(89 days)
Engine, power supply and controller for dental handpiece
The new device submission covers two handengine controllers designed to operate the 45E and RX-100 dental handengines. The 45E and the RX-100 are low-voltage DC-motors with Econnector type front ends. Both the RX-100 may be operated by the Mark 20 or Mark 25 Controller. Both engines have Off/On or variable speed footswitches. Both engines accept various and straight front handpieces on the motor to do different types of dental work or surgical procedures. The Mark 20 and Mark 25 Controllers are typical rheostat based hand engine controllers. The Mark 20 or Mark 25 Controller allows the practitioner infinite control over the speed of the engine and dental front handpiece up to the rated speed capacity of the selected engine and handpiece. Both the Mark 20 and Mark 25 Controller allow the selected hand engine and dental front hand piece to be operated in forward or reverse directions as well as by local control or remote foot switch. Dental or endodontic surgical procedures needing irrigation are supported by the integral fluid pump. The pump is constant speed in the Mark 20 and is variable speed in the Mark 25 unit.
This document is a 510(k) Premarket Notification Summary for a medical device, specifically dental handengine controllers. As such, it does not contain the kind of detailed study information (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) that would typically be found in a clinical trial report or a submission for a device involving AI or complex diagnostic interpretations.
The acceptance criteria here refer to the performance characteristics of the new device (Mark 20 and Mark 25 Controllers) compared to a predicate device (25-D hand engine with C-310 Console) to establish substantial equivalence. The "study" proving this is primarily a comparison of technical specifications and features.
Here's the information broken down based on your request, with an emphasis on what's available and what's not in this type of document:
1. Table of acceptance criteria and the reported device performance
The "acceptance criteria" are implied by the features and performance metrics of the predicate device, which the new devices aim to meet or exceed while remaining substantially equivalent. The "reported device performance" is the specified performance of the Mark 20 and Mark 25 controllers.
| Feature / Acceptance Criteria (based on Predicate) | Predicate Device (25-D hand engine w/ C-310 Console) | Mark 20 Controller (Reported Performance) | Mark 25 Controller (Reported Performance) | Meets Acceptance (Substantially Equivalent) |
|---|---|---|---|---|
| Intended Use | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Yes |
| Forward & Reverse Switch | Yes | Yes | Yes | Yes |
| Engine Torque | 320 gram centimeters | 400 gram centimeters | 400 gram centimeters | No (Exceeds predicate) |
| Automatic Torque Limiting | No | No | Yes | No (Mark 25 has new feature) |
| Direct - remote selector switch | Yes | Yes | Yes | Yes |
| Speed Control | Yes | Yes | Yes | Yes |
| Power Supply | AC - 110-115 VAC, 50/60 Hz | AC - 110-115 VAC, 50/60 Hz | AC - 110-115 VAC, 50/60 Hz | Yes |
| UL/ETL Compliant | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes |
| Engine Models | 25D hand engine | 45E hand engine - RX-100 | 45E hand engine - RX-100 | Yes (Accommodates equivalent functionality) |
| Irrigation Support | None | Yes - Constant speed | Yes - Variable speed | No (New feature) |
| Digital speed readout | No | Yes | Yes | No (New feature) |
| Voltage output | 2 - 20 volts DC | 3 - 30 volts DC | 3 - 30 volts DC | Yes (Equivalent or exceeds, deemed substantially equivalent) |
Explanation of "SE?" column from the original document: The "SE?" column in the provided table indicates "Substantially Equivalent?". A "Yes" means that feature is considered equivalent to the predicate. A "No" means there's a difference, which then needs justification for substantial equivalence (e.g., increased torque or added features are typically considered improvements that don't raise new questions of safety or effectiveness).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is a comparison of device specifications and performance rather than a clinical study involving patient samples or data. The "test set" would be the devices themselves, subjected to engineering tests (not detailed in this summary).
- Data Provenance: Not applicable for clinical data. The data provenance relates to the specifications and performance characteristics of the devices, likely derived from internal engineering and manufacturing records.
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)
- Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this device (a dental handengine controller). The "ground truth" here is the measured performance and design specifications as evaluated by engineers during the device development and testing phases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not relevant here.
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 is not an AI-assisted diagnostic device, nor is it a device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical/electrical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device is based on engineering specifications, measured physical performance (e.g., torque, RPM, voltage output), and compliance with recognized safety standards (like UL-544). This is not clinical ground truth.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. Device development involves engineering design, prototyping, and testing, not algorithmic training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.