(257 days)
Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit. The electrical drive, EM-12 L is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
The W&H electric motor EM-12 L is designed to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as described above. The advantage to driving a handpiece with this electro motor is the adjustable speed and near-constant torque applied by the electric brushless micro motor. The system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (Dental unit) and acquires +24 VAC from the chair system 300 W power supply secondary voltage output. The motor tubing extends from the motor controller inside the control head to the micro-motor with ISO-E-coupler suitable to a handpiece attachment for the intended dental procedure. The Electric Handpiece Motor is to be installed in A-dec dental operative units. The power/CAN-Bus will be provided by the dental unit controller board and connected to the controller.
The provided text describes the 510(k) premarket notification for the "Electric Handpiece Motor EM-12 L". It focuses on establishing substantial equivalence to a predicate device and details non-clinical testing. It explicitly states that clinical performance testing was NOT conducted. Therefore, there is no study described that proves the device meets acceptance criteria related to clinical performance. The acceptance criteria and "device performance" in this context refer to the successful completion of non-clinical tests and the device's adherence to relevant standards, not clinical efficacy or diagnostic accuracy.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005+A1:2012 (3.1 Edition) | Compliant |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-1:2007 | Compliant |
| Product Function & Life Cycle | ISO 14457:2012 (Dentistry – Handpieces and Motors) | Compliant |
| Motor Cooling Air, Spray Air & Water Supply | ISO 14457:2012 | Compliant |
| Temperature Testing | ISO 14457:2012 | Compliant |
| Reprocessing Validation | FDA Guidance for Reprocessing of Medical Devices in Health Care Setting (March 17, 2015) | Compliant |
| Software Documentation | FDA Guidance Document for Software Contained in Medical Devices (May 11, 2005) (Moderate Level of Concern) | Compliant |
| Software Validation | IEC 62304:2006 (Medical device software) | Compliant |
| Thermal Safety | IEC 62471:2006 (Photobiological safety) | Compliant |
| Biocompatibility | ISO 10993 | Compliant (meets requirements) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each non-clinical test. The testing was performed on the device itself and its components.
- Data Provenance: The tests were conducted internally by the manufacturer (W&H Dentalwerk Bürmoos GmbH) or by accredited labs on their behalf, adhering to international and FDA standards. The country of origin is Austria (manufacturer location). This is retrospective data regarding the device's design and manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for these non-clinical tests is established by the specified international standards (e.g., IEC 60601, ISO 14457, ISO 10993) and FDA guidance documents. Compliance with these standards indicates the "ground truth" of safety and performance for this type of device in a regulatory context. There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.
4. Adjudication method for the test set
- Not applicable for non-clinical engineering and safety tests. The "adjudication" is whether the device's performance characteristics (e.g., electrical safety, EMC emissions, torque, temperature) meet the predefined limits and requirements set forth in the relevant 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. This is a dental handpiece motor, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device (dental handpiece motor), not an algorithm. Performance assessment is based on physical and electrical characteristics against predefined engineering and safety standards.
7. The type of ground truth used
- The ground truth used for these non-clinical tests is compliance with established international and national standards, regulations, and validated test methodologies. For example, for Electrical Safety, the ground truth is defined by IEC 60601-1. For biocompatibility, it's ISO 10993.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
§ 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.