The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Device Description

The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.

AI/ML Overview

This document is a 510(k) premarket notification for the Dorsal Appliance, an intraoral device intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The submission argues for substantial equivalence to a predicate device, the Acrylic Herbst Appliance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, there are no explicit "acceptance criteria" defined in terms of specific performance metrics or thresholds for the target device (Dorsal Appliance). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Acrylic Herbst Appliance) through a comparison of technological characteristics, materials, and intended use. The performance "reported" is primarily a statement that the materials and fabrication processes are identical to the predicate device, implying similar performance.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence:	The Dorsal Appliance has the "same intended use" as the predicate: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)."
Technological Characteristics Equivalence (no new safety/effectiveness questions):	The "fundamental scientific technology... is the same" as the predicate. "Each of the design features is common to the predicate."
Material Equivalence:	"The materials and fabrication processes used in the manufacture of the subject device are identical to the materials and fabrication processes used in the manufacture of the predicate device." Materials: medical grade polymethylmethacrylate (acrylic splints) and stainless steel (adjustment screw mechanism).
Biocompatibility:	"Because material biocompatibility was accepted for the predicate and because there are no differences in manufacturing which could affect biocompatibility, additional biocompatibility testing was not supplied in support of this clearance."
Physical Properties:	"Data regarding performance testing of the device material was provided." "Because the identical material is used for both the subject and predicate devices, these performance results support the finding of substantial equivalence. The results included general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus)." (Specific numerical values for these properties are not provided in the excerpt.)
Risk Mitigation:	"A risk analysis was performed... The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling."
Differences addressed:	The only differences noted are the "type of advancement mechanism used" (turnbuckle for the subject device vs. telescopic for the primary predicate) and the "adjustable range" (5mm for the subject device vs. 5.5mm for the primary predicate). These differences are argued not to raise new safety and effectiveness questions, as the turnbuckle mechanism is used in other similar intra-oral devices (reference predicate Dorsal Appliance, K103076) and the adjustable range falls within limits of other similar predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not applicable. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance." This was a substantial equivalence submission based on non-clinical data (material properties, design comparison, risk analysis) relative to a predicate device.
Data provenance: Not applicable, as there was no clinical test set. The data presented relates to material properties and comparative design analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical test set requiring ground truth establishment by experts for performance evaluation.

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

Not applicable. No clinical test set was used.

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

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable for a clinical test set. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate device (Acrylic Herbst Appliance, K113126) and the materials used, as well as regulatory guidance for this device class.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning system that requires a "training set."

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

Not applicable. This device is not an AI/machine learning system.

Summary

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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2015

Gergen's Orthodontic Lab, Inc. c/o Karen E. Warden, Ph.D. BackRoads Consulting P.O. Box 566 Chesterland, OH 44026

Re: K143591

Trade/Device Name: Dorsal Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral device for snoring and intraoral device for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK

Dated: January 25, 2015 Received: January 28, 2015

Dear Dr. Warden:

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. 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.

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Page 2 - Karen E. Warden, Ph.D.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K143591

Device Name Dorsal Appliance

Indications for Use (Describe)

The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 8 – 510(k) Summary

Date:	17 December 2014
Sponsor:	Gergen's Orthodontic Lab Inc.1745 West Deer Valley Rd, Suite 112Phoenix, AZ 85027Phone: 623-879-6066Fax: 623-879-6166
Contact Person:	Chris Morrison, Lab Manager
Proposed Trade Name	Dorsal Appliance
Common Name:	Anti-snoring appliance
Device Classification	Class II
Classification Name:	Device, Anti-Snoring
Regulation Number,Name:	872.5570, Intraoral devices for snoring and intraoral devices for snoring andobstructive sleep apnea
Device Product Code:	LRK
Submission Purpose:	The Dorsal Appliance is a modification of the Acrylic Herbst Appliance.
Device Description:	The Dorsal Appliance is comprised of upper and lower customized acrylicsplints for the treatment of mild to moderate sleep apnea. The upper splintcomprises bilateral turnbuckle adjustment mechanisms.The device aims to improve the patient's air exchange thereby reducingsnoring and apnea by increasing the pharyngeal space through anteriorrepositioning of the mandible.
Intended Use:	The Dorsal Appliance is intended for the reduction of night time snoring andmild to moderate obstructive sleep apnea (OSA) in adults 18 years of age orolder.
Materials:	Medical grade polymethylmethacrylate (acrylic splints) and stainless steel(adjustment screw mechanism)
Predicate Devices:	Primary: Acrylic Herbst Appliance (Gergen's, K113126)Reference: Dorsal Appliance (Dynaflex Inc., K103076)
Performance Data:	The materials and fabrication processes used in the manufacture of thesubject device are identical to the materials and fabrication processes usedin the manufacture of the predicate device.Because material biocompatibility was accepted for the predicate andbecause there are no differences in manufacturing which could affectbiocompatibility, additional biocompatibility testing was not supplied insupport of this clearance.Data regarding performance testing of the device material was provided.Because the identical material is used for both the subject and predicatedevices, these performance results support the finding of substantialequivalence. The results included general properties (water solubility andabsorption) and physical properties (tensile and flexural strength, and elasticmodulus).Clinical testing of the subject device was not used in support of clearance.Per the Class II Special Controls Guidance Document: Intraoral Devices forSnoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, arisk analysis was performed with respect to the subject device. The risksidentified in the guidance (e.g., intraoral gingival, palatal, or dental soreness;TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening orflaring of lower anterior teeth or general tooth movement) and those detectedby the risk analysis were mitigated though the use of biocompatible materialsidentical to those used in the predicate and the use of appropriate labeling.

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Technological The fundamental scientific technology of the Gergen's Orthodontic Dorsal Appliance is the same as the previously cleared device shown below, i.e., Characteristics: each of the design features is common to the predicate.

System:	Dorsal Appliance	Acrylic Herbst Appliance
Manufacturer:	Gergen's Orthodontic	Gergen's Orthodontic
510(k):	Under review	K113126
Intended use:	The reduction of night time snoringand mild to moderate obstructivesleep apnea (OSA)	The reduction of night time snoringand mild to moderate obstructivesleep apnea (OSA)
Target population:	Adults	Adults
Prescription use:	Prescription only	Prescription only
Basic Design:	Upper and lower splints having anadjustment mechanism	Upper and lower splints having anadjustment mechanism
Function:	To increase the patient's thepharyngeal space and improve airexchange thereby reduce snoringand apnea by anterior repositioningof the mandible	To increase the patient's thepharyngeal space and improve airexchange thereby reduce snoringand apnea by anterior repositioningof the mandible
Materials ofmanufacture:	Medical grade acrylic and stainlesssteel	Medical grade acrylic and stainlesssteel
Adjustability:	Yes, by prescribing dentist orphysician	Yes, by prescribing dentist orphysician
Adjustmentmechanism:	Yes, turnbuckle	Yes, telescopic
Adjustable range:	5mm	5.5mm
Method ofmanufacture:	Patient-specific customizedfabrication	Patient-specific customizedfabrication
Sterility:	Non-sterile	Non-sterile

From the chart above, the only differences between the subject device and Conclusion: the primary predicate is the type of advancement mechanism used and the adjustable range allowed by the devices. Although the advancement mechanism differs, the type used for the subject device is also used in other similar intra-oral devices such as the reference predicate device (Dorsal Appliance). Therefore, the difference in the type of advancement mechanism does not raise any new safety and effectiveness questions. The adjustable range of the primary predicate device is slightly higher than the subject device; however this range falls within the limits of other similar predicate devices.

In comparison to the predicate device, the Dorsal Appliance has

the same intended use (as described above),
. technological characteristics which do not raise new questions of safety and effectiveness.

Therefore the Dorsal Appliance can be found substantially equivalent to the predicate device.

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.”