The Emerald Herbst 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 and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.

The Emerald Herbst appliance is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.

The Emerald Herbst is offered in two options:

Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if it becomes loose.
Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Emerald Herbst" oral appliance, intended for the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new device-specific clinical trials to prove safety and effectiveness. Therefore, the information regarding acceptance criteria and a study that proves the device meets these criteria will be different from what would be expected for a device requiring new clinical evidence.

Here's an analysis of the acceptance criteria and the "study" (or rather, the justification for equivalence) based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" are primarily established by the characteristics and performance of the predicate device. The goal is to show that the new device is "substantially equivalent" to an existing one. The provided document includes a "Substantial Equivalence Table" which acts as a comparison of key characteristics between the subject device (Emerald Herbst) and its predicate devices (Respire Pink Series Herbst and Herbst EF).

Feature / Acceptance Criteria (based on Predicate)	Reported Emerald Herbst Performance
Intended Use:
Treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18+	Intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18+
Class II medical device	Class II
Intraoral device	Yes
Reduce snoring	Yes
Treat mild to moderate OSA	Yes
Nighttime use	Yes
Single patient, multiuse	Yes
Use at home or sleep labs	Yes
For adults, 18 years or older	Yes
Design:
Customized fit for each patient	Yes
Mechanism of action: Mandibular advancement	Yes
Can be adjusted or refit	Yes
Range of forward movement of mandible	Yes (implicitly, as it uses the same Herbst telescoping hinge)
Upper & lower trays disengage for easy removal	Yes
Permits patient to breathe through the mouth	Yes
Has tracking device	No (this is a difference from one predicate, but not deemed to impact substantial equivalence here)
Cleaned and inspected daily by patient	Yes
Materials:
Hard surface material	Yes
Soft lining material	No (for Hard option), Yes (for Hard/Soft option)
Advancement mechanism (Herbst telescoping hinge, stainless steel)	Yes
Cobalt Chrome Mesh inside Acrylic	Yes
Mechanism:
Mechanism of Action: Mandibular Advancement	Mandibular Advancement
Method of Positioning the Mandible: Herbst Telescoping Hinge	Herbst Telescoping Hinge
Maximum Amount of Mandible Protrusion: 6 mm	6 mm
Labeling:
Prescription Only	Yes

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

This submission does not involve a "test set" in the sense of a clinical study with a patient cohort. The "study" here is a demonstration of substantial equivalence through comparison of design, materials, and function to a predicate device. Therefore, clinical sample sizes, data provenance (country, retrospective/prospective), expert ground truth, and adjudication methods are not applicable in the traditional sense for this 510(k). The evaluation is based on manufacturer data, existing predicate device information, and bench testing.

3. 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 described in #2, there was no clinical "test set" requiring expert ground truth or adjudication.

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

Not applicable. As described in #2, there was no clinical "test set" requiring adjudication.

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 intraoral appliance, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI-based device.

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

Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices and the physical/material properties of the subject device. The primary "ground truth" demonstrated is that the Emerald Herbst appliance is made of the same materials, using the same manufacturing procedures, and has the same mechanism of action as the legally marketed predicate devices, and therefore is expected to have the same performance.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" for this device.

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

Not applicable. As there is no training set, there's no ground truth for it to be established.

Summary of the Study/Justification provided in the text:

The "study" or evidence provided to meet acceptance criteria for the Emerald Herbst device is primarily a demonstration of substantial equivalence to existing predicate devices (Respire Pink Series Herbst and Herbst EF).

Clinical and Non-Clinical Data: A biocompatibility and physical properties assessment was completed. This assessment concluded that the subject device was substantially equivalent to the primary predicate device based on its material composition. A risk assessment was also conducted, concluding no additional risks compared to the predicate device(s).
Performance Testing: The document states that the Emerald Herbst is "equivalent to the predicate device, Pink Series, as it uses all the same materials, same manufacturing procedure and same manufacturer." Therefore, no mechanical testing was conducted to establish equivalence in general. However, specific performance testing mentioned is:
- The Emerald Herbst was subjected to pre and post accelerated aging test measured by deflection strength. The result was that "Aging did not decrease the strength of the device."
Differences: The only significant difference highlighted is the color (green vs. pink). This difference was justified by referencing another cleared device (K942667) that includes the use of various colors, including the green used for Emerald Herbst.

In essence, the "study" establishing that the Emerald Herbst meets acceptance criteria is a regulatory comparison and material/design verification, rather than a clinical trial or algorithm performance study. The acceptance criteria are "to be substantially equivalent to the predicate device" in terms of intended use, technological characteristics, and safety/effectiveness profile, which is achieved by demonstrating identical or very similar materials, design, mechanism of action, and manufacturing processes, with any minor differences (like color) being justified.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

May 10, 2023

Island Dental Lab, Inc dba Emerald Dental % Colette Cozean, Phd Regulatory Consultant The EyeDeas Company 21581 Midcrest Dr. Lake Forest, California 92630

Re: K223624

Trade/Device Name: Emerald Herbst 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, LQZ Dated: November 30, 2022 Received: December 5, 2022

Dear Colette Cozean, Phd:

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/cfpmn/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.

{1}------------------------------------------------

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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -2

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223624

Device Name Emerald Herbst

Indications for Use (Describe)

The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(k) Summary

Applicant:	Island Dental Lab, Inc dba Emerald Dental Lab76 S. Central Ave., # 1DValley Stream, NY, 11580516-327-0810347-522-9800
Contact Person:	Colette Cozean, PhD21581 Midcrest DriveLake Forest, CA 92630(949) 855-2885colettecozean@gmail.com
Date Prepared	August 15, 2022
Proprietary Name	Emerald Herbst Appliance (Hard and Hard/Soft)
Common Name	Device, Snoring and Mild to Moderate Obstructive Sleep Apnea
Classification Name	Intraoral devices for snoring; intraoral devices for snoring and obstructive sleep apnea(Class II, 21 CFR872.5570, Product Code LRK and LQZ)
Primary Predicate Device	Respire Pink Series with DentiTrac(K170692) refers to Herbst ( (K131138),Respire Pink Series – Herbst EF (K150572)
Reference Device	Dent-O-Cryl Orthodontic Acrylic (K942667) is used to justify theuse of a different color. Emerald Dental certifies that the HerbstEmerald Device uses the following identical materials found inthe Respire Pink Series:

Description: The Emerald Herbst 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 and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.

The Emerald Herbst is offered in two options:

Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if 1. it becomes loose.
1. Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.

These two options are also available in the predicate, Respire Pink Series.

Indications for Use: The Emerald Herbst appliance is intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older. This indication for use is identical to that of the predicate device(s).

Technological Characteristics: The Emerald Herbst appliance consists of upper and lower interlocking, customized trays. The Emerald Herbst appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic ball clasps for retention. The Emerald Herbst appliance allows for inter1ocking of the upper and lower trays to adjust the mandibular position of the user. The technical characteristics are identical to the predicate devices.

{4}------------------------------------------------

Mechanism of Action: All predicate devices (Respire Pink Series) also function as mandibular advancement devices to increase the patient's pharyngeal space and improve the ability to exchange air during sleep. They each have customized upper and lower trays that interlock to advance the mandible. The mechanism of action of the subject device is substantially equivalent to the predicate devices.

Substantial Equivalence Table:

		SubjectDevice	PrimaryPredicateDevice	Included inPrimaryPredicateDevice	Included inPrimaryPredicateDevice
		EmeraldDental	Respire PinkSeries	Respire PinkSeries -Herbst	Respire PinkSeries -Herbst EF
			K170692	K131138	K150572
Intended Use
	Indication forUse	Intended totreat snoringand mild tomoderateobstructivesleep apnea(OSA) in adultpatients 18years of ageor older	Intended totreat snoringand mild tomoderateObstructiveSleep Apnea(OSA) in adultpatients 18years of ageor older	Intended totreat mild tomoderateOSA	Intended totreat mild tomoderateOSA
	Class	II	II	II	II
	Intended asIntraoralDevice	Yes	Yes	Yes	Yes
	Intended toreduce snoring	Yes	Yes	Yes	Yes
	Intended totreat mild tomoderate OSA	Yes	Yes	Yes	Yes
	Intended fornighttime use	Yes	Yes	Yes	Yes
	Intended forsingle patientmultiuse	Yes	Yes	Yes	Yes
	Intended foruse at homeor sleep labs	Yes	Yes	Yes	Yes
	Intended foradults, 18years or older	Yes	Yes	Yes	Yes
Design
	Customized fitfor eachpatient	Yes	Yes	Yes	Yes
	Mechanism ofaction:Mandibular	Yes	Yes	Yes	Yes
	Can beadjusted orrefit	Yes	Yes	Yes	Yes
	Range offorwardmovement ofmandible	Yes	Yes	Yes	Yes
	Upper & lowertraysdisengage foreasy removal	Yes	Yes	Yes	Yes
	Permitspatient tobreathethrough themouth	Yes	Yes	Yes	Yes
	Has trackingdevice	No	Yes	No	No
	Cleaned andinspected dailyby patient	Yes	Yes	Yes	Yes
Materials
	Hard surfacematerial	Yes	Yes	Yes	Yes
	Soft liningmaterial	No Hard, YesHard/Soft	No Herbst,Yes Herbst EF	No	Yes
	Advancementmechanism	Yes	Yes	Yes	Yes
	Advancementmechanism -Herbsttelescopinghinge,stainless steel	Yes	Yes	Yes	Yes
	Cobalt ChromeMesh insideAcrylic	Yes	Yes	Yes	Yes
Mechanism
	Mechanism ofAction	MandibularAdvancement	MandibularAdvancement	MandibularAdvancement	MandibularAdvancement
	Method ofPositioning theMandible	HerbstTelescopingHinge	HerbstTelescopingHinge	HerbstTelescopingHinge	HerbstTelescopingHinge
	MaximumAmount ofMandibleProtrusion	6 mm	6 mm	6 mm	6 mm
Labeling
	PrescriptionOnly	Yes	Yes	Yes	Yes

{5}------------------------------------------------

{6}------------------------------------------------

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).

Performance Testing: The Emerald Herbst is equivalent to the predicate device, Pink Series, as it uses all the same materials, same manufacturing procedure and same manufacturer. Therefore, no mechanical testing was conducted to establish equivalence. The Emerald Herbst was subjected to pre and post accelerated aging test measured by deflection strength. Aging did not decrease the strength of the device.

Differences: The Emerald Herbst is green unlike the Pink Series, which is pink. Both colors have received premarket approval in K942667 for the reference device, Dent-O-Cryl. This reference device justifies the use of all colors submitted by Dentauraum for Dent-O-Cryl, including the Emerald Herbst green and the Pink Series pink color additives. This 510(k) contains all the information considered by the FDA to determine substantial equivalence, including physical parameters and biocompatibility.

Summary: Based on the intended use, technical characteristics, biocompatibility assessment, labeling and other data provided in this submission, the Emerald Herbst appliance demonstrates substantial equivalence to the predicate devices in both safety and efficacy.

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.”