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Dr's Finder NEO is intended for detecting the apex of root canal.

The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.

The provided text describes the Dr's Finder NEO, an apex locator device, and its substantial equivalence to predicate devices. Here's a breakdown of the requested information 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 mentions "comparison testing on Dr's Finder NEO and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth and a stainless steel file."

• Test Set Sample Size: Not explicitly stated. The phrase "extracted tooth" implies multiple teeth were used, but a specific number is not provided.
• Data Provenance: The study used "extracted tooth," suggesting an in vitro setting. The country of origin for the data is not specified, but the manufacturer is Good Doctors Co., Ltd. from the Republic of Korea. The study appears to be prospective in nature as it was conducted for this 510(k) submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth method described below does not inherently require human expert interpretation as the measurement is electrical.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for an apex locator's accuracy is typically established by direct measurement relative to the actual apical foramen in an ex vivo setting, rather than through expert adjudication of images or clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Improvement

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The study conducted was a technical performance comparison between two devices, not an evaluation of human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance test was done. The document states, "The comparison testing on Dr's Finder NEO and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth and a stainless steel file." This describes the device operating on its own to locate the apex.

7. The Type of Ground Truth Used

The ground truth explicitly stated for accuracy is ±0.2mm. For an apex locator, this ground truth is typically established by:

• Direct Measurement/Physical Measurement: In an ex vivo setting (e.g., extracted teeth), the actual length to the anatomical apex is physically measured (e.g., with a microscope or calipers after sectioning) and compared to the device's reading. The document's mention of "extracted tooth" supports this type of ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set. Apex locators like the Dr's Finder NEO are typically based on electrical impedance principles and calibrated during manufacturing, rather than "trained" in the machine learning sense with a data set.

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

As no training set is discussed or implied by the technology, this question is not applicable based on the provided information.

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