The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving device performance in the way typically associated with medical device clinical or performance studies (i.e., sensitivity, specificity, accuracy, etc., for a diagnostic device).

This document is a 510(k) summary for a DENTSPLY Mystique MB Ceramic Brackets, seeking substantial equivalence to a predicate device (K042178). The key points from the document are:

Device Description: The Mystique MB Ceramic Brackets are a modification to an existing orthodontic ceramic bracket, primarily involving a mechanical lock base and specific design features (rhomboid, "torque-in-the-base"). The bracket itself is transparent and has indented walls, available with or without glass coating in the wire slot.
Intended Use: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. This is explicitly stated to be the same as the predicate device (K042178).
Technological Characteristics: The manufacturer claims minor design modification and no changes in intended use or fundamental scientific technology compared to the predicate device. All components have been used in legally marketed devices and/or found safe for dental use. The composition is stated as the same as the predicate device.
Justification for Safety and Effectiveness: The manufacturer states that "prior use of the components of Mystique MB Ceramic Brackets in the legally marketed devices, the performance data provided, and previously submitted biocompatibility data support the safety and effectiveness."

Based on this, the 510(k) emphasizes substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance criteria for a new device's efficacy or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from 510k)	Reported Device Performance
Biocompatibility: Components are safe for dental use, and composition is same as predicate device.	"All of the components found in Mystique MB Ceramic Brackets have been used in legally marketed devices and/or were found safe for dental use." "Mystique MB Ceramic Brackets are the same composition as the predicate device. Therefore, further biocompatibility testing is not necessary."
Functional Equivalence: Device performs its intended function (orthodontic movement of natural teeth) similarly to the predicate device despite minor design modifications.	"Mystique MB Ceramic Brackets represent a minor design modification to K042178. There are no changes in intended use or fundamental scientific technology." "The performance data provided" (specifics not detailed in the summary). Implied to be equivalent based on the 510(k) clearance.
Intended Use: Device is suitable for the same indicated uses as the predicate device.	"Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth." "These are the same indications for use previously cleared for K042178."

2. Sample size used for the test set and the data provenance:
* Not available. The document refers to "performance data provided" but does not detail any specific test sets, their sizes, or provenance. This is typical for a 510(k) summary relying on substantial equivalence and previous data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not available. No specific "ground truth" establishment for a test set is described, as this is not a diagnostic device and the clearance is based on substantial equivalence to an existing device.

4. Adjudication method for the test set:
* Not applicable/Not available. No test set or adjudication method is described.

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 device is an orthodontic bracket, not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is an orthodontic bracket, not an algorithm or software.

7. The type of ground truth used:
* Not applicable/Not available. No "ground truth" in the context of diagnostic accuracy is discussed. The "truth" for this device lies in its physical properties, biocompatibility, and ability to facilitate orthodontic movement, which is inferred to be equivalent to the predicate device.

8. The sample size for the training set:
* Not applicable/Not available. No "training set" in the machine learning sense is used or mentioned. The manufacturer relies on prior use of components and existing data.

9. How the ground truth for the training set was established:
* Not applicable/Not available. See point 8.

Summary

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K082974

NOV - 7 2008

DENTSPLY Internat World Headquarters Susquehanna Commer 221 West Philadelphic ork, PA 17405-087 800) 877-0020 Fax 17171 849-4343 ww.dentsply.com

510(k) SUMMARY

CONTACT: Helen Lewis DATE PREPARED: October 2, 2008 TRADE OR PROPRIETARY NAME: Mystique MB Ceramic Brackets CLASSIFICATION NAME: Orthodontic Ceramic Brackets 872.5470 PREDICATE DEVICES: Orthodontic Ceramic Brackets K042178

DEVICE DESCRIPTION: The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.

INTENDED USE: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

(ECHNOLOGICAL CHARACTERISTICS: The Mystique MB Ceramic Brackets represent a minor design modification to K042178. There are no changes in intended use or fundamental scientific technology.

All of the components found in Mystique MB Ceramic Brackets have been used in legally marketed devices and/or were found safe for dental use. Mystique MB Ceramic Brackets are the same composition as the predicate device. Therefore, further biocompatibility testing is not necessary.

We believe that the prior use of the components of Mystique MB Ceramic Brackets in the legally marketed devices, the performance data provided, and previously submitted biocompatibility data support the safety and effectiveness of Mystique MB Ceramic Brackets for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

NOV - 7 2008

Re: K082974

Trade/Device Name: Mystique MB Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: October 2, 2008 Received: October 9, 2008

Dear Ms. Lewis:

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. Lewis

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sutte Y. Mchail Ows..

DR. CHIL LIN Chiu S. Lin, Ph. D FOR Division 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

510(k) Number (if known):

K082974

Device Name: Mystique MB Ceramic Brackets

Indications for Use:

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

These are the same indications for use previously cleared for K042178.

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

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

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

Concurrence of CDRH Office of Device Evaluation (ODE)

MGR

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

510(k) Number: K082974

Premarket Notification

Mystique MB Ceramic Brackets

DENTSPLY International

000017

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.