(267 days)
Dr's Finder 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 Dr's Finder device is an apex locator "intended for detecting the apex of root canal."
Here's an analysis of its acceptance criteria and the study conducted to prove it:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Dr's Finder) |
|---|---|
| Accuracy | ±0.2mm |
2. Sample Size and Data Provenance:
The document mentions "comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth."
- Sample Size: The exact number of extracted teeth used is not specified in the provided document.
- Data Provenance: The study was conducted using extracted teeth, which implies a "non-clinical" setting. The country of origin for the data is not explicitly stated, but the manufacturer, "Good Doctors Co., Ltd.," is located in "Incheon, Republic of Korea."
3. Number of Experts and Qualifications:
The document does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method:
The adjudication method for establishing ground truth is not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on comparing the performance of the device against a predicate device using test cases, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The "comparison testing" on the Dr's Finder focused on its performance in locating the apex of root canals in extracted teeth, which is an evaluation of the algorithm/device's performance in isolation.
7. Type of Ground Truth Used:
The ground truth for the performance study was established by measurements on extracted teeth. The document does not elaborate on how this ground truth measurement was precisely determined (e.g., direct visual inspection, microscopic analysis, etc.), but it is implied to be a direct physical measurement.
8. Sample Size for Training Set:
The document does not mention a training set or its sample size. This suggests that the device's development might not have involved a typical machine learning training and testing paradigm as is common with some AI devices. It's more likely based on established electrical impedance principles.
9. How Ground Truth for Training Set Was Established:
Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided information.
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