The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories. It is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.

Device Description

The Dental Crafters' IST Snoring Appliance is a 2 piece upper and lower arch system designed to posture the lower jaw forward which increases the lower airway passage and alleviates snoring. It is custom-fit to a patient's teeth by a professional dentist. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) ISTplus mechanism produced by Dr Hinz Dental. The acrylic arches of the appliance are secured to the occlusal surface. 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 dentist determines the position in which the lower jaw is supported in an anterior position.

AI/ML Overview

The provided text is a 510(k) summary for the Dental Crafter's IST Device, an anti-snoring and obstructive sleep apnea appliance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device itself.

Therefore, the document does not contain the detailed information required to fill out your request, such as a table of acceptance criteria, specific device performance results, sample sizes for test/training sets, expert qualifications, or details about MRMC studies.

Here's a breakdown of why the information is missing based on what is provided:

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

Not found. The document states that the new device "is substantially equivalent to other legally marketed Anti-Snoring Devices" and lists predicate devices. This implies that its performance is presumed to be similar to legally marketed devices, but explicit performance criteria or a comparison table are not included in this summary.

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

Not found. No clinical study or test set is described for the IST Snoring Appliance. Substantial equivalence claims often rely on comparison of technological characteristics and intended use, not necessarily new clinical trial data, especially for Class II devices.

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 found. As no test set is described, there's no mention of experts or ground truth establishment.

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

Not found. No test set or adjudication process is detailed.

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/Not found. This device is an intraoral appliance, not an AI-powered diagnostic tool requiring human reader studies.

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

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

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

Not found. No ground truth is described because no specific clinical performance study for the device is presented in this document.

8. The sample size for the training set:

Not found. This is not an AI device, so there is no "training set."

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

Not applicable.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on intended use, principles of operation, and technological characteristics. It does not contain a report of a specific study to prove new device performance against acceptance criteria. For such details, one would typically look for a full clinical study report or a different type of regulatory submission (like a PMA).

Summary

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SEP 1 1 2009

K090911

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Attachment 6

510(k) SUMMARY Dental Crafter's IST Device

Submitter's Name, Address, Telephone Number, Contact Person

Robert Slominski Co-Owner 1000 Corporate Drive PO Box 770 Marshfield, WI 54449 715/387-2642 800/472-8302 715/387-4100 (fax) bobs@dentalcrafters.net

Date Prepared:

Name of Device: IST Snoring Appliance

Name/Address of Sponsor

Common or Usual Name: Apnea and Anti-Snoring Device

Classification Name: Anti-Snoring Device

Predicate Devices:

Endsnor (K072731)

Removable Arylic Herbst Allesee Snore (K070327)

TAP® III (K062951)

Intended Use: The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories.

Indications for Use: The IST Snoring Appliance is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.

Technological Characteristics and Substantial Equivalence:

The Dental Crafters' IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multiuse at home or sleep laboratories.

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K090911

The Company's anti-snoring device covered by this submission is substantially equivalent to other legally marketed Anti-Snoring Devices. Specifically, the Dental Crafters' IST Snoring Appliance is substantially equivalent to Endsnor (K072731), Removable Arylic Herbst Allesee Snore (K070327), and TAP® III (K062951). IST has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

SEP 1 1 2009

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

Ms. Amy Nystrom Chief Financial Officer Dental Crafters 1000 Corporate Drive PO Box 770 Marshfield, Wisconsin 54449

Re: K090911

Trade/Device Name: IST Snore Appliance

· Regulation Number: 872.5570

Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea

Regulatory Class: II Product Code: LOZ Dated: September 2, 2009 Received: September 4, 2009

Dear Ms. Nystrom:

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 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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K090911

Attachment 8

510(k) Number (if known):

Device Name: IST Snore Appliance

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER LINE IF NECESSARY0

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic & ENT Devices

510(k) Number

ઋ Prescription Use

Over-The-Counter Use (Optional Format 1-2-96)

EyeIC Additional Information for K March 17. 2009 Page 1 of

Susan Ringer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K090911

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.”