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support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.

The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.

The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.

Main unit: measure and display working length.

Measurement wire A: connect file clip and lip hook with main unit.

Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)

File clip: Connect to file.

Lip hook: hook patient's lip.

Touch Probe: promote to measure molar.

Power Adapter: use for charging.

Tester: use for checking whether the device is normal.

The provided document is a 510(k) summary for the Apex Locator (Model: AL-Pex, AL-Pex+). It outlines why the device is considered substantially equivalent to a predicate device, but it does not contain the specific details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• "Clinical testing is not required." This means there isn't a clinical study with real patient data to generate the performance metrics typically seen in such tables (sensitivity, specificity, accuracy, etc.) against a human or definitive ground truth.
• The performance data section primarily lists compliance with standards (electrical safety, EMC, biocompatibility) and "Accuracy verification: Internal method." This suggests the accuracy was verified through internal, non-clinical means.

Therefore, I cannot extract the information required for:

1. A table of acceptance criteria and the reported device performance: No such table is in the document for the device's main function (determining working length). The "Accuracy: ±0.5mm" mentioned in the comparison table is likely the design specification and presumed achieved, but no study results are provided to explicitly "prove" it meets this with a test set.
2. Sample size used for the test set and data provenance: No information on a test set (e.g., number of roots/teeth tested) or its provenance (country, retrospective/prospective) is provided, as clinical testing was not required.
3. Number of experts used to establish ground truth and qualifications: Not applicable as no clinical study leveraging human expert ground truth is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as no human reader study is described.
6. Standalone performance: No detailed standalone performance metrics (like accuracy with a confidence interval) are presented from a formal study. The "±0.5mm" is a general specification.
7. Type of ground truth used: Not explicitly stated for accuracy verification beyond "Internal method." For devices like apex locators, the ground truth is typically a known or precisely measured length, often in experimental setups or ex-vivo teeth, rather than clinical outcomes or pathology.
8. Sample size for the training set: Not applicable, as this is a traditional medical device, not an AI/ML-driven software device that would have a "training set" in the context of machine learning.
9. How ground truth for training set was established: Not applicable.

In summary, the provided FDA document focuses on confirming substantial equivalence through device design, intended use, and compliance with general medical device safety and performance standards (electrical safety, EMC, biocompatibility, reprocessing validation), rather than presenting specific quantitative performance data from a clinical or extensive non-clinical study that would fit the requested criteria for acceptance and proof of performance. The "Accuracy: ±0.5mm" found in the comparison table is a functional specification, not a reported result from a study described in the document.

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