(142 days)
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
The provided text describes the 510(k) summary for the Clarity™ Advanced Ceramic Brackets, focusing on substantial equivalence to predicate devices through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Clarity™ Advanced) |
|---|---|
| Bond Strength (Shear-peel) | Comparable to Clarity™ SL and Clarity™ brackets; exceeds minimum bond strength to hold the bracket to the tooth. |
| Bracket Strength (Torsional force to break a bracket) | Comparable to Clarity™ Metal-Reinforced Ceramic Brackets and InVu® Aesthetic Braces; exceeds minimum requirements. |
| Material Friction (Surface frictional forces of wire against bracket) | Zirconia-coated aluminum oxide surface exhibited lower coefficients of friction as compared to the uncoated aluminum oxide surface (a positive outcome). |
| Debond Strength/Mechanism (Squeeze debond) | Squeeze debond moments are comparable to Clarity™ SL brackets and slightly lower for Clarity™ brackets. |
| Biocompatibility | Assessment developed using standard risk assessment techniques and consideration of FDA and internationally recognized guidelines; conclusion that the device is safe. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "nonclinical performance testing."
- Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "The test results showed that..." for each test, implying a sample was used but not quantifying it.
- Data Provenance: The data is based on bench testing conducted by the manufacturer, 3M Unitek Corp, a US-based company. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate performance. There is no indication of external data sources or retrospective analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance tests (bond strength, bracket strength, friction, debonding) is established by the physical and mechanical properties of the materials and device and measured through standardized engineering tests, not through expert human interpretation or consensus.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "truth" for these physical performance tests is directly measured by instruments, not human review or adjudication.
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 a physical orthodontic bracket, not an AI-powered diagnostic or treatment planning tool that involves human readers or interpretation of medical images. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on objective, quantitative measurements of physical properties, such as force (bond strength, debond strength, bracket strength) and coefficients of friction, using standardized testing methodologies.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is generated through physical bench testing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.
§ 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.