(219 days)
RAYPEX® 6 is a microprocessor controlled device used for locating the apex.
RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex. The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal. RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device. Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories. For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the RAYPEX® 6 apex locator:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in terms of accuracy metrics (e.g., percentage deviation from true apex within a specific range). Instead, the acceptance criterion for RAYPEX® 6 is based on demonstrating substantial equivalence to its predicate device, the BINGO PRO apex locator (K111474). This means the performance of RAYPEX® 6 must be "equivalent to" or "clinically acceptable" compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (RAYPEX® 6) |
|---|---|
| Clinically acceptable measurements | "The results obtained with RAYPEX® 6 were compared to the results of the FDA cleared device - BINGO PRO apex locator. The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable." |
| Equivalence to the predicate device (BINGO PRO) | "The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable since they are equivalent to the results of BINGO PRO device." |
| Clinically acceptable measurements in presence of irrigation liquids | "RAYPEX® 6 measurements in presence of different, irrigation liquids are clinically acceptable." |
| Same intended use as predicate | "RAYPEX® 6 has the same intended use... as its predicate device - BINGO PRO (K111474)." |
| Same fundamental scientific technology as predicate | "RAYPEX® 6 has the same... fundamental scientific technology as its predicate device - BINGO PRO (K111474)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of "extracted teeth" used for the ex-vivo test. It only states that the test was performed "on extracted teeth."
- Data Provenance: The study was conducted "ex-vivo" (meaning outside a living organism, likely in a laboratory setting using extracted human or animal teeth). The country of origin for the data is not specified. It is a retrospective or prospective study from the perspective of how the test set was collected. Given that it's an ex-vivo test on extracted teeth, it would be considered prospective in the sense that the test was specifically designed and executed for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the extracted teeth. The "ground truth" for an apex locator study typically involves physically measuring the true apex after the teeth have been prepared or sectioned.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (such as 2+1, 3+1, or none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. This study focuses on the standalone performance of the device compared to a predicate device, not on how human readers improve with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "ex-vivo test was performed on extracted teeth" directly evaluating the RAYPEX® 6 apex locator's measurements and comparing them to those of the BINGO PRO apex locator. This assesses the device's ability to locate the apex on its own, without direct real-time human intervention influencing its measurement output.
7. Type of Ground Truth Used
The type of ground truth used is implied to be a physical measurement of the true apex on extracted teeth. While not explicitly stated, ex-vivo apex locator studies typically rely on histological or direct microscopic measurement of the true anatomical apex after the tooth has been prepared or sectioned.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. Apex locators like RAYPEX® 6 are typically engineered based on physical principles (impedance measurement at different frequencies) and do not usually involve machine learning models that require a "training set" in the conventional sense (i.e., for supervised learning). The "microprocessor controlled device" refers to its operational logic, not necessarily an AI algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of machine learning) is described for this device.
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