(8 days)
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
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Root Canal Length Measurement (Primary function of an apex locator) | "finer resolution in terms of its LED display" - This implies an improvement in the precision of the output, which indirectly suggests better accuracy or at least better representation of the measurement. |
| Safety and Efficacy (General) | Not explicitly stated with specific metrics. The document states "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This indicates that some form of testing was conducted to ensure the modifications did not negatively impact safety or efficacy compared to the predicate. |
| Predicate Equivalence | The device is deemed "substantially equivalent" to the predicate device (MedicNRG Electronic Apex Locator, K032743) regarding technology and intended use. This means its performance is considered comparable to a device already on the market. |
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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