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510(k) Data Aggregation
(155 days)
MTM CLEAR ALIGNER IN-OFFICE
MTM® Clear Aligner In-Office 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 In-Office is a system of plastic aligners fabricated in the dental professional's office that are modified with thermoplier accessories to create force points and spaces necessary for tooth movement by way of continuous gentle force. Commercially available auxiliaries such as hooks and orthodontic elastics may also be used in order to create the desired tooth movement. 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 each desired incremental tooth movement has occurred, the aligner can be modified to increase the size of the force points or a new aligner may be fabricated. Each aligner moves the patient's teeth in small increments from their original state.
This document describes the acceptance criteria and the study conducted to prove that the MTM® Clear Aligner In-Office device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MTM® Clear Aligner In-Office were based on its ability to achieve incremental minor tooth movements, as stated in its Indications for Use. The clinical study aimed to demonstrate this capability.
| Acceptance Criteria (Ability to achieve) | Reported Device Performance (Number of cases successfully treated) |
|---|---|
| Incremental minor tooth movement: Torque | 5 cases |
| Incremental minor tooth movement: Tipping | 7 cases |
| Incremental minor tooth movement: Rotation | 14 cases |
| Incremental minor tooth movement: Bodily Movement | 11 cases |
| Safety (No adverse events, including root resorption) | No adverse events reported |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document lists the number of cases successfully treated for each type of tooth movement: 5 for Torque, 7 for Tipping, 14 for Rotation, and 11 for Bodily Movement. The total number of unique patients or overall cases included in the study is not explicitly stated but is implicitly the sum of cases across all movement types if each case represented a unique patient with a primary movement type, or possibly a smaller number if a single patient experienced multiple types of movements. Without further detail, it's difficult to ascertain the exact total number of individuals.
- Data Provenance: The study was a "prospective open-label safety and effectiveness study." The country of origin for the data is not specified.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: The document does not specify the number of experts explicitly. However, it mentions that the study included a "pretreatment period for establishing baseline root integrity and tooth position and to develop a treatment plan." This implies that dental professionals (likely orthodontists or dentists) were involved in assessing the initial state and planning the treatment for each patient.
- Qualifications of Experts: The specific qualifications of these experts are not detailed, but it can be inferred that they were dental practitioners responsible for treatment planning and monitoring.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or evaluating the outcomes of the test set. The study design focused on documenting "progression of the case" and establishing "final tooth position and root integrity," which suggests that the clinical outcomes were assessed directly by the participating practitioners as part of the prospective study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only)
This device is an in-office system of physical aligners and accessories, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires human intervention (dental professional's fabrication, modification, and patient's wear).
7. Type of Ground Truth Used
The ground truth used was based on clinical outcomes assessed by dental professionals. This included:
- Pre-treatment establishment of "baseline root integrity and tooth position."
- Documentation of "progression of the case" during treatment.
- Post-treatment establishment of "final tooth position and root integrity" to determine the "magnitude of total tooth movement."
- Monitoring for "adverse events, including root resorption."
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. The MTM® Clear Aligner In-Office system is a physical medical device, not a software algorithm that requires a training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.
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