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The AIR-FLOW handy 3.0 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The proposed AIR-FLOW handy 3.0 is a modification of the AIR-FLOW handy 2 Dental Handpiece previously cleared under K022119. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 are identical to the parent AIR-FLOW handy 2. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 are essentially identical to the AIR-FLOW handy 2 dental handpiece.

Both the proposed AIR-FLOW handy 3.0 and the predicate AIR-FLOW handy 2 connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.

Modifications made to the AIR-FLOW handy 2 Dental Handpiece to produce the AIR-FLOW handy 3.0 were limited to minor design changes to enhance the ergonomics of the design, including:

• Location of the powder chamber is modified to improve the visibility of the mouth of patient by the practitioner during the treatment.
• Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of patient by the practitioner during the treatment.
• Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
• The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
• The body of the handy 3.0 is made of 2 glued molded part instead of 1 molded part.
• The handpiece is shorter and slimmer to improve ergonomics.

Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

In addition, the AIR-FLOW CLASSIC COMFORT prophylaxis powder has been added to the panel of available prophylaxis powders. The chemical composition of the AIR-FLOW CLASSIC COMFORT Powder is identical to the AIR-FLOW CLASSIC that was described in the 510(k) Premarket Notification for the AIR-FLOW MASTER (K073284). The grain size was slightly reduced from a median particle size of

This document describes the AIR-FLOW handy 3.0 dental handpiece. The submission for this device is a Special 510(k) Premarket Notification, indicating that it is a modification of a previously cleared device (AIR-FLOW handy 2, K022119) and shares the same indications for use, fundamental technology, and design. Therefore, the device proves substantial equivalence to its predicate device rather than meeting specific quantifiable performance criteria as would be required for a novel device.

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

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) based on substantial equivalence to a predicate device due to minor modifications (ergonomics, slightly reduced powder chamber capacity, and a new powder with smaller grain size for comfort), there are no specific quantifiable acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or other clinical outcomes.

The "acceptance criteria" here are implicitly that the modified device performs at least as well as the predicate device for its intended use, and that the modifications do not introduce new questions of safety or effectiveness.

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The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.

The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.

The provided text describes a 510(k) summary for the EMS AIR-FLOW MASTER device. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods in the manner typically expected for a detailed study report.

The text primarily focuses on:

• Device description and intended use: Detailing what the device is and what it's used for (non-surgical removal of subgingival plaque in pockets up to 5mm).
• Technological characteristics and substantial equivalence: Comparing the new device to a predicate device and explaining why it is substantially equivalent.
• Testing performed: Stating that electrical safety, electromagnetic compatibility, performance testing, and clinical data were provided.

Therefore, I cannot fulfill all aspects of your request as the specific information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

Specific numerical acceptance criteria (e.g., minimum plaque removal percentage, maximum adverse event rate) and detailed performance metrics are not provided.

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

• Sample size for test set: Not specified. The document only mentions "clinical data" was provided.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set:

• Not specified.

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:

• No MRMC study is mentioned. This device is an air-polishing unit, not an AI diagnostic tool that requires human readers.

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

• This is not applicable as the device is a physical dental tool, not an algorithm.

7. The type of ground truth used:

• For a device like this, ground truth would typically refer to the clinical assessment of plaque removal and pocket depth reduction by a dental professional. However, the exact methodology for establishing this "ground truth" in the clinical data is not detailed.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, and the concept of a "training set" as used in AI/machine learning does not apply in this context unless referring to product development and testing cycles, which are not detailed here.

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

• Not applicable/Not specified for the reasons above.

In summary: The provided document is a 510(k) summary, which is a regulatory filing. While it states that performance testing and clinical data were provided, it does not offer the granular detail regarding study design, acceptance criteria, sample sizes, or ground truth establishment that you are requesting. Such details would typically be found in the full study report, not in this summary document.

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