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The Star E900 Electric System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

The Star E900 Electric System is comprised of a power supply, control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100-40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.

The system has two different operating modes, preparation mode for dental restorations and prophylaxis procedures and endodontic mode for endodontic procedures. Within each mode there are 10 different profile settings that can be customized by the user. Each profile can be customized for the gear ratio, speed, direction of rotation, light and for the endodontic mode, the torque can also be customized.

The motor incorporates RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag allows the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader allows the practitioner to track such things as usage and maintenance.

The control unit is programmed to detect a rise in the temperature of the handpiece, if the handpiece is equipped with a thermal sensor, in order to reduce the risk of patient injury. It will also detect if there is an overcurrent condition in the motor which could cause damage to the system.

The Star E900 Electric System is available in two different models. One model is a tabletop stand-alone unit and the other model can be integrated into a dental delivery unit.

The Star E900 Electric System uses a cellular connection to connect with the cloud. Through this connection, the system transmits data concerning the operation of the system. There is no patient information transmitted or stored on the cloud. The system cannot be operated through the cellular connection. System updates are transmitted as needed through this connection. The user has the option of accessing a web application that will allow the user to see the functions of the system.

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The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio.

Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.

Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces

The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces.

The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's.

These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities.

All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved.

The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant.

All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader will enable the practitioner to track such things as usage and maintenance.

The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.

The provided text is a 510(k) premarket notification for a medical device (DentalEZ, Inc., StarDental Division's Star E900 Handpiece Series). This document describes the device and its equivalence to legally marketed predicate devices, but it does not contain acceptance criteria or study results in the format you requested for AI/algorithm performance.

The document describes bench tests conducted to evaluate the functional performance and safety of the device against standards like ISO 14457:2017 and IEC 60601-1:2020. It also mentions biocompatibility testing leveraged from a reference device and sterilization/cleaning validation. However, these are evaluations of the physical medical device itself, not an AI or algorithm.

Therefore, I cannot fulfill your request to provide:

• A table of acceptance criteria and reported device performance (for an AI/algorithm).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional dental handpiece, not a device that utilizes AI or an algorithm that would have "ground truth" or "training sets" in the context of your request.

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