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The Root Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Root Apex Locator C-ROOT I is a oral equipment used for root canal measurement. The device includes a TFT colour display with touch panel displays parameters such as battery status, connection status of test wire and apex position, etc. Users can also set and modify the sound level, brightness level, DR'S CHOICE via a touch panel, and provide a functional check of the device and cable.

The Root Apex Locator is a dental device used to detect the apex of the root canal. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily based on the accuracy testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Internal test method" for accuracy testing. It does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It only mentions "Internal test method" for accuracy.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the accuracy test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focuses on the device's standalone accuracy and compliance with various non-clinical standards, and substantiates equivalence to a predicate device. There is no mention of human readers improving with AI assistance, as this is not an AI-powered device.

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

Yes, a standalone performance test was done for the device's accuracy. The "Accuracy Testing" section explicitly states that the "Internal test method demonstrated that the apex position measurement accuracy of the proposed Root Apex Locator C-ROOT I meets the requirement of ±0.5mm." This indicates a measurement of the device's intrinsic performance.

7. The Type of Ground Truth Used

The type of "ground truth" for the accuracy testing is implied to be a precise measurement of the actual apex position, against which the device's measurement is compared. The document does not specify if this was established by expert consensus, pathology, or outcomes data. However, for a root apex locator, the ground truth would typically be a verified measurement of the true working length (e.g., direct measurement on extracted teeth or high-resolution imaging).

8. The Sample Size for the Training Set

The device described is a medical instrument (Root Apex Locator), not an AI/ML algorithm that typically requires a 'training set'. Therefore, the concept of a training set and its sample size is not applicable in this context. The performance evaluation is based on non-clinical testing for accuracy, safety, and compliance with standards.

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

As this is not an AI/ML algorithm, there is no training set and thus no ground truth establishment for a training set. The device's functionality is based on bioelectrical principles for sensing the root apex, not on learned patterns from a training dataset.

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Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

The subject device is a lightweight, fully-automatic, batteryoperated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. 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 500 Hz and 2000 Hz. The current between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.

The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.

Here is an analysis of the provided text, focusing on acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the "JUSTWO" Model TME-601 Root Apex Locator. Instead, it focuses on demonstrating substantial equivalence to a predicate device and proving its accuracy. However, we can infer the unstated acceptance criterion related to accuracy based on the study's findings.

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

• Test Set Sample Size: The document mentions "sample extracted teeth" but does not specify the exact number of teeth or measurements used in the in vitro testing model.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the company is Japanese (Toei Electric Co., Ltd., Japan). The study itself is an in vitro test.
  • Retrospective or Prospective: The study was a prospective in vitro testing model.

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

The document does not specify the number of experts or their qualifications. The ground truth was established through physical measurements, radiographic measurements, and Ingle's calculated length. While these methods imply the involvement of skilled individuals (e.g., those performing physical measurements or reading radiographs), the text does not detail their expertise.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts making decisions. The comparison was made against established measurement methods (physical, radiographic, Ingle's).

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

• Was an MRMC study done? No, the document does not describe an MRMC comparative effectiveness study involving human readers. The study was an in vitro assessment of the device's accuracy.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study involving human readers or AI assistance was conducted.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone study was done. The in vitro testing model assessed the device's accuracy directly by comparing its measurements to physical, radiographic, and Ingle's calculated lengths. This evaluates the algorithm's (or device's electrical measurement system's) performance without direct human intervention in the measurement process beyond initiating the device and recording results.

7. Type of Ground Truth Used

The ground truth used was a combination of:

• Physical measurements: Directly measuring the length of the extracted teeth.
• Radiographic measurements: Measurements obtained from radiographs.
• Ingle's calculated length: A standardized method for calculating working length in endodontics.

8. Sample Size for the Training Set

The document does not mention a discrete training set. The device's design and underlying electrical principles are based on established knowledge of impedance/current changes in the root canal. The "accuracy" study described serves as a validation or test set, not a training set for the device itself.

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

Not applicable, as a separate training set for a "machine learning" type algorithm is not described. The device operates based on fixed electrical principles using two frequencies (500 Hz and 2000 Hz) and comparing currents, rather than being "trained" on a dataset in the modern AI sense.

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Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.

The subject device is a lightweight, fully-automatic, battery-operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. 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 500 Hz and 2000 Hz. The impedance between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.

The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, the performance evaluation aims to demonstrate "no significant difference" between the subject device and the predicate device, and "no significant statistical differences" between the subject device and Ingle's method.

Given this, the table below reflects what can be inferred as the implicit performance target based on the study's conclusions.

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

• Sample Size: The document states that "sample extracted teeth having both straight and curved canals" were used, but it does not specify the exact number of teeth used in the test set.
• Data Provenance: The study was an "in vitro testing model," meaning it was conducted in a laboratory setting using extracted teeth, not on live human subjects. The country of origin of the data is implicitly Japan, as the submitter, Toei Electric Co., Ltd., is based in Japan. The study is described as a "Non-Clinical Data" study.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth was established through "measurements obtained physically, radiographically, and using an Ingle's calculated length." This suggests a combination of objective physical measurements and a recognized clinical method (Ingle's).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers/experts for the test set. The ground truth was established through specific measurement techniques (physical, radiographic, Ingle's method).

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

This was not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an electronic root canal length measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, the concept of human reader improvement with/without AI assistance does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was effectively a standalone performance study of the device. The "accuracy of the subject device was confirmed using an in vitro testing model" by comparing its output directly against established ground truth methods. It measures an objective physical characteristic (length) and does not involve human interpretation as part of its primary function during this test.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Physical measurements: Direct measurements on the extracted teeth.
• Radiographic measurements: Measurements derived from X-ray images.
• Ingle's calculated length: A well-known clinical method for determining root canal length.

8. The Sample Size for the Training Set

The document does not mention a training set. This type of device, an electronic measurement tool, typically does not involve machine learning or AI models that require a separate training set. Its functionality is based on established electrical impedance principles.

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

As no training set is mentioned or implied for this device, information on how its ground truth was established is not applicable/provided.

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