The SUAD™ Device is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts. The SUAD™ Device has modifications in the combination of materials used, the assembly, and the fabrication technique compared to the predicate device. The casted framework is substantially equivalent to casted frameworks used in dentures prior to 1976. The "tube and rod" assembly of the pivot and tube is substantially equivalent to the Herbst appliance, with a changed angle of the connecting tube to the pivot for greater stability. The framework strengthens the device. Smooth "buttons," frames covering all occlusal and incisal surfaces, and the use of vacuum-formed thermo-plastic result in less exposed wires.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document for the SUAD™ Device (K023836) does not present traditional acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) for a device that provides an automated output or diagnostic assessment. Instead, the "acceptance criteria" are implied by its substantial equivalence comparison to predicate devices, focusing on functional characteristics and intended use. The "device performance" is therefore described in terms of its ability to perform these functions and address identified risks, similar to its predicates.

Acceptance Criteria Category (Implied by Substantial Equivalence)	Reported Device Performance (SUAD™ Device)
Intended Use Equivalence:
- Intraoral device	Yes
- Reduce snoring	Yes
- Reduce obstructive sleep apnea	Yes
Design Equivalence:
- Removable device	Yes
- Custom fit	Yes
- Adjustable	Yes
- Allows lateral and vertical movement	Yes
- Frames cover all occlusal and incisal surfaces	Yes
Material Equivalence:
- Base material, vinyl	Yes
- Ethylene acrylic overlay	Yes
- Steel metal components	Yes
Risk Mitigation (Implied by Special Controls):
- Intraoral gingival, palatal, or dental soreness	The internal framework and specific materials used provide for a comfortable fit.
- Obstruction of oral breathing	The angle of the upper connecting tube has been redirected, allowing for greater stability of the upper form. With the retruded force of the mandible, the new direction of the tube forces the upper frame to stay in a properly seated position.
- Loosening or flaring of lower anterior teeth/general tooth movement	The frames are designed to cover all the occlusal and incisal surfaces.

Study Details:

The provided document (510(k) K023836) does not detail a study involving quantitative performance metrics for the SUAD™ Device itself. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly the Removable Herbst Appliance (K955822).

The 'study' presented is a comparison table (Table 1 - Substantial Equivalence Comparison) that outlines the attributes of the SUAD™ Device against several predicate devices (Herbst, Klearway, Silencer, TAP). This table serves as the primary evidence to "prove" the device meets the acceptance criteria, by showing it shares the same intended use, fundamental design characteristics, and materials.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. There is no specific "test set" of patients or data mentioned in the context of performance evaluation for this 510(k). The evaluation is based on a comparison of device characteristics and design.
- Data Provenance: Not applicable. The document focuses on declarative statements about device features and a comparison to predicate devices, rather than data collected from a study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no human-in-the-loop performance measurement or diagnostic assessment is described for the device, there is no mention of experts establishing a ground truth for a test set. The designers and manufacturers are the experts cited for the device's characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or human interpretation requiring adjudication.
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:
- No MRMC study was done. This device is a physical mandibular appliance, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was done. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for the substantial equivalence claim is the established performance and safety profile of the predicate devices. The SUAD™ Device is considered safe and effective because its characteristics are similar to those already proven safe and effective. Risk mitigation strategies (Table 2) are described for potential risks, but these are design features rather than outcomes data from a specific study.
The sample size for the training set:
- Not applicable. This document does not describe a training set as would be relevant for an AI/algorithm-based device.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.

In summary, the K023836 submission for the SUAD™ Device primarily demonstrates acceptance by proving substantial equivalence to predicate devices already on the market, rather than through a new clinical performance study with specific quantitative acceptance criteria or a "test set" in the context of an AI/diagnostic device. The "proof" is in the detailed comparison of design, materials, and intended use, along with a discussion of how the device addresses potential risks through its design modifications.

Summary

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K023836

		510(k) Summary of Safety and Effectiveness
Submitter:	Patrick J. Strong
	Strong Dental Inc.
	33 Princess Street, Suite 403
	Leamington, Ontario, Canada
	N8H 5C5

	Telephone:	1-800-339-4452
	Facsimile:	(519) 322-1320
	Contact Person:	Patrick J. Strong or Mary Lou Strong
	Description of the Device:
Trade name:		The SUAD™ Device
Descriptive name:		Mandibular advancement device/appliance (MAD)
Common Name:		Sleep apnea/Anti-snoring device
Product code:		LRK Anti-snoring device
Device Class:		Class II
	Establishment Registration
Number:		None
Intended Use:		To reduce or alleviate nighttime snoring and
		obstructive sleep apnea (OSA).

The Removable Herbs1 Appliance is the predicate device for the SUAD™ Device, having all the same functional characteristics. The Removable Herbst Appliance (510(k) K955822) is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts.

The SUAD" Device has the following modifications: the combination of the materials used, the assembly and the fabrication technique. Detailed drawings of The SUAD" device are available in the patent, Patent No. US 6,418,933 B1 [Reference 1 ].

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1. 510(k) Summary of Safety and Effectiveness (continued)

The SUAD™ Device functions in a similar manner to other comparative predicate devices and the intended uses are the same (See Table 1). The general differences or modifications between the device and predicate devices are minor and do not raise new safety concerns. Table 2 lists the risks identified for this device and summarizes how Strong Dental Inc. has addressed the risk.

The casted framework is substantially equivalent to the casted framework used in dentures used prior to 1976. The "tube and rod" assembly of the pivot and ube is substantially equivalent to the Herbst appliance. The angle of the connecting tube to the pivot has been changed to allow for greater stability of the appliance. The framework is used to strengthen the device. The smooth "buttons," frames that cover all the occlusal and incisal surfaces, and the use of the vacuum-formed thermo-plastic to hold the appliance results in less exposed wires.

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دت بے بے اس

I. 510(k) Summary of Safety and Effectiveness (continued)

Table 1. Substantial Equivalence Comparison

Attribute	SUAD™	Herbst	Klearway	Silencer	TAP
USE
Intraoral device	Yes	Yes	Yes	Yes	Yes
Reduce snoring	Yes	Yes	Yes	Yes	Yes
Reduce obstructivesleep apnea	Yes	Yes	Yes	Yes	Yes
DESIGN
Removable device	Yes	Yes	Yes	Yes	Yes
Custom fit	Yes	Yes	Yes	Yes	Yes
Adjustable	Yes	Yes	Yes	Yes	Yes
Allows lateral andvertical movement	Yes	Yes	Yes	Yes	Yes
Clasps required	No	Yes	Yes	Yes	Yes
Frames cover allocclusal and incisalsurfaces	Yes	Yes	Yes	Yes	Yes
Buttons attached toframes to attachconventional elastics	Yes	No	No	No	No
Angle of upperconnecting tuberedirected for greaterstability of the upperform	Yes	No	No	No	No
Casted frameworkinserted into upperand lower frames	Yes	No	No	No	No
MATERIALS
Base material, vinyl	Yes	Yes	Yes	Yes	Yes
Ethylene acrylicoverlay	Yes	Yes	Yes	Yes	Yes
Steel metalcomponents	Yes	Yes	Yes	Yes	Yes
Casted metalframework	Yes	No	No	No	No
TESTING
Not applicable	Yes	Yes	Yes	Yes	Yes

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I. 510(k) Summary of Safcty and Effectivencss (continued)

Table 2. Risk Profile

Identified risk	Special controls
Intraoral gingival, palatal, or dental soreness	The internal framework and specific materialsused provides for a comfortable fit.
Obstruction of oral breathing	The angle of the upper connecting tube hasbeen redirected, allowing for greater stability ofthe upper form. With the retruded force of themandible, the new direction of the tube forcesthe upper frame to stay in a properly seatedposition.
Loosening or flaring of lower anterior teeth orgeneral tooth movement	The frames are designed to cover all theocclusal and incisal surfaces.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Strong Dental Incorporated C/O Clyde A. Takeguchi, Ph. D. Phoenix Regulatory Associates, Limited 21525 Ridgetop Circle, Suite 240 Sterling, Virginia 20166

JUL 0 8 2003

Re: K023836 Trade/Device Name: SUAD™ Device Regulation Number: 21 CFR 872.5570 Regulation Name: Anti-Snoring Device Regulatory Class: II Product Code: LRK Dated: April 11, 2003 Received: April 11, 2003

Dear Dr. Takeguchi:

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 - Dr. Takeguchi

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 (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), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

Suer Runner

Susan Runner, DDS, MA Interim 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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II. Indications for Usc

510(k) Number: K023836

Devicc Name: SUAD™ Devicc

A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.

Contraindications:

The device is contraindicated for paticnts who:

Have central siccp apnea ●
Have severe respiratory disorders .
Have an edentulous arch .
Have loose tecth or advanced periodontal discasc .

. .

Are under 18 years of age. .
Keen Mely for MSP

ivision Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number: K 023836

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.”