(415 days)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
This document is a 510(k) summary for a medical device called "ROSA Bracket," an orthodontic ceramic bracket. It states that no clinical performance testing was performed on ROSA brackets. Therefore, it is not possible to describe acceptance criteria and a study proving the device meets those criteria, as no such study was conducted according to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Speed Dental Co., Ltd's Orthodontics Bracket, K150141) through non-clinical performance data and biocompatibility testing.
Here's a breakdown of the information that is available, addressing the elements requested where applicable, and explicitly stating where information is not present:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance for a clinical study, as no clinical study was performed. Instead, it provides a "Substantial equivalence comparison" table comparing the ROSA Bracket to its predicate device based on material, design, and dimensions, aiming to demonstrate that the differences are not expected to affect overall performance.
Table 1: Substantial equivalence comparison (from the document)
| Manufacturer | GNI Co., LTD (ROSA Bracket) | Speed Dental Co., Ltd (Predicate Device) |
|---|---|---|
| 510(k) Number | K182672 | K150141 |
| Common Name | Orthodontic Ceramic Brackets | Orthodontic Ceramic Brackets |
| Trade Name | ROSA Bracket | Orthodontics Bracket |
| Indication for Use | This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only | This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only |
| Target Population | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993 |
| Transparency | Half-transparency | Half-transparency |
| Design | Hook, Slot, Round home, base and marking | Hook, Slot, Round home, base and marking |
| Maxillary In-out(mm) | 1.0-1.2 | 1.04-1.19 |
| **Maxillary Torque (°) ** | -7 to +17 | -7 to +17 |
| Maxillary Angulation | 0-11 | 0-10 |
| Slot Size | 0.022 inch | 0.022 inch |
| Orientation marking | Colored dot on external surface | Colored dot on external surface |
| Single Use | YES | YES |
| Non-sterile | YES | YES |
The document concludes that the "Rosa Bracket has the same device characteristics as the predicate device... We conclude that Rosa Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K150141)."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set was used.
- Non-clinical performance data: The document mentions that "design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015, Dentistry -Testing of adhesion to tooth structure." It does not specify the sample size for these non-clinical tests or the data provenance.
- Biocompatibility testing: Was completed according to ISO 10993 series. No sample sizes are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set requiring expert ground truth was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set or adjudication was performed.
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 device is an orthodontic bracket, not an AI or imaging diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a clinical study, as none was performed. For the non-clinical tests, the "ground truth" would be established by the standards and methodologies outlined in ISO 27020:2010 and ISO 11405:2015 for physical and mechanical properties.
8. The sample size for the training set:
Not applicable. This document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the ROSA Bracket received 510(k) clearance based on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical performance testing (adherence to ISO standards for material, design, and mechanical properties) and biocompatibility testing, rather than through a clinical study with acceptance criteria and direct performance measurement in a patient population.
§ 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.