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

Device Description

The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket. The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%). This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement.

AI/ML Overview

The document provided is a 510(k) premarket notification for an Orthodontic Ceramic Bracket (Mach Brackets, Bright Brackets). It details the device's description, intended use, technological characteristics, and performance testing for biocompatibility.

Here's an analysis of the acceptance criteria and study information based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Items	Acceptance Criteria	Reported Device Performance
In vitro cytotoxicity	Expected to pass ISO10993-5 standards	Passed
Oral mucous membrane irritation test	Expected to pass ISO10993-10 standards	Passed
BrdU as a guideline for testing skin sensitization	Expected to pass ISO10993-10 standards	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Bench tests were performed" for biocompatibility. However, it does not provide any details regarding:

The specific sample size used for any of the biocompatibility tests.
The data provenance (e.g., country of origin, retrospective or prospective) for these tests. Biocompatibility tests are typically laboratory-based and not derived from clinical patient data in the same way clinical trials are.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Biocompatibility tests, as described, do not typically involve human expert establishment of ground truth in the same way clinical diagnostic studies do. The "ground truth" for these tests is defined by the standards (ISO10993-5, ISO10993-10) themselves and the methodologies executed by the testing laboratory.

The tests were performed by the "Dental Devices Testing & Evaluation Center, Yeonsei University, College of Dentistry." While this indicates a reputable institution, no information is provided on:

The specific number of experts involved in analyzing the test results.
The qualifications of those experts (e.g., toxicologists, material scientists, with specific years of experience).

4. Adjudication Method for the Test Set

As these are laboratory-based biocompatibility tests and not clinical studies requiring human interpretation of outcomes, no adjudication method (like 2+1 or 3+1 consensus) is mentioned or typically applicable. The results are objective measurements against defined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes biocompatibility bench tests, not a clinical study involving human readers or cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is applicable to AI/ML devices. The Mach Brackets are physical orthodontic ceramic brackets, not an algorithm or software device. Therefore, a standalone performance study is not relevant or applicable in this context.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the biocompatibility tests:

The "ground truth" is established by the international standards (ISO10993-5 and ISO10993-10) that define acceptable biological responses for medical devices.
The test results (e.g., "Passed") indicate compliance with these predefined criteria.

8. The Sample Size for the Training Set

This question refers to the training data for AI/ML algorithms. Since the Mach Brackets are a physical medical device and not an AI/ML product, there is no training set in the context of machine learning. The device itself is manufactured; it does not "learn" from data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no training set for this type of device. Therefore, the establishment of ground truth for a training set is not applicable.

Summary

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K120471 : Device: Orthodontic Ceramic Bracket

JUN - 4 2012

See 510(k) Summary, below.

Trade Name: . MACH BRACKETS , BRIGHT BRACKETS 1. Common Name: Orthodontic Ceramic Bracket Classification Name: Bracket, Ceramic, Orthodontic, product code NJM Product Code: NJM Requlation: 872.5470 Class of device : Class II.

1. The legally marketed device to which we are claiming equivalence: Orthodontic Ceramic brackets (K090933 )

2. Description of device:

The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position.

The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket.

1. Intended 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 to be single used only.
1. Technological Characteristics:
  The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%).

This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement

1. Performance: Bench tests were performed.

Test Items		Test method	Tested by	Test results
BiocompatibilityTests	In vitro cytotoxicity	ISO10993-5	Dental Devices Testing& Evaluation CenterYeonsei University,College of Dentistry	Passed
	Oral mucous membrane irritationtest	ISO10993-10		Passed
	BrdU' as a guideline for testing skinsensiztization	ISO10993-10		Passed

Biocompatibility as follows;

The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

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

World Bio Tech Company, Limited C/O Mr. Peter Chung Correspondent 300 Atwood Street Pittsburgh, Pennsylvania 15213

JUN - 4 2012

Re: K120471

Trade/Device Name: Mach Brackets, Bright Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: April 28, 2012 Received: May 9, 2012

Dear Mr. Chung:

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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Page 2 - Mr. Chung

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 vou 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,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Statement 4.

Indications for Use

510(k) Number (if known): K 12 O 4 71

Device Name: Orthodontic Ceramic Bracket.

Indications For Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumsey

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(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120477

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.