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E-connect S is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The E-connect S is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The E-connect S can be used for enlargement and preparation of root canals and can also be used as an apex locator.

The motor drives the file to rotate at a certain speed and torque through the contra angle gearing. The rotating file will cut the root canal wall along the direction of the root canal. The speed and torque of the motor are controlled by the central processor and are configurable to accommodate different files. With built-in apex locator, this device monitors the file tip position in the root canal during root canal treatment.

The components of the E-connect S include a charge base, handpiece, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle. The contra angle is compatible with files shafts conforming to ISO 1971-1, Type 1. The key panel on the handpiece is used to control/adjust the power, memory settings, operation modes (motor/apex,) and adjust the parameters. The body of the handpiece is to be covered with a FDA cleared barrier sleeve.

The provided document is a 510(k) summary for the E-connect S Endo Motor with built-in Apex Locator. It details the device's performance data and comparison to a predicate device, but it does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The study described focuses on non-clinical performance evaluations and comparative testing against a predicate device.

Here's the information extracted and organized, with an emphasis on what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a table format with pass/fail metrics. Instead, the document describes performance tests against recognized standards and a comparative test against a predicate device. The most relevant performance criterion discussed is the accuracy of the root apex locator function.

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