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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.

Device Description

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.

AI/ML Overview

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.

Physical Property / Test Description	Standard	Acceptance Criteria (Implied)	Reported Device Performance (K160825)	Predicate Device Performance (K110753)
Bluetooth Compatibility	DENTSPLY Professional Internal Test Method	Verify communication at 15 feet when exposed to RF interference.	Pass (Bluetooth)	Pass (Zigbee)
SmartMode™ Performance	DENTSPLY Professional Internal Test Method	Verify SmartMode™ performance, user override, and motor stop features.	Pass	N/A (Predicate does not have SmartMode™ Technology)
SmartMode™ Technology Performance with Various Types of DPA's	DENTSPLY Professional Internal Test Method	Verify SmartMode™ performance with different DPA types.	Pass	N/A (Predicate does not have SmartMode™ Technology)
Cordless Handpiece Inner Module Push Button, Battery Indicator, Sleep Mode Functionality	DENTSPLY Professional Internal Test Method	Verify functionality of button, battery indicator, and sleep mode.	Pass	N/A (Predicate lacks some features)
Speed Control and Level of Usage on a Single Charge	DENTSPLY Professional Internal Test Method	Verify capability to perform one day's worth (10 procedures) on a single charge.	Pass	Pass
Speed Torque Performance	DENTSPLY Professional Internal Test Method	Verify speed performance meets specifications under various loads.	Pass	Pass
Outer Sheath Insertion/Extraction Forces	DENTSPLY Professional Internal Test Method	Verify acceptable insertion/extraction forces per design specifications.	Pass	Pass
System Component Physical Attributes	DENTSPLY Professional Internal Test Method	Verify general size, shape, weight, and center of gravity attributes.	Pass	Pass
Cordless Handpiece Inner Module Liquids Ingress Test	DENTSPLY Professional Internal Test Method/IEC	Verify fluid does not accumulate in the Inner Module.	Pass	Pass
Foot Pedal Performance	DENTSPLY Professional Internal Test Method	Verify battery capacity and ability to operate on drained battery when plugged in.	Pass	Pass
Cordless Handpiece Maximum Speed (no load with foot pedal)	Not explicitly stated	Proposed: 3400 ± 300 rpm; Predicate: 3300 ± 300 rpm	3400 ± 300 rpm	3300 ± 300 rpm
Maximum Torque using Foot Pedal	Not explicitly stated	9 mNm maximum load @ 3000 ± 10% rpm	9 mNm maximum load @ 3000 ± 10% rpm	10 mNm maximum load @ 3000 ± 10% rpm
Maximum Torque using SmartMode™ (without Foot Pedal)	Not explicitly stated	9 mNm maximum load @ 3000 ± 10% rpm	9 mNm maximum load @ 3000 ± 10% rpm	N/A (Not offered)

Study Information:

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.
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."
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.
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.
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).
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.
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.
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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