(164 days)
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.
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (ApexNRG Rider) |
|---|---|
| Intended Use: | To measure 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 |
| Electric Current: | Less than 10 μA |
| Method of calculating location of root canal apex: | Comparison of a multi-frequency response signal using DSP technology with a different algorithm reducing the delay between calculation and display of measurement. The signals are generated as a response to multi-frequency signals having a 6.5 and 1.3 kHz repetition rate. The frequencies used for comparison 6.5 kHz - 1.3 kHz Square Wave with 3 cycles used for measurement. |
| Frequencies used for comparison: | 6.5 kHz - 1.3 kHz Square Wave |
| Number of cycles used for measurement: | 3 |
| Display: | 6 LED- Distance provided every 0.25 mm from 0.5 mm to the apex. (Note: Predicate has 8 LED, but "Distance provided every 0.25 mm from 0.5 mm to the apex" is deemed "Same")* |
| Adjustment before measurement: | Not required |
| Measuring Voltage: | Up to 15 mV |
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.
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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).
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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.
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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.
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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.
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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.
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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).
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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.
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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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