(72 days)
The SureCure Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
Digital Orthodontic Care's SureCure Orthodontic Aligner System consists of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
Digital Orthodontic Care manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Digital Orthodontic Care manufactures models from the impressions and those models are scanned using standard validated software. The digital files are used to produce the aligner series with the thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
The provided text describes the 510(k) premarket notification for the SureCure Orthodontic Aligner System. However, it does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria in the format requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (ClearCorrect System, K113618) based on material, intended use, mode of action, and manufacturing methods.
Here's what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The substantial equivalence argument relies on similarity to the predicate device.
- Reported Device Performance: No specific performance metrics or clinical outcomes are reported in the context of acceptance criteria. The document states that the material passed biocompatibility testing and the device passed shelf-life testing, which are general safety and quality assurance measures rather than performance criteria for efficacy in tooth movement.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance metrics provided for efficacy |
| Biocompatibility (ISO 10993) | Passed |
| Shelf-life | 5 years (after real-time storage) |
2. Sample size used for the test set and the data provenance:
- The document states that "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device."
- Therefore, there is no specific test set or associated data provenance for evaluating the clinical performance of the device itself.
- Biocompatibility and shelf-life testing would have used material samples, but the sample sizes are not provided, nor is the provenance of raw material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As there was no clinical human or animal testing outlined for the device's efficacy, there was no test set for which ground truth was established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Since no clinical test set for performance evaluation was conducted, there was no adjudication method described.
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:
- The device described is an orthodontic aligner system, not a diagnostic AI device that involves human "readers" or AI assistance for interpretation.
- Therefore, no MRMC comparative effectiveness study was done in the context of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical orthodontic aligner system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- No specific ground truth for clinical efficacy was used as no clinical trials were conducted for the new device.
- The ground truth for biocompatibility and shelf-life would be based on established international standards (ISO 10993) and real-time degradation measurements, respectively.
8. The sample size for the training set:
- This question is typically relevant for AI/machine learning models.
- The document mentions that "Digital Orthodontic Care manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Digital Orthodontic Care manufactures models from the impressions and those models are scanned using standard validated software."
- This indicates the use of software in the manufacturing process (e.g., for 3D printing models), but it does not describe a "training set" in the context of an AI algorithm or a study for the aligner's clinical performance.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model or clinical performance study for the aligner system is described.
§ 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.