(123 days)
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.
The provided text is a 510(k) summary for Edgewise Ceramic Brackets and Roth Ceramic Brackets by Dental Morelli Ltda. It describes the device, its intended use, and compares it to a predicate device (Clarity Advanced Ceramic Brackets by 3M Unitek Corporation, K102803).
This document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to an already legally marketed device to obtain FDA clearance for a physical medical device (orthodontic brackets).
Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria and reported device performance (as these are not defined for an AI/ML device in this document).
- Sample size for a test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, or training set details (as these are relevant for AI/ML studies, not this type of medical device clearance).
- Type of ground truth (as it would be relevant for an AI/ML study, not for demonstrating substantial equivalence of a physical bracket).
The document focuses on comparing the new device's characteristics (materials, indications for use, anatomical site, location of use, etc.) to a predicate device. The "acceptance criteria" here is effectively the demonstration of sufficient similarity and safety/effectiveness compared to the legally marketed predicate device.
However, I can extract the information related to the device comparison, which serves as the basis for establishing "acceptance" for clearance in this context:
Acceptance Criteria and Device Performance (based on Substantial Equivalence to Predicate Device)
The "acceptance criteria" for the Edgewise and Roth Ceramic Brackets are met by demonstrating their substantial equivalence to the predicate device, Clarity Advanced Ceramic Brackets (K102803). This means the new devices exhibit similar performance and safety characteristics.
Table 1: Device Comparison ("Acceptance Criteria" through Substantial Equivalence)
| Characteristic | Edgewise Ceramic Brackets by Dental Morelli | Roth Ceramic Brackets by Dental Morelli | Predicate: Clarity Advance Ceramic Brackets by 3M Unitek Corporation (K102803) |
|---|---|---|---|
| Indications for use | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. |
| Target Population | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction |
| Anatomical Site | Teeth | Teeth | Teeth |
| Location of use | Use only by professional orthodontists | Use only by professional orthodontists | Use only by professional orthodontists |
| Materials | Aluminum oxide | Aluminum oxide | Aluminum oxide |
| Biocompatibility | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. |
| Compatibility with the environment and other devices | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Maxillary In-out (mm) | 0.94 | 0.6-1.2 | 0.53-.089 |
| Maxillary Torque | 0 | -7 to +8 | -7 to +17 |
| Maxillary Angulation | 0 | 0 to +12 | 0 to +8 |
| Mandibular In-out (mm) | 0.94 | 0.6 - 1.2 | 0.51-1.14 |
| Mandibular Torque | 0 | -22 to 0 | -17 to 0 |
| Slot | 0.022" | 0.022" | 0.022" |
Study/Evaluation Proving Acceptance:
The non-clinical data and biocompatibility evaluation presented in the 510(k) submission served as the "study" to prove the device meets acceptance criteria by demonstrating substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset for algorithm performance. The "test set" is the physical device being compared. Data provenance is not described in this context beyond the device's characteristics and materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical device like an orthodontic bracket, "ground truth" relates to material properties, dimensions, and performance characteristics consistent with established standards or the predicate device. The core "ground truth" for clearance is the performance and safety profile of the legally marketed predicate device. The new device's characteristics are compared against this established profile.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary: The "acceptance criteria" for these orthodontic ceramic brackets were met by demonstrating that they are substantially equivalent to a predicate device (Clarity Advanced Ceramic Brackets) in terms of intended use, indications for use, materials, design, and performance characteristics. The evaluation was a non-clinical comparison and biocompatibility assessment, not a clinical trial or AI/ML performance study.
§ 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.