The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Device Description

The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward. The ApnoDent® design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort. The ApnoDent® appliance consists of upper and lower interlocking, customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user.

AI/ML Overview

The provided text is a 510(k) Summary for the ApnoDent Appliance. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain the specific information required to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning device study.

The document is a traditional medical device submission, focusing on material composition, mechanism of action, and comparison to existing non-AI devices. There is no mention of an algorithm, AI, machine learning, or any study involving a test set, ground truth experts, MRMC studies, or standalone performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving an AI device's performance from this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

Intended Use: Reducing nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
Technological Characteristics: Customized oral device with upper and lower trays, interlocking system, made from standard orthodontic acrylics and wires, and using screw adjustment for mandibular advancement.
Performance: The document states that a "biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s)." This indicates the "acceptance criteria" likely pertained to material safety and function, not AI performance metrics.

To answer your specific questions, I would need a document detailing an AI/ML clinical validation study.

Summary

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November 24, 2018

ApnoMed, Inc. % Colette Cozean Regulatory Consultant Dr. Colette Cozean, PhD 21581 Midcrest Drive Lake Forest, California 92630

Re: K181123

Trade/Device Name: ApnoDent Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK, LOZ Dated: October 18, 2018 Received: October 19, 2018

Dear Colette Cozean:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mar Mary S. S Runner - 53 Runner - S3 - Date: 2018.11.21 11:29:46 -05'00 For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K181123

Device Name ApnoDent

Indications for Use (Describe)

The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(k) Summary

Applicant:	ApnoMed, Inc.1515 116th Ave NE. Suite 105CBellevue WA, 98004(425) 443-4020
Contact Person:	Colette Cozean, PhD21581 Midcrest DriveLake Forest, CA 92630(949) 855-2885colettecozean@gmail.com
Date Prepared	August 31, 2018
Proprietary Name	ApnoDent® Appliance
Common Name	Device, Snoring and Mild to Moderate Sleep Apnea
Classification Name	Intraoral devices for snoring; intraoral devices for snoring and obstructive sleep apnea(Class II, 21 CFR872.5570, Product Code LRK, LQZ)
Primary Predicate Device	mRNA (K130067)
Reference Predicate Devices	DynaFlex (K103076), OASYS-Oral Airway (K030440), Apinator-Oral Airway (K160123)

Description: The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use.

The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward.

The ApnoDent® design vields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort.

Indications for Use: The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Technological Characteristics: The ApnoDent® appliance consists of upper and lower interlocking. customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user. The technical characteristics are identical to the predicate devices.

All predicate devices (mRNA, DynaFlex, OASYS, Apinator-Oral Airway) also function as mandibular advancement devices to increase the patient's pharyngeal space and improve the ability to exchange air during

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sleep. They each have customized upper and lower trays that interlock to advance the mandible. In all technological characteristics the subject device is substantially equivalent to the predicate devices.

	Subject Device	PrimaryPredicate	ReferencePredicate #1	ReferencePredicate #2	ReferencePredicate #3
	ApnoDent®	mRNA Appliance	DynaFlex Anti-Snoring andSleep ApneaDevices	Apinator-OralAirway System	OASYS-OralAirway System
510(k) Number	K181123	K130067	KI03076	K160123	K030440
Indication forUse	Intended toreduce nighttime snoring andmild tomoderateobstructive sleepapnea (OSA) inadults.	Intended toreduce nighttime snoring andmild tomoderateobstructive sleepapnea (OSA) inadults.	Intended toreduce nighttime snoring andmild tomoderateobstructive sleepapnea (OSA) inadults.	Intended for useon adult patients18 years of ageand older as anaid for thereduction and/oralleviation ofsnoring and mildto moderateobstructive sleepapnea	Intended toreduce nighttime snoring andmild tomoderateobstructive sleepapnea (OSA) inadults.
ClassificationName	Device, Anti-Snoring andObstructiveSleep Apnea	Device, Anti-Snoring andObstructiveSleep Apnea	Device, Anti-Snoring andObstructiveSleep Apnea	Device, Anti-Snoring andObstructiveSleep Apnea	Device, Anti-Snoring andObstructiveSleep Apnea
Class	II	II	II	II	II
Product Code	LRK, LQZ	LRK, LQZ	LRK, LQZ	LRK, LQZ	LRK, LQZ
May be used inСРАРIntolerance	yes	yes	yes	yes	yes
Area of Use	mouth	mouth	mouth	mouth	mouth

Technological Characteristics

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Construction	Industry-standard dentalacrylic, stainlesssteel orthodonticwires,orthodonticadjustmentscrews	Industry-standard dentalacrylic, stainlesssteel orthodonticwires,orthodonticadjustmentscrews	Industry-standard dentalacrylic, stainlesssteel orthodonticwires,orthodonticadjustmentscrews	Industry-standard dentalacrylic, stainlesssteel orthodonticwires,orthodonticadjustmentscrews	Industry-standard dentalacrylic, stainlesssteel orthodonticwires,orthodonticadjustmentscrews
Fabrication	Customized	Customized	Customized	Customized	Customized
Mechanism ofAction	Advancing themandible	Advancing themandible	Advancing themandible	Advancing themandible	Advancing themandible
Method ofpositioning ofthe mandible	Screwadjustment	Screwadjustment	Screwadjustment	Screwadjustment	Screwadjustment
Amount ofmandibleprotrusion	6-8 mm	6-8 mm	6-8 mm	6-8 mm	6-8 mm
Prescription only	yes	yes	yes	yes	yes

Clinical and Non-Clinical Data: A biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s).

Summary: Based on the intended use, technical characteristics, and other data provided in this submission, the ApnoDent® appliance demonstrates substantial equivalence to the predicate devices in both safety and

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.”