Search Results

Avex® CX2 ceramic brackets are intended for use in orthodontic treatment.

Avex® CX2 ceramic brackets are intended to be bonded to teeth upon which an orthodontic wire is placed in a slot to re-position the teeth to desired positions. Avex CX2 ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide adhesion to the tooth, yet allow for removal when necessary. The raw material has been documented to be biocompatible for its intended contact and duration of contact. There are several other products in the market that have the same indications as these products and the proposed modification does not affect composition, intended use, or indications for use. Opal Orthodontics has followed design control processes outlined in 21 CFR 820.30 and internal procedures to complete our design control procedure and documentation for the Avex CX2.

Avex CX2 ceramic brackets are esthetically preferred as ceramic colored arch wires are available and the vision of "metal mouth" is no longer the case for the bracket wearer. These ceramic brackets and certain arch wires are intended to match natural tooth coloring in order to reduce visibility.

Avex CX2 ceramic brackets are indicated for use in patients of all ages when prescribed by a dentist or orthodontist.

This document describes the premarket notification for the Avex CX2 ceramic brackets. The information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance against acceptance criteria in the way a diagnostic AI/ML device might.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in the form of numerical performance metrics (e.g., sensitivity, specificity, F1-score) typical for AI/ML devices. Instead, it relies on demonstrating equivalence through:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI/ML algorithm. The "testing" referred to is bench testing for physical and mechanical properties.

• Sample size: Not explicitly stated for each test (e.g., how many brackets were tested for bond strength). It refers to "various prescriptions" and "various slot sizes" which implies multiple configurations were tested.
• Data provenance: Not applicable in the context of clinical data. It's in-house bench testing ("in-house testing").
• Retrospective or prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The ground truth for this device is based on established engineering standards for material properties, mechanical performance (like bond strength), and biocompatibility. No clinical "ground truth" or expert review of images/cases is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of clinical data. Testing methods would follow established laboratory protocols for each specific mechanical or material test (e.g., ISO standards).

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. This is a medical device (orthodontic bracket), not an AI/ML diagnostic tool. Therefore, an MRMC study is not performed, and AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

• Engineering standards: Compliance with ISO 27020:2010.
• Biocompatibility standards: Compliance with ISO 10993-1, often through existing literature for the material.
• Bench test results: Mechanical properties like bond strength, de-bond evaluations, and adhesive shear strength are measured against pre-defined engineering design inputs, rather than an "expert consensus" or "pathology."

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set and associated ground truth.

Ask a specific question about this device

AVEX® CX2 and AVEX® CXi2 ceramic brackets are intended for use in orthodontic treatment.

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.

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

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 specific question about this device