(90 days)
The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to drive the COMFORT drive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry
The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord.
The provided document is a 510(k) premarket notification for a medical device called "ELECTROmatic." This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria in the way a novel AI or diagnostic device might.
The ELECTROmatic is a dental control unit, and the "acceptance criteria" discussed are largely related to meeting established industry standards for safety and performance, as well as demonstrating that its technological characteristics do not raise new concerns compared to the predicate device.
Here's an analysis based on your requested information, acknowledging that many of the points you asked for are not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a dental control unit), acceptance criteria are primarily defined by compliance with recognized international and national standards for medical electrical equipment, dental instruments, and biocompatibility. The document states that performance bench testing was conducted to demonstrate conformance to these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 9168:2009 (Dentistry – Hose connectors for air-driven dental handpieces) | Performance bench testing conducted to determine conformance. (Implicit: Device meets requirements) |
| ISO 14457:2012 (Dentistry – Handpieces and motors) | Performance bench testing conducted to determine conformance. (Implicit: Device meets requirements) |
| IEC 60601-1:2005 (Medical electrical equipment – General requirements for basic safety and essential performance) | Performance bench testing conducted to determine conformance (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)). (Implicit: Device meets safety and essential performance requirements) |
| IEC 60601-1-2:2007 (Medical electrical equipment – Electromagnetic compatibility) | Performance bench testing conducted to determine conformance (IEC 60601-1-2:2007 / EN 60601-1-2:2007). (Implicit: Device meets EMC requirements) |
| ANSI/AAMI ES60601-1:2005/A2:2010 (Medical electrical equipment – General requirements for basic safety and essential performance) | Performance bench testing conducted to determine conformance. (Implicit: Device meets safety and essential performance requirements) |
| IEC 62304:2006 (Medical device software – Software life cycle processes) | Performance bench testing conducted to determine conformance (IEC 62304:2006 -First edition). (Implicit: Software development followed recognized life cycle processes, ensuring safety and performance) |
| ISO 7405:2008 & ISO 10993-1:2009 (Biocompatibility of medical devices) | Biocompatibility studies completed for the applicable components. (Implicit: Materials are biocompatible) |
| Sterilization Studies (for applicable components) | Sterilization studies completed for the applicable components. (Implicit: Applicable components can be effectively sterilized) |
| Substantial Equivalence (General) | The performance tests demonstrate that the differences in technological characteristics do not raise different concerns regarding substantial equivalence to the predicate device. The device satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent. |
2. Sample size used for the test set and the data provenance
This document describes a premarket notification for a medical device that converts pneumatic output to electrical energy to drive dental handpieces. It is not a study involving patient data or a test set in the context of clinical performance of a diagnostic or AI device.
- Test Set Sample Size: Not applicable. The "tests" described are bench tests against engineering standards, not tests on a dataset of patient samples.
- Data Provenance: Not applicable. The "data" involves engineering measurements and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" in the clinical sense being established by experts for a test set in this 510(k) submission. The design and performance verification are conducted by engineers and specialists in accordance with specified standards.
4. Adjudication method for the test set
Not applicable. There is no multi-reader or adjudication process for interpreting results in this submission. Compliance is determined through objective measurements against engineering and safety 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 a dental control unit, not an AI diagnostic tool or system that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It's a hardware device with embedded software for controlling motor functions. Its "performance" refers to its ability to meet engineering specifications and safety standards, not a diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. The "ground truth" for this device's performance evaluation is its adherence to the specified technical and safety standards (e.g., ISO, IEC, ANSI/AAMI) through bench testing. The device is expected to operate within defined electrical, mechanical, and safety parameters, which are objectively measurable.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The software mentioned controls motor functions based on deterministic algorithms, not learned patterns from data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established in this context. The software's functionality is designed based on known physics and engineering principles, not derived from labeled data.
In summary:
The ELECTROmatic is a Class I dental control unit that demonstrated substantial equivalence to a predicate device by showing compliance with a range of recognized international and national standards for medical electrical equipment, dental instruments, software lifecycle processes, and biocompatibility through non-clinical bench testing. The evaluation focused on engineering performance and safety compliance, rather than clinical performance based on patient data or the development of a diagnostic AI algorithm.
§ 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.