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510(k) Data Aggregation
(279 days)
Aerodentis System
The Aerodentis System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.
The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments. The system is composed of two primary components: A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner. The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube.
The provided document describes the Aerodentis System, an orthodontic device for teeth movement. However, it does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria as typically found in a standalone performance study with quantifiable metrics.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Invisalign System and Acceledent Aura) for FDA 510(k) clearance. This means the device is compared to legally marketed devices based on technological characteristics and performance, rather than against predefined, quantitative acceptance criteria for a novel device.
The "Performance Data" section describes a clinical trial for safety and efficacy, but the results are presented in a comparative and qualitative manner, not against pre-specified numerical thresholds.
Given the information in the provided text, I will construct an answer that reinterprets "acceptance criteria" as the outcomes and findings from the clinical trial and performance testing described, as these are the "criteria" used to support substantial equivalence.
Acceptance Criteria and Device Performance for the Aerodentis System
The provided FDA 510(k) submission for the Aerodentis System does not explicitly state precise, quantifiable acceptance criteria in the format typically used for performance studies establishing specific statistical thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices by showing that the Aerodentis System is as safe and effective. The "acceptance criteria" can therefore be inferred from the outcomes presented in the clinical trial and performance data, which are compared to the performance characteristics expected of similar legally marketed devices.
The clinical trial aimed to demonstrate safety (absence of adverse events and significant root resorption) and efficacy (achieving an average Little's Irregularity Index (LII) of 1.5 or less), as compared to the Invisalign control.
1. Table of "Acceptance Criteria" (Inferred from Study Outcomes) and Reported Device Performance
| "Acceptance Criteria" (Inferred from Clinical Study Goals) | Reported Device Performance (Aerodentis System) |
|---|---|
| Safety: | |
| - Absence of adverse events | No adverse events reported. |
| - No clinically significant root resorption | No clinically significant root resorption observed. |
| Efficacy: | |
| - Achieve average Little's Irregularity Index (LII) of 1.5 or less | All subjects who completed treatment achieved an average LII score of 1.5 or less. |
| Comparative Performance (vs. Invisalign control): | |
| - Safe as the predicate device | Excellent safety profile, similar to predicate. |
| - Effective in achieving tooth alignment | Effective in achieving an LII of 1.5 or less. |
| - Potentially higher rates of tooth movement (when accounting for actual use hours) | Statistically significantly higher rates of tooth movement when accounting for actual hours of device use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Investigational Arm (Aerodentis System): 28 subjects enrolled, 5 dropped = 23 subjects completed.
- Control Arm (Invisalign): 15 subjects enrolled, 2 dropped = 13 subjects completed.
- Total completed subjects: 36 subjects.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submitter (Dror Orthodesign, Inc.) is located in Jerusalem, Israel, suggesting the study may have been conducted there or internationally.
- Retrospective or Prospective: Prospective. It was a "single center, controlled, clinical trial" where subjects were "followed until" specific endpoints, indicating a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (e.g., LII scoring). The LII is an objective measurement index, likely applied by trained personnel. However, the document does not detail this specific aspect of the study.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating outcomes. The Little's Irregularity Index is a quantitative measure, and adverse events/root resorption evaluation would typically follow standard clinical assessment protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No background AI assistance/AI-based interpretation. This device is an orthodontic treatment system, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable to this device. The clinical trial compared the device itself to a predicate device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. The Aerodentis System is a physical medical device (mouthpiece and controller) used for orthodontic treatment involving a patient and clinical oversight, not a standalone algorithm. The "software validation" mentioned refers to the software controlling the device and developing patient-specific plans, not a standalone diagnostic algorithm for assessment.
7. The Type of Ground Truth Used
- Clinical Measurements and Observations:
- Efficacy: The primary efficacy "ground truth" was the average Little's Irregularity Index (LII) score of 1.5 or less. LII is an objective measurement of incisor alignment.
- Safety: Adverse event reporting and radiographic assessment of root resorption served as the safety ground truth.
8. The Sample Size for the Training Set
- Not applicable. This device is an orthodontic treatment system, and the provided document describes a clinical trial for its safety and effectiveness, not the development or training of an AI algorithm from a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" or "ground truth for a training set" discussed in the context of AI model development for this device. The study described is a clinical trial to evaluate the device itself.
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