(90 days)
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
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Identical materials and fabrication methods to predicate device. | The patient contacting part (lip clip) is composed of identical materials and fabricated using the same methods as the primary predicate device (K131907). |
| Electrical Safety | Conformance to IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012. | The proposed Propex IQ® Apex Locator conforms to the standard requirements. |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2014. | The proposed Propex IQ® Apex Locator conforms to the standard requirements. |
| Software Verification & Validation | Conformance to IEC 62304:2015 and FDA guidance "General Principles of Software Validation". | Software Verification and Validation tests were conducted in accordance with the specified standards and guidance. |
| Accuracy Testing (vs. RAYPEX® 6) | Performance equivalent to primary predicate device RAYPEX® 6 (K131907). | The performance of the proposed Propex IQ® Apex Locator is equivalent to that of the primary predicate device RAYPEX® 6 (K131907). |
| Accuracy Testing (vs. Root ZX II) | Performance equivalent to reference device Root ZX II Apex Locator (K071190). | The performance of the proposed Propex IQ® Apex Locator is equivalent to that of the reference device: Root ZX II Apex Locator (K071190). |
| Disinfectant Resistance | Resistance to chemical disinfectants supporting substantial equivalence. | Applicable device components were assessed for resistance to chemical disinfectants and the results support substantial equivalence. |
| Information Display Latency | Latency supporting substantial equivalence. | Device display latency in all modes was assessed and the results support substantial equivalence. |
| Hardware Requirements Verification (Battery, Audio, Temp, Ingress, Mating Components) | Performance meeting device hardware requirements. | Verification testing of hardware requirements (battery performance, audio alarm, temperature, liquid ingress, mating components connection cycling) was included, and results support substantial equivalence. |
| Wireless Coexistence | Maintained functional wireless performance in the presence of unintended signals. | The proposed Propex IQ® Apex Locator maintained functional wireless performance in the presence of unintended signals. |
| Usability Study | Users able to use the device correctly and safely without use error. | Usability Studies conducted showed that users were able to use the device correctly and safely without use error. |
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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