(199 days)
The CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth.
The CDB Clip is a passive ligation clip which functions to retain the orthodontic archwire in the slot of an orthodontic bracket. It is made of Celcon MT 24U01 Acetal (POM) with no fillers.
The provided text describes a 510(k) summary for the "CDB Clip - Orthodontic Bracket Accessory". This is a medical device submission, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable or not provided in this type of regulatory document.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criterion Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | "The CDB Clip, commonly known as an orthodontic ligation clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth." This matches the description of the predicate's intended use implied by the substantial equivalence claim. |
| Technological Characteristics | Same as predicate NEO-CLIP ORTHODONTIC BRACKET ACCESSORY (specifically material and overall intended use) | "The function and performance of the CDB Clip is identical to the predicate device listed above. There is no difference in the fundamental technology. The CDB Clip is made of the same material as the predicate device currently on the market and has the same overall intended use." The material is specified as "Celcon MT 24U01 Acetal (POM) with no fillers." |
| Safety and Effectiveness | No new questions regarding safety and effectiveness compared to the predicate. | "There are no major differences between the CDB Clip and the predicate device cited, therefore, the CDB Clip does not raise any questions regarding the safety and effectiveness. The CDB Clip, as designed, is as safe and effective as the predicate device..." |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This document is a 510(k) summary for a Class II orthodontic device. The demonstration of substantial equivalence for such devices typically relies on comparative analysis of design, materials, and intended use with a legally marketed predicate, rather than a clinical performance study with a "test set" as one might find for diagnostic AI software. The claim is that the device is identical in function and performance to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. See point 2. There was no "ground truth" to establish for a test set in the context of this 510(k) submission.
4. Adjudication method for the test set:
- Not Applicable / Not Provided. See point 2.
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 / Not Provided. This device is an orthodontic bracket accessory, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance metrics are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This is a physical, passive mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The "ground truth" for this submission is essentially the established safety and effectiveness of the legally marketed predicate device (NEO-CLIP ORTHODONTIC BRACKET ACCESSORY, K042905). The applicant is demonstrating that their device is sufficiently similar to that predicate.
8. The sample size for the training set:
- Not Applicable / Not Provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. See point 8.
§ 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.