(80 days)
The MIDWEST® RDH Freedom™ Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.
The MIDWEST® RDH Freedom™ Cordless Prophy System is comprised of a cordless, electric motor-driven handpiece, an AC powered battery charging base and a wireless foot pedal. The handpiece utilizes Freedom disposable prophylaxis angles (single use) that are available with soft cup, hard cup or brush features. The handpiece has been designed for comfort and control. The handpiece has no direct operator controls, and has an internal motion sensing by the user. The motion sensor prepares the handpiece for operation when the handpiece is picked up. The handpiece can only be operated by the cordless foot pedal, and the amount of vertical displacement on the foot pedal corresponds to the speed of the handpiece. The handpiece is quieter than traditional hygiene and low speed handpieces and features an autoclavable outer sheath for infection control. The MIDWEST® RDH Freedom™ Cordless Prophy System handpiece battery has sufficient power to complete a day's worth of procedures on a single charge, and the system is capable of completing one cleaning procedure after only fifteen minutes of charging. The charging base and the foot pedal are all housed in various plastics. The autoclavable outer sheath is made from aluminum, and the single use disposable prophy angles are made from plastic (and rubber cups).
This device, the MIDWEST® RDH Freedom™ Cordless Prophy System, is a Class I medical device (Dental Handpiece and Accessories (21 CFR 872.4200)). Class I devices are subject to general controls but typically exempt from premarket notification unless they pose a high risk. This device is exempt from clinical performance data verification due to its low-risk nature. Therefore, the information provided mainly covers non-clinical performance and a declaration of substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Design Verification | Verified component specifications, speed and torque control, battery life, noise, sterilizability, and biocompatibility. |
| Speed and Torque Control (comparative to predicate) | Similar to the predicate device (Zen Cordless Prophy System) and well within the range of traditional air-driven hygiene handpieces. |
| Battery Life | Capable of performing a "full day's worth of procedures" on a single charge and one cleaning procedure after 15 minutes of charging. |
| Noise Levels | Quieter than traditional hygiene and low-speed handpieces. |
| Software Validation | Performed. (No specific metrics provided). |
| Sterilizability | Outer sheath is autoclavable. |
| Biocompatibility | Testing performed. (No specific metrics provided). |
| Electrical Equipment Safety | Testing performed. (No specific metrics provided). |
| Substantial Equivalence | Found to be substantially equivalent to the Zen Cordless Prophy System in design, function, safety, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a "test set" in the context of a typical clinical study with a defined sample size. The testing described is non-clinical performance testing. Therefore, details such as country of origin or retrospective/prospective nature are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device's evaluation did not involve human experts establishing ground truth for a test set in a clinical trial format. Its safety and efficacy were established through non-clinical performance testing and comparison to a predicate device.
4. Adjudication Method
Not applicable. There was no clinical study involving human judgment or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Not applicable. This is a physical medical device (dental handpiece), not a software algorithm that operates without human intervention. Its "performance" refers to its mechanical and electrical functions, which are inherently evaluated in a standalone manner (e.g., testing torque, speed, battery life).
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily based on:
- Engineering specifications and design requirements: For aspects like speed, torque, battery life, noise.
- Established standards and regulations: For sterilizability, biocompatibility, and electrical safety.
- Comparison to the predicate device: The characteristics of the legally marketed Zen Cordless Prophy System served as a benchmark for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device that does not involve machine learning algorithms requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for a machine learning algorithm.
§ 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.