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The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.

Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.

The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.

Here's an analysis of the acceptance criteria and study information for the Electronic Apex Locator (Alpha Apex I), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for the accuracy testing test set (e.g., number of teeth, number of measurements). It only mentions that "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted."

The data provenance is not specified. It is unclear if the data was collected retrospectively or prospectively, or its country of origin.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the performance testing.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. The device is an electronic apex locator, which is typically used directly by a single dental practitioner, not for multi-reader interpretation of images or data.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Accuracy Testing" section states, "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm." This indicates the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used for the accuracy measurements (e.g., direct visual measurement through transparent tooth, X-ray confirmation, histological analysis). It only refers to "internal technical requirements" for verifying accuracy.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is likely because the Electronic Apex Locator is a hardware device based on electrical impedance principles, and while it contains a microprocessor and software, the core "measurement" algorithm is typically determined through engineering design and calibration rather than machine learning training on a large dataset in the way a diagnostic AI would be. The software validation (Alpha Apex I.1.0.0) focuses on general software development life cycle processes, not necessarily on a training and testing paradigm for an AI model.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established. The device relies on physical principles and calibrated measurements rather than a trained AI model in the conventional sense.

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