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EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.

EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.

The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.

The provided text describes the 510(k) summary for the EQ-PEX Electronic Apex Locator. Based on the document, here's a description of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The primary performance criterion for the EQ-PEX, as stated and compared to the predicate device, is Accuracy of Apex.

This table indicates that the EQ-PEX meets the same accuracy specification as its predicate device. This suggests that the acceptance criterion for accuracy was to demonstrate performance equivalent to or better than the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "Comparative performance testing of the accuracy of the apex locator and usability validation." However, it does not specify the sample size for this performance testing.

Regarding data provenance:

• Country of Origin: Not explicitly stated for the testing data. The manufacturer is Meta Systems Co., Ltd., located in Seongnam-si, Gyeonggi-do, Korea. It's plausible the testing was conducted in Korea or an affiliated lab.
• Retrospective or Prospective: The document does not specify whether the data used for performance testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

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

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not provide information on the adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An Electronic Apex Locator like EQ-PEX is a measuring device designed to assist a clinician in a procedure, not an AI diagnostic tool that assists human readers in interpreting medical images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and was not mentioned as being performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone measuring instrument. The performance testing of "Accuracy of Apex" at <±0.5mm is an assessment of the device's standalone performance in measuring root canal length. While a user operates it, the accuracy being measured is the accuracy of the device's measurement output. So, yes, a standalone performance test was done to assess its accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For an Electronic Apex Locator, the ground truth for working length measurement is typically established by direct, precise measurements, often through radiographic methods (e.g., radiography with a file in place, or CBCT), or potentially by the physical measurement of extracted teeth. The document does not explicitly state the specific method used to establish the ground truth for the "Accuracy of Apex" performance testing, but it would almost certainly be an objective, highly precise measurement technique.

8. The sample size for the training set:

The document does not specify a training set sample size. Electronic Apex Locators, particularly those based on impedance measurements, typically rely on established physical principles and calibrated hardware rather than deep learning models that require large training datasets in the conventional sense. The "training" for such devices is primarily in their design, calibration, and manufacturing process.

9. How the ground truth for the training set was established:

As mentioned in point 8, the concept of a "training set" with established ground truth, as applied to AI/machine learning models, does not directly apply to this type of medical device which relies on electrical impedance measurement principles. The "ground truth" for its operation is inherent in the laws of physics governing electrical circuits and biological tissues, and its accuracy is validated through performance testing against known objective measurements.

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