(164 days)
The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.
The e3 Torque Control Motor is an electric motor-driven handpiece intended for the endodontic industry. It works in both reciprocating mode and continuous rotation. This motor is provided with pre-programmed settings for the most popular nickel titanium rotary file systems sold by DENTSPLY. The dentist is also able to program 15 settings of their choice for speed and torque control. The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate the motor. A power supply is also connected to the control unit to allow the dealer to charge the battery. The motor is connected to the control unit and a 6:1 contra angle. Files attach to the contra angle.
This submission K103653 for the e3 Torque Control Motor is a 510(k) premarket notification claiming substantial equivalence to a predicate device, the X-Smart™ Easy (K092614). It does not contain a study that demonstrates the device meets specific performance acceptance criteria in the way a clinical trial or a detailed scientific study would for a novel medical device.
Instead, the submission focuses on demonstrating substantial equivalence through:
- Technological Characteristics Comparison: Highlighting similarities and minor differences between the subject device and the predicate device.
- Compliance with Recognized Standards: Showing that the device meets safety and performance standards (e.g., Biocompatibility, EMC, Electrical Safety, Software Validation).
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, in the context of performance metrics like accuracy, sensitivity, or specificity, is not applicable to this type of submission. There are no performance acceptance criteria defined in terms of quantifiable device output that would typically be fulfilled by a comparative effectiveness study or a standalone algorithm performance study.
Here's a breakdown of what is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense of a performance study. The "acceptance criteria" here are compliance with recognized standards and the "performance" is demonstrated by meeting these standards and showing comparable technological characteristics to a legally marketed predicate device.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Status) |
|---|---|
| Biocompatibility (ISO 10993) | All patient contact components demonstrated biocompatibility. |
| Electromagnetic Compatibility (EN 60601-1-2) | Conforms to EN 60601-1-2:2007. |
| Electrical Safety (EN 60601-1, EN 60601-1-8) | Conforms to EN 60601-1:2007 and EN 60601-1-8:2007. |
| Software Validation (EN 62304) | Meets software validation requirements per EN 62304. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission did not involve a "test set" of patient data or samples for performance evaluation in the way a diagnostic or AI-driven device would. The testing was primarily against engineering and safety standards.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. Ground truth, in the context of clinical or diagnostic performance, was not established for this device as it's an electromechanical tool rather than an interpretive one.
4. Adjudication Method
Not applicable. No adjudication was performed as there was no assessment of diagnostic output or subjective interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers or interpreters are involved (e.g., radiologists interpreting images). The e3 Torque Control Motor is an electromechanical handpiece for dentists.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. There is no "algorithm" in the sense of an AI or diagnostic algorithm whose standalone performance needs to be evaluated. The device has software for control, but its performance is assessed through compliance with standards like EN 62304 for software validation, not through clinical output metrics.
7. Type of Ground Truth Used
Not applicable. The "ground truth" here is compliance with established engineering, safety, and biocompatibility standards, rather than clinical outcomes or pathology reports.
8. Sample Size for the Training Set
Not applicable. There was no "training set" in the context of machine learning or algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary: The K103653 submission for the e3 Torque Control Motor demonstrates substantial equivalence by comparing its technological characteristics to a predicate device and by showing compliance with relevant international and national standards for safety, biocompatibility, electromagnetic compatibility, electrical safety, and software validation. It does not involve performance studies in the way an AI/ML or diagnostic device would, and therefore, many of the requested points are not relevant to this submission.
§ 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.