(58 days)
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation
This FDA 510(k) submission for the "CDB Flip-Slide-Clip Bracket" is a premarket notification for a Class II medical device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the information you're requesting regarding detailed acceptance criteria, study designs, sample sizes, expert involvement, and comparative effectiveness studies is not typically present in this type of submission.
Here's an assessment based on the provided document:
Analysis of Acceptance Criteria and Device Performance Study
The provided document describes a 510(k) submission for an orthodontic bracket. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metric acceptance criteria through new clinical efficacy studies. Therefore, the submission relies on the established safety and effectiveness of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit quantitative acceptance criteria or detailed performance metrics are provided in this 510(k) submission. The core "acceptance criteria" here is the FDA's determination of substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Framework) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use: Device is indicated for orthodontic movement of natural teeth. | The device is indicated for orthodontic movement of natural teeth, identical to the predicate device. |
| Technological Characteristics: Similar materials and functional principles. | "The function and performance of the CDB Flip-Slide-Clip Bracket is similar to the predicate." "Minor design changes and incorporation of self-ligation are the only modifications..." "All of the materials used in the device have been used in legally marketed CDB Corporation's devices." |
| Safety and Effectiveness: Does not raise new questions regarding safety and effectiveness. | "There are no major differences... therefore the CDB Flip-Slide-Clip Bracket does not raise any questions regarding the safety and effectiveness." "The CDB Flip-Slide-Clip Bracket... is as safe and effective as the predicate device(s)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical "test set" for performance evaluation in the way you might expect for a diagnostic or AI device. The comparison is primarily based on design specifications, material equivalency, and functional principles relative to the predicate devices.
- Data Provenance: Not applicable. No new clinical performance data from a test set is presented. The "data" provenance would relate to the established safety and effectiveness of the cited predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No ground truth was established by experts for a novel test set performance evaluation. The "ground truth" here is effectively historical: the predicate devices have established their safety and effectiveness through their regulatory history and market use.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No performance adjudication of a new test set was conducted for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. Such studies are typically reserved for devices where the performance difference between a new device (especially AI-assisted) and standard practice is being quantified, which is beyond the scope of a substantial equivalence claim for a mechanical bracket.
- Effect Size of Human Readers Improvement with AI vs. Without AI: Not applicable, as this is not an AI-based device and no such study was conducted.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Not applicable. This device is a mechanical orthodontic bracket, not an algorithm. Therefore, no standalone algorithmic performance study was conducted or is relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices currently on the market. This is based on their historical regulatory clearances, clinical use, and performance data accrued over time, rather than a prospectively established gold standard for a new device's performance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm.
In summary: This 510(k) submission is for a modified mechanical device. Its acceptance hinges on demonstrating that it is as safe and effective as existing devices (predicates) through a comparison of intended use, technological characteristics, and materials. It does not involve new clinical performance studies with specific acceptance criteria, test sets, or expert ground truthing as would be associated with the evaluation of a new diagnostic or AI-driven medical device.
§ 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.