(352 days)
The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.
ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.
The provided text describes the ClearPath Aligner, a device for correcting dental malocclusion. However, it explicitly states that no performance testing was warranted for this product. Therefore, there is no study described that proves the device meets specific acceptance criteria.
The submission relies on a comparison to predicate devices and asserts substantial equivalence based on similarities in intended use, design, material composition, and mechanism of action.
Given this, I cannot provide a table of acceptance criteria and reported device performance or other details of a study that does not exist for this device.
Here's the information that can be extracted or inferred based on the provided text, along with clarifications for items that are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific acceptance criteria were defined or tested in the provided document. | No device performance data was reported as no bench testing was warranted. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set was used as no performance testing was conducted.
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. No test set was used and therefore no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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
- No. This product is a physical dental aligner, not an AI-assisted diagnostic tool.
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. No ground truth was established for a performance study. The submission relies on the established safety and efficacy of predicate devices (K073121 - NuBrace Invisible Removable Orthodontics and K981095 - Align System) and scientific literature for the materials used.
8. The sample size for the training set
- Not applicable. No training set was used as no algorithm was developed or tested.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.