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

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.

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:

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.

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