TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT by AIRWAY MANAGEMENT INC.

The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria using metrics like sensitivity, specificity, or accuracy. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance thresholds in a clinical study.

Therefore, many of the requested details related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.

However, based on the available information, here's what can be inferred or directly stated:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document's purpose is to establish substantial equivalence to predicate devices, not to report on specific performance metrics against defined acceptance criteria.

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

This information is not provided in the document. The text does not describe a clinical study with a test set.

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

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The device, TAP II, is an oral appliance (anti-snoring device), not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.

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

This information is not applicable/not provided in the context of an oral appliance. The TAP II is a physical medical device, not an algorithm.

7. The type of ground truth used:

This information is not provided in the document as no specific clinical study with ground truth establishment is detailed. The basis for substantial equivalence is comparison to legally marketed predicate devices.

8. The sample size for the training set:

This information is not provided in the document. The text does not detail the development of an algorithm that would typically involve a training set.

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

This information is not provided in the document.

Summary based on the provided text:

The provided documents, a Non-Confidential Summary of Safety and Effectiveness and an FDA clearance letter for the TAP II oral appliance, primarily focus on demonstrating substantial equivalence to predicate devices. This process does not typically involve the detailed performance studies, acceptance criteria, test sets, or expert ground truth adjudication that would be requested in the prompt. The clearance is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as devices already on the market (listed as Nellcor Puritan Bennett - TAP-K962516, Thornton Oral Appliance - TOA-K972061, OASYS Oral Airway System - K030440).

Summary

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Airway Management Inc. 6116 North Central Expressway Suite 605 Dallas, Texas 75206

1. 7 1. 1

Non-Confidential Summary of Safety and Effectiveness May 7, 2006

Airway Management Inc. 6116 North Central Expressway Suite 605 Dallas, Texas 75225

Tel- (972) 369-0978

Fax- (214) 691-3151

Official Contact	Darren Edward Henderson
Proprietary or Trade Name	TAP II
Common / Usual Name	Oral Appliance - anti snoring device.
Classification Name	Anti -Snoring device
Device:	TAP II
Predicate Device	Nellcor Puritan Bennett - TAP-K962516Thornton Oral Appliance - TOA-K972061OASYS Oral Airway System - K030440

Device Description: July 2017 11:00 11:00 11:00 11:00 11:00 1

The TAP II Anti-Snoring device is comprised of:

& Lower tray fitted over the lower teeth.
Upper tray fitted over the upper teeth.
Impression material
Hook and Base mechanism to attach lower tray to upper tray.

Intended Use: Indicated Use --The TAP II is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA. . . . . . . . . . . .

Environment of Use --Home and sleep laboratories.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which is the symbol of the HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2006

Mr. Darren Henderson Quality Manager Airway Management, Incorporated 6116 North Central Expressway, Suite 605 Dallas, Texas 75206

Re: K060388

Trade/Device Name: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appli Regulation Number: 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 10, 2006 Received: May 11, 2006

Dear Mr. Henderson:

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 - Mr. Henderson

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Tin Liu, Ph.D.

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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K060388 (To be assigned) 510(k) Number:

Device Name:

TAP II

Intended Use:

To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

Environment of use:

Disposable / Reusable:

Single patient -- multi -- use

Home and sleep laboratories

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runnes

Sign-Off n of Anesthesiology, General Hospital. on Control, Der

Number: K060388

Prescription Use

Over-the-counter use

(Per CFR 801.109)

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.”