(947 days)
ELEC Master & ELEC Master Dual are 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.
This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.
This document is a 510(k) Premarket Notification from the FDA for a dental handpiece and accessories called "ELEC Master" and "ELEC Master Dual" by MGNEWTON Ltd. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a detailed study report. Therefore, most of the requested information regarding acceptance criteria and performance studies is not explicitly provided in the typical format of a medical device performance study report.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy, sensitivity, specificity, or other clinical performance metrics that would be associated with a diagnostic or treatment guidance AI device.
Instead, the "acceptance criteria" here relate to conformity with established standards for dental handpieces and electrical safety, and substantial equivalence to a predicate device. The "reported device performance" is essentially that the device complies with these standards and has equivalent specifications to the predicate.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Compliance/Equivalence) |
|---|---|---|
| Indications for Use (Substantial Equivalence) | Matches the indications for use of the predicate device (A-dec NLZ electric motor system). | "ELEC Master & ELEC Master Dual are 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." This is reported as "Substantially Equivalent" to the predicate's indications. |
| Technological Characteristics (Substantial Equivalence) | Similar drive, device components, light, range of rotation speed, rotation direction, and max torque as the predicate device. Differences in spray air/water pressure are deemed not to raise new questions of safety/effectiveness. | The device's drive, components, light, rotation speed, rotation direction, and max torque are all listed as "Substantially Equivalent." Differences in spray air pressure (44 psi vs 29 psi) and spray water pressure (22 psi vs 29 psi) were identified but deemed acceptable as "optional features" not affecting substantial equivalence. |
| Standards Conformance | Compliance with specific ISO and IEC standards for dental handpiece coupling, general dental unit requirements, handpieces and motors, electrical safety, EMC, basic safety and essential performance of dental equipment, and usability engineering. | Non-clinical bench tests were performed to ISO 3964, ISO 7494-1, ISO 14457, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC 62366. It's stated that "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard." |
| Sterilization Validation | Validation of the sterilization method. | "sterilization validation... were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.) |
| Software Validation | Validation of the device's software. | "...software validation were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical bench tests (performance tests, electrical safety, EMC, sterilization validation, software validation) against recognized standards and a comparison of technical specifications to a predicate device. It does not involve a study with a test set of human subjects or patient data in the way an AI diagnostic device would. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The "test set" here refers to the actual device prototypes undergoing the specified bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "ground truth" for this type of device is established by adherence to engineering specifications and international standards (e.g., maximum torque defined by a standard, electrical safety requirements). These are objective measurements against predefined criteria, not subjective interpretations requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert interpretations (e.g., radiologists reading images) where disagreement might occur. For objective bench tests and compliance with engineering standards, no such adjudication is needed.
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
This section is not applicable. This device is a dental handpiece motor system, not an AI-powered diagnostic or treatment assistance tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics as determined by bench testing against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the compliance with predefined technical specifications and international consensus standards. For example, the "ground truth" for torque is the specified 3Ncm, and the test verifies that the device meets this. The "ground truth" for electrical safety is its conformity to IEC 60601-1.
8. The sample size for the training set
This section is not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.