A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.

Device Description

SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units. The connectors between the upper and lower plates are flexible elastomeric tubes that have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.

AI/ML Overview

The provided text describes a medical device called "SleepBite," a mandibular advancement device intended for anti-snoring and sleep bruxism. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

It primarily focuses on:

Device identification: Trade name, common name, classification.
Substantial equivalence: Comparing SleepBite to existing predicate devices (EMA and Silent Nite).
Description: How the SleepBite device works, its adjustable screw mechanism, and flexible connectors.
Intended Use: Specific indications for which the device is prescribed.
Technological Characteristics: Highlighting the differences and similarities with predicate devices.
Regulatory clearance: The FDA's 510(k) clearance letter, indicating substantial equivalence.

Therefore, based on the provided text, I cannot answer most of your questions as the information is not present in the document.

Below is a table reflecting the absence of the requested information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Regarding the other questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The document is primarily a device description and regulatory clearance, not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described.
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 a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
8. The sample size for the training set: Not applicable and not described.
9. How the ground truth for the training set was established: Not applicable and not described.

In summary, the provided document does not contain the detailed study information regarding acceptance criteria, performance metrics, or clinical trial design that your questions refer to. It is a regulatory submission focused on demonstrating substantial equivalence to previously cleared devices.

Summary

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of Specialized Dental Technology

WILLIAM A. BELFER, D.M.D., M.Sc.D.

K013808

JAN 3 0 2002

804 West Park Avenue, Ocean Township
New Jersey 07712
732-493-4747 - Fax 732-493-4742

510(k) Summary

Nov. 10, 2001

William A. Belfer, DMD Dental Imagineers 804 West Park Avenue Ocean, New Jersey 07712

Phone: (732) 493-4747 Fax: (732) 493-4742

SleepBite (proposed) Device/Trade Name: Mandibular Advancement Device (MAD) Descriptive Name: Anti-snoring Device Common Name:

Device, Anti-snoring Classification Name:

Substantial Equivalence Devices: The SleepBite appliance is substantially equivalent Substailersic Mandibular Appliance, also referred to as EMA, K971724. It is also substantially equivalent to the Silent Nite appliance, K972424.

Description: SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units.

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The connectors between the upper and lower plates are flexible elastomeric tubes that The connectors between the upper alls iown particles advancement of the mandible
have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl
sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.

Intended Use: Sleep Bite is prescribed for the patient by the healthcare professional.

A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Dite is indreated its testing for obstructive sleep apnea.
C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.

Technological Characteristics: SleepBite, Silent Nite and EMA are all dual plate Technological Characteristics: Steeping, one readed by flexible comectors that appliances in which the upper and lower plates are concess the adjustment of
hold the mandible in an advanced position. With the predicate devices the adjustment of hold the mandible in an advanced position. With are propriate league connector in order to hold the the appliance is made be selecting the appential single . The appliances are supplied mandible in the most effective posture to open the clinician must tremove these appliances
with a kit of connectors of various sizes. The climician must remove a special plan with a kit of connectors of various sizes. The children Nite requires a special plier to attach the connector to the structure.

The difference in SleepBite is that it has an anterior adjustment screw that (a) enables the mannitude The difference in SleepBite is that it has an and for enams. (0) visualize the magnitude clinician to serial advance the mandiolo in this. In this can be done by turning the screw while the patient is wearing the appliance.

There are differences in the vertical/diagonal direction of the comectors. Both EMA and There are differences in the vertical unagotial of the lower plate to the anterior.
Silent Nite have connector which go from the posterior of the plates. The Silent Nite have connector which go iron the buccal aspect of the plates. The of the upper plate and attached to shilli batterior plate in the first molar ates on the SleepBite connector attaches to the upper posses from and attaches to the rigid wire buccal side of the acryne plate, willie the other varies enable the devices to advance the mandible by reciprocal action.

Conclusion: SleepBite is appropriate for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Mr. William A. Belfer President Dental Imagineers & Associates 804 West Park Avenue Ocean, New Jersey 07712

Re: K013808

Trade/Device Name: SleepBite Regulation Number: None Regulation Name: Device, Anti-Snoring Regulatory Class: Unclassified Product Code: LRK Dated: November 11, 2001 Received: November 15, 2001

Dear Mr. Belfer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller bro(s) procession 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 interstate comments, or to truy 20, 1978, entreasified in accordance with the rrovisions of Amendments, of to devices mat nave obon recuire approval of a prematice approval of a premarket the Federal Pood, Drug, and Cosmetto , therefore, market the device, subject to the general approval application (1 Mr.). - Four general controls provisions of the Act include controls provisions of the Fist - 100 - 11sting 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 II your device is classified (See aboutional controls. Existing major regulations affecting (PMA), it may be subject to Such addines from Regulations, Title 21, Parts 800 to 898. In the Coderel your device can be found in the Sous recements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTS issuaires on that your device complies with other requirements meall that IDA has made a deceminations administered by other Federal agencies.

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Page 2 - Mr. Belfer

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou mast comply with and are reveling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idocling (21 cegulation (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 This letter will anow you to begin marketing your substantial equivalence of your device to 310(K) premained nourceated. " "The 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 II you desire specific advice for your for in vitro diagnostic devices), please contact the and additionally 21 CLR Part 009110 103. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for question and (301) 504-4 Office of Comphance at (301) see contact the Office of Compliance at (301) 594-4639. advertising or your arregulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under llouiteanon (21CF ICPart 00197). Sales gold Manufacturers, International and the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Aliltrud

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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510(k) Number (if known):
---------------------------	--

Device Name:

SleepBite

Indications For Use:

SleepBite is prescribed for the patient by the healthcare professional.

A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runsey

(Division Sign-Off) (Division Sign-on)
Division of Dental, Infection Control, and General Hospital Dexices ) - રજી 510(k) Number -

Prescription Use ?er 21 CFR 801.109)

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.”