Search Results

AVEX® CX2 and AVEX® CXi2 ceramic brackets are intended to be bonded to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. AVEX® CX2 and AVEX® CXi2 Ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide maximum adhesion to the tooth, yet allow for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth. AVEX® CX2 and AVEX® CXi2 are the exact same brackets except AVEX® CXi2 has a stainless steel 17-4 insert inside the archwire slot will facilitate archwire movement without force and preventing "notching" of the slot.

AI/ML Overview

This document describes the premarket notification for the AVEX® CX2 and AVEX® CXi2 ceramic orthodontic brackets. The submission demonstrates substantial equivalence to a predicate device, K973776 Reflections Ceramic Brackets by CDB Corporation, primarily through materials characterization and bench testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Bond Strength	Comparable to predicate device; Exceed minimum bond strength to hold bracket to tooth.	"The test results showed that the bond strengths of AVEX® CX2 and AVEX® CXi2 and our predicates are comparable and exceed the minimum bond strength to hold the bracket to the tooth."
Doctor Debond Testing	Debonding force not excessive to cause enamel damage to the tooth.	"Doctor de-bond testing was evaluated and documented that when de-bonding the brackets the bond strength was not excessive to cause enamel damage to the tooth."
Adhesive Shear Strength (AVEX® CXi2 metal slot liner)	Stronger and more consistent than the predicate's bracket adhesive for metal slot liners.	"The test results show that de-bond adhesives we selected for AVEX® CXi2 metal slot liners are more consistent and stronger to that of our predicate's bracket adhesive."
Materials	Polycrystalline alumina (ceramic) for bracket body; 17-4 Stainless steel for metal slot liner.	"AVEX® CX2 and AVEX® CXi2 and our predicate devices all have a bracket body made of polycrystalline alumina ceramic. The AVEX® CXi2 contains a metal slot liner made from 17-4 Stainless steel."
Design Features	Substantially equivalent to predicate devices (e.g., tie-wing undercut spaces, rounded corners).	"AVEX® CX2 and AVEX® CXi2 Ceramic Brackets are substantially equivalent in design features to the predicate devices. The AVEX® CX2 is a ceramic bracket with an arch wire slot that does not have a metal liner. The AVEX® CXi2 is the same exact ceramic bracket with the addition of a stainless steel 17-4 slot liner." (Further descriptions of design provided too).
Biocompatibility	Biocompatible for intended use.	"Biocompatibility testing according to ISO 10993-1:2009 was not conducted on our ceramic brackets and metal slot liners as the biocompatibility of polycrystalline alumina (ceramic) and stainless steel 17-4 has been shown by many other predicate device manufacturers over the past decades. Our literature search of biocompatibility testing shows that these components of the brackets are safe and effective."

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

The document does not explicitly state the numerical sample size for each bench test conducted. It refers to "tests" and "test results" in plural, implying multiple samples were used for each test. The data provenance is from in-house testing conducted by the applicant, Opal Orthodontics by Ultradent Products, Inc., in the United States. The testing was retrospective in the sense that it was conducted as part of the R&D and 510(k) submission process for these devices, comparing them to an already marketed predicate.

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

This information is not provided in the document. The bench tests are objective physical measurements rather than subjective expert evaluations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The testing described is bench testing, which involves objective measurements against established physical criteria or comparison to a predicate, rather than subjective interpretation requiring 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

No, an MRMC comparative effectiveness study was not done. This device is a passive orthodontic bracket and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical orthodontic bracket and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench tests was based on:

Performance criteria derived from the function of orthodontic brackets (e.g., sufficient bond strength, non-damaging debonding).
Direct comparisons to the performance of the legally marketed predicate device (K973776 Reflections Ceramic Brackets by CDB Corporation) in terms of various physical properties and characteristics.
Material specifications (polycrystalline alumina, 17-4 Stainless steel) with established biocompatibility and performance histories.

8. The Sample Size for the Training Set

This refers to the sample size for the bench tests to evaluate performance, not a "training set" in the context of an algorithm. As mentioned in point 2, the exact numerical sample sizes for the bench tests are not explicitly stated in the provided text.

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

Similarly to point 7, the "ground truth" for these bench tests was established by:

Pre-defined engineering and material specifications.
The performance characteristics and material composition of the legally marketed predicate device, used as a direct benchmark for "substantial equivalence."
Accepted industry standards for materials (e.g., biocompatibility of polycrystalline alumina and 17-4 stainless steel, as proven by decades of use and literature).

Ask a Question

Ask a specific question about this device

Page 1 of 1