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The EMS AIR-FLOW® handy 2 is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate 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 AIR-FLOW® handy 2 is a modified version of the AirFlow® handy previously cleared under K991857. As with the original AirFlow® handy device, the proposed AIR-FLOW® handy 2 is a turbine-adaptable air polisher that consists of a hand-held device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.

Both the original and the modified device function by connecting to a standard turbine connection of the dental unit, which supplies air and water. The AIR-FLOW® handy 2 is activated when the AIR-FLOW® handy 2 Handpiece is fixed to the turbine connection and the dental unit pedal is pressed. Air enters the proximal end of the device and into the powder chamber where it is mixed with the AIR-FLOW® handy 2 powder. The air/powder mixture leaves the powder chamber and exits the distal end of the device through the AIR-FLOW® handpiece orifice where the air/powder mixture is enveloped by a water spray and directed onto the tooth surface.

The provided document is a 510(k) summary for a medical device (EMS AIR-FLOW® handy 2 Dental Handpiece). It details the device's intended use, description, and basis for substantial equivalence to a predicate device. However, it does not contain the detailed study information typically required to describe acceptance criteria and the methods used to prove the device meets them in the way modern AI/ML device submissions would.

Specifically, the document states:

"Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met."

This is a general statement about fulfilling design requirements and risk analysis, but it does not include:

• Specific acceptance criteria: What quantitative or qualitative metrics were used to determine "design requirements were met"?
• Reported device performance: What were the actual outcomes against those criteria?
• Details about the study: No information on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating where information is NOT available:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the EMS AIR-FLOW® handy 2 Dental Handpiece states that "Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met." However, it does not detail specific acceptance criteria or the reported performance data against those criteria in a tabular format as would typically be presented for performance studies. The submission focuses on demonstrating substantial equivalence to a predicate device (AirFlow® handy, K991857) through design modifications and function rather than an efficacy study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Verification and validation of the device design requirements were performed," but provides no details on any test subjects, cases, or the number of items tested.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective)

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

• Not applicable/Not specified. The document does not describe a clinical study that would require expert-established ground truth. The "testing" referred to appears to be engineering design verification and validation.

4. Adjudication method for the test set

• Not applicable/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. This device is a dental handpiece, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable.

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

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

7. The type of ground truth used

• Not applicable. For a physical device like this, "ground truth" would typically refer to engineering specifications and performance against those specifications (e.g., air pressure, water flow, powder delivery rate, material strength, safety standards). The document generally states "all design requirements were met" but doesn't elaborate on the specific "ground truth" used or how it was established for performance aspects.

8. The sample size for the training set

• Not applicable. This device is a dental handpiece, not an AI/ML model that requires a training set.

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

• Not applicable.

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