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The ApexNRG Rider is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

The ApexNRG Rider is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ApexNRG Rider device:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device (MedicNRG DAL Apex Locator, K080113) rather than detailing specific acceptance criteria and a standalone study for the ApexNRG Rider's clinical performance. The testing mentioned is non-clinical.

Summary of Device Performance and Acceptance Criteria (Based on Substantial Equivalence to Predicate):

The document doesn't explicitly state numerical acceptance criteria for clinical performance that the ApexNRG Rider itself must meet in a standalone study. Instead, its performance is implicitly accepted as meeting the same standards as its predicate device because it is deemed "substantially equivalent" in technology and intended use.

The table below reflects the characteristics stated to be "same" as the predicate, implying these common characteristics are the de facto "acceptance criteria" through equivalence.

Interpretation Note: While the predicate has 8 LEDs and the modified device has 6, the document states "Same" for the 'Display' characteristic, implying that the critical function of providing distance every 0.25mm from 0.5mm to the apex is preserved and equivalent, despite the different number of LEDs.

Detailed Study Information:

Based on the provided text, a formal clinical study with detailed results for the ApexNRG Rider to meet specific acceptance criteria is not described. The document explicitly states:

• "The determination of substantial equivalence is based on an assessment of non-clinical performance data. This testing consisted EMC and Electrical Testing as well as Software Validation. The results of this testing supported a determination of substantial equivalence."

Therefore, many of the requested items cannot be answered as directly applicable to a clinical performance study of the ApexNRG Rider itself.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated for clinical performance. The "testing" mentioned is non-clinical (EMC, Electrical, Software Validation).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not stated. No clinical test set with a ground truth established by experts is described for the ApexNRG Rider.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not stated. No clinical test set requiring adjudication is described.

4. 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 such study was done/described. The device is an apex locator, which is a measurement device, not an AI-assisted diagnostic tool for human readers.

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

   • A "standalone" performance was not described in the clinical sense. The entire submission hinges on demonstrating substantial equivalence to a predicate device, focusing on non-clinical performance data and technological similarities. There is no specific clinical "algorithm only" performance study detailed for this device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not stated for clinical performance. The "ground truth" for the non-clinical tests would be defined by engineering standards and specifications (e.g., electrical safety standards for EMC and Electrical Testing, software requirements for Software Validation).

7. The sample size for the training set:

   • Not applicable/Not stated. The document describes a specific dental apex locator for measurement, not a machine learning or AI system that requires a "training set" in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable/Not stated. As no "training set" for an AI/ML algorithm is mentioned, this information is not provided.

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The Apex DAL is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

The Apex DAL is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.

The provided text is a 510(k) summary and FDA clearance letter for a dental apex locator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and data provenance: No details regarding a test set, its sample size, or data origin are mentioned.
3. Number of experts used to establish ground truth and their qualifications: The document does not describe any ground truth establishment for a test set or the experts involved.
4. Adjudication method: No adjudication method is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The text does not refer to any such study or human reader improvement with AI assistance.
6. Standalone performance study: While the device is "algorithm only" in the sense it measures electronically, no dedicated standalone performance study with specific metrics is detailed. The comparison focuses on technological characteristics rather than performance metrics against a gold standard.
7. Type of ground truth used: No ground truth type (e.g., pathology, outcomes data) is specified for any performance evaluation.
8. Sample size for the training set: There is no mention of a training set or its sample size.
9. How ground truth for the training set was established: Correspondingly, no information on ground truth establishment for a training set is provided.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, rather than detailed performance study results against specific acceptance criteria. It mentions that the manufacturer "believes this difference does [not] raise additional safety of efficacy concerns" based upon "testing results," but these results are not elaborated upon in the provided summary.

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The ApexNRG-Blue is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

The ApexNRG Blue is a dental apex locator which has the ability to measure the depth of the root canal by electronic means. It has Blue-Tooth Capability.

This 510(k) summary (K071133) for the ApexNRG-Blue (Apex Locator) does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Here's an breakdown of the requested information based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided 510(k) summary does not explicitly state any specific acceptance criteria (e.g., accuracy thresholds, precision ranges) or numerical performance metrics for the ApexNRG-Blue. The document primarily focuses on establishing "substantial equivalence" to predicate devices based on technological characteristics and intended use.

The only statement related to performance is: "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This implies testing was done, but the results and the criteria used to evaluate them are not presented.

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

The document does not specify any sample size for a test set or the provenance of any data. It mentions "testing results" in a general sense but provides no details about the datasets used for these tests.

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

The document does not mention any experts, ground truth establishment, or their qualifications in the context of a performance study.

4. Adjudication Method

The document does not describe any adjudication method.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text.

6. Standalone Performance Study

While the statement "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns" implies some form of testing was conducted on the device's performance, the document does not present the results of a standalone (algorithm only without human-in-the-loop performance) study. The focus is on the device's technical characteristics and similarity to predicate devices.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The device described is an "Apex Locator," which is a hardware device for measuring root canal length, implying direct measurement rather than a machine learning algorithm that would require training data.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary of what is present:

• Device Name: ApexNRG-Blue (Apex Locator)
• Intended Use: Measurement of the length of root canals for dental procedures by a trained professional.
• Predicate Devices: MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG Electronic Apex Locator (K032743).
• Primary Difference from Predicate: Blue-Tooth Capability.
• Conclusion (regarding performance): "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns."

In conclusion, this 510(k) summary primarily addresses substantial equivalence based on technological characteristics and intended use, rather than detailing a specific performance study with explicit acceptance criteria, robust sample sizes, or detailed ground truth methodologies that would be typical for a device with an AI/ML component or complex imaging analysis. The device, an "Apex Locator," is likely a direct measurement tool, and its safety and efficacy would be evaluated through different means than a typical AI-driven diagnostic device.

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The ApexNRG XFR is intended for the measurement of the length of the root canal for purposes of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

The ApexNRG XFR is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

The ApexNRG XFR is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report to prove the device meets these criteria. The document is a 510(k) summary for a medical device (ApexNRG XFR Apex Locator), which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a full performance study with acceptance criteria.

However, based on the limited information, here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for a complete table: Specific quantitative metrics for accuracy (e.g., within +/- 0.5mm of the actual apex), precision, reliability, or clinical effectiveness. The current document is a summary and does not delve into these specifics.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified. The manufacturer is MedicNRG, Ltd. in Israel, but the location where the testing was conducted or the origin of the data is not mentioned.
• Retrospective/Prospective: Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• Was an MRMC study done? Not mentioned. This type of study is more common for diagnostic imaging devices where AI assists human readers. An apex locator is a direct measurement tool, so an MRMC study in the traditional sense is unlikely to be applicable for evaluating its primary function.
• Effect size of human readers with AI vs without AI assistance: Not applicable based on the device type and lack of mention.

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

• Was a standalone study done? The device itself is a standalone electronic apex locator, meaning its performance is inherently standalone in generating the root canal length measurement. It is not an AI algorithm that assists a human; it performs the measurement directly. The statement "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns" implies that the standalone performance of the device was evaluated. However, specific details of this evaluation (e.g., test setup, methodology) are not provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. For an apex locator, ground truth would typically be established by direct visual measurement (e.g., using a microscope, direct measurement on extracted teeth, or through surgical/histological confirmation in animal or cadaver studies).

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is an electronic measurement tool, not an AI/machine learning algorithm that requires a training set in the conventional sense. It's based on electrical impedance principles.

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

• How Ground Truth Established: Not applicable, as there's no training set for this type of device.

Summary of what the document does state regarding performance/testing:

• The primary differences from the predicate device are "finer resolution in terms of its LED display and the electrode connections has been changed."
• "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This is the only direct reference to testing results influencing the safety and efficacy claim. It suggests that some form of internal testing was conducted to confirm the changes did not negatively impact the device's performance or safety compared to the predicate. This testing would have implicitly involved checking the core functionality and accuracy.

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