(92 days)
MTM® Clear-Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear-Aligner sequentially positions teeth by way of continuous gentle force.
MTM® Clear-Aligner is a system of plastic aligners fabricated in an orthodontic appliance laboratory. The formed aligners contain force points and spaces necessary for tooth movement by way of continuous gentle force. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After the entire series of aligners are produced by the MTM® Service Center for the prescribed case, they are shipped to the dental practitioner. Each individual aligner moves the patient's teeth in small increments from their original state to a final state.
This submission for the MTM® Clear-Aligner is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific acceptance criteria for novel devices. Therefore, much of the requested information regarding clinical studies and detailed performance metrics (like effect sizes for MRMC studies, standalone performance with AI, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not provided in this type of submission.
The core of this submission revolves around demonstrating that the new device (MTM® Clear-Aligner) is substantially equivalent to a previously cleared predicate device (MTM® Clear Aligner In-Office). The acceptance criterion here is "substantial equivalence" based on technological characteristics, indications for use, and safety/performance.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are effectively the characteristics of the predicate device that the new device must match or be demonstrably as safe and effective as. The "reported device performance" is a comparison to those characteristics.
| Acceptance Criteria (Predicate Device K123925) | Reported Device Performance (MTM® Clear-Aligner) |
|---|---|
| Product Code: NXC | Product Code: NXC |
| Indication Statement: Treatment of anterior tooth malocclusions in patients with permanent dentition, using incremental minor tooth movements (torque, tipping, rotation, bodily movement) to sequentially position teeth via continuous gentle force. | Indication Statement: Identical to predicate device. |
| Material: Thermoformed co-polyester or co-polymer | Material: Identical to predicate device. |
| Method of Application/Removal: Removable by patient for eating and cleaning. | Method of Application/Removal: Identical to predicate device. |
| Duration of Use: Worn 20-22 hours/day, removed only for eating, brushing, flossing. Each aligner worn 2-3 weeks. | Duration of Use: Identical to predicate device. |
| Mechanism of Action: Incorporates force points to exert continuous force for tooth movement. | Mechanism of Action: Identical to predicate device. |
| Software: Not utilized in predicate device or during fabrication in dental office. | Software: Commercially available dental software used to assist in manufacture of aligners. (This is a difference handled by performance qualification of the software). |
| OTC or Rx: Rx | OTC or Rx: Rx |
Device Performance Claim: The MTM® Clear-Aligner is substantially equivalent to the predicate device because it shares the same indications for use, intended use, fundamental technological characteristics, and materials. The use of commercially available software is addressed by "performance qualification" of that software.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No dedicated 'test set' in the context of a new clinical study is described for this 510(k) submission.
- Data Provenance: The submission relies on "All non-clinical performance data was included in the predicate submission, premarket notification K123925." A "clinical evaluation was performed utilizing the predicate device MTM® Clear Aligner In-Office cleared under K123925" which collected safety and performance data. This data would be retrospective relative to this current application but was originally prospective for the predicate device. No new human clinical data was included in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. There is no new clinical study with a test set requiring expert-established ground truth for this submission. The submission references data from the predicate device's clinical evaluation.
4. Adjudication Method
- Not applicable. No new clinical study requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done for this submission. The submission explicitly states "No new human clinical data has been included in this premarket notification." The study focuses on demonstrating substantial equivalence, not comparative effectiveness of human readers with/without AI assistance.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Not directly applicable in the terms of typical AI/ML algorithm evaluation. The device involves the use of "commercially available dental software to create digital images and 3D overlays of the patient's dentition." A "performance qualification of the commercially available software utilized in the processing steps of the subject MTM® Clear-Aligner has been included to support substantial equivalence." This "performance qualification" would be the closest analogue to a standalone performance evaluation, but specifics of that qualification (metrics, data, etc.) are not provided in this document as it refers to a software component rather than the device as a whole.
7. Type of Ground Truth Used
- For the performance data referenced from the predicate device, it's implied that the "safety and performance data regarding DENTSPLY aligner materials and force points to demonstrate the ability of the MTM® Clear-Aligner technology to achieve sequential incremental minor tooth movement" would be based on clinical outcomes (e.g., actual tooth movement, patient comfort, treatment success rates as assessed by dental practitioners). However, the details are not provided in this document.
8. Sample Size for the Training Set
- Not applicable. This submission does not describe the development or training of a new AI/ML model for which a training set would be used. The software mentioned is "commercially available dental software" which likely means a pre-existing package not developed by DENTSPLY for this specific submission, and its internal training data is not part of this document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there's no description of a training set for a new AI/ML model in this submission.
§ 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.