(57 days)
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.
The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.
The provided text describes a 510(k) premarket notification for "TruKlear Orthodontic Ceramic Brackets." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against new acceptance criteria.
Therefore, the document does not contain information on the following:
- A table of acceptance criteria and reported device performance (beyond compliance with ISO standards for material and mechanism).
- Sample size used for a test set or its data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the submission for the TruKlear Orthodontic Ceramic Brackets relies on non-clinical data (bench testing) and biocompatibility testing to demonstrate substantial equivalence to a previously cleared predicate device (Orthodontic Ceramic Brackets, K090933) from the same manufacturer.
Here's a summary of the information that is available regarding the device's acceptance criteria and the "study" (bench testing and biocompatibility) proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details compliance with established standards rather than specific performance metrics against novel acceptance criteria.
| Acceptance Criteria (Standard of Compliance) | Device Performance (Testing Completed) |
|---|---|
| Material Strength (Din EN ISO 27020) | TruKlear Bracket underwent Material Strength testing. |
| Slider Mechanism (Din EN ISO 27020) | TruKlear Bracket underwent Slider Mechanism testing. |
| Bonding Test (DIN 13990-2) | TruKlear Bracket underwent Bonding testing. |
| Biocompatibility (ISO 10993 Series) | Acute Systemic Toxicity, Cytotoxicity, Extractable Organic Substances, Irritation Test, Reverse Mutation Assay, Delayed Type Hypersensitivity (Nonpolar & Polar Extract) tests performed. |
The "Rational for Substantial Equivalence" states: "The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the new TruKlear bracket exhibits comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable." This implies that meeting these standards and showing comparability to the predicate device's performance was the acceptance criterion.
2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The evaluation was based on bench testing of the device itself and biocompatibility testing, not on clinical data from a "test set" of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for clinical studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance was established via adherence to engineering and biocompatibility standards.
4. Adjudication method for the test set:
Not applicable.
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 medical device (orthodontic bracket), not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used:
For the non-clinical and biocompatibility tests, the "ground truth" was derived from predefined values and methodologies specified in the respective ISO and DIN standards. For example, for material strength, the 'ground truth' is the material's ability to withstand certain forces as per the standard; for biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for physical device bench testing or biocompatibility analysis in the context of this 510(k) submission.
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.