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The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing procedures. The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is comprised of an electric motor-driven prophylaxis cordless handpiece (consisting of an inner module and outer sheath), a direct current (DC) powered charging base for cordless handpiece, cradle for cordless handpiece, direct current (DC) power supply and cord, and uses proprietary disposable prophy angles (DPAs). The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, uses a USB mini connector to provide battery charging power to the charging base for the cordless handpiece and operates using Bluetooth low energy (BLE) wireless radio frequency. An optional wireless foot pedal is sold separately.

This document describes the Dentsply Sirona MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology (K160825), a dental handpiece used for cleaning and polishing teeth. The submission compares this new device to a predicate device, the MIDWEST® RDH Freedom® Cordless System (K110753).

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. It does not explicitly state acceptance criteria in a quantitative, pass/fail manner for features beyond "Pass," but rather compares performance to the predicate device and internal Dentsply Professional test methods.

Study Information:

1. Sample Size used for the test set and the data provenance:
   The document does not specify exact sample sizes for the non-clinical performance tests. It mentions "multiple professional evaluations with typodonts" for the clinical performance section, but does not quantify the number of typodonts or treatments. The data provenance is internal to DENTSPLY Professional ("DENTSPLY Professional Internal Test Method"). The studies are effectively prospective as they were conducted to test the performance of the proposed device. The country of origin is not explicitly stated but can be inferred as the US, given the FDA submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document states that "Professional evaluations were conducted considering the proposed device intended use, users, and use environments. All studies were completed by practicing registered dental hygienists." The number of dental hygienists is not specified, nor are their exact qualifications beyond "practicing registered dental hygienists."

3. Adjudication method for the test set:
   The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the non-clinical or clinical performance evaluations. The results are presented as "Pass" based on internal test methods, implying a direct comparison to pre-defined technical specifications or successful operation.

4. 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:
   No MRMC comparative effectiveness study was done. This device is a dental handpiece, not an AI-powered diagnostic tool, so such a study would not be applicable. The "SmartMode™ Technology" refers to an automated control mechanism based on force applied, not an AI feature involving human "readers" or diagnostic improvement.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   The non-clinical performance tests described, particularly those for SmartMode™ functionality, speed, and torque, represent a form of standalone performance evaluation of the device's automated capabilities. These tests verify the device's technical specifications and how it responds to various inputs (e.g., applied force, different DPAs).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" is based on internal engineering specifications and standards (e.g., "meet specifications," "acceptable per design specifications," "fluid does not accumulate"). For the "clinical human factor validations," the "ground truth" seems to be the absence of "unacceptable risks or unacceptable use related hazards related to SmartMode™ Technology" as assessed by practicing registered dental hygienists. This implies an expert assessment of performance and safety on typodonts.

7. The sample size for the training set:
   Not applicable. This is a medical device clearance, not an AI model requiring a training set. The "SmartMode™ Technology" is described as a control mechanism, not a learned AI algorithm.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

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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

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.

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