The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor" appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance.

Device Description

The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients' teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth.

AI/ML Overview

The provided text is a 510(k) summary for the EndSnor™ device, which is an anti-snoring/sleep apnea device. It establishes substantial equivalence to a predicate device, the Adjustable PM Positioner, rather than presenting a study proving the device meets specific acceptance criteria in the context of a clinical trial.

Therefore, many of the requested categories for acceptance criteria and study details are not directly addressed in this type of regulatory submission. A 510(k) generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and intended use, rather than through independent clinical studies with predefined acceptance criteria.

However, I can extract the relevant information from the document to address the aspects that are covered:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or specific performance metrics from a study. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing attributes. The "performance" is implicitly deemed equivalent to the predicate device.

Attribute to Demonstrate Equivalence	EndSnor™ Performance/Characteristic	Acceptance Criteria (Implicit: Equivalent to Predicate)
Intended Use	Reduce snoring and mild to moderate obstructive sleep apnea in persons 18 or older.	Equivalent to Adjustable PM Positioner's intended use.
Function	Mandibular Repositioning Device (MRP)	Equivalent to Adjustable PM Positioner's function.
Materials	Cold cure splint acrylic; dental expansion screws; non-sterile; optional stainless steel ball clasps; dental lingual bar.	Materials deemed safe and effective as per predicate and common orthodontic use.
Design	Custom fit; mandible adjustable with 4 buccal expansion screws; permits breathing through mouth; acrylic fits over upper/lower posterior teeth; labial supporting bar for anterior gap.	Differences from predicate do not raise new safety concerns. Overall design considered safe and effective for intended use.
Safety and Efficacy	Similar design and function to predicate; differences do not raise new safety risks.	No new safety concerns or risks compared to predicate. Literature supports the historical significance of such devices.

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

Not applicable. This 510(k) submission does not describe a clinical trial with a test set of data. It relies on a comparison to a predicate device and existing literature.

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

Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is 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 appliance, not an AI or diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a physical appliance and operates with a human user (patient) and a prescribing dentist. No algorithm-only performance is relevant.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device, the Adjustable PM Positioner (K922203), cleared on February 8, 1996, and the general clinical understanding of mandibular repositioning devices for snoring and sleep apnea. The submission asserts that the EndSnor™ device is substantially equivalent to this predicate.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set in this context. The basis for evaluating the EndSnor™ is its comparison to a legally marketed predicate device.

Summary

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April 23, 2008

JUN 1 2 2008

Dockstader Orthodontic Lab, Inc. 340 West Cromwell Fresno, CA 93711

Establishment Registration Number: 510(k) Number:

SBD070202 K072731

Contact Person: Michael C Bausman (559) 439-5160 Telephone: Fax: (559) 439-8147

Device

Trade Name:	EndSnor™
Common Name:	Anti-Snoring/Sleep Apnea Device
Classification Name:	Device, Anti-Snoring
Product Code:	LRK
Class:	II
Regulation Number:	872.5570

Description of Device: The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients' teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth.

Image /page/0/Picture/10 description: In the image, a cartoon drawing shows a person sitting in a container filled with what appears to be rocks or debris. The person is lying down and seems to be relaxing or lounging amidst the rocks. The container is a hexagonal shape and is overflowing with the contents. There are also some objects or debris falling out of the container.

340 West Cromwell, Suite 102 California 93711-611 19-5160

Tolf Free Inside U.S.A

1-800/433-7168 559/439-8147

Intended Use Statement: The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor" appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the
need for an EndSnor" appliance.

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Identification of Legally Marketed Device, (predicate) for Substantial Equivalence:

Name: Adjustable PM Positioner K Number: K922203 Date Cleared: 02/08/1996

Technological Characteristics Summary:

Similarities between both devices are the following:

Indications for use .
. Function (MRP) - Mandibular Repositioning Device
. Single Patient
Multi-Use .
Prescription Device
Custom Fabricated (Fit) from Common Orthodontic Appliance Materials .
Adjustable .
Environment Home/Sleep Laboratories .
. Removable

Non Sterile .

Comparison to Predicate Device

Attribute	EndSnorTM	Adjustable PM Positioner
Use:
Intended as a Dentistprescribed intraoral device	YES	YES
Intended to reduceor help snoring andminor to moderateobstructive sleep apnea	YES	YES
Intended for use withpatients 18 years or olderwho snore or have minorto moderate obstructivesleep apnea	YES	YES
Indicated for singlepatient multi-use	YES	YES
Attribute	EndSnor™™	Adjustable PM Positioner
Use cont:
Indicated for use athome or sleeplaboratories	YES	YES
Design:
Custom fit for eachuser	YES	YES
Mandible can beadvanced with buccalexpansion screws	YES	YES
Expansion screwplacement on buccalfor unobstructed airwaypassage	YES	YES
Permits user tobreath through mouth,opens the airway	YES	YES
Acrylic fits overupper and lowerposterior teeth	YES	YES
Anterior Acrylicconnector over upperand lower anterior teeth	NO	YES
Attribute	EndSnor™	Adjustable PM Positioner
Design cont:
Anterior connectoron labial usingdental lingual barfor orthodontic splints	YES	NO
Prevents grindingof teeth	YES	YES
Easily removedfrom mouth	YES	YES
Placed in usersmouth each evening	YES	YES
Cleaned daily	YES	YES
Materials:
Dental expansionscrews for mandibularadjustment	YES	YES
Non-Sterile	YES	YES
Acrylic	YES	YES
Heat-sensitive acrylic	NO	YES
Retention clasps forretention if needed	YES	NO
Dental lingual barfor splints	YES	NO

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Comparison to Predicate Device cont:

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Differences Between EndSnor™ and Adjustable PM Positioner, a Marketed Predicated Device

Differences are:

EndSnor™ has 4 buccal expansion screws instead of 2 for mandible . advancement.
A labial supporting dental lingual bar for orthodontic splints is used to bridge the . anterior gap on the labial instead of acrylic over the anterior upper and lower teeth, thus creating less obstruction of the airway and to remove the occurrence of loosening or harming of lower anterior teeth. The labial supporting dental lingual bar is placed so there isn't any contact with the lower or upper anterior teeth.
. EndSnor™ is made of cold cure splint acrylic that is commonly used in dental labs for orthodontic splint fabrication. The Adjustable PM Positioner is made of a heat sensitive acrylic.
The dentist can chose to add retention clasps if needed for retention of the ● EndSnor™ appliance in the mouth. These commonly used orthodontic retainer clasps are Ball Clasps. These are made of stainless steel wire commonly used in the fabrication of orthodontic appliances.

Safety and Efficacy:

The EndSnor™ device is similar to the Adjustable PM Positioner, a marketed . predicated device, both are mandibular repositioning devices (MRP) and both are similar in design and function. The difference between the EndSnor™ and the Adjustable PM Positioner, a predicated device, are minor and do not raise any new safety concerns or risks.
Literature supports the historical significance of oral devices that reposition the . mandible and reduce and mange snoring as well as mild to moderate sleep apnea.

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Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a protective shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2008

Mr. Michael C. Bausman Chief Executive Officer Dockstader Orthodontic Lab, Incorporated 340 West Cromwell Fresno, California 93711-6113

Re: K072731

Trade/Device Name: EndSnor™ Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices For Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: April 25, 2008 Received: April 25, 2008

Dear Mr. Bausman;

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.

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 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. Bausman

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CIFR 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), please contact the Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sutte y. Michien Dm.d.

Chiu Lin. Ph.D. 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

510(k) Number (if known): K072731

Device Name: _EndSnor™

Intended Use Statement: The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor " appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

07273

Melle fer MSR

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

510(k) Number:

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.”