(592 days)
Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm.
The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction.
The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center.
The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
The provided text is a 510(k) summary for a "Dental Electric Motor." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/ML powered medical device. Therefore, the information required to answer your questions regarding acceptance criteria and supporting studies for an AI device is largely not present in this document.
Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
This document does not define specific performance acceptance criteria or report performance in the typical sense for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it conducts a comparison to predicate devices, where "performance" is implicitly evaluated by demonstrating that the subject device meets relevant safety and performance standards (like IEC 60601-1, IEC 60601-1-2, ISO 14457).
The closest to "acceptance criteria" for this conventional device are the general safety and performance standards it was tested against. The "reported device performance" would be that it complies with these standards.
| Acceptance Criteria (Implied from testing standards) | Reported Device Performance (Implied from Summary) |
|---|---|
| Compliance with IEC 60601-1 (Medical electrical equipment basic safety and essential performance) | Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1-2. |
| Compliance with ISO 14457 (Dentistry Handpieces and motors) | Device has been evaluated for safety and performance by lab bench testing according to ISO 14457. Additionally, specific features like speed and gear ratio are stated to comply with ISO 14457. |
| Moderate level of software documentation and verification | Performed (stated as "Moderate level of software documentation and verification per the FDA Guidance Document for Software Contained in Medical Devices"). |
| Sterilization and cleaning validation | Performed per ISO 17665-1 and FDA Guidance Document for Reprocessing of Medical Device. |
| Biological evaluation (in vitro cytotoxicity) | Performed per ISO 10993-5:2009. |
| Biological evaluation (irritation and skin sensitization) | Performed per ISO 10993-10:2010. |
| Substantial Equivalence to Predicate Device (in terms of design, intended use, indications for use, functions, material and applicable standards) | Concluded as substantially equivalent, with minor differences not affecting safety and effectiveness. |
| Speed Range (2000-40000rpm) | Achieved 2000-40000rpm (Subject Device, Technical Specifications). |
| Speed Ratio (16:1, 1:1, 1:5) | Achieved 16:1, 1:1, 1:5 (Subject Device, Technical Specifications). |
| Maximum Torque (4.20 N*cm) | Achieved 4.20 N*cm (Subject Device, Technical Specifications). |
| Torque Range (1-3.0 N*cm) | Achieved 1-3.0 N*cm (Subject Device, Technical Specifications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because the submission describes testing of a physical device against standards, not an AI/ML model for which "test sets" of data are typically defined in this manner. The testing described is lab bench testing of the physical hardware.
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 is not applicable as there is no AI/ML model and thus no "ground truth" establishment in the context of expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device substantial equivalence submission.
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
Not applicable. This device is a dental electric motor, a piece of hardware, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in the device description.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device, compliance with standards and functional specifications constitutes the "truth" or verification of its performance.
8. The sample size for the training set
Not applicable. This document pertains to a physical dental electric motor, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or training set discussed.
§ 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.