(25 days)
Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.
The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.
The provided 510(k) summary for the Allure® MB Ceramic Brackets (K090454) is for a dental device, specifically orthodontic brackets. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and material composition, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k)) | Reported Device Performance (from 510(k)) | Notes |
|---|---|---|
| Technological Characteristics: The Allure® MB Ceramic Brackets represent a modification to K852179. | The Allure® MB Ceramic Brackets have a mechanical lock base, which includes rhomboid and "torque-in-the-base" features. This replaces the chemically treated base of the predicate device (Allure, K852179). | The device's performance is not quantified in terms of specific metrics but rather through its technical characteristics and material composition, deemed safe and effective based on predicate devices. |
| Material Composition and Safety: All components have been used in legally marketed devices and/or were found safe for dental use. | Allure® MB Ceramic Brackets are of the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary. | Safety is established through prior use of components and general biocompatibility data from predicate devices. No specific quantitative performance metrics are provided. |
| Intended Use Equivalence: Substantially equivalent to legally marketed predicate devices. | "We believe that the prior use of the component of Allure® MB Ceramic Brackets in legally marketed devices, the performance data provided, and the previously submitted biocompatibility data each provide support regarding the safety and effectiveness for the indicated uses." | The device is deemed substantially equivalent for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This 510(k) relies on demonstrating substantial equivalence through technical characteristics and material composition, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no clinical study or test set with ground truth was presented in this 510(k) for AI performance.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication for AI performance was presented.
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 is a device modification for an orthodontic bracket, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not Applicable. While the device seeks "substantial equivalence," the "ground truth" in this context is the safety and effectiveness of the predicate devices and their components. This is not derived from expert consensus, pathology, or outcomes data in the way an AI system's performance would be.
8. The sample size for the training set
- Not Applicable. This device did not involve an AI training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used for this type of device submission.
§ 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.