Oral-B® Sonic Complete™ is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power handle. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® Sonic Complete™ electric toothbrush has a vibrating brush head that moves with a side-to-side movement. The brush head is designed to facilitate deeper penetration of interdental areas. The brush head moves side along the axis of the brush head at 260 Hz at an unloaded angle of ± 5 degrees. The brush head has no moving parts and is similar to a manual brush. The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12. The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.

AI/ML Overview

The provided text describes the Oral-B® Sonic Complete™ rechargeable electric toothbrush. While it states that the device has been tested in numerous controlled clinical studies and that these trials evaluated oral soft and hard tissue for safety, plaque, gingivitis, and bleeding, it does not explicitly detail specific quantitative acceptance criteria or the full study methodology in the typical format for medical device performance studies. The document focuses on demonstrating substantial equivalence for an expanded indication for use (treating and preventing gingivitis) rather than presenting a detailed performance study with predefined acceptance criteria for the device itself.

However, based on the information provided, we can infer some aspects related to the testing and "acceptance" of the device in the context of its 510(k) submission.

Here's an attempt to structure the information based on the typical requirements, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance

The document does not provide a table with quantitative acceptance criteria for device performance. Instead, the acceptance is based on demonstrating the device's safety and effectiveness for its intended use, particularly the expanded indication of "treating and preventing gingivitis," and its substantial equivalence to predicate devices. The "reported device performance" is descriptive rather than quantitative in the provided text excerpts.

Acceptance Criteria (Inferred from submission)	Reported Device Performance (as stated in the document)
Safety: Device is electrically safe and does not cause harm to oral soft and hard tissue.	"Electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431.""Oral soft and hard tissue evaluated for safety in numerous controlled clinical studies.""Results from these tests support the safety... of Oral-B® Sonic Complete™.""Evaluated and comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431)."
Effectiveness (Plaque Removal): Device promotes good oral hygiene and effectively removes plaque.	"Indications for Use: To promote good oral hygiene, including plaque removal...""Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis." (Plaque removal is a prerequisite for this.)
Effectiveness (Gingivitis Treatment/Prevention): Device is effective at treating and preventing gingivitis.	"Expanded indication for use of treating and preventing gingivitis.""Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis."
Mechanical Integrity/Quality: Device maintains its integrity and functionality over time.	"Quality assurance testing on the Oral-B® Sonic Complete™ electric toothbrush has been conducted to ensure the integrity of products."
Compliance with Standards: Device meets relevant electrical and safety standards.	"Inductively charged and therefore electrically safe in accordance with UL 1431.""All electrical components are housed within thermoplastic enclosures and the provided with a Listed flexible supply cord.""Comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431)."
Substantial Equivalence: Device is functionally and technologically similar to legally marketed predicate devices without raising new safety or effectiveness issues.	"Results from these tests support the safety and effectiveness... and its substantial equivalence to the predicate device without raising new safety or effectiveness issues." (Specifically compared to Sonicare® Advance K040416 and Oral-B® Sonic Complete™ for its original indication).

Study Details

The document states that "Oral-B® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis." However, it does not provide all the granular details requested for a single, comprehensive study. It references two clinical studies in the bibliography.

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in the summary.
- Data provenance:
  - Study 1 reference (Cronin et al., 2004): Conducted by "New Institutional Service Co., Inc., Dental Research and Product Testing, Northfield, New Jersey, USA." This suggests the data is prospective and from the USA.
  - Study 2 reference (Rosema et al., 2004): Department of Periodontology, Academic Centre for Dentistry Amsterdam. This suggests the data is prospective and from Amsterdam (Netherlands).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in the provided text. Clinical studies of this nature would typically involve trained dental professionals (e.g., periodontists, dental hygienists) for assessments.
Adjudication method for the test set: Not explicitly stated. For clinical studies evaluating gingivitis and plaque, assessments are typically performed by trained examiners following standardized protocols, and reliability checks (e.g., inter-rater agreement) are common, but specific adjudication methods like "2+1" are not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- The provided text refers to "controlled clinical studies" demonstrating effectiveness, but it does not describe an MRMC study comparing human readers with and without AI assistance. This type of study (MRMC for AI) is typically for diagnostic imaging devices, not direct-to-consumer toothbrushes.
- The studies mentioned compare the device itself (with its cleaning mechanism) against either a control or another toothbrush, not human readers and AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a physical toothbrush, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The device's performance is inherently "human-in-the-loop" as a user operates it.
The type of ground truth used:
- Clinical Endpoints: Based on the description ("evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding"), the ground truth would be based on clinical assessments/measurements (e.g., Gingival Index, Plaque Index, Bleeding on Probing) performed by trained dental professionals.
- Bibliography references studies that focus on "efficacy of two toothbrushes" (Study 1) and "Healing Effect of Experimental Gingivitis Using 2 Sonic Toothbrushes" (Study 2), further indicating clinical measures as ground truth.
The sample size for the training set: Not applicable in the context of this device and the provided documentation. This information is relevant for AI/machine learning models which are not described here. The "training set" for a physical device would refer to data used during its development and optimization, which is not detailed in a 510(k) summary for a toothbrush.
How the ground truth for the training set was established: Not applicable, as explained above.

Summary

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510(k) SUMMARY

JUN - 5 2006

Applicant:	Braun GmbHFrankfurter Strasse 14561476 KronbergGermany
Application Correspondent:	Amanda HeffernanManager, Regulatory AffairsClinical Research & Dental affairsThe Gillette Company800 Boylston StreetPrudential Tower Building, Floor 46Boston, MA 02199-8004
	Telephone: 617.463.9532Fax:617.463.9578Email: amanda_heffernan@gillette.com
Date summary prepared:	January 6, 2006
Proprietary name of device:	Oral-B® Sonic Complete™
Generic/classification name:	Toothbrush, Powered
Product code (classification):	JEQ (Class 1, 21 C.F.R. 872.6865)

Legally Marketed Predicate Devices:

Sonicare® Advance Toothbrush (K040416) . Philips Oral Healthcare, Inc.
. Oral-B® Sonic Complete™ Braun GmbH

Device Description and Technological Characteristics:

The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12.

Page 1 of 3 in section 5.0

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K06/351

510{k} SUMMARY Cont'd

The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.

While power toothbrushes are 510(k) exempt device, we believe the expanded indication for use of treating and preventing gingivitis may exceed the limitation for 510(k) exemption. The expanded indications for use (i.e., treating and preventing gingivitis) are the only changes from the currently marketed device Oral-B® Sonic Complete™ . There are no changes to the design, materials or manufacturing process of this device.

Indications for Use:

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

Testing:

Oral-B® ® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis,

Quality assurance testing on the Oral-B® Sonic Complete™ electric toothbrush has been conducted to ensure the integrity of products.

Oral-B® Sonic Complete™ product is a rechargeable battery operated toothbrush. The toothbrush handle is inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.

Oral-B® Sonic Complete™ products are evaluated and comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431).

Conclusions:

The results from these tests support the safety and effectiveness of Oral-B® Sonic Complete™ power toothbrush and its substantial equivalence to the predicate device without raising new safety or effectiveness issues.

Page 2 of 3 in section 5.0

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K061351

510(k) SUMMARY Cont'd

Bibliography

1. M.J. Cronin, W.Z. Dembling, M.A. Cugini, ; A 90 Day Clinical Comparison of the Safety and Efficacy of Two Toothbrushes, Final report: Study Number 01 16 04 03, Date of Report: April 5, 2004, New Institutional Service Co., Inc., Dental Research and Product Testing , Northfield, New Jersey
1. N.A.M Rosema, M.F. Timmerman, M. Fiscaer, P.A. Versteeg, U. Van Der Velden, G.A. Van Der Weijden. ; Healing Effect of Experimental Gingivitis Using 2 Sonic Toothbrushes. Department of Periodontology, Academic Centre for Dentistry Amsterdam, 6 April 2004

Page 3 of 3 in section 5.0

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2006

Braun GmbH C/O Ms. Amanda Heffernan The Gillette Company 800 Boylston Street Prudential Tower Building, Floor 46 Boston, Massachusetts 02199-8004

Re: K061351

Trade/Device Name: Oral-B® Sonic Complete™ Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: I Product Code: JEQ Dated: May 11, 2006 Received: May 15, 2006

Dear Ms. Heffernan:

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 - Ms. Heffernan

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sudie Y. Michael, M.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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K06 1351

Indications for Use

510(k) Number (if known): _________________

Device Name: Oral-B® Sonic Complete™

Indications for Use: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

Anesthesiology, General Hospital, Son Control, Dental Dev

- - - ) Number:_

Page 1 of 1 in section 4.0

Regulation Number and Section

§ 872.6865 Powered toothbrush.

(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is 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.