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510(k) Data Aggregation
(175 days)
The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.
CDB Self Ligating Bracket 8F is 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 placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket.
The provided document is a 510(k) premarket notification for a medical device (CDB Self Ligating Bracket 8F), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving independent performance against acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and the study that proves the device meets them, especially in the context of an AI/algorithm-driven device.
Here's why and what information is available:
- Type of Device: The CDB Self Ligating Bracket 8F is an orthodontic bracket, a physical medical device. It is not an AI or algorithm-driven diagnostic or therapeutic device. The performance testing conducted is engineering-focused (e.g., comparative shear bond strength testing), not clinical performance metrics like sensitivity, specificity, or reader improvement.
- Regulatory Pathway: A 510(k) submission establishes substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and is as safe and effective as the predicate. It usually does not require a full de novo clinical performance study against pre-defined acceptance criteria for diagnostic accuracy, as would be expected for an AI device.
However, based on the limited information about "performance testing" provided, here's what can be extracted, reformatted to align with your request, but emphasizing the lack of clinical study data for AI:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's limited scope):
| Acceptance Criterion | Description from Document (Inferred) | Reported Device Performance (from Document) |
|---|---|---|
| Bond Strength | The device's bond strength should be as strong as or stronger than the primary predicate device (Dentsply In-Ovation C) to ensure secure attachment to teeth during orthodontic treatment and comparable material performance. This is critical for function and patient safety. | "Comparative shear bond strength testing was conducted to the noted predicate device and that the results demonstrated that the bond strength was as strong as the predicate." |
| Functional Equivalence | The device's function, performance, and contact material should be similar to the predicate device, with minor design changes not impacting safety or effectiveness. The principles of operation (wire ligation) should be consistent with the predicate. | "The function, performance, and contact material of the CDB Self Ligating 8F is similar to the predicate." "The wire is held in a passive, interactive, or active state by the clip. The clip slides into and out of place to ligate the wire." (Identical description for both device and predicate). |
| Material Composition Equivalence | The material composition, especially for components that contact the patient, should be substantially equivalent to, or well-established through, predicate or reference devices to demonstrate biocompatibility and performance. | Bracket Composition: Aluminum Oxide (Predicate: Aluminum Oxide, Silicon Dioxide) |
| Clip Material: Nickel Titanium (Predicate: Manganese, Nickel, Chromium, Molybdenum, Niobium, Titanium, Iron, Cobalt; Reference devices: Nickel Titanium) | ||
| Clip Coating: Gold Rhodium (Identical for both device and predicate) | ||
| Intended Use Equivalence | The indications for use should be the same as the predicate device. | "The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid." (Identical to predicate's intended use). |
Regarding the other requested points (which are highly relevant to AI/algorithm studies but not explicitly described for this physical device's 510(k) submission):
- Sample size used for the test set and the data provenance: Not applicable in the context of this device's "performance testing." The "comparative shear bond strength testing" likely involved a certain number of brackets tested in a lab, but the document does not specify the sample size or provenance of "data" in the sense of clinical cases for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthodontic bracket's performance is typically established through engineering standards and physical measurements, not expert clinical interpretation of images or patient outcomes for diagnostic accuracy.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "performance testing," the ground truth was likely engineering measurements (e.g., force required to shear the bond).
- The sample size for the training set: Not applicable. There is no AI model or "training set" for this physical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (orthodontic bracket) under the 510(k) pathway, focusing on demonstrating equivalence to predicate devices rather than a clinical trial proving performance against predefined clinical acceptance criteria for an AI or diagnostic algorithm.
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