits the mandible freedom of vertical and lateral motion. Furthermore, it allows the device to be adjustabled to fit different jaw sizes and it is a convenient means of titrating the mandibular advancement. SnoreFree® and SnoreGuard® require remolding in order to adjust the mandibular advancement and there is little if any freedom of lateral jaw motion.

Clinical Data:

Clinical testing of the Snore-Aid@plus (MAPTO) appliance was done on 25 subjects who were diagnosed with snoring and mild to severe OSA. Twelve channel polysomnography was used to test subjects during full night sleep studies which were done pretreatment and repeated 4 weeks post-treatment. Treatment success was defined as a 50% reduction in RDI and a post-treatment RDI≤ 10. In 18 of 18 patients who had an initial RDI ≤30 there was treatment success. In 7 individuals who had severe apnea (RDI > 30) all achieved a reduction in RDI which was below of the pretreatment index, but only one achieved a RDI≤10. In none of the subjects was there any indication of TMJ pain or muscle sorness. None of the subjects reported bite changes upon awakening from sleep. Two patients reported nocturnal bruxism which caused temporary soreness of incisor teeth.

Conclusion:

Snore-Aid@plus is appropriate for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 2 2 1999

William A. Belfer, D.M.D., M.Sc.D. Chief Executive Officer Dental Imagineers & Associates 804 West Park Avenue Ocean, New Jersey 07712

Re : K991449 Snore-Aid® plus Trade Name: Requlatory Class: Unclassified LRK Product Code: Dated: April 21, 1999 Received: April 26,1999

Dear Dr. Belfer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Belfer

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Snore-Aid® plus

Device Name:

Indications For Use:

Snore-Aid®plus is prescribed_for the patient by the healthcare professional.

A. Snore-Aid®plus is indicated for use in patients with primary snoring or snoring and mild obstructive sleep apnea (OSA) where mandibular advancement and positioning of the tongue can increase pharyngeal air space.

Snore-Aid®plus is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

and General Hospital De 510(k) Number

3-1

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.”