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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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AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.

AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece.

The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.

The provided document is a 510(k) premarket notification for the AcceleDent Aura, an orthodontic accessory. It explicitly states: "No further clinical data were collected for AcceleDent® Aura." This means there isn't a new study demonstrating the device meets acceptance criteria as typically understood for new medical devices requiring clinical trials.

Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (AcceleDent, K110661). The acceptance criteria and "proof" in this context refer to engineering and performance testing comparing the new device (AcceleDent Aura) to the predicate device to ensure it performs safely and as intended, without significant differences in safety or effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the AcceleDent Aura performs functionally equivalently to the predicate AcceleDent, particularly regarding the therapeutic vibration parameters and intended use. The performance data presented is primarily a comparison table that shows identical specifications for the core therapeutic elements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of clinical testing for this 510(k) submission. The changes were evaluated through design control review, risk analysis (ISO 14971), and verification testing (IEC 60601 and device specifications), rather than a sample of patient data.
• Data Provenance: Not applicable for clinical data. The engineering and performance testing would have been conducted by the manufacturer, OrthoAccel Technologies, Inc., based in Bellaire, TX, USA. These are laboratory/bench tests, not patient-derived data.
• Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as there was no clinical test set for which ground truth needed to be established by experts. The "ground truth" for this 510(k) is the performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as there was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an orthodontic vibrating accessory, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For this 510(k), the "ground truth" for performance is the established safety and effectiveness of the predicate device (AcceleDent, K110661), which was presumably demonstrated through its own testing and clinical data at the time of its 510(k) clearance. The AcceleDent Aura is deemed substantially equivalent because its modifications do not alter its fundamental scientific technology, intended use, or therapeutic parameters (output force, frequency).

8. The sample size for the training set

• Not applicable, as no clinical training set was used for this 510(k) submission for the AcceleDent Aura device.

9. How the ground truth for the training set was established

• Not applicable, as no clinical training set was used.

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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:

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.

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