(155 days)
The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
The ClearCorrect device is fabricated of clear, thin, thermoformed polycarbonate plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
This 510(k) summary for the ClearCorrect device does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with acceptance criteria.
Here's a breakdown of why the information is missing from the provided text:
- Type of Submission: This is a Traditional 510(k) for a device that is essentially identical to its predicates. The primary goal of such a submission is to show substantial equivalence through technological characteristics and intended use, rather than extensive de novo performance testing against specific acceptance criteria.
- Device Type: ClearCorrect aligners are physical, custom-made orthodontic devices. The "performance" in this context is the physical repositioning of teeth, which is a clinical outcome over time, not a measurable, instantaneous output like a diagnostic algorithm.
- Focus of the Document: The document explicitly states: "The information discussed above demonstrates that the ClearCorrect device is substantially equivalent to the predicate devices." It then provides a table comparing features like Intended Use, Mode of Action, and Material, to show this equivalence. No study data or acceptance criteria are presented.
Based on the provided text, I cannot complete the table or answer most of your detailed questions. The document does not describe:
- Specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or any measurable clinical outcome percentages).
- A study validating device performance against such criteria.
- Sample sizes for test or training sets.
- Details about ground truth establishment or expert qualifications.
- Any multi-reader, multi-case studies or standalone algorithm performance.
Here's what can be inferred or stated as "not provided" based on the text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated/measured in this document) | Reported Device Performance (Not explicitly stated/measured in this document) |
|---|---|
| *No explicit numerical or qualitative acceptance criteria provided. | No quantitative device performance metrics (e.g., success rate of alignment, percentage of cases achieving desired outcome) are provided. |
| The submission relies on substantial equivalence to predicate devices. | The device's performance is inferred to be similar to its predicates based on identical technological characteristics and intended use. |
Missing Information Based on the Provided Text:
- Sample sizes used for the test set and the data provenance: Not provided. The submission does not detail a specific test set or study.
- 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 provided. No test set or ground truth establishment process is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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 is not an AI-based diagnostic or interpretative device; it's a physical orthodontic appliance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.