(167 days)
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
The A-dec/W&H Electric Motel EA-53 is designed to accommodate existing and new Alegra, Proxeo, Endea, and Synea handpiece attachments for the purpose of performing dental restoration procedures. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. The significant advantage to driving a handpiece with the electric micromotor is the near-constant torque applied by the electric brushless micromotor. With air motor drive, the handpiece will tend to stall in extreme torque situations. The near-constant torque applied by the electric micromotor results in a more uniform and efficient dental reduction of the operatory site. The electric micromotor is autoclavable. This 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 300W power supply secondary voltage output. The handpiece tubing extends from the control head to the ISO-E coupler. The micromotor is attached to the coupler on one end and attached on the other (output) end to a handpiece attachment suitable for the intended dental procedure. This system will include: Motor Controller, Electric Micromotor, Handpiece tubing with E-connector.
The provided text describes a 510(k) premarket notification for the A-dec/W&H Electric Motor, Model EA-53. However, it explicitly states that clinical testing has not been conducted for this product. Therefore, no studies proving the device meets acceptance criteria via clinical performance data are available in this document.
The submission focuses on demonstrating substantial equivalence to a predicate device (A-dec/W&H Electric Motor, Model EA-50LT) based on technological characteristics and non-clinical test data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) are reported for clinical performance, as clinical testing was not performed. The non-clinical tests focused on functional and safety parameters.
| Acceptance Criteria Category | Reported Device Performance (Non-Clinical) |
|---|---|
| Torque | Studies conducted to determine parameters. |
| Direction | Studies conducted to determine parameters. |
| Stop Time | Studies conducted to determine parameters. |
| Electromagnetic Compatibility | Successfully validated. |
| Electrical Safety | Successfully validated. |
| Thermal Safety | Successfully validated. |
| Photobiological Safety | Successfully validated. |
| Sterilization | Studies done to determine safety and effectiveness. |
| Biocompatibility | Studies done to determine safety and effectiveness. |
The document states, "The A-dec/W&H Electric Motor, Model EA-53 has been successfully validated to confirm the performance of the device," for all listed non-clinical tests. However, the exact pass/fail criteria or quantitative results for these validations are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for clinical performance, as no clinical testing was conducted. For non-clinical tests (e.g., EMC, electrical safety), the sample size of tested devices is not specified, but typically involves a limited number of production units.
- Data Provenance: Not applicable for clinical performance. For non-clinical tests, the data would be generated internally by the manufacturer or by a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical ground truth was established due to the absence of clinical testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported, as there was no clinical testing involving human readers or AI assistance.
6. Standalone Performance Study
No standalone performance study (algorithm only) was conducted or reported, as the device is a mechanical/electrical dental motor, not an AI algorithm.
7. Type of Ground Truth Used
- Clinical Ground Truth: Not applicable, as no clinical testing was performed.
- Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" would be defined by the relevant consensus standards (e.g., for electrical safety, EMC) against which the device's performance was measured. In essence, the standard is the ground truth.
8. Sample Size for the Training Set
Not applicable. The device is a physical product (electric motor) and does not involve AI or machine learning that requires a "training set" of data in the conventional sense. Its functionality is based on established engineering principles and mechanical/electrical design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.