A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure. The device is intended for use as an aid to reduce simple snoring.

It is customized for patients with or without natural teeth and for mixed dentition. Reflex action reverts to mouth breathing instantly should the nasal passages congest

Device Description

A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure.

AI/ML Overview

The provided document describes a premarket notification for an "Oral Sleep Disorder Aid" and does not contain a comprehensive study with detailed acceptance criteria and reported device performance in a quantitative manner. Instead, it relies on a comparison to predicate devices and non-clinical self-observations.

Here's a breakdown of the information available based on your request, along with what is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category / Comparison Point	Acceptance Criteria (Implied)	Reported Device Performance
Efficacy	Perform as intended (reduce snoring, encourage nasal breathing).	"Total" oral snore control (non-clinical evaluation, voice-actuated tape recorder at bedside) unless interrupted by nasal congestion. "Definite success" in trial subjects.
Safety	No dislodging leading to choking; safe use.	Safely used by applicant for over 5 years. Precision occlusal match and snug tongue restraint compartment contribute to stability. Can remain seated or be expelled with a push of the tongue in case of nasal congestion or vomiting. Coughing or sneezing causes no problem.
Material Biocompatibility	Use medical grade material, similar to those used in prosthetic oral devices.	Uses medical grade material; used by dental profession for prosthetic oral devices (same as predicates).
Technological Characteristics (Similarities)	Employ same tongue restraint principles to encourage nasal breathing and oral control/snoring.	Confirmed.
Technological Characteristics (Differences)	Improve on prediacte (e.g., totally concealed).	Totally concealed (unlike predicates).
Substantial Equivalence	As safe and effective and perform as well as legally marketed oral devices.	Non-clinical tests demonstrate the new device is "as safe and effective and perform as well as the legally marketed oral devices."

What is missing from the document regarding acceptance criteria and performance:

Specific, quantifiable metrics for "snore control" (e.g., percentage reduction in AHI, snore events per hour).
Defined thresholds for "success" or "effectiveness."
Data on patient comfort, adherence, or other common performance indicators for sleep aids.

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

Sample Size for Test Set: Not explicitly defined as a formal "test set" in the context of a clinical trial. The "trials" mentioned were on the applicant's wife and son (sample size = 2).
Data Provenance: The document explicitly states, "Clinical tests have not been taken." The data comes from non-clinical observations and personal use by the applicant and two family members. It is retrospective for the applicant's 5+ years of use, and a short-term observation for the wife and son. The country of origin is implicitly the USA as the submission is to the FDA.

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

Number of Experts: Zero in a formal sense. The evaluation was primarily self-assessment by the inventor (Arthur Perlis) and anecdotal feedback from his wife and son.
Qualifications of Experts: Not applicable, as no external experts were used for ground truth establishment.

4. Adjudication Method for the Test Set

Adjudication Method: None. There was no formal adjudication process as there were no multiple readers/experts evaluating the device's performance against a pre-established ground truth. The inventor directly observed and interpreted the results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical tests have not been taken."

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 oral appliance, not an algorithm or AI. Standalone performance typically refers to the performance of an AI model without human intervention.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the device's effectiveness was established through self-observation and qualitative feedback, primarily using a voice-actuated tape recorder to distinguish between oral and nasal snoring and personal assessment of "total" oral snore control. For safety, it was the applicant's 5+ years of personal use without adverse events and the ability to expel the device easily.

8. The Sample Size for the Training Set

Sample Size for Training Set: The concept of a "training set" is not applicable here as the device's design and development were based on the inventor's personal experience and iterative improvements, not a machine learning model. If interpreted loosely as the developmental user base, it would be the inventor himself (N=1) over 5 years.

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

How Ground Truth for Training Set was Established: Again, the concept of a formal "training set" and "ground truth" establishment for it doesn't apply to this type of device development. The inventor's own experiences ("mitigate a dry mouth problem and frequent awakenings") with a "failed nasal operation that aggravated a chronic dry mouth problem" led to the invention. The "ground truth" for the invention's need and initial development was the inventor's personal symptoms and his continuous self-monitoring using a voice-actuated tape recorder to refine the device's function.

Summary

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Perl-Rad Sleep Disorder Lab. 440 E. Romie Lane Salinas. CA 93901-4017

1. Premarket Notification

510(k) SUMMARY OFF SAFETY AND EFFECTIVENESS

2. Submitter:	Arthur Perlis5315 Carmel Valley Rd., A-208Carmel, CA 93923-9558
Phone:	(831) 626-1222
No Fax No.
Contact Person:	Arthur Perlis
Date of Preparation:	04/05/99
3. Device Name:	Oral Sleep Disorder Aid
Common and

Common and trade name:	Anti-Snore Device
Classification:	Device Anti-snoring
Product Code:	77LRK

Legally Marketed Devices to which I claim equivalence. 4. Predicates: Class 1 Charles F. Samelson - Inventor: 510(k) 870611 Victor Gardy - Inventor: 510(k) 870871

Description of Predicates

ട്. Samelson Device:
.

A prescription anti-snore mouthpiece of integrally molded acrylic. It is positioned and secured within the mouth by dental engaging portions located in the incisor area. It has a rearwardly opening socket for cooperating with the forward portion of the user's tongue so as to increase the nasopharyngeal area for easier nasal breathing. Molds must be used to construct the device.

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Gardy Oral Device:

A prescription anti-snore mouthpiece, similar in design and purpose as the Samelson device. The major difference being: the Gardy device has air duct passages on either side of the mouth.

It is composed of medical grade silastic having a tongue retractor compartment, in which a vacuum develops at the tip in proportion to the force generated by tongue relapse.

Summary Describes Intended Use (Predicates):

Samelson Device:

To control the effects of snoring with a customized mouthpiece. It substantially eliminates oral breathing and provides improved nasal breathing space in the nasopharyngeal area of the throat.

Gardy Device:

Significantly reduces the effects of snoring with a universal type oral device,

offered in 3 sizes. It too provides improved nasal breathing.

Technological Characteristics Comparison

(Similarities)

Although the predicates and the new device have some technological differences, they all employ the same tongue restraint principles to encourage nasal breathing and oral controlysnoring.

All are made by prescription.

All are stabilized in the mouth by registering on a dental arch and employing a forwardly tongue restraint vacuum.

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All increase the unobstructed dimension of the nasopharyngeal area, to facilitate nasal breathing.

(Differences)

The Samelson device is locked between upper and lower incisor dental engaging portions; the Gardy device on one portion.

The new device registers upon the maxillary dental arch for dentulous use, edentulous, those with mixed dentition; and for "daytime use" over an existing maxillary denture, for patients living in arid geographical areas.

The predicates protrude beyond the lips. The new device is totally concealed.

The Gardy device claims significant reduction in snoring.

The new device, in a non-clinical evaluation showed "total" oral snore control by use of a voice actuated tape recorder at bed-side, unless or until interrupted by nasal congestion.

All three oral devices have automatic fail-safe returns to mouth breathing by reflex action should the nasal passages congest.

Gardy states all oral devices used for snore control have a potential hazard of dislodging and choking the patient.

The new device has been safely used by this applicant for over five (5) years. A precision occlusal match and a snug tongue restraint compartment are stability factors that contribute to safety and effectiveness.

Efficacy: All three devices perform as intended.

Effectiveness: The predicates claim effective use of their oral devices, as does the new device.

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In case of nasal congestion or vomiting, the new device can remain seated Safety: upon the maxillary dental arch or be expelled with a push of the tongue.

Coughing or sneezing causes no problem.

The predicates must be detached from teeth and removed when expelling anything. Bicompatibility:

All three devices use medical grade material and have been used by the dental profession for prosthetic oral devices.

Summarv

Non-Clinical Performance

(discussion)

History:

To mitigate a dry mouth problem and frequent awakenings, I invented a mouthclosure intra-oral device with tongue restraint compartment to prevent mouth breathing, the cause of oral dry-out and oral snoring.

That prompted the invention of a simple external nostril dilator to conjoin with the oral device.

To monitor my progress, I used a "voice actuated" tape recorder at bedside. I soon distinguished between oral and nasal snoring. Oral breathing would resume instantly should the nasal passages congest, without disturbing the oral device.

Performance:

Having proved its worth, I enlisted my wife and son as trial subjects. Her problem was a dry mouth due to mouth drying medication; his was snoring. His dentist made molds of upper and lower dentition, the latter as a reference tool, including a centric wax

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The trials were a definite success.

Clinical tests have not been taken.

Non-Clinical Test Conclusions: 10.

They demonstrate the new device to be as safe and effective and perform as well as the legally marketed oral devices as used "without" the nostril dilator, as necessary to qualify for substantial equivalence. There have been no adverse effects.

Since most prior art currently marketed require the patient to sleep with lower jaw extended, in different degrees, I believe the new device will satisfy a long-awaited need.

My "Oral Sleep Disorder Aid" was born of necessity due to a failed nasal operation that aggravated a chronic dry mouth problem. It has spared me years of suffering.

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Image /page/5/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the bottom profile being the largest and the top profile being the smallest. The profiles are connected by a curved line that runs along the bottom of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

SEP 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Arthur Perlis Perl-Rad Sleep Disorder Lab 5315 Carmel Valley Road A-208 Carmel, California 93923

K991209 Re : Oral Sleep Disorder Aid Trade Name: Regulatory Class: Unclassified LRK Product Code: Dated: June 30, 1999 Received: July 6, 1999

Dear Mr. Perlis:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Perlis

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one 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,

Patroux Cucurite/foe

Timothy A. Ulatowski 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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Page 1 of 1

Labels	Values
510(k) Number (if known):	K991209
Device Name:	ORAL Sleep Disorder Aid

Indications For Use:

A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure. The device is intended for use as an aid to reduce simple snoring.

It is customized for patients with or without natural teeth and for mixed dentition. Reflex action reverts to mouth breathing instantly should the nasal passages congest

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Ruase
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
	ICA91209

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)

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.”