The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.

The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.

AI/ML Overview

The provided text is a 510(k) summary for the "Breath-So-Fresh Tongue Cleaner," which is a traditional medical device (a tongue scraper) and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "acceptance criteria" in this context would be the FDA's determination of substantial equivalence, which is granted if the device's intended use and technological characteristics are similar enough to a legally marketed predicate device such that it raises no new questions of safety and effectiveness.

Here's the relevant information that can be extracted from the provided text, structured to align as closely as possible with your request, even though the core AI/ML metrics are not present:

1. Table of Acceptance Criteria and the Reported Device Performance (as infered for a traditional device):

Acceptance Criteria (for 510(k) Substantial Equivalence of traditional devices)	Reported Device Performance/Characteristics
Intended Use Equivalence: To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.	Intended Use: "To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath." (Matches predicate devices implicitly)
Technological Characteristics Equivalence: Design, materials, and functional features should be substantially similar to predicate devices, or any differences should not raise new questions of safety or effectiveness.	Similar shape to "The Professional Tongue Cleaner" (handle, rounded portion for tongue). Combines with a rippled cleaning edge, similar to "Oolitt Tongue Cleaner". Composed of hard white polycarbonate or similar plastic, flexible and durable, no sharp edges.
Safety and Effectiveness: Does not raise new questions concerning safety or effectiveness compared to predicate devices.	The document implies that the device's design and materials are safe and effective for its intended use, as it is substantially equivalent to legally marketed predicate devices. No specific "performance metrics" in the typical sense (e.g., sensitivity, specificity) are reported for this type of device in a 510(k) summary.

The remaining points (2-9) are specific to studies for AI/ML device performance and are not found or applicable in this 510(k) summary for a manual tongue cleaner. No clinical trials or performance studies with "test sets," "ground truth," or "experts" in the context of diagnostic accuracy are described. The regulatory review for this type of device relies on the comparison to predicate devices, not on de novo clinical performance studies.

Summary

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K972644

SEP 1 1997

510 (K) Summary of Safety and Effectiveness for Breath-So-Fresh Tongue Cleaner

International Dental Design Specialists, Inc. 829 Ninth Street, Imperial Beach, California 91932 Telephone: (619) 424-5115 Fax: (619) 424-5128

1) SUBMITTER:

Name:	International Dental Design Specialists, Inc.
Address:	629 Ninth Street, Imperial Beach, CA 91932
Telephone:	(619) 424-5115
Fax:	(619) 424-5128
Contact Person:	Clifford Yudelman
Date:	July 11, 1997

2) NAME OF DEVICE:

Proprietary Name:	Breath-So-Fresh Tongue Cleaner
Common/Usual Name:	Tongue Scraper/Tongue Cleaner
Classification Name:	Tongue Scraper

3) PREDICATE DEVICES:

"The Professional Tongue Cleaner" (K961660)

"Oolitt Tongue Cleaner" (K962941)

4) DESCRIPTION OF DEVICE

5) INTENDED USE

To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

6) TECHNOLOGICAL CHARACTERISTICS

The shape of the Breath-So-Fresh Tongue Cleaner is similar to the predicate device, the Professional Tongue Cleaner (K961660) in that both have a sturdy handle at one end and a rounded portion for placement on the tongue on the other end. The Breath-So-Fresh Tongue Cleaner combines this design with another feature: a rippled cleaning edge. Both the Breath-So-Fresh and the Oolitt (K962941) tongue cleaners have a rippled edge to enhance tongue scraping.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Clifford Yudelman International Dental Design Specialists, Incorporated 629 Ninth Street

SEP 1 1 1997

91932 Imperial Beach, California

K972644 Re : Breath-So-Fresh Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: ICN Dated: July 11, 1997 Received: July 15, 1997

Dear Mr. Yudelman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Yudelman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known):

Device Name:_Tongue_Cleaner

Indications For Use:

To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ringer

(Division Sign-Off) Division of Dental, Inf and General Hospital De 510/k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.6855 Manual toothbrush.

(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.