ORTHODONTIC CERAMIC BRACKETS 1.1 are designed to move teeth to improve their alignment. ORTHODONTIC CERAMIC BRACKETS 1.1 are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Orthodontic Ceramic Brackets 1.1 by Tomy Inc. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study for an AI/CADe device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI system is not applicable or present in this document.

However, I can extract the information relevant to the performance data and equivalence claims for the physical device as described:

Acceptance Criteria and Device Performance (for physical device)

The device, Orthodontic Ceramic Brackets 1.1, claims conformance to a recognized consensus standard and reports performance based on specific mechanical tests.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 27020 First edition 2010-12-15: Dentistry - Brackets and Tubes for use in Orthodontics	The device conforms to this standard.
Shear Bond Strength	Tested. (Specific numerical results not provided in this summary, but the implication is that it met acceptable levels for equivalence).
Torque Strength	Tested. (Specific numerical results not provided in this summary, but the implication is that it met acceptable levels for equivalence).

Note: The document states that the device was tested for Shear Bond Strength and Torque Strength, and it conforms to the ISO standard. It does not provide specific numerical acceptance thresholds or the measured performance results in this summary. The primary goal of this submission is to demonstrate substantial equivalence, implying these tests would have shown comparable performance to the predicate devices.

Study Information (for this physical device, not AI/CADe)

Since this document pertains to a physical orthodontic bracket and not an AI/CADe device, most of the detailed study and AI-specific questions are not applicable.

Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical brackets, not a test set of data for an AI system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI system is not relevant here.
Adjudication method for the test set: Not applicable.
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 is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used: Not applicable for an AI device. For this physical device, the "ground truth" or standard of comparison is the performance of the predicate devices and conformance to the ISO standard for mechanical properties.
The sample size for the training set: Not applicable. This is not an AI device, so there is no training set.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

Device Type: Physical orthodontic ceramic brackets.
Purpose of Submission: To demonstrate substantial equivalence to previously cleared predicate devices, specifically the addition of brackets for mandibular bicuspids.
Performance Data Provided: Conformance to ISO 27020 and bench testing for Shear Bond Strength and Torque Strength. Specific numerical results are not detailed in this summary.
Biocompatibility: Not re-evaluated because the materials are the same as legally marketed predicate devices, and no material or manufacturing changes were made.
Clinical Testing: No animal studies or clinical testing were required for these devices.
Conclusion: The manufacturer believes the device is substantially equivalent to predicate devices based on design, principles of performance, and intended use, and the added mandibular bicuspid brackets do not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

August 26, 2016

Tomy, Inc. c/o Ms. Carolyn Primus Consultant Primus Consulting 7046 Owls Nest Terr Bradenton, Florida 34203

Re: K160615

Trade/Device Name: Orthodontic Ceramic Brackets 1.1 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: July 24, 2016 Received: July 28, 2016

Dear Ms. Carolyn Primus:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
	Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number ( if known )	K16 0615
Device Name	ORTHODONTIC CERAMIC BRACKETS 1.1
Indications for Use (Describe)	ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Premarket Notification

Tomy Inc. ORTHODONTIC CERAMIC BRACKETS 1.1

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510(k) Summary per 21CFR807.92

I. SUBMITTER

TOMY. Inc. Tenko Bldg. 3-16-7 Midoricho, Fuchu City, Tokyo 183-0006 Japan

PHONE: 81-246-42-3883 FAX #: 81-246-42-2275

Contact Person: Mr. Jinichi Watanabe Date Prepared: August 24, 2016

II. DEVICE

Name of Device: ORTHODONTIC CERAMIC BRACKETS 1.1 Common or Usual Name: Bracket, Ceramic, Orthodontic Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II Product Code: NJM

III. PREDICATE DEVICES

ORTHODONTIC CERAMIC BRACKETS are substantially equivalent to the following predicate devices with respect to intended use, materials, and design:

510(k) #	Device	Manufacturer
K102803(primary)	Clarity Advanced Ceramic Brackets	3M Unitek Corp.
K123094(secondary)	Orthodontic Ceramic Brackets	TOMY, Inc.

ORTHODONTIC CERAMIC BRACKETS 1.1 are equivalent to Clarity Advanced Ceramic Brackets (K102803) with regard to indications for use, materials, technological characteristics, and device design. ORTHODONTIC CERAMIC BRACKETS 1.1 have been slightly modified from TOMY Orthodontic Ceramic Brackets (K123094) to allow for the inclusion of the use of brackets for the mandibular bicuspid.

Premarket Notification

Page 25 of 160

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IV. DEVICE DESCRIPTION:

ORTHODONTIC CERAMIC BRACKETS 1.1 are designed to move teeth to improve their alignment.

ORTHODONTIC CERAMIC BRACKETS 1.1 are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

V. INDICATIONS FOR USE:

ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

ORTHODONTIC CERAMIC BRACKETS 1.1 are composed of a polycrystalline alumina ceramic, and have an orthodontic bracket design, which includes an archwire slot and tiewings. The self-ligating ORTHODONTIC CERAMIC BRACKETS 1.1 have a metal clip so that no other ligation of the archwire is needed.

Bench testing was performed to ensure that the ORTHODONTIC CERAMIC BRACKETS 1.1 performance was achieved and verified.

The ORTHODONTIC CERAMIC BRACKETS 1.1 were not evaluated for biocompatibility because the materials are the same as the legally marketed predicates. TOMY made no material changes or manufacturing process changes since the clearance of their already marketed Orthodontic Ceramic Brackets (K123094). Therefore, no new questions of substantial equivalence are raised with the subject devices.

We believe the ORTHODONTIC CERAMIC BRACKETS 1.1 are substantially equivalent to the predicate devices identified above. The difference between the ORTHODONTIC CERAMIC BRACKETS 1.1 and the Orthodontic Ceramic Brackets (K123094) that TOMY currently markets is the INCLUSION of the brackets for the mandibular bicuspid. Additionally, the ORTHODONTIC CERAMIC BRACKETS 1.1 have the same intended use, composition, design, function, physical properties, and performance of the predicate device, 3M Unitek Corp.'s Clarity Advanced Ceramic Brackets (K102803). However, the difference being that the ORTHODONTIC CERAMIC BRACKETS 1.1 includes both self-ligating and non-self-ligating, whereas Clarity Advanced are non-self-ligating. However, self-ligating brackets would not be expected to impact the intended use

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or performance of the brackets on the mandibular bicuspids.

We believe that the performance data provided herein support the substantial equivalence of the ORTHODONTIC CERAMIC BRACKETS 1.1.

Table VI-1 below provides a comparison of the subject devices and the predicate devices.

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	Subject DeviceORTHODONTIC CERAMICBRACKETS 1.1	Primary Predicate DeviceClarity Advanced CeramicBrackets	Secondary Predicate DeviceOrthodontic Ceramic Brackets
510(k) Number	N/A	K102803	K123094
Manufacture	TOMY Inc.	3M Unitek Corp.	TOMY Inc.
Device Name	Bracket, Ceramic, Orthodontic	Bracket, Ceramic, Orthodontic	Bracket, Ceramic, Orthodontic
Description	Orthodontic ceramic bracket	Orthodontic ceramic bracket	Orthodontic ceramic bracket
Medical Specialty	Dental	Dental	Dental
Product Code	NJM	NJM	NJM
Rag Number	872.5470	872.5470	872.5470
Class	2	2	2
Materials	Polycrystalline (translucent)alumina	Polycrystalline (translucent)alumina	Polycrystalline (translucent)alumina
Base	Mechanical Lock Base	Glass-grit roughened Base	Mechanical Lock Base
Design	Archwire slot, tiewings for ligatureand identification marks forplacementHooks for ligation, for additionaltooth movementMolded ceramic body with roundedcorners and edgesSlot to hold orthodontic wires	Archwire slot, tiewings for ligatureand identification marks forplacementHooks for ligation, for additionaltooth movementMolded ceramic body with roundedcorners and edgesSlot to hold orthodontic wires	Archwire slot, tiewings for ligatureand identification marks forplacementHooks for ligation, for additionaltooth movementMolded ceramic body with roundedcorners and edgesSlot to hold orthodontic wires
Ligation	Non-Self-Ligating	Non-Self-Ligating	Non-Self-Ligating
	Self-Ligating		Self-Ligating
Indications forUse	ORTHODONTIC CERAMICBRACKETS 1.1 are indicated fororthodontic movement of naturalteeth.	Clarity Advanced Ceramic Bracketsare intended for use in orthodontictreatment. The brackets are affixedto teeth so that pressure can beexerted on the teeth.	Orthodontic Ceramic Brackets areindicated for orthodontic movementof natural teeth, excludingmandibular bicuspid teeth.
	Sterility	Non-Sterile	Non-Sterile	Non-Sterile
	Utility	Single-use Only	Single-use Only	Single-use Only
		Subject DeviceORTHODONTIC CERAMICBRACKETS 1.1		Primary Predicate DeviceClarity Advanced CeramicBrackets	Secondary Predicate DeviceOrthodontic Ceramic Brackets
	Picture of Device	Non-Self-LigatingMandibularBicuspidImage: Non-Self-Ligating Mandibular Bicuspid Orthodontic Ceramic BracketSelf-LigatingMandibularBicuspidImage: Self-Ligating Mandibular Bicuspid Orthodontic Ceramic Bracket	Non-Self-Ligating for allother TeethImage: Non-Self-Ligating Orthodontic Ceramic Bracket for all other teethSelf-Ligating forall other TeethImage: Self-Ligating Orthodontic Ceramic Bracket for all other teeth	Non-Self-LigatingImage: Clarity Advanced Ceramic Bracket	Non-Self-LigatingImage: Non-Self-Ligating Orthodontic Ceramic BracketSelf-LigatingImage: Self-Ligating Orthodontic Ceramic Bracket

Table VI-1. Comparison of Subject ORTHODONTIC CERAMIC BRACKETS 1.1 to Predicates (3M Unitek Clarity Advanced Ceramic Brackets, K102803 and TOMY Orthodontic Ceramic Brackets, K123094)

Premarket Notification

Tomy Inc. ORTHODONTIC CERAMIC BRACKETS 1.1 Page 28 of 160

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VII. PERFORMANCE DATA

ORTHODONTIC CERAMIC BRACKETS 1.1 conform to the following Recognized Consensus Standard:

. ISO 27020 First edition 2010-12-15 Dentistry - Brackets and Tubes for use in Orthodontics
ORTHODONTIC CERAMIC BRACKETS 1.1 were tested for Shear Bond Strength and Torque Strength.

All of the components found in the ORTHODONTIC CERAMIC BRACKETS 1.1 have been used in legally marketed devices. ORTHODONTIC CERAMIC BRACKETS 1.1 have the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary.

No animal studies or clinical testing have been required for these devices.

VIII. CONCLUSIONS

There are no known substantial differences in terms of composition and mechanical properties between the ORTHODONTIC CERAMIC BRACKETS 1.1 and the predicate devices. This new 510(k) includes Orthodontic Ceramic Brackets (K123094) and their modified brackets. The difference in the modified brackets is the addition of the mandibular bicuspid brackets. Thus, the indication of use is equivalent to the predicate device Clarity ADVANCED Ceramic Brackets (K102803). The technological characteristics and materials are identical to Orthodontic Ceramic Brackets (K123094). Therefore, we believe that the information provided herein demonstrates that the ORTHODONTIC CERAMIC BRACKETS 1.1 are substantially equivalent to the predicate devices in design, principles of performance, and intended use.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.