(479 days)
The Maxima Electric System 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. This system is designed for use by a trained professional in the field of general dentistry.
Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm. Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program. The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces. The control box is power by a power supply AC/DC voltage 36 VDC. Maxima Electric System consists of the following components: 1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord A control unit, Motor Cable and a Micro-motor.
The provided document is a 510(k) Pre-Market Notification for the Maxima Electric System, a dental device. It does not describe a study involving an AI/ML algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's overall performance in a quantitative manner as one would for an AI/ML model. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance testing.
| Feature/Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Maxima Electric System) |
|---|---|---|
| Indications for Use | Convert pneumatic output to electrical energy to drive electric micro-motor for electrically-driven handpieces in general dentistry. | Same as predicate. |
| Patient Contact | None | None |
| Device Design | Power Supply, Control Box, Micro Motor, AC cord. | Power Supply, Control Box, Micro Motor, AC cord. |
| Speed control button | Yes | Yes |
| Speed Range | 100-40,000 rpm | 100-40,000 rpm |
| Digital Speed reading | Yes | Yes |
| Rotation Control | Clockwise & Counter Clockwise | Clockwise & Counter Clockwise |
| Light ON/OFF | Yes | Yes |
| Water Spray ON/OFF | Yes | Yes |
| Programmable setting | 2 | 3 |
| Power Supply | 100-240 VAC, 47-63 Hz, 36-38 V DC, 120 W | 100-240 VAC, 47-63 Hz, 36-38 V DC, 105 W |
| Micro Motor Speed | 40,000 rpm | 40,000 rpm |
| Micro Motor Dimensions | 21mm (Diameter) x 65mm (Length) | 20mm (Diameter) x 63mm (Length) |
| Micro Motor Weight | 69.6 gm | 69 gm |
| Micro Motor LED | White LED | White LED |
| Torque | 3.0 N-Cm | 3.0 N-Cm |
| Max Air Pressure | 5.0 Bar | 4.0 Bar Max. |
| Max Water Pressure | 2.0 Bar | 2.5 Bar Max. |
| Handpiece Connection | ISO-3964 | ISO-3964 |
| Dental System Connection | ISO-9168 | ISO-9168 |
| Performance Testing (Speed Vs Torque) | Similar trend between test and predicate over 250 cycles. | "no significant differences in performance of testing handpieces after 250 cycles... The Speed Vs Torque table shows the similar trend..." |
2. Sample size used for the test set and the data provenance
The document mentions "250 cycles of testing" for handpieces to compare Speed Vs Torque performance between the subject device and the predicate. It does not provide details on the number of handpieces tested, the specific testing parameters beyond "Speed Vs Torque," or the data provenance (e.g., country of origin, retrospective/prospective). This testing appears to be a bench test, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth, in this context, is derived from engineering specifications, industry standards (ISO), and the performance metrics of the predicate device, not direct expert interpretation of clinical data.
4. Adjudication method for the test set
Not applicable. This is not a study that uses human adjudication for a test set. Bench testing results are compared to established benchmarks or predicate device performance.
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 handpiece system, not an AI/ML diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware with embedded software for control, not a standalone algorithm in the context of AI/ML. The "software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light." This is basic control software, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Engineering Specifications and Standard Compliance: Adherence to standards like ISO 14971, ISO 17665-1, ISO 17665-2, ISO 10993-1, ISO 10993-5, IEC 60601-1, IEC 60601-1-2, ISO 14457, IEC 60601-1-6, IEC 63266, and IEC 80601-2-60.
- Predicate Device Performance: Direct comparison of technological characteristics and performance data (Speed Vs Torque) to a legally marketed predicate device (ELECTROtorque TLC4893 with INTRAmatic KL 702).
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm or a training set.
§ 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.