To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.

Device Description

Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a dental floss product (Crest Glide Dental Floss). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical performance against specific acceptance criteria for AI/ML-based medical devices.

Therefore, many of the requested fields regarding AI/ML device evaluation criteria (such as number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

Here's a breakdown of the applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed predicate devices and that the device is safe and effective for its intended use. Specifically, for the expanded indication of "treatment and prevention of gingivitis," the acceptance criterion appears to be showing that the addition of dental floss to toothbrushing is effective.

Reported Device Performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Glide Comfort Plus Dental Floss)	Crest Glide Dental Floss has the same design and manufacturing process as the currently marketed Glide Comfort Plus Dental Floss. The predicate is indicated for plaque removal and prevention of tooth decay. Crest Glide Dental Floss uses the same mechanism of action (mechanical removal of plaque). No new issues of safety or effectiveness.
Substantial Equivalence to Predicate Devices (Oral-B Toothbrush)	Currently marketed Oral-B Toothbrush is indicated for treating and preventing gingivitis and uses the same mechanism of action as Crest Glide Dental Floss (mechanical removal of plaque) to achieve this benefit. No new issues of safety or effectiveness.
Effectiveness for Treatment and Prevention of Gingivitis (Expanded Indication) when added to toothbrushing.	Data from four clinical trials collectively show the addition of dental floss to toothbrushing is effective at treatment and prevention of gingivitis via the physical removal of plaque. The floss treatments in these studies were well tolerated with no safety issues.

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

The document references four clinical trials to support the expanded indication. The individual sample sizes for each study are not explicitly stated in this summary.

Study 1: "Assessment of treatment responses to dental flossing in twins." J of Periodont; August 2006, 77(8):1386-91. (Specific sample size not provided)
Study 2: "A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing." The University of Texas Health Science Center at San Antonio Dental School, USA. Study conducted in Guatemala. Final Study Report. (Specific sample size not provided. Provenance: Guatemala)
Study 3: "Comparative effectiveness of flossing and brushing in reducing interproximal bleeding." J of Periodontol; May 1989; 60(5): 243-247. (Specific sample size not provided)
Study 4: "Comparison of the use of different modes of mechanical oral hygiene in prevention of plaque and gingivitis." J of Periodontol; August 2008; 79(8): 1386-1394. (Specific sample size not provided)

The studies appear to be prospective clinical trials, given their titles and publication dates.

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

Not applicable. This is a dental mechanical device, and the endpoint for clinical studies would typically involve objective measurements (e.g., plaque indices, bleeding scores) rather than subjective expert interpretation for "ground truth" in the AI/ML sense.

4. Adjudication method for the test set

Not applicable. This is a dental mechanical device; adjudication in the context of expert review for AI/ML ground truth is not relevant here. Clinical trial methodologies would have their own blinding and assessment protocols.

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 manual dental floss, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable. This is a manual dental floss.

7. The type of ground truth used

The "ground truth" or primary outcome measures in these studies would likely be objective clinical parameters related to oral health, such as:

Plaque scores/indices
Gingival bleeding scores/indices
(Potentially) Measures of inflammation or other periodontal health indicators.

These are direct clinical measurements, not expert consensus or pathology in the context of diagnostic imaging.

8. The sample size for the training set

Not applicable. This is a traditional medical device (dental floss), not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, this is not an AI/ML device.

Summary

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510(k) Number K091964 Summary

Applicant:

Applicant Correspondent:

Procter & Gamble 8700 Mason-Montgomery Road Mason, OH 45202

Victoria P. Schofield, Pharm.D. Regulatory Affairs Manager Procter & Gamble 8700 Mason-Montgomery Road Mason, OH 45040

Telephone: (513) 622-4851 Fax: (513) 622-1907 E-mail: schofield.vp@pg.com

Date Summary Prepared: September 04, 2009 Proprietary Name of Device: Crest Glide Dental Floss Generic/Classification Name: Dental floss Product Code (Classification): JES (Class I, 21CFR 872.6390) Legally Marketed Predicate Devices: Glide Comfort Plus Dental Floss

Oral-B Toothbrush (K073224)

Device Description and Technical Characteristics: Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.

Indication for Use: To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.

Supporting Information: Two substantially equivalent predicates have been provided, as well as clinical data to support the expanded indication.

Currently marketed Glide Comfort Plus Dental Floss has the same design and . manufacturing process as the Crest Glide Dental Floss and is indicated for removal of plaque and prevention of tooth decay. Crest Glide Dental Floss uses the same mechanism of action (mechanical removal of plaque) to provide treatment and prevention of gingivitis. There are no new issues of safety or effectiveness.
. Currently marketed Oral-B Toothbrush is indicated for treating and preventing gingivitis and uses the same mechanism of action as Crest Glide Dental Floss (mechanical removal of plaque) to achieve this benefit. There are no new issues of safety or effectiveness.
Data from four clinical trials are provided that collectively show the addition of dental . floss to tooth brushing is effective at treatment and prevention of gingivitis via the

SEP 2 4 2009

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physical removal of plaque. The floss treatments in these studies were well tolerated with no safety issues.

Conclusions: Crest Glide Dental Floss is substantially equivalent to Glide Comfort Plus Dental Floss and Oral-B Toothbrush without raising any new safety and effectiveness issues. In addition, clinical data support the indication of treatment and prevention of gingivitis for dental floss above that provided by tooth brushing alone.

Bibliography

Assessment of treatment responses to dental flossing in twins. Biesbrock A, Corby P, l. Bartizek R, Corby A, Coelho M, Costa S, Bretz WAG, Bretz WA. J of Periodont; August 2006,77(8):1386-91.
1. A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing. The University of Texas Health Science Center at San Antonio Dental School, USA. Study conducted in Guatemala. Final Study Report.
1. Comparative effectiveness of flossing and brushing in reducing interproximal bleeding. Graves RC, Disney JA, Stamm JW. J of Periodontol; May 1989;60(5): 243-247.
Comparison of the use of different modes of mechanical oral hygiene in prevention 4. of plaque and gingivitis. Rosema NAM, Timmerman MF, Versteeg PA, van Palenstein Helderman WH, Van der Velden U, Van der Weijden GA. J of Periodontol; August 2008;79(8): 1386-1394.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 4 2009

Procter & Gamble Company Ms. Victoria P. Schofield Regulatory Affairs Manager Oral Care 8700 Mason-Montgomery Road Mason, Ohio 45040

Re: K091964

Trade/Device Name: Crest Glide Dental Floss Regulation Number: 872.6390 Regulation Name: Dental Floss Regulatory Class: I Product Code: JES Dated: June 30, 2009 Received: July 1, 2009

Dear Ms. Schofield:

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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Page 2- Ms. Schofield

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh 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

Enclosure

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Indication for Use

510(k) Number: K091964

Device Name: Crest Glide Dental Floss

Indication For Use:

To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Kein Mulley for NSR
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091964

Section 4

Regulation Number and Section

§ 872.6390 Dental floss.

(a)
Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.(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 § 872.9.