The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

Device Description

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "TruKlear Orthodontic Ceramic Brackets." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against new acceptance criteria.

Therefore, the document does not contain information on the following:

A table of acceptance criteria and reported device performance (beyond compliance with ISO standards for material and mechanism).
Sample size used for a test set or its data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
Sample size for a training set.
How ground truth for a training set was established.

Instead, the submission for the TruKlear Orthodontic Ceramic Brackets relies on non-clinical data (bench testing) and biocompatibility testing to demonstrate substantial equivalence to a previously cleared predicate device (Orthodontic Ceramic Brackets, K090933) from the same manufacturer.

Here's a summary of the information that is available regarding the device's acceptance criteria and the "study" (bench testing and biocompatibility) proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details compliance with established standards rather than specific performance metrics against novel acceptance criteria.

Acceptance Criteria (Standard of Compliance)	Device Performance (Testing Completed)
Material Strength (Din EN ISO 27020)	TruKlear Bracket underwent Material Strength testing.
Slider Mechanism (Din EN ISO 27020)	TruKlear Bracket underwent Slider Mechanism testing.
Bonding Test (DIN 13990-2)	TruKlear Bracket underwent Bonding testing.
Biocompatibility (ISO 10993 Series)	Acute Systemic Toxicity, Cytotoxicity, Extractable Organic Substances, Irritation Test, Reverse Mutation Assay, Delayed Type Hypersensitivity (Nonpolar & Polar Extract) tests performed.

The "Rational for Substantial Equivalence" states: "The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the new TruKlear bracket exhibits comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable." This implies that meeting these standards and showing comparability to the predicate device's performance was the acceptance criterion.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The evaluation was based on bench testing of the device itself and biocompatibility testing, not on clinical data from a "test set" of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for clinical studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance was established via adherence to engineering and biocompatibility standards.

4. Adjudication method for the test set:
Not applicable.

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 is a medical device (orthodontic bracket), not an AI/software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.

7. The type of ground truth used:
For the non-clinical and biocompatibility tests, the "ground truth" was derived from predefined values and methodologies specified in the respective ISO and DIN standards. For example, for material strength, the 'ground truth' is the material's ability to withstand certain forces as per the standard; for biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993.

8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for physical device bench testing or biocompatibility analysis in the context of this 510(k) submission.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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JUN 2 5 2014

510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:	AJW Technology Consultants Inc.445 Apollo Beach BlvdApollo Beach, FL 33572Contact: Tanya O'Brientmobrien@ajwtech.com813-645-2855 x 102813-645-2856
Submitter of 510(k):	Bernhard Forster GmbHWestliche Karl - Friedrichstraße 15175172 Pforzheim, GermanyContact: Michael Fiessmichael.fiess@forestadent.comTelephone: 049-7231-459-0Fax: 049-7231-459-102
Date of Summary:	June 17, 2014
Trade/Proprietary Name:	TruKlear Orthodontic Ceramic Brackets
Common Name:	Bracket, Ceramic, Orthodontic
Classification Name:	Orthodontic Ceramic Bracket
Device Class:	II
Regulation Number:	872.5470
Device Panel:	Dental
Product Code:	NJM

Intended Use:

This device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

. .

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Device Description:

The function and performance of the orthodontic ceramic brackets are equal to the predicate device.

The material was selected according the requirements of ISO 6474:1994. Ceramic materials are based on High purity aluminia.

Substantial Equivalence:

The Orthodontic Ceramic Brackets are substantial equivalent in intended use and similar technological characteristics to the:

Orthodontic Ceramic Brackets (K090933) for the orthodontic movement of teeth to alter tooth position.

Applicantand DeviceName	Forestadent BernhardForster GmbHOrthodontic CeramicbracketsTruKlear	Forestadent Bernhard ForsterGmbHOrthodontic Ceramic bracketsQuicklear
510(k) -Number	This submission	(K090933)
Deviceclassificationname	Orthodontic CeramicBracket CFR 872.5470,NJM	Orthodontic Ceramic bracketCFR 872.5470; NJM
Material	AL2O3mechanism plastic material	AL2O3
Intended use	The device is intended fororthodontic movement ofteeth. It is used temporarilyand is removed afterorthodontic treatment hasbeen completed. The devicesare intended to be singleused only.	The device is intended fororthodontic movement ofteeth. It is used temporarilyand is removed afterorthodontic treatment hasbeen completed. The devicesare intended to be single usedonly.
Single use	Single Use	Single Use
Sterility	Non-sterile	Non-sterile
Method oftooth adhesion	Bonding to tooth	Bonding to tooth

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Method oftoothmovement	Application of force through orthodontic wire	Application of force through orthodontic wire
Performance	Self-ligating, aesthetic ceramic bracket	Self-ligating, aesthetic ceramic bracket
Slidemechanism	Ceramic slide mechanism	Metallic clip

Rational for Substantial Equivalence:

The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the new TruKlear bracket exhibits comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable. Based on those characteristics, the Forestadent Bernhard-Forster TruKlear bracket is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Summary of Non-Clinical Data:

The TruKlear bracket underwent bench testing according to several different performance standards. Below is a chart of the different testing that was completed.

Device.	Performance Test	Standard of Compliance
TruKlear Bracket	Material Strength	Din EN ISO 27020
TruKlear Bracket	Slider Mechanism	Din EN ISO 27020
TruKlear Bracket	Bonding Test	DIN 13990-2

Summary of Biocompatibility Testing:

The TruKlear bracket underwent biocompatibility testing according to several different performance standards. Below is a list of the different testing that was completed:

1. Acute Systemic Toxicity in Mouse according to ISO 10993-1: 2009, ISO 10993-11: 2006, ISO 10993-12:2012.
1. Cytotoxicity Growth Inhibition Test according to ISO 10993-5, ISO 10993-12.
1. Extractable Organic Substances after Liquid Extraction according to ISO 10993-18 and ISO 10993-12.
1. Irritation Test according to ISO 10993-1: 2009. ISO 10993-10: 2010. and ISO 10993-12: 2012.
1. Reverse Mutation Assay according to ISO 10993-1: 2009, ISO 10993-3: 2003, and ISO 10993-12: 2012.
1. Delayed Type Hypersensitivity Nonpolar Extract according to ISO 10993-1: 2009, ISO 10993-10: 2010, and ISO 10993-12: 2012.
1. Delayed Type Hypersensitivity Polar Extract according to ISO 10993-1: 2009. ISO 10993-10: 2010 and ISO 10993-12: 2012.

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Conclusion

Based on the conclusions of each of these tests it is determined that the TruKlear bracket demonstrates that the device is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2014

Bernhard Forster GmbH c/o Ms. Tanya O'Brien RN/BSN/CPAN AWJ Technology Consultants, Inc. 445 Apollo Beach Boulevard Apollo Beach, FL 33572

Re: K141104

Trade/Device Name: TruKlear Orthodontic Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Bracket, Ceramic, Orthodontic Regulatory Class: II Product Code: NJM Dated: May 21, 2014 Received: May 27, 2014

Dear Ms. O'Brien:

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.

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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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known): K141104

Device Name: Orthodontic Ceramic Bracket

Indications For Use: The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

and the comments of the comments of the comments of the comments of

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

・

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Sheena A. Green -S 2014.06.23 09:49:25 -04'00'

Bernhard Forster GmbH TruKlear Special 510(k)

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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.