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The AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and airpolishing unit within a single chassis. The AIR-FLOW MASTER PIEZON is intended for use in the following dental and periodontal applications:

• Removing supra and subgingival calculus deposits and stains from teeth .
• Periodontal pocket lavage with simultaneous ultrasonic tip movement .
• Scaling and root planing .
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha .
• Plugging for amalgam condensation .
• Amalgam burnishing .
• Preparing, cleaning and irrigating root canals .
• Cavity preparation .
• Cementing inlays and onlays .
• · Retrograde preparation of root canals

The AIR-FLOW MASTER PIEZON is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The AIR-FLOW MASTER PIEZON can be used for the following cleaning procedures:

• plaque removal for placement of sealants .
• surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers .
• surface preparation prior to placing composite restorations .
• effective plaque and stain removal for orthodontic patients .
• cleaning prior to bonding ortho brackets .
• cleaning implant fixture prior to loading .
• · stain removal for shade determination
• plaque removal prior to fluoride treatment .
• plaque and stain removal prior to whitening procedure .

The AIR-FLOW MASTER PIEZON is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIR-FLOW MASTER PIEZON 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 PIEZON is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of the base control unit, hoses and connectors for two handpieces, and a foot control containing a four-position switch. There are two mounts on the top of the base unit, one for an irrigation liquid container and the other for one of the two air-polishing chambers supplied with the device.

The AIR-FLOW MASTER PIEZON is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.

The AIR-FLOW MASTER PIEZON is also supplied with the AIR-FLOW Handpiece and PERIO-FLOW Handpiece for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC (sodium bicarbonate), AIR-FLOW SOFT (glycine), and AIR-FLOW PERIO (glycine) prophylaxis powders.

The AIR-FLOW MASTER PIEZON is supplied with accessories for attaching and removing instruments and nozzles from the handpieces and containers for storage and sterilization of the reusable components and accessories.

Here's an analysis of the provided text regarding the EMS AIR-FLOW MASTER PIEZON, focusing on acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• Operational Characteristics
• Functional Technological Characteristics | Demonstrated through direct comparison and testing of integrated functionalities. The device fulfills prospectively defined design and performance specifications. |

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

The document describes non-clinical performance testing against established standards. These involve engineering and laboratory tests, not tests on a "test set" in the sense of patient data. Therefore, notions of sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this submission. The testing was performed on the device itself and its components.

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

This information is not applicable as the study involved non-clinical performance testing against pre-defined engineering and medical device standards, not clinical diagnostic accuracy or efficacy requiring expert ground truth in the traditional sense. The "ground truth" here is the adherence to the specifications outlined in the standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involved non-clinical performance testing against established standards. There was no "test set" requiring adjudication by clinicians for diagnostic accuracy or outcome.

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 was conducted. This device is an ultrasonic scaler and air-polishing unit, not an AI software or diagnostic tool that assists human readers.

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

No standalone algorithm performance study was done. This device is a physical dental instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the compliance with recognized international and national consensus standards for medical device safety, electrical safety, electromagnetic compatibility, and sterilization/reprocessing. These standards define objective, measurable criteria for performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical dental instrument, not an AI model requiring a training set.

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

This is not applicable as there was no training set.

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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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