The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

Device Description

The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.
The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.
The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.

AI/ML Overview

The provided document K070327 is a 510(k) premarket notification for several intraoral devices intended for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA). A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies or acceptance criteria with specific metrics from clinical trials, especially when not a novel device requiring such studies.

Based on the information provided, there is no specific study described that outlines acceptance criteria in terms of quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) and then proves the device meets these criteria with statistical data. The document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use, device description, principle of operation, materials, and technological characteristics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present within this 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is not available in a typical 510(k) submission focused on substantial equivalence:

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

No specific, quantifiable acceptance criteria or reported device performance metrics (e.g., in terms of snoring reduction percentage, AHI reduction) are stated in this 510(k) document for the devices Removable Acrylic Herbst, Allesee Snore Appliance (ASA), or Enoch Snorinator.

The "acceptance criteria" in the context of a 510(k) submission for these devices typically revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as the predicate. This is proven by similarity in:

Intended Use: All devices share the intended use of reducing snoring and mild to moderate OSA by repositioning the lower jaw.
Technological Characteristics: All devices are intraoral appliances designed to move the lower jaw forward.
Materials: Implied to be similar to legally marketed devices (e.g., acrylic, stainless steel).
Performance: Implied to be similar to legally marketed devices in their ability to reposition the jaw and alleviate snoring/OSA symptoms, although no specific performance data is presented.

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

Not applicable. The document does not describe a clinical test set or performance study for these specific devices. The basis for substantial equivalence is comparison to predicate devices, not specific clinical performance data from a new study.

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. No ground truth establishment by experts for a test set is described.

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

Not applicable. No adjudication method is described as there is no reported test set or clinical study for these devices.

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. These are mechanical intraoral devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. These are physical medical devices, not algorithms.

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

Not applicable. The substantial equivalence determination relies on comparing the device's characteristics and intended use to existing, legally marketed predicate devices, not on a new clinical ground truth establishment for novel performance claims.

8. The sample size for the training set

Not applicable. No training set is described as this is not an AI/machine learning device.

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

Not applicable. No training set or associated ground truth establishment is described.

Summary of Device and Predicate Information Present in the Document:

The 510(k) submission K070327 is for three intraoral devices:

Removable Acrylic Herbst
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: State University of New York at Buffalo, School of Dental Medicine, Removable Herbst Appliance.
Enoch Snorinator
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: Hays & Meade Inc., Snore Guard.
Allesee Snore Appliance (ASA)
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: Great Lakes Orthodontic Laboratory, NAPA Appliance.

In all cases, substantial equivalence is claimed based on similarities in intended use and device characteristics to predicate devices already on the market, which is a common pathway for mechanical medical devices in a 510(k) submission. The FDA's letter states that they reviewed the submission and determined "the device is substantially equivalent... for the indications for use stated in the enclosure." This administrative determination of substantial equivalence, rather than a clinical performance study with specific metrics, is the "proof" the document refers to.

Summary

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K070327

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.

MAY 2 5 2007

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

Device Name:

Trade Name Removable Acrylic Herbst .
. Common Name - Intraoral Device for Snoring and/or Sleep Apnea
Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and � Obstructive Sleep Apnea, per 21 CFR § 872.5570

Devices for Which Substantial Equivalence is Claimed:

State University of New York at Buffalo, School of Dental Medicine, Removable Herbst . Appliance

Device Description:

Intended Use of the Device:

The intended use of the Removable Acrylic Herbst is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

Substantial Equivalence:

The Removable Acrylic Herbst is substantially equivalent to another legally marketed device in the United States. The Removable Acrylic Herbst is used in a manner similar to the Removable Herbst Appliance developed by the State University of NY at Buffalo, School of Dental Medicine.

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K070327

Image /page/1/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.

Submitter:

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

Device Name:

. Trade Name - Enoch Snorinator
. Common Name - Intraoral Device for Snoring and/or Sleep Apnea
. Classification Name - Intraoral Device for Snoring and Intraoral Device for Snoring and Obstructive Sleep Apnea, per 21 CFR § 872.5570

Devices for Which Substantial Equivalence is Claimed:

. Hays & Meade Inc., Snore Guard

Device Description:

The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.

Intended Use of the Device:

The intended use of the Enoch Snorinator is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

Substantial Equivalence:

The Enoch Snorinator is substantially equivalent to another legally marketed device in the United States. The Enoch Snorinator is used in a manner similar to the Snore Guard appliance developed by Hays & Meade Inc.

1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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070327

Image /page/2/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a bold, sans-serif font. The word 'Submitter:' is printed below the company name.

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

Contact:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2007

Device Name:

. Trade Name - Allesee Snore Appliance (ASA)
. Common Name - Intraoral Device for Snoring and/or Sleep Apnea
Classification Name Intraoral Device for Snoring and Intraoral Device for Snoring and ● Obstructive Sleep Apnea, per 21 CFR § 872.5570

Devices for Which Substantial Equivalence is Claimed:

. Great Lakes Orthodontic Laboratory, NAPA Appliance

Device Description:

The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.

Intended Use of the Device:

The intended use of the Allesee Snore Appliance (ASA) is for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw.

Substantial Equivalence:

The Allesee Snore Appliance (ASA) is substantially equivalent to another legally marketed device in the United States. The Allesee Snore Appliance (ASA) is used in a manner similar to the NAPA Appliance produced by Great Lakes Orthodontic Laboratory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

MAY 2 5 2007

Re: K070327

Trade/Device Name: Removable Acrylic Herbst, Allesee Snore Appliance (ASA), and Enoch Snorinator Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 11, 2007 Received: May 14, 2007

Dear Ms. Boswell:

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 - Ms. Boswell

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suyite y. Michie Omp.

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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K070327

Indications for Use

510(k) Number (if known): K070327

Device Name: Removable Acrylic Herbst

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBer DOS for Dr. Susan Runner

ospital

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K070327

Indications for Use

510(k) Number (if known): K070327

Device Name: Allesee Snore Appliance (ASA)

Indications for Use:

The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

× Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr Susan Runner

Hospital

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70327

Indications for Use

510(k) Number (if known): K070327

Device Name: Enoch Snorinator

Indications for Use:

The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr. Susan Rummer

Hospital

310(k): K070327

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.”