(128 days)
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
- implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching
- crowns and bridges
- fixed bands and brackets prior to placement on orthodontic appliances.
The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
The provided text describes a 510(k) summary for a medical device called AirFlow handy, a dental handpiece. However, it does not contain acceptance criteria for device performance or a detailed study description that proves the device meets specific acceptance criteria.
The section titled "PERFORMANCE TESTING" briefly mentions that testing was performed to support a minimal reuse life and connection integrity, but it does not specify acceptance criteria (e.g., "device must withstand X cycles without failure") or detailed results against such criteria.
Therefore, many of the requested details cannot be extracted from the given input.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Reuse life: Supported a minimal reuse life of 130 treatments (corresponding to 15 hours of use). |
| Not specified | Connection integrity: The connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This document is a regulatory submission from a Swiss company (Electro Medical Systems SA, Nyon, Switzerland) to the US FDA, so the testing likely occurred as part of the product development and validation for market approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "performance testing" described is mechanical/durability testing, not related to expert evaluation of clinical performance or ground truth establishment in a diagnostic context.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as this was not a study involving human reader interpretation or adjudication of results.
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:
- MRMC Study: No. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a non-AI mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable in the context of expert consensus, pathology, or outcomes data as it relates to diagnostic performance. The "ground truth" for the performance testing cited would be the successful completion of the specified number of treatments and maintenance of connection integrity under pressure, as per engineering specifications.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.