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The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental 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 AIRFLOW Prophylaxis Master 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 AIRFLOW Prophylaxis Master 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 AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The AIRFLOW One 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 AIRFLOW One can be used for the following cleaning procedures:

• · plaque removal for placement of sealants
• · surface preparation prior to bonding/cementation of inlays, 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 AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIRFLOW Prophylaxis Master 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 a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device.

The AIRFLOW Prophylaxis Master 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 AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders.

The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces.

The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.

This document describes the non-clinical performance testing for the EMS AIRFLOW Prophylaxis Master and EMS AIRFLOW One devices to establish substantial equivalence to a predicate device.

Here's the requested information:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance results. Instead, it refers to compliance with a list of regulatory standards. The reported device performance is that the devices passed these compliance tests, thereby confirming they are "safe and effective for the indications for use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test sets. The tests are non-clinical performance tests, likely involving units of the device rather than patient data. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are not relevant for non-clinical device performance testing against engineering standards.

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)

This is not applicable as no clinical studies with expert ground truth establishment are reported. The "ground truth" here is compliance with established engineering and safety standards.

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

This is not applicable as no clinical studies requiring adjudication are reported. The testing involves standardized procedures for demonstrating compliance with engineering standards.

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 comparative effectiveness study was done. This device is a physical dental instrument, not an AI-assisted diagnostic tool involving human readers.

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

This is not applicable. The device is a physical dental instrument, not an algorithm.

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

The "ground truth" for the non-clinical performance testing is compliance with the requirements outlined in the listed international and national standards (e.g., ISO 14971, ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).

8. The sample size for the training set

This is not applicable. The device is a physical dental instrument, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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Scaling:

• Removal of supragingival and subgingival calculus
• Removal of stains

The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The provided text describes a 510(k) premarket notification for a medical device, the PIEZON BUILT-IN KIT, which is an ultrasonic scaler intended for dental cleaning. The primary claim for substantial equivalence is that the new device is essentially the same as a previously cleared predicate device (PIEZON 150), with the main difference being that the components are integrated into a dental chair rather than being a standalone unit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A Table of Acceptance Criteria and the Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the sense of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for an AI/CADe device. Instead, the acceptance criteria are related to engineering performance, electrical safety, electromagnetic compatibility, and functional integration, demonstrating that the reconfigured device performs equivalently to its predicate.

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

The document does not describe a "test set" in the context of a clinical study or AI model validation with patient data. The testing performed is related to engineering verification and validation of the device's physical and electrical properties, and its functional integration.

• Sample Size: Not applicable in the context of patient data. The "sample" for testing would be units of the device (PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED) and their integration within dental chairs. The document states "All tests were successfully performed," implying sufficient physical units were tested to demonstrate compliance.
• Data Provenance: Not applicable in the sense of patient data origin. The "data" comes from engineering tests performed by the manufacturer. It is internal company data.
• Retrospective or Prospective: Not applicable in the sense of patient data. The engineering tests were implicitly prospective (i.e., designed and executed to verify the new product configuration).

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

Not applicable. This device is an ultrasonic scaler, a physical medical device, not a diagnostic AI/CADe system requiring expert-adjudicated ground truth from medical images. The "ground truth" for its performance is derived from engineering standards, functional tests, and comparison to the predicate device's proven performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for image interpretation or diagnosis described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an ultrasonic scaler, not an AI/CADe system for diagnostic assistance. Therefore, an MRMC study is not relevant to its clearance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence claim relies on:

• Engineering Standards: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
• Functional Verification: Demonstrating that the device operates as intended in its new integrated configuration.
• Predicate Equivalence: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (PIEZON 150). The argument is that since the new device uses the same internal components and technology and only differs in its housing (integrated into a dental chair vs. standalone), its performance is inherently equivalent.
• Risk Analysis: A detailed risk assessment confirming that the change in housing does not introduce new or unacceptable risks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

In summary, the provided document details a 510(k) submission for a traditional medical device (ultrasonic scaler) where the primary evidence for substantial equivalence comes from engineering testing and a comparison to a predicate device, rather than a clinical study involving patient data or AI model performance metrics. The "acceptance criteria" and "proof" relate to the physical and electrical performance of the device and its safe integration into a dental chair.

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