(77 days)
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
| Acceptance Criteria (Performance Specifications) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI ST79:2006 (Steam Sterilization & Sterility Assurance) | Fulfilled |
| Compliance with ISO 17664 (2004) (Sterilization of Medical Devices Information to be Provided by the Manufacturer) | Fulfilled |
| Compliance with ANSI/AAMI/ISO 17665-1:2006 (Sterilization, Moist Heat) | Fulfilled |
| Compliance with IEC 60601-1:1988 +A1: 1991 + A2: 1995 (Medical Electrical Equipment Safety) | Fulfilled |
| Compliance with IEC 60601-1-2 (Medical Electrical Equipment EMC Requirements and Tests) | Fulfilled |
| Compliance with ISTA 2A (2008) (Pre-shipment Testing for Packaged Products) | Fulfilled |
| Substantial Equivalence to Predicate Devices (AIR-FLOW S2, PIEZON MASTER 700, AIR-FLOW MASTER, AIR-FLOW MASTER STANDARD) based on: |
- 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.
§ 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.