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It's intended use is for dental drilling applications and other dental treatments, where a smooth and slowly rotating drive is required, e.g. the for polishing dental surfaces, caries removal and root canal preparation.

The EndoStepper 1 system is to be used by practising dentists only.

To be used for dental drilling and other dental drive applications.

Device Description

The EndoStepper System is an electronically controlled drive for dental drilling applications. The system consists of (1) a console type housing containing the electronics with a LCD display and a keypad, (2) a foot pedal unit, (3) a drive unit to be used with (4) a protective cover and a commercially available contraangle.

AI/ML Overview

The medical device in question is the Phytron EndoStepper 1, a microcontroller-controlled dental handpiece based on a stepper motor.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate Device: TCM Endo)	Reported Device Performance (EndoStepper®)
Intended Use	Micro-processor controlled dental handpiece with controlled electric motor torque; dental drilling applications	Micro-processor controlled dental handpiece with controlled electric motor torque; general dental drilling applications
Input Voltage	115 V / 230 V, 50/60 Hz	115 V / 230 V, 50/60 Hz
Materials	Electronic parts and components	Same
Indications for Use	Dental drilling applications, especially endodontic drilling	Same
Torque Control	Yes	Yes
Torque Control Precision	1 Ncm	Better than 0.1 Ncm
System Reaction in case of Blocking	Reverse motion with undefined angle of rotation and continuation without dentist intervention	Motor stops within several degrees of rotation; dentist can decide how to proceed

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail a specific test set, its sample size, or data provenance for performance evaluation. The comparison appears to be based on an analysis of device specifications and characteristics against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the use of experts to establish ground truth for a test set. This type of submission relies on technical specifications and comparison to an already cleared predicate device.

4. Adjudication Method for the Test Set

As there is no explicit test set discussed in terms of human performance or expert review, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for the EndoStepper 1. The submission focuses on device characteristics and substantial equivalence to a predicate.

6. Standalone (Algorithm Only) Performance Study

The EndoStepper 1 is a physical dental handpiece system; therefore, the concept of an "algorithm only" or standalone performance study in the context of AI is not applicable to this device. Its performance is inherent to its mechanical and electronic design.

7. Type of Ground Truth Used

The "ground truth" for the EndoStepper 1's performance claims is primarily based on engineering specifications and measurements of its physical characteristics (e.g., torque control, speed, blocking reaction) as compared to the stated specifications of the predicate device. Compliance with recognized standards (IEC, ISO) also serves as a form of performance validation.

8. Sample Size for the Training Set

As this device is a physical electromechanical system and not an AI/machine learning algorithm that requires training data, the concept of a "training set" and its sample size is not applicable.

9. How Ground Truth for the Training Set Was Established

Since there is no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

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