(254 days)
AcceleDent is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
The AcceleDent™ System is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent™ should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment with fixed appliances such as braces. The Activator and Mouthpiece assembly is light (2.7 oz or 75 g), comfortable, handsfree, and can be used while multi-tasking or while engaged in a variety of other daily activities.
The AcceleDent™ System is an orthodontic accessory intended to facilitate minor anterior tooth movement when used in conjunction with orthodontic appliances like braces.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Device Performance (Study Results) |
|---|---|
| Increase the rate of tooth movement when used as an adjunct to conventional orthodontic treatment. | The study demonstrated that the AcceleDent™ increased the rate of tooth movement when used as an adjunct to conventional orthodontic treatment. |
| No significant safety risks. | The study demonstrated that the AcceleDent™ increased the rate of tooth movement... without any significant risks, including evaluation of root resorption. |
2. Sample Size and Data Provenance:
- Test set sample size: Not explicitly stated in the provided text. The text mentions "Patients were followed at regular intervals," implying a clinical study with human subjects.
- Data provenance: Prospective clinical study ("A clinical study was performed to support this 510(k) Notification"). The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the study was likely conducted or overseen in a region compliant with their regulations.
3. Number and Qualifications of Experts for Ground Truth:
- Not applicable/Not explicitly stated for the primary outcome. The study directly measured "rate of tooth movement" by following patients at regular intervals until "closure was achieved." This is an objective, measurable outcome.
- For safety assessments, "evaluation of root resorption" would typically involve dental professionals (e.g., orthodontists, radiologists), but the number and specific qualifications of these experts are not provided.
4. Adjudication Method for the Test Set:
- Not explicitly stated. Given the objective nature of measuring tooth movement and root resorption, it's possible that direct measurements were taken, and consensus or multiple readings might not have been a primary concern for the direct outcome measures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described.
- The study compared "standard orthodontics plus the AcceleDent™ device" to "standard orthodontics plus a sham control," indicating a comparative clinical trial, but not necessarily focused on human reader performance with or without AI assistance. This device is not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not described. The device is a physical orthodontic accessory for direct patient use, not a diagnostic algorithm.
7. Type of Ground Truth Used:
- Objective Clinical Measurements:
- Rate of tooth movement: Measured directly by following patients at regular intervals until closure was achieved.
- Root resorption: Evaluated as a safety assessment.
8. Sample Size for the Training Set:
- Not applicable/Not stated. This device is a physical medical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable. The device is a physical medical device, not an AI model.
§ 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.