(77 days)
Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to internediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state.
Red, White & Blue is a relainer system which offers a solution to those patients who want a simple, aesthetic system to correct minor to intermediate tooth mal-alignments without the use of conventional wire and brucket orthodontic technology. The system consists of a scrics of three, clear lightweight, plastic retainers. Each appliance applics incremental tooth correction by means of repositioning the anterior teeth. In this way, the patient's tecth will get progressively closer to the desired final state.
The dental practitioner will make dental improssions of his patient's tecth and select the anterior tecth that are to be repositioned. The impressions or a model of the tecth made from the improssion is then sent to AOA along with a prescription form. The teeth selected for treatment are cut from the model and progressively repositioned. After each repositioning, AOA will create a corresponding appliance for a total of three active appliances. Depending upon the complexity of the case, it is possible that a patient may require less or more than the series of three appliances. The Red, White & Blue retainers are mailed to the dental practitioner, who in turn, will provide them to their patient with the instructions for use.
This 510(k) premarket notification is for a dental device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, and performance metrics for an AI/ML device, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable and not available in the provided document.
The document describes the "Red, White & Blue" orthodontic retainer system and claims substantial equivalence to the Invisalign system.
Here's the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
This information is not applicable and not provided in the document as this is not an AI/ML device. The document focuses on regulatory clearance based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable for a physical medical device. The document does not describe a "test set" in the context of an AI/ML algorithm.
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 for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical medical device.
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 for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a physical medical device. The "ground truth" for this device would be its ability to correct minor to intermediate anterior tooth mal-alignments, which is assessed through clinical use and comparison to predicate devices, not specific "ground truth" data points for an algorithm.
8. The sample size for the training set:
Not applicable for a physical medical device.
9. How the ground truth for the training set was established:
Not applicable for a physical 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.