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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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The PROPEL Device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.

The PROPEL Device has a stainless steel drill tip with an outer diameter (drill bit OD) of 1.6 mm that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth (0, 3, 5, or 7 mm), thus preventing the drill tip from penetrating the bone beyond the targeted depth when used for osteotomies during dental operative procedures. The handle contains the red LED operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The provided text is a 510(k) summary for the PROPEL Device, which is a manual bone drill used in orthodontics and dental operative procedures. The submission is focused on demonstrating substantial equivalence to a predicate device (K150392).

Based on the provided information, the device is a manual bone-cutting instrument, not an AI or imaging device, and therefore the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC) and an MRMC study are not applicable in this context. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and bench testing performed to ensure the device's functional integrity and safety.

Here's an analysis of the provided text in relation to your request, with an emphasis on why certain aspects of your prompt are not present or applicable given the nature of this medical device:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of "acceptance criteria" with quantitative performance metrics in the way one would for an AI algorithm's diagnostic performance. Instead, it relies on demonstrating that the proposed device is substantially equivalent to its predicate. The "performance" is implicitly tied to meeting the same standards as the predicate and the general expectations for such a device.

Here's how we can extract the implicit acceptance criteria and reported performance:

• Bit reliability, including deflection resistance and hole depth repeatability
• Various tensile and compression tests of components
• Dial and bit depth reliability
• LED light reliability (Applicable to the proposed device, as no changes were made apart from the added indication). |
  | Ability to Create Micro-osteoperforations (New Indication) | Clinical studies demonstrate that the PROPEL Device (which is the same device as the predicate) can be used as a tool to create micro-osteoperforations (OD 1.6 mm and depth of 0, 3, 5, and 7 mm). This is the key "performance" demonstration for the new specific indication. The document states "performance testing supports the subject device for the proposed indications for use" in the "Substantial Equivalence Conclusion." |

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many bits were tested for reliability, how many devices for electrical safety). It refers to "bench testing" and "clinical studies" but doesn't provide numbers of subjects or devices.
• Data Provenance: Not specified. Given it's a medical device, the studies would typically be conducted under Good Laboratory Practice (GLP) or similar standards. The clinical studies mentioned are stated to "demonstrate that the PROPEL Device (1) can be used to manually drill holes... and (2) can be used as a tool to create micro-osteoperforations." This suggests a prospective design for clinical evaluation, but details like location (country), number of subjects, or how the studies were conducted are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here. Ground truth in the context of an AI device typically refers to definitive labels or diagnoses from experts or pathology to train/evaluate the AI. For a manual surgical instrument, "ground truth" would be established by the physical and mechanical properties of the device, its manufacturing specifications, and its ability to perform its intended function in a clinical setting (i.e., successfully drilling holes/micro-osteoperforations). The "experts" are the engineers and clinicians who conducted and evaluated the bench and clinical studies, ensuring the device met its functional requirements and safety standards. Their qualifications are implicit in the fact that the studies were conducted within a regulated medical device development framework.

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

Not applicable. This is a method used for resolving discrepancies in expert labeling for AI training/evaluation datasets.

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. The PROPEL Device is a manual instrument, not an AI or imaging diagnostic tool that assists human "readers." The "clinical studies" mentioned are to show the device's capability, not to compare human performance with and without AI.

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

Not applicable, as this is not an AI algorithm. Its "standalone" performance is its mechanical and electrical function.

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

For this device, "ground truth" would be:

• Engineering Specifications: For dimensions, material properties, electrical function (LED light).
• Standardized Test Methods: Compliance with ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, and mechanical performance.
• Clinical Observation/Functionality: Evidence from clinical use showing that the device can manually drill holes and create micro-osteoperforations as intended, to the specified depths and diameters.

8. The sample size for the training set:

Not applicable. This device does not use an AI algorithm that requires a "training set."

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

Not applicable. No AI training set is involved.

Summary of Key Takeaways from the document relevant to your request:

The fundamental premise of this 510(k) submission is that the proposed device is substantially equivalent to a previously cleared predicate device. This means that:

• The non-clinical testing already performed for the predicate device (biocompatibility, sterilization, electrical safety, bench testing for mechanical reliability) supports the proposed device because there are no changes to its core design, materials, or underlying technology.
• The only new element is the explicit addition of "micro-osteoperforations" to the indications for use. For this specific addition, the document states that "performance testing supports the subject device for the proposed indications for use," and "Clinical studies demonstrate that the PROPEL Device... can be used as a tool to create micro-osteoperforations." This implies that the clinical studies provided sufficient evidence for this expanded indication without needing a full de novo clearance or a different type of study, given the device's existing clearance for drilling holes in bone.

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The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver.

The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The device is provided sterile and is for single use only.

The document provided does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a clinical trial or performance study with detailed statistical results. Instead, it is a 510(k) Premarket Notification from the FDA to Propel Orthodontics, LLC, confirming substantial equivalence of their PROPEL Device to a predicate device.

The information primarily focuses on comparing the PROPEL device's features to a predicate device (Synthes 90° Screwdriver, K082649) to demonstrate substantial equivalence, rather than setting specific performance acceptance criteria and then validating against them with a dedicated study.

However, based on the provided text, I can extract information related to "acceptance criteria" in the sense of compliance with standards and "reported device performance" from bench testing, and information about the evidence used to support substantial equivalence.

Here's an analysis based on the structure of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, "acceptance criteria" here refer more to compliance with recognized standards and successful completion of bench tests, rather than explicit numerical thresholds for clinical performance.

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

The document does not detail specific sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients or cases). The "supporting data" section refers to:

• Bench testing: Conducted to demonstrate performance, but no sample sizes (e.g., number of devices tested for reliability) are provided.
• Clinical literature article: Only one article is cited ("Alikhani M, Rapis M, Soldan B, et al. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 144:639-48; 2013."). The provenance of data within this article (country of origin, retrospective/prospective) is not specified in the 510(k) summary. This is presented as existing published literature, not a study specifically commissioned for this 510(k) submission with a freshly collected test set.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a process of establishing ground truth by experts for a specific test set. The clinical literature cited (Alikhani et al.) would have its own methodology and expert involvement, but this is not detailed in the 510(k) summary.

4. Adjudication Method

Not applicable. There is no mention of a ground truth adjudication method as there is no specific test set undergoing expert review described.

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

No. The document presents a comparison of the PROPEL device to a predicate device (Synthes 90° Screwdriver) for substantial equivalence based on technological characteristics and intended use, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a manual drilling tool, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

No. This is a physical medical device (a manual drill), not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests (biocompatibility, sterilization, shelf-life, electrical safety, bench tests), "ground truth" is defined by compliance with established international and national standards (ISO, ASTM, IEC) and the device's own product specifications.

For the claim of being able to create holes in alveolar bone, the "ground truth" is supported by a citation to published clinical literature.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices like a manual bone drill.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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