ORAL-B SUB-BRAND MANUAL TOOTHBRUSH by PROCTER & GAMBLE

The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.

AI/ML Overview

The provided text describes a 510(k) submission for an Oral-B® manual toothbrush, where the manufacturer is seeking to expand the indication for use to include "treating and preventing gingivitis." The core of the submission emphasizes that the device is substantially equivalent to legally marketed predicate devices, with no changes in material, design, or manufacturing process, but only an expanded indication.

However, the document does not contain specific acceptance criteria in a quantitative format (e.g., a specific percentage reduction in gingivitis or plaque). Instead, it states that numerous controlled clinical studies have been performed and "collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque."

Therefore, it is not possible to construct a table of acceptance criteria and reported device performance as requested, because specific quantitative metrics and thresholds for acceptance are not detailed in the provided text.

Furthermore, the document primarily functions as a 510(k) summary and the FDA's response, rather than a detailed study report. As such, many of the specific details about the studies (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the given text.

Based on the provided information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly list quantitative acceptance criteria. Instead, it refers to a body of clinical evidence supporting the expanded indication. The reported "performance" is qualitative, indicating effectiveness in treating and preventing gingivitis and removing plaque.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Qualitative)
`[Specific quantitative metrics for plaque removal or gingivitis reduction are not provided in this document]`	The Oral-B® manual toothbrush is "effective at treating and preventing gingivitis via the physical/mechanical removal of plaque."
`[Specific thresholds for safety endpoints are not provided]`	"Safety was assessed," and the studies support the "safety and effectiveness."

Study Details

Due to the nature of the provided document (a 510(k) summary and FDA letter), many of the specific study details are not available in the text.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text. The document states "numerous controlled clinical studies" but does not provide specific sample sizes for these studies, their design (retrospective/prospective), or their geographic origin. The bibliography lists several clinical investigations but does not offer these details in the provided snippets.
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 available in the provided text. This type of detail is typical for device performance studies involving interpretation, but for a manual toothbrush assessing plaque and gingivitis, the "ground truth" would likely be based on clinical measurements (e.g., Gingival Index, Plaque Index) performed by trained dental professionals rather than "experts establishing ground truth" in the diagnostic imaging sense. However, no specific details on the assessors or their qualifications are provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in the provided text. Adjudication methods are typically relevant for studies where subjective assessments by multiple readers need to be reconciled, such as in diagnostic imaging. For clinical measurements of plaque and gingivitis, standard clinical protocols for measurement and inter-examiner reliability would be more typical, but no such details are provided.
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 question pertains to AI-assisted diagnostic tools. The device in question is a manual toothbrush, which is a physical device, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this question is for AI/software devices. The manual toothbrush is a standalone physical device. Its performance is its intrinsic mechanical action.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Clinical Measurements/Outcomes: While not explicitly stated, for plaque removal and gingivitis improvement, the ground truth would be based on clinical indices and outcomes data (e.g., Gingival Index scores, Plaque Index scores, bleeding on probing, etc.) measured by trained dental examiners.
The sample size for the training set:
- Not applicable. This question is typically for machine learning models. For a physical device like a toothbrush, there isn't a "training set" in the machine learning sense. The clinical studies establish its effectiveness.
How the ground truth for the training set was established:
- Not applicable. As above, this refers to machine learning models.

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

Device: Oral-B® "sub-brand" manual toothbrush.
Expanded Indication: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
Proof basis: "Numerous controlled clinical studies" have evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health, and assessed soft and hard tissue safety.
Conclusion: These studies "demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque." The information "supports the safety and effectiveness" and "substantial equivalence to the predicate devices without raising any new safety and effectiveness issues."
Underlying studies: A bibliography lists several clinical investigations conducted from 1996 to 2007, some of which compare power toothbrushes to manual toothbrushes, or compare different manual toothbrushes. These titles suggest that the studies indeed focused on efficacy in plaque removal and gingivitis reduction.

In essence, the 510(k) relies on a body of existing clinical evidence to support the expanded indication, rather than presenting a single, new, dedicated study with detailed acceptance criteria and performance metrics for this specific submission. The FDA's approval indicates they found this collective evidence sufficient to establish substantial equivalence for the expanded indication.

Summary

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510(k) Summary
Applicant:	Procter & Gamble8700 Mason-Montgomery RoadMason, OH 45202
Applicant Correspondent:	Michael A. Kaminski, Ph.D.Senior Scientist, Regulatory Affairs ManagerProcter & Gamble8700 Mason-Montgomery RoadMason, OH 45202FEB - 6 2008
	Telephone: (513) 622-2879Fax: (513) 622-1907E-mail: kaminski.ma@pg.com
Date Summary Prepared:	October 12, 2007
Proprietary Name of Device:	Oral-B® “sub-brand” manual toothbrush(i.e. CrossAction, Advantage, Pulsar, Pro-Health)
Generic/Classification Name:	Toothbrush, Manual
Product Code (Classification):	EFW (Class I, 21CFR 872.6855)
Legally Marketed Predicate Devices:	Toothbrush, Manual EFW (21 CFR 872.6855)Toothbrush, Power JEQ (21 CFR 872.6865) K061351

Device Description and Technical Characteristics: The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.

While manual toothbrushes are exempt devices, we believe the expansion of the indication to include for use of treating and preventing gingivitis may exceed the limitations of the 510(k) exemption. The expansion of the indication (treating and preventing gingivitis) is the only change from the currently marketed exempt device. There are no changes to the material, design or manufacturing process.

Indication for Use: To promote good oral hygier e including plaque removal and treating and preventing gingivitis.

Testing: Oral-B® manual toothbrushes have been tested in numerous controlled clinical studies. These trials evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health. In addition on:l soft and hard tissue safety was assessed. Collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque.

The information provided supports the safety and effectiveness of Oral-BBC Conclusions: manual toothbrushes and their substantial equivalence to the predicate devices without raising any new safety and effectiveness issues.

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Bibliography

1. M. J. Cronin, W. Dembling, N. Conforti, J. Liebman, M.A. Cugini, P. Warren: A single use and 3-month clinical inverstigation of the comparative efficacy of a battery-operated power toothbrush and a manual toothbrush. Special issue article Am J Dent 2001: 14:19B-24B
N. Sharma, J. Qaqish, H. Galustians, D. King, M. Low, D. Jacobs, D. Weber: A 3-month r i comparative Investigation of the safety and c:Ticacy of a new toothbrush: Results from two independent clinical studies. Am J. Dent 2000, 13: Special Issue, 27A-32A
A Six-Week clinical comparison of the Safety and Efficacy of Two manual Toothbrushes ﺘﻢ Hilltop Research. Inc. West palm Beach, Flerida, Final Report
Nathoo S., Chaknis P., Petrone M., DeVizio W and Volpe AR: A Clinical Comparison of न the Gingivitis Reduction and Plaque-remov I Efficacy of a New Manual Toothbrush. Compendium 2004, 25(10) Suppl. 2:37-45
Goyal C.R., Quaish J.G. and Galustians 1.: Efficacy and Safety of a New Power 5. Toothbrush in a population with Mild to Mederate Gingivitis. J Clin Dent 2007, 18:65-(59
Yankell S.M., Emling R. and Percz B.: A Six-Month Clinical Evaluation of the Dentrust (). Toothbrush. J Clin Dent 1996, 7:106-109

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized 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 depicted in black, and the text is also in black against a white background. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Michael A. Kaminski Senior Scientist, Regulatory Affairs Manager Procter & Gamble Company 8700 Mason-Montgomery Road Mason, Ohio 45040-9462

Re: K073224

Trade/Device Name: Oral-B® "sub-brand" manual toothbrush Regulation Number: 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: November 12, 2007 Received: November 15, 2007

Dear Dr. Kaminski:

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 – Dr. Kaminski

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chin-Lin, 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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Indication for Use

K673224 510(k) Number (if known):

Device Name: Oral-B® "sub-brand" manual toothbrush

Indication For Use:

To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

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

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Susan Dunne

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073224

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.