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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.

Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.

The provided text is a 510(k) summary for a medical device called "Apex Locator". It details a comparison to a predicate device and states that non-clinical tests were performed. However, it explicitly states that no clinical test data was used to support the decision of substantial equivalence. This means that a study proving the device meets acceptance criteria, as typically understood in the context of clinical trials or performance evaluations with human subjects/data, was not conducted or reported in this submission. The "acceptance criteria" and "device performance" mentioned here refer to specifications confirmed through non-clinical testing and comparison to the predicate.

Given this, I cannot provide information on:

• The study that "proves the device meets the acceptance criteria" in a clinical sense.
• Sample size used for the test set and data provenance (as no clinical test data was used).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth (as no clinical data).
• Sample size for the training set (as no clinical data).
• How ground truth for the training set was established (as no clinical data).

I can, however, provide the acceptance criteria based on the non-clinical tests and the device performance as reported in the comparison table and discussion of differences.

Non-Clinical Acceptance Criteria and Reported Device Performance

The provided document describes acceptance criteria and reported "performance" based on non-clinical tests and comparison to a predicate device. The primary method for demonstrating performance and safety was through compliance with recognized standards and verification that design differences do not affect safety and effectiveness.

Key takeaway: This submission focuses on engineering, safety, and functional conformance rather than clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Study that proves the device meets the acceptance criteria":

The "study" referenced in the document is a series of non-clinical tests and a detailed comparison to a legally marketed predicate device. The conclusion of substantial equivalence is based on demonstrating that the proposed device:

1. Complies with relevant recognized safety and performance standards: These include IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability), IEC 62304 (software), ISO 10993-1 and ISO 10993-11 (biocompatibility), and IEC 62133-2 (battery safety).
2. Performs the same intended function as the predicate device.
3. Has fundamental technological characteristics that are substantially equivalent to the predicate device.
4. Any differences in technological characteristics (e.g., dimensions, weight, battery capacity, means of input) do not raise new questions of safety or effectiveness. For each noted difference, the submitter provided a justification that it "would not affect its safety and effectiveness" or "could not effects the performance and safety."
5. Achieves the same specified performance metric as the predicate device where applicable (e.g., Measurement Accuracy: ±0.5mm).

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no clinical study that "proves the device meets the acceptance criteria" in terms of patient outcomes or comparative clinical performance. The acceptance is based on engineering principles, compliance with standards, and a robust non-clinical comparison to a predicate device.

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The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.

Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.

The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.

Here's an analysis of the acceptance criteria and study information for the Electronic Apex Locator (Alpha Apex I), 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 does not explicitly state the numerical sample size used for the accuracy testing test set (e.g., number of teeth, number of measurements). It only mentions that "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted."

The data provenance is not specified. It is unclear if the data was collected retrospectively or prospectively, or its country of origin.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

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

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. The device is an electronic apex locator, which is typically used directly by a single dental practitioner, not for multi-reader interpretation of images or data.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Accuracy Testing" section states, "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm." This indicates the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used for the accuracy measurements (e.g., direct visual measurement through transparent tooth, X-ray confirmation, histological analysis). It only refers to "internal technical requirements" for verifying accuracy.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is likely because the Electronic Apex Locator is a hardware device based on electrical impedance principles, and while it contains a microprocessor and software, the core "measurement" algorithm is typically determined through engineering design and calibration rather than machine learning training on a large dataset in the way a diagnostic AI would be. The software validation (Alpha Apex I.1.0.0) focuses on general software development life cycle processes, not necessarily on a training and testing paradigm for an AI model.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established. The device relies on physical principles and calibrated measurements rather than a trained AI model in the conventional sense.

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APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).

The provided text is a 510(k) summary for an "Apex Locator" device. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about AI/ML models, clinical studies for AI device performance, or acceptance criteria and proven performance related to such models.

The document explicitly states: "Clinical performance testing was not conducted." This directly indicates that there is no data to address the points in your request that pertain to acceptance criteria and study proving performance for an AI/ML device.

Therefore, I cannot provide the requested information because the document describes a traditional medical device (an Apex Locator based on electrical impedance measurement) and not an AI/ML-driven device. The review focuses on substantial equivalence based on technological characteristics and non-clinical performance (electrical safety, EMC, usability, biocompatibility, reprocessing validation), not on AI/ML model performance.

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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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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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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.

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BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BOMEDENT Apex locator, WISMY Apex locator

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states that multiple tests were conducted to demonstrate the device meets the acceptance criteria. These include:

• Internal test method for Accuracy Testing: This test shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806).
• Compliance with International Standards:
  • IEC 60601-1:2005+A1:2012 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
  • IEC 80601-2-60:2012 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment)
  • IEC 60601-1-2:2014 (Electromagnetic Compatibility)
  • IEC 62133:2012 (Secondary cells and batteries safety requirements)
  • ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
  • ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
• Compliance with FDA Software Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
• Cleaning, Low Level Disinfection, and Sterilization validation: Per FDA Guidance Document, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.

Detailed Information about the Study:

• The document mentions "Internal test method" for accuracy testing, but provides no specific details such as test parameters, methodology, or results beyond the claim of equivalence.

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

• Sample Size: Not specified in the provided text for the accuracy testing.
• Data Provenance: Not specified. It only states "Internal test method." No information on country of origin or whether it was retrospective/prospective.

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

• Not applicable/Not specified. The accuracy testing seems to be a technical performance comparison against a predicate device, not involving expert-established ground truth in a clinical setting.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. This information is not relevant for the type of technical performance testing described.

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

• No, a MRMC comparative effectiveness study was not done. The document states, "Clinical testing is not required."
• Effect Size: Not applicable.

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

• Yes, a standalone performance test was done in the form of "Accuracy Testing" using an "Internal test method" which evaluated the device's ability to determine working length. The device itself (an apex locator) is a standalone measurement tool, indicating its performance without human intervention (beyond operating it).

7. Type of Ground Truth Used:

• Not explicitly stated as a "ground truth" in clinical terms. For the accuracy testing, the performance of the predicate device (Propex IQ® Apex Locator, K191806) serves as the benchmark against which the subject device's performance is compared for demonstrating equivalence. This implies a technical or simulated ground truth established by comparing measurement outputs, rather than a clinical outcome or pathology.

8. Sample Size for the Training Set:

• Not applicable/Not specified. The device is a measurement tool, not an AI/machine learning algorithm requiring a "training set" in the traditional sense.

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

• Not applicable. As there is no mention of a training set for an AI/ML algorithm, this information is not relevant.

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Propex IQ® Apex Locator supports the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The proposed Propex IQ® Apex Locator is a microprocessor-controlled device that supports the dentist during endodontic treatments for the determination of the file to the reference point for endodontic working length determination. To do so, the proposed Propex IQ® Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed Propex IQ® Apex Locator product configuration consists of the following components:

• The proposed Propex IO® Apex Locator
• The proposed Propex IQ® Apex Locator Measurement cable
• The Proposed X-Smart IO® Measurement Cable
• The proposed Propex IQ® Apex Locator External Tester
• The Propex IQ® Disposable Barrier Sleeve
• The proposed Propex IQ® Lip clip
• The proposed Propex IQ® File clip
• The proposed Propex IQ® Clamp
• Propex IQ® Charger and AC Adapter Plugs

The document describes the Dentsply Sirona Propex IQ Apex Locator and its non-clinical performance data to demonstrate substantial equivalence to its predicate devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the "Accuracy Testing" or "Disinfectant Resistance Testing." It refers to "Internal test method" for accuracy, suggesting it was conducted in a controlled lab or in-house environment rather than a clinical setting. Given the nature of the device (apex locator), the "test set" for accuracy would likely involve extracted teeth or simulated root canals.

The data provenance is non-clinical performance data, primarily from internal testing and conformance to international standards. There is no mention of country of origin for the data; it is assumed to be performed by the manufacturer, Dentsply Sirona. The tests are retrospective in the sense that they are conducted on a developed device to prove its performance against established standards and predicates.

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 or qualifications of experts used to establish ground truth for the non-clinical tests. For "Accuracy Testing," the "ground truth" would likely be the actual measured length of the root canal established by precise laboratory methods or a gold-standard manual measurement. This might involve trained technicians or dental professionals, but their specific roles and numbers are not detailed.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as this was a non-clinical study focused on direct measurement and conformance to standards, not subjective interpretation.

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

No MRMC comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool; it is an apex locator, a measurement device for determining root canal length. There is no "human reader" component in the context of interpretation or AI assistance.

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

The accuracy testing on the Propex IQ Apex Locator and its comparison with predicate devices served as a standalone performance assessment of the device's ability to measure root canal length. The device itself operates to provide a measurement, and its performance was evaluated independently.

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth would be the actual physical measurements of root canal length, likely established by high-precision manual or digital methods that are considered the gold standard for such measurements in dental research (e.g., direct visualization after sectioning, or radiographic measurements validated post-extraction). The document states "Internal test method," implying a controlled experimental setup to determine true root canal length.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is not described as being based on machine learning or AI that requires training data. It is a measurement device based on electrical resistance principles.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.

Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex. Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.

The provided text describes a 510(k) premarket notification for the Apex Locator, DPEX III. It aims to demonstrate substantial equivalence to a predicate device, the RAYPEX 6.

Here's an analysis of the acceptance criteria and study information based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria for performance were met by demonstrating equivalence to the predicate device through performance comparison testing.

Note: The document does not provide quantitative specific acceptance criteria (e.g., "accuracy must be within X mm") or numerical performance data for the device. Instead, it relies on demonstrating equivalence to a legally marketed predicate device.

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

• Sample Size: The document mentions "using extracted tooth" for the performance comparison test, but it does not specify the sample size (i.e., number of extracted teeth) used for this test set.
• Data Provenance: The data provenance is retrospective, as it involves testing performed by the manufacturer to demonstrate equivalence. The country of origin of the data is not explicitly stated, but the manufacturer is "Guilin Woodpecker Medical Instrument Co., Ltd." in P.R. China.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The performance comparison test relies on a comparison against the predicate device, and the method for establishing "ground truth" for the apex location is not described beyond "using extracted tooth." There is no mention of human experts defining ground truth for the device's accuracy.

4. Adjudication Method for the Test Set

No adjudication method is described. Given the type of device (apex locator) and the testing described (comparison using extracted teeth), a human adjudication process by multiple experts is not indicated as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This indicates that there was no human-in-the-loop study comparing human readers with and without AI assistance.

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

The performance comparison test "using extracted tooth" functions as a standalone performance test for the device's ability to locate the apex. It evaluates the device's accuracy against the predicate without direct human interaction influencing the measurement outcome during the test itself. However, it's not an "algorithm" in the sense of a software AI model; it's a physical device measurement.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison test appears to be established by the measurement of the predicate device (RAYPEX 6). The aim was to show the new device's measurements were equivalent. For an apex locator, the true anatomical apex location in an extracted tooth would be the actual ground truth, but the document frames the comparison against the predicate as the basis for performance acceptance. It's essentially "predicate device performance" as the de facto standard for this submission.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is an electrical impedance-based apex locator, not an AI/ML device that requires a training set in the conventional sense. Its "knowledge" is embedded in its electrical design and algorithms, which are determined during engineering and design, not through a data-driven training process.

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

Not applicable/Not provided. As stated above, this is not an AI/ML device that uses a "training set" with established ground truth.

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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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