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The VPro5® is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement.

The VPro5® is a rechargeable, hand-held, powered, high-frequency vibration device. The device consists of the following components: the VPro5 Oscillator, the VPro5 Mouthpiece, a charging cable, and a wall charging adapter. The oscillator and mouthpiece are coupled together prior to use. During use, the C-shaped mouth piece adapter is manually applied to the occlusal surface of the teeth. The VPro5® is to be used 5 minutes per day in a single session in conjunction with aligner orthodontic treatment. The mouthpiece is connected to the oscillator and turned on by depressing a white on-switch located on the unit. When turned on the device will slowly ramp up to full vibration frequency of 120Hz. The vibrations are applied to the occlusal surface of the teeth. The device will automatically shut off after a duration of 5 minutes. The oscillator also contains LED light notifications which indicate status of the cycle progression. The mouthpiece is to be cleaned and stored in a dry place. The USB port can also be connected to a computer to display usage data.

The provided document describes the VPro5 device, intended for use by orthodontic patients with aligners to facilitate minor anterior tooth movement. The submission seeks to demonstrate substantial equivalence to a predicate device, AcceleDent® Aura (K153048).

Acceptance Criteria and Device Performance:

The document describes performance testing, but it does not present a formal table of explicit acceptance criteria with corresponding performance metrics for an AI/CADeX device as one might expect for software. Instead, it describes two clinical studies that demonstrate the device's effectiveness and safety, and non-clinical tests for electrical safety, EMC, biocompatibility, and bench testing of the device's physical functionality.

Therefore, I will interpret "acceptance criteria" here based on the successful demonstration of:

1. Clinical Efficacy: Achieving statistically significant faster rates of tooth movement and comparable tracking to the control arm.
2. Safety: No serious device-related adverse events, and demonstration of biocompatibility.
3. Functional Performance: Meeting product specifications for ramp-up, vibratory frequency, acceleration, and time functionality.
4. Conformity to Standards: Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.

Since this is a physical device, not an AI/CADeX system for diagnostic analysis, the "reported device performance" is the successful outcome of the clinical trials and the conformance to the non-clinical tests.

Table of Acceptance Criteria (Inferred from study outcomes) and Reported Device Performance:

(Regarding the specific questions about AI/CADeX systems, which this device is not):

Given that the VPro5 is a physical medical device (an orthodontic vibratory accessory) and not an AI/CADeX diagnostic or therapeutic software, many of the requested fields are not directly applicable. I will address them by stating their non-applicability or reinterpreting them where possible for a physical device.

1. A table of acceptance criteria and the reported device performance: (Provided above)

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

• Prospective Pivotal Clinical Trial (Table 1A):
  • Sample Size: 63 subjects.
  • Data Provenance: Prospective, randomized, controlled multicenter trial. The document does not specify the country of origin, but FDA submissions typically include data from studies primarily conducted in the USA or internationally recognized for their quality.
• Retrospective Study (Table 1B):
  • Sample Size: 30 subjects.
  • Data Provenance: Retrospective, controlled, multicenter study. Country of origin not specified.
• Bench Testing: 40 units of the VPro5.
• Shelf Life Validation: (Number of units not specified, but done to evaluate shelf life of mouthpiece and vibration device).

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 in the context of ground truth for diagnostic image interpretation. For this physical device, "ground truth" relates to the physiological outcomes (tooth movement, tracking, root resorption) measured directly from the subjects, which are objective and quantifiable (e.g., mm/week, percentage tracking, tooth length). These measurements would typically be performed by trained clinical staff or using specialized equipment. The document does not specify the number or qualifications of clinicians involved in measurements, though it would be overseen by orthodontists as part of a clinical trial.

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

• Not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of expert consensus for difficult or subjective ground truth labeling (e.g., in radiology image interpretation). For the VPro5, the outcomes (tooth movement, tracking, root resorption) are objective measurements, not subjective interpretations 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 is a physical device, not an AI or CADeX system. Therefore, MRMC studies involving human readers or AI assistance are not relevant to its evaluation. The clinical studies compare the device's effects on tooth movement directly against control arms (e.g., aligners only, sham device) and the predicate device's indicated effect.

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

• Not applicable. This is a physical device, not an algorithm. Bench tests and functional tests evaluate the device's standalone performance in terms of its physical mechanisms (vibration frequency, ramp-up, etc.).

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

• The "ground truth" in these studies is based on outcomes data, specifically:
  • Rate of tooth movement (mm/week) and Total tooth movement (percent tracking) measured directly from the subjects during orthodontic treatment.
  • Root resorption measured by tooth length (e.g., using imaging like periapical radiographs or CBCT scans, though not specified).
    These are objective, quantifiable physiological changes.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The studies described are performance studies for device validation.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant.

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

The provided text is a 510(k) summary for the AcceleDent® Optima device, which is an orthodontic accessory. It focuses on demonstrating substantial equivalence to a predicate device (AcceleDent® Aura, K153048) rather than presenting a standalone study with clinical acceptance criteria for a new clinical claim.

Therefore, the document does not contain a study that proves the device meets clinical acceptance criteria in the way medical imaging or diagnostic devices typically would. Instead, it demonstrates that the modified device (AcceleDent® Optima) maintains the safety and performance characteristics of its predicate device, primarily through non-clinical (engineering, material, and software) testing.

Here's an attempt to extract the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed in the document are primarily for engineering, material, and software verification, ensuring the modified device functions safely and as intended, similar to its predicate. There are no clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in treatment time) with associated acceptance criteria reported in this document.

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

The document does not specify exact sample sizes for each test where such information might be relevant (e.g., how many units were tested for biocompatibility, system verification, or human factors). It refers to "the full 3G system" or "the 3G product" as being tested.

The data provenance is from non-clinical testing performed by the manufacturer (OrthoAccel Technology Inc.) and potentially by third-party testing labs (e.g., for certifications like Bluetooth, FCC, IEC standards). The data is retrospective in the sense that it describes tests performed on the device. No country of origin for the internal testing data is specified, but the device is marketed in the US.

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

Not applicable. This is a 510(k) submission for a modified orthodontic accessory, relying on engineering and safety testing, not clinical studies requiring expert-established ground truth for a diagnostic outcome. The human factors testing ("Summative Testing") would have involved intended users, but they are not referred to as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations for a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This device is not an AI-assisted diagnostic tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is a physical orthodontic accessory; it does not have a standalone "algorithm-only" performance as would be relevant for an AI or diagnostic software device. Its function is to facilitate tooth movement in conjunction with traditional orthodontic treatment. The "software" aspect refers to data transfer and internal device control, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Established standards and regulations: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ASTM for packaging, Bluetooth SIG, and FCC regulations.
• Design requirements/specifications: for internal system, firmware, and subsystem verifications, ensuring the device meets its intended engineering performance.
• Performance of the predicate device (AcceleDent® Aura): for verifying that the therapeutic force delivery, battery charging, usage logging, and environmental operation are maintained.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set was used.

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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.

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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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