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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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