(18 days)
Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.
The provided document is a 510(k) summary for a medical device (Elation MB Metal Reinforced Plastic Brackets), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format typically used for software or AI/ML device evaluations. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical metrics, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or available in this type of regulatory submission.
This document describes a modification to an existing device and justifies its safety and substantial equivalence based on prior use of components and material composition, not through a performance study that measures diagnostic accuracy or clinical outcomes with quantifiable metrics against acceptance criteria.
However, I can extract and infer some information based on the context of a 510(k) submission for a non-software/AI device:
1. A table of acceptance criteria and the reported device performance
For a mechanical device like an orthodontic bracket, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and fit, often tested against industry standards or the performance of a predicate device. The document states that the device meets these, but detailed quantitative criteria and performance values are not provided in this summary.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from document) |
|---|---|
| Biocompatibility | "All of the components found in Elation MB Metal Reinforced Plastic Brackets have been used in legally marketed devices and/or were specified on the basis of having biocompatibility data..." |
| Mechanical Lock/Bonding | "A modification has been made to replace the base with the previously tested mechanical lock base..." (Implies meeting performance of the predicate's mechanical lock) |
| Material Composition & Safety | "All of the components... were found safe for dental use. The performance data provided, and the bio-compatibility data support the use of Elation MB Metal Reinforced Plastic Brackets for the indicated uses." |
| Equivalence to Predicate Indications for Use | "Elation MB is indicated for orthodontic movement of natural teeth." (Matches the inferred indication of the predicate devices) |
2. Sample sizes used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This document does not describe a clinical or performance study with a test set of data points in the way a software/AI device would. The "tests" here refer to material and mechanical evaluations, likely performed on a sufficient number of bracket samples to ensure product quality and regulatory compliance, but specific sample sizes are not disclosed in this summary. Data provenance is not described as it is not a data-driven device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a mechanical device like this is established through material science principles, engineering testing (e.g., tensile strength, bond strength), and biocompatibility assessments, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no "test set" in the context of clinical cases 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
Not applicable. This is a physical orthodontic bracket, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical orthodontic bracket.
7. The type of ground truth used
For a non-AI/ML medical device like this, the "ground truth" is typically:
- Material Science Specifications: Conformance to established standards for materials (e.g., plastics, metals used in the bracket).
- Biocompatibility Data: Established safety profiles for the materials used, often from prior regulatory clearances or published standards.
- Mechanical Engineering Principles: Performance of the mechanical lock, retention, and overall structural integrity, verified through in-vitro laboratory testing (e.g., bond strength tests).
- Predicate Device Performance: The underlying assumption that if the new device's materials, design modifications (like the base), and intended use are substantially equivalent to a legally marketed predicate device, its performance and safety are also equivalent.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.