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The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.

Both the predicate and the new proposed devices are operated by connecting to a standard turbine connection of a dental unit, which supplies air and water. The device is activated when the dental unit is activated and compressed air and water are supplied to the device. Air enters into the powder chamber where it is mixed with the prophylaxis powder. The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.

Acceptance Criteria and Device Performance for QUICK JET M (K133170)

This document describes the acceptance criteria and supporting study for the QUICK JET M dental handpiece, as detailed in the 510(k) summary K133170.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for QUICK JET M (K133170) does not explicitly define quantitative acceptance criteria or specific performance metrics for the device. Instead, the submission relies on a comparison to a predicate device, the AIR-FLOW handy 2 (K022119), through the demonstration of substantial equivalence.

The "Comparison result" table in the submission highlights similarities between the proposed device and the predicate device across various technological characteristics. This indicates that the "acceptance criteria" were implicitly met by demonstrating that the QUICK JET M performs equivalently to the legally marketed predicate device, especially for its intended use.

Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided document:

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

The 510(k) summary explicitly states: "No clinical tests were performed for the proposed device." Therefore, there was no "test set" in the context of clinical data used to prove device performance. The assessment of substantial equivalence was based on non-clinical testing and comparison of technological characteristics to the predicate device.

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

As no clinical testing was performed and no test set was used, there were no experts involved in establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The 510(k) summary clearly states that no clinical tests were performed, which would include MRMC studies.

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

The device is a dental handpiece, a mechanical tool, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable to this device.

7. The Type of Ground Truth Used

As no clinical tests were performed, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the QUICK JET M in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety profile of the predicate device, AIR-FLOW handy 2 (K022119), as assessed through non-clinical comparisons of technological characteristics.

8. The Sample Size for the Training Set

The device is a mechanical dental handpiece, not a machine learning or AI algorithm. Therefore, the concept of a "training set" is not applicable.

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

As the concept of a training set is not applicable to this device, there was no ground truth established for a training set.

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SSS is intended for the applications below in the area of dental treatment by dental professionals.
· Removal of dental calculus, plaque or stain

This air scaler is intended to remove dental plaque, calculus and stain from tooth surface or root by dental professionals only.

As with its predicate device, SSS is an air scaler for use by dental professionals. The basic design of the predicate and modified devices are same: both are made in the shape of handpiece like dental turbines, used on a dental treatment unit and activated by compressed air delivered from the dental unit.

The common operation principle to the predicate is used in the modified device: When the compressed air runs into scaler's built-in vibratory cartridge, it generates elliptical movement of the scaling tip mounted.

The scaling tip movement removes dental calculus, plaque or stain from teeth.

The provided text is a 510(k) summary for the Air Scaler SSS, a dental device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving performance against those criteria in the context of typical AI/ML medical device evaluations. The information provided is primarily about the device's design, intended use, and comparison to a predicate device, not performance metrics and studies as would be expected for an AI/ML device.

Therefore, I cannot extract the requested information in the format typically associated with AI/ML device evaluation. The document states that the device is an "Air Scaler SSS" for "Removal of dental calculus, plaque or stain" and is not an AI/ML powered device.

However, I can provide the available information relevant to regulatory submission for this non-AI dental device based on the provided text, while acknowledging that it doesn't align with the detailed performance study requests for an AI model.

Here's a breakdown of what can be extracted and what cannot be extracted given the nature of the device:

Cannot Be Extracted (as it's not an AI/ML device):

• A table of acceptance criteria and the reported device performance (in terms of sensitivity, specificity, etc. typical for AI).
• Sample sizes used for test sets and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

What is Available in the Document (Relevant to a traditional medical device submission):

The submission focuses on substantial equivalence to a predicate device, not on demonstrating performance against specific numerical acceptance criteria typical for AI. The "study" here is primarily a comparison to a predicate device and adherence to standards.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria for this device are focused on substantial equivalence to the predicate and compliance with standards, not performance metrics like accuracy or sensitivity.
• The document implies that the device "meets" its purpose by being substantially equivalent to a legally marketed predicate device and by conforming to relevant standards.

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

• Not applicable / Not explicitly stated. This device is an air scaler, a mechanical device. Performance testing would likely involve engineering tests (e.g., vibration frequency measurements, noise levels, material compatibility, durability) rather than a "test set" of clinical data in the way an AI model would be evaluated. The documentation refers to design control activities and risk analysis based on FMEA, not a clinical "test set" with patients.

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. Ground truth in the context of an AI device typically refers to expert labels on data. For this mechanical device, "ground truth" would relate to its physical specifications and performance against engineering standards, not expert interpretations of clinical images or data.

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

• Not applicable. Adjudication methods are used to resolve disagreements among human experts labeling data, which is not relevant for the evaluation of this device.

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 a dental tool, not an AI-powered diagnostic or assistive technology for human readers.

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

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

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

• Not applicable / Implicit in standards compliance. For a mechanical device like this, "ground truth" generally refers to physical measurements and specifications aligning with engineering standards and the device's functional design (e.g., vibration frequency measured at 16,000-17,000 Hz). The FMEA process identifies potential failure modes.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" for this device.

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The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding heavy calculus and plaque deposits from tooth and root surfaces.

The VIP 60 is an air scaler used with scaling tips and a coolant water spray. It is described as causing much less pain, less oppressive pain and irritation, and much less bleeding compared to ultrasonic scaling. It also provides post operative refreshness from pocket irrigation. For operators, it allows direct connection to a handpiece hose, minimum water spraying for clear visibility, and a delicate tip for reaching subgingival pockets, interdental areas, and molar furcations. The delicate tip also allows the operator to feel calculus adherence and avoid touching hypersensitive areas.

The provided text is a 510(k) summary for the MICRON CORPORATION VIP 60 air scaler. It details the device's intended use, description, and claims of substantial equivalence to a predicate device (KAVO AMERICA'S SONICFLEX). This document focuses on regulatory approval based on equivalence rather than explicit performance criteria defined by a study against specific acceptance metrics.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, intended use, technological characteristics, and safety and effectiveness information, rather than conducting new clinical trials to establish de novo performance against acceptance criteria.

The information relevant to the provided text is as follows:

• Device Name: VIP 60 Model 115-000-1 and Model 115-000-2 (Sonic Scaler)
• Intended Use: "The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces."
• Predicate Device: KAVO AMERICA'S SONICFLEX
• Technological Characteristics and Substantial Equivalence: "The general components, design, characteristics, and mode of operation of the VIP60 and accessories are substantially Equivalent to Kavo America's SONICFLEX."

Without a separate clinical performance study described in the document, it's impossible to fill in the requested table and details.

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