A prescription anti-snoring mouthpiece that is similar in design and purpose as the Samelson device. The tongue is placed at the roof of the mouth with a tongue platform holding the tongue in the forward position by a naturally occurring tongue suction and lip seal. It requires upper and lower molds. It is constructed of flexible, thermoforming mouthguard materials.

AI/ML Overview

The provided text is a 510(k) summary for the NOSE BREATHE® MOUTHPIECE for HEAVY SNORER. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for the new device.

Therefore, many of the requested elements are not explicitly available in the provided text. I will extract what is present and indicate where information is missing.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it relies on a qualitative assessment of "safety," "effectiveness," and "efficacy" in comparison to predicate devices.

Missing Information: Specific, quantifiable acceptance criteria (e.g., reduction in AHI, specific decibel reduction in snoring, percentage of users reporting improvement).

Here's an interpretation of what can be gleaned:

Acceptance Criteria (Inferred from text)	Reported Device Performance
Safety: Device is safely used and easily removed; no dislodgment/choking episodes.	"The new device has been safely used for over four (4) years." "has not had a single episode of it happening since its inception in 1997." "All four (4) devices can be easily removed with the push of the tongue when expelling anything." "There have been no adverse effects."
Efficacy: Performs as intended (mitigate dry mouth, control snoring).	"All devices perform as intended." "The new device has performed well and is still being worn by the first-time users for more than four years."
Effectiveness: Reduces snoring.	"The predicates claim effective use of their oral devices, as does the new device in reducing snoring." "Siblings, relatives, and friends and their spouses and significant others have all benefited from the reduction in snoring." "The new device...an effective approach in reducing snoring"
Biocompatibility: Uses medical-grade material.	"All four (4) devices use medical grade material and have been used by the dental profession for the construction of oral devices."

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a formal "test set." The document mentions "Siblings, relatives, and friends" and "a few hospital sleep lab patients." The number of individuals in these groups is not quantified.
Data Provenance: The origin of the data is personal anecdotal observations (siblings, relatives, friends, spouses, significant others) and "a few hospital sleep lab patients" who were referred by their physicians. The location of these individuals is implied to be within the United States (Honolulu, Hawaii, and general references to US regulatory bodies). It appears to be a retrospective collection of anecdotal observations rather than a prospectively designed clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The "performance" claims are based on user feedback from "Siblings, relatives, and friends" and observational data from "a few hospital sleep lab patients." There's no mention of independent experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Information not provided. Given the nature of the "performance" data (anecdotal user feedback), a formal adjudication method is highly unlikely to have been employed.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging or diagnostic AI, which is not relevant to this mechanical anti-snoring device.

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

Standalone Performance Study: Not applicable. This device is a mechanical mouthpiece, not an algorithm. Its performance is inherently "human-in-the-loop" as it requires a user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth Type:
- For safety and effectiveness: Primarily user-reported outcomes/satisfaction (from siblings, relatives, friends) and qualitative observations.
- For the "few hospital sleep lab patients," it's mentioned "no follow up studies have been made with the new device in place," which implies that even for these patients, formal outcome data (like AHI reduction from sleep studies) was not collected or analyzed for the purpose of this submission.
- The "ground truth" seems to be informal user feedback and the absence of reported adverse events over four years.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set. The "design" evolution involved using "many different designs and types of dental oral anti-snoring devices" which led to the current design, implying an iterative development process driven by observation rather than a formal training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no formal training set for an algorithm. The "discovery" (leading to the design) was based on observing "a pre-existing, naturally occurring lip seal and tongue suction... when the tongue is placed at the roof of the mouth," which was identified during a process of trying various designs. This is more akin to design iteration and observation than establishing ground truth for a dataset.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and qualitative claims of safety and effectiveness, rather than quantitative performance metrics from a rigorous clinical study. The "study" mentioned for the new device is anecdotal and qualitative, involving siblings, relatives, friends, and a few sleep lab patients without formal follow-up or quantifiable data.

Summary

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NOSE BREATHE® MOUTHPIECE for HEAVY SNORER 2065 S. King Street, Suite 304 Honolulu, HI 96826

3. Premarket Notification

510(K) SUMMARY OFF SAFETY AND EFFECTIVENESS

4 -- 6. See Table of Contents

7. Description:

Perlis Device:

A prescription anti-snoring intra-oral mouthpiece with tongue restraint compartment to prevent mouth breathing, the cause of oral dry-out and oral snoring. Molds must be taken to construct the device. The lower molds are used to set the occlusion and not used to construct the device.

Samelson Device:

A prescription anti-snoring mouthpiece of integrally molded acrylic used to displace the tongue in the forward position. It is positioned and secured with the mouth by dental engaging portions located in the incisor area. It has a rearwardly opening socket for cooperation with forward portion of the user's tongue. Molds must be used to construct the device.

Grady Device:

A prescription anti-snoring mouthpiece that is similar in design and purpose as the Samelson device. The major difference being the Grady 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.

New Device:

8. Summary Describes Intended Use:

Perlis Device:

It is to mitigate dry mouth problems and oral snoring with the use of a customized mouthpiece. It prevents mouth breathing.

Samelson Device:

It is to control the effects of snoring with a customized mouthpiece. It substantially eliminated oral breathing.

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Grady Device:

It reduces the effects of snoring with a universal type oral device, offered in 3 sizes.

New Device:

It reduces snoring by placing the tongue forward to the roof of the mouth. It is customized and requires a prescription.

Technological Characteristics Comparison: 9.

Similarities:

Although the predicates and the new device have some technological differences, they all employ the same tongue restraint principles and control simple snoring.

All are made by prescription.

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

Differences:

The Perlis device registers upon the maxillary dental arch for dentulous, edentulous, those with mixed dentition; and for "daytime use' over an existing maxillary denture; the Samelson device is locked between upper and lower incisor dental engaging portions; the Grady device locks on one portion.

The new device registers upon the maxillary and mandibular arches for dentulous patients.

The Perlis device is concealed; the Samelson and Grady devices protrude beyond the lips.

The new device is within the confines of the oral cavity,

Grady states all oral devices used for snore control have a potential hazard of dislodging and choking the patients. There is always that possibility but the new device has not had a single episode of it happening since its inception in 1997.

The new device has been safely used for over four (4) years.

Efficacy:

All devices perform as intended.

Effectiveness:

The predicates claim effective use of their oral devices, as does the new device in reducing snoring.

Safery:

All four (4) devices can be easily removed with the push of the tongue when expelling anything

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Biocompatibility:

All four (4) devices use medical grade material and have been used by the dental profession for the construction of oral devices.

Summary Non-Clinical Performance (Discussion)

10. History and Performance:

After using many different designs and types of dental oral anti-snoring devices, in private practice and from the marketplace, a pre-existing, naturally occurring lip seal and tongue suction were discovered when the tongue is placed at the roof of the mouth. The lip seal and tongue suction are present only during nasal breathing. This discovery lead to the design of a simple, comfortable, non-invasive dental oral anti-snoring device for reducing snoring.

Performance:

Siblings, relatives, and friends have used the new device with excellent results. The new device has performed well and is still being worn by the first-time users for more than four years. The trials have been successful.

11. Clinical Tests:

Clinical tests have not been taken. However, a few hospital sleep lab patients have used the new device after being referred by their physicians. At present, no follow up studies have been made with the new device in place.

12. Non-Clinical Test Conclusions:

The new device has demonstrated to be as safe, effective, and performs as well as the legally marketed oral devices, as necessary to qualify as substantially equivalent. There have been no adverse effects. Siblings, relatives, and friends and their spouses and significant others have all benefited from the reduction in snoring.

The predicates and the new device keep the tongue forward and away from the back of the throat, thereby resulting in the reduction of snoring.

The new device is simple, comfortable, non-invasive, and an effective approach in reducing snoring, in a gentle and safe way.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 8 2002

Dr. Steven K. Sue C/O Nose Breathe Division 2065 S. King Street, Suite 304 Honolulu, Hawaii 96826

Re: K013687

Trade/Device Name: Nose Breathe Mouthpiece For Heavy Snorer Regulation Number: None Regulation Name: Anti-Snoring Device Regulatory Class: Unclassified Product Code: LRK Dated: April 29, 2002 Received: May 3, 2002

Dear Dr. Sue:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your and have determined the device is substantially equivalent (for the relevelocal above and have the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrsate conmisees prior to that have been reclassified in accordance with the provisions of Amendinente, or to act connetic Act (Act) that do not require approval of a premarket the roderal 1 00at, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provins 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), It issue of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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.

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Page 2 - Dr. Sue.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ulatowski Tin 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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K013687

Page _1 of 1

K013687 510(k) NUMBER (IF KNOWN):

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER DEVICE NAME:

INDICATIONS FOR USE:

It is a prescription device intended to reduce snoring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √ the text block reads

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.”