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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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