(61 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance and Equivalence Claim |
|---|---|
| Material Characteristics: Polycrystalline alumina (ceramic) | Met: "Avex® CX2 is composed of polycrystalline alumina... The raw material has been documented to be biocompatible for its intended contact and duration of contact." Table 5-1 also shows both predicate and subject devices use "Polycrystalline alumina (ceramic)". |
| Physical Properties: Molded ceramic body, rounded corners, edges, hooks, prepared base; specific slot sizes and prescriptions. | Met: Table 5-1: "Molded ceramic body with rounded corners, edges, and hooks, and physically prepared base." "Available in .018 and .022 slot sizes and various prescriptions." |
| Compliance to applicable standard(s): ISO 27020:2010 | Met: Table 5-1 explicitly states: "Complies to ISO 27020:2010" for both predicate and subject device. |
| Biocompatibility: Non-toxic per ISO 10993-1 | Met: Table 5-1: "Device demonstrated through literature studies to be non-toxic per ISO 10993-1" for both predicate and subject device. The text also states: "The raw material has been documented to be biocompatible for its intended contact and duration of contact." |
| Bond Strength, De-bond Evaluations, Adhesive Shear Strength Evaluation. | Met: "Avex CX2 has been tested for bond strength, de-bond evaluations, and adhesive shear strength evaluation and met all other design inputs." The comparative testing "demonstrated that the modified Avex CX2 is substantially equivalent to the predicate, Avex CX2 and Avex CXi2." (No specific numerical results provided, just that they "met" and "demonstrated equivalence"). |
| Intended Use/Indications for Use: Orthodontic treatment by dental/orthodontic professional. | Met: Both predicate and subject devices have identical "Indications for Use" and "Intended user" as "Dental or Orthodontic professional." |
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.
§ 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.