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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.

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

• Sample Size: Not specified for any of the non-clinical tests or the comparative root canal measurement test. The document states "Comparative Root Canal Measurement Performance Test to evaluate the root canal length measurement accuracy to the predicate device," but the number of cases or samples used in this test is not provided.
• Data Provenance: Not specified. The document does not mention the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) summary, it's typically a report of manufacturer-conducted tests.

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

• Not applicable / Not specified. The document describes non-clinical performance and comparative testing. It does not mention any ground truth established by experts for a test set in the context of clinical or diagnostic performance. The apex locator accuracy is a technical measurement, not an expert-driven clinical ground truth.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. There is no mention of adjudication methods as no expert-based ground truth or clinical test set adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There were no clinical tests performed for the E-connect S device." The performance data section describes non-clinical tests and a comparative evaluation of the root canal measurement accuracy to the predicate device, not a human reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Partially applicable. The "apex locator function" is a standalone algorithm/device function. Its accuracy is reported as -0.5mm to +0.5mm for Apex position. This is a direct measurement of the device's technical performance without human interpretation or intervention in the measurement itself outside of proper device usage. The study compared this measurement accuracy to that of the predicate device.

7. The Type of Ground Truth Used

• Technical/Instrumental Measurement. For the apex locator function, the "ground truth" would be an objective, precise measurement of the actual root canal length, likely established under controlled laboratory conditions or cadaveric/ex vivo studies using highly accurate reference methods (e.g., direct physical measurement, micro-CT). The document does not detail how this "ground truth" was specifically established but refers to the "Accuracy of the root apex locator function." For other performance aspects, the ground truth refers to conformance to established international standards (e.g., IEC 60601, ISO 10993).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This device is a motor and apex locator, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of medical imaging or diagnostic AI. The document does not describe any machine learning components that would necessitate training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable / Not specified. As there is no described training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant here.

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