(268 days)
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.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.