(5 days)
The EndoStepper 1 system is a microcontroller controlled dental handpiece based on a stepper motor.
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.
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.
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.
§ 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.