(112 days)
The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.
The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.
The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.
Here's an analysis of the provided text regarding the E-STATIS 40 System, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary for a medical device (E-STATIS 40 Electric Motor System). A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be found in a PMA (Premarket Approval) submission. Therefore, some of the information requested, particularly regarding clinical study details like sample sizes, expert qualifications, and specific efficacy metrics, is not typically included or required in a 510(k) submission of this nature.
However, I will extract and infer information relevant to your request based on the available text.
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format for a clinical study. Instead, the "performance" discussed relates to the engineering and functional specifications of the device, which are typically verified through validation testing.
Table of Acceptance Criteria and Reported Device Performance (Inferred/Summarized):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Rotational Speed Range | 100 - 40000 rpm |
| Rotational Direction | Clockwise and counter-clockwise direction |
| Torque Measurement | Performance testing conducted to evaluate torque measurements |
| Electrical Safety | Testing conducted in accordance with recognized standards |
| Electromagnetic Compatibility (EMC) | Testing conducted in accordance with recognized standards |
| Software Validation/Verification | Validation verification testing of the software conducted |
| Intended Use | Suitable for dental restoration, prophylaxis, and endodontic procedures |
| Operating Principles | Same as predicate devices |
| Technology and Design | Similar to predicate devices |
Study Details:
Given the nature of a 510(k) for a dental handpiece, the "study" referred to is primarily performance testing (bench testing) and validation testing rather than a large-scale clinical trial.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance testing. For devices like this, the "sample size" would refer to the number of units tested. This information is typically detailed in internal validation reports, not in the 510(k) summary.
- Data Provenance: The testing was conducted by or for the manufacturer, SciCan, based in Toronto, Canada. The data is internal testing data. It is retrospective/prospective bench testing, not clinical data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of submission. The "ground truth" for the device's functional performance (speed, torque, safety) is established by engineering specifications, recognized industry standards (e.g., for electrical safety, EMC), and material science principles, not by expert consensus on clinical cases.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where human interpretation of data (e.g., radiology images) requires consensus. For device performance testing, results are quantitative and objective.
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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 was not done. This device is a mechanical dental motor system, not an AI-assisted diagnostic tool. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly in imaging.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this was not done. This is not an algorithmic or AI-based device. Its performance is purely mechanical and electrical, designed to be used by a human dental professional.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing of this device is based on engineering specifications, industry standards, and validated measurement techniques. For example, the accuracy of the RPM measurement would be verified against traceable calibration standards. Software functionality would be verified against design requirements.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device's operation is deterministic based on its hardware and programmed software, not learned from a dataset.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set.
Summary regarding the 510(k) context:
A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device. For mechanical and electrical devices like the E-STATIS 40 System, this primarily involves:
- Showing the same intended use.
- Having similar technological characteristics (e.g., operating principles, design).
- Providing performance testing (bench testing) to ensure the device meets its own specifications and is safe and effective when compared to the predicate, often by referencing recognized standards (e.g., electrical safety, EMC).
- Software validation to ensure the software performs as intended.
The document states, "Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software. Testing was conducted in accordance with recognized standards." This sentence summarizes the scope and nature of the "study" that supports the device meeting its functional requirements and, by extension, being substantially equivalent to its predicates.
§ 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.