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AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

The provided text describes a 510(k) premarket notification for a modified medical device, the AcceleDent® Aura, which is an orthodontic accessory. The submission focuses on expanding the indications for use to include patients undergoing orthodontic treatment with aligners.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a specific performance metric. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly regarding clinical outcomes with aligners. The key "performance" aspect is the demonstration of facilitation of tooth movement.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: 97 subjects (for the AcceleDent Aura aligner study).
• Data Provenance: Retrospective AcceleDent Aligner Study Report (Source mentioned in Table 5-1). The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the clinical study. The "Outcome Measures" for the AcceleDent Aura study state "Treatment Time (Weeks) Rate of Tooth Movement (ABO DI per Week) Total time in orthodontic aligner treatment," which would likely be objectively measured by the treating orthodontist or study investigators.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the clinical study data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not reported. The study described is a clinical cohort study comparing AcceleDent Aura users with non-users, and a comparison against a predicate device's reported outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device, AcceleDent® Aura, is a physical medical device (an orthodontic accessory) and not an algorithm or AI system. Its function is to provide mechanical vibration to facilitate tooth movement, used by the patient.

7. The Type of Ground Truth Used:

The ground truth for the clinical study was based on clinical outcome measures such as:

• Treatment Time (Weeks)
• Rate of Tooth Movement (ABO DI per Week)
• Total time in orthodontic aligner treatment

These are objective measurements based on patient clinical records and assessments by treating orthodontists, rather than expert consensus on image interpretation or pathology results.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The clinical study described in the document is an evaluation of the device's performance, not for training an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" in the context of an AI/ML algorithm being evaluated.

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