(323 days)
The device is intended to be used for endodontics (canal preparation and canal cleaning).
The prosed device is used by dental professionals for removal of dentine debris in root canals in the field of endodontics. A turbine hose from a dental unit that supplies the device with compressed air and water is attached of the device in order to use the device. The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site. The device consists of the handpiece including the connection to a hose and file holder.
The proposed device has two model 4H connects to the Midwest 4-hole turbine hose and the model K A connects to the KaVo MULTIflex® quick-disconnect coupling.
The associated accessories include:
- file holder to attach endodontics files
- replacement wrench for the holder
The proposed device and accessories are supplied non-sterile and must be sterilized in an autoclave prior to the first use and after every patient by the end-user.
The provided document is a 510(k) premarket notification for the AW-100 ultrasonic scaler. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a clinical study in the way typically required for AI/ML devices or new medical technologies.
Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, and training set details are not applicable to this type of submission as they were not required or performed.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the applicable international standard ISO 18397:2016 for powered scalers. The document states that the device passed all performance criteria outlined in this standard.
| Acceptance Criteria (from ISO 18397:2016 - details not fully described in the document) | Reported Device Performance (AW-100) |
|---|---|
| Output frequency (as per ISO 18397:2016) | 2000 to 3000 Hz (measured at 0.28 MPa air pressure) – Passed |
| Amplitude (as per ISO 18397:2016) | Tested at 0.28 MPa air pressure – Passed |
| Resistance to autoclave sterilization | Tested as per relevant standards – Passed |
| Corrosion resistance | Tested as per relevant standards – Passed |
| Basic safety and performance requirements (as per relevant standards) | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Risk management | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Biocompatibility testing | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Reprocessing validation | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or cases. Non-clinical bench testing was performed on the AW-100 device.
- Data Provenance: Not applicable. This was a non-clinical bench performance study, likely conducted by the manufacturer, Micron Corporation, in Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical bench testing is typically established by engineering measurements and compliance with standard specifications, not by expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was non-clinical bench testing against industry 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
Not applicable. This device is an ultrasonic scaler, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance was compliance with the technical specifications and safety requirements outlined in international standards, specifically ISO 18397:2016 (Dentistry – Powered scaler) and ISO 9168:2009 (Dentistry -- Hose connectors for air driven dental handpieces). This involves objective measurements of physical parameters such as frequency, amplitude, and material properties.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable.
§ 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.