(265 days)
Detect is an electronic device used to indicate the location of the apex and the working length. This product must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
Detect is a modern apex locator intended for precise localization of root canal apex. The measurements in Detect 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 Detect is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in Detect is based on high resolution TFT color graphic display. Clear real time presentation of endodontic file movement inside the canal is designed to make dentist's work easier and to increase his confidence. Display indicators are carefully designed to be intuitively understood and to serve for instant troubleshooting during device usage. Detect 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 and numerical 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. Numerical values and the numerical scale 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 Detect 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. Very dry canals should be wetted by hypochlorite or saline solution. Full automation of the apex locator operation simplifies the use and increases the reliability of the measurements. Detect may only be used with stainless steel or nickel titanium endodontic files. Built-in Demo mode of Detect enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria for the "Detect" device. However, it implicitly uses the performance of the predicate device, "BINGO PRO," as the benchmark for substantial equivalence. The key performance aspect for both devices is "precise apex localization" and "clinically acceptable results".
| Acceptance Criteria (Implied) | Reported Device Performance (Detect) |
|---|---|
| Precise apex localization | The apex localization obtained with Detect is the same as BINGO PRO. |
| Clinically acceptable results | Detect provides clinically acceptable results. |
| Same intended use as BINGO PRO | Detect has the same intended use as BINGO PRO. |
| Same fundamental scientific technology as BINGO PRO | Detect has the same fundamental scientific technology as BINGO PRO. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated, the document only mentions "ex-vivo test was performed on extracted teeth." The exact number of teeth used is not provided.
- Data Provenance: "ex-vivo test was performed on extracted teeth." This indicates the data was collected from biological samples (extracted teeth) outside of a live patient setting. The country of origin is not specified. The study is ex-vivo, which is a form of prospective testing on biological specimens.
3. 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):
This information is not provided in the document. The document simply states that the results of "Detect" were compared to the results of "BINGO PRO," implying that "BINGO PRO" served as a reference or a form of ground truth for the comparison, but without detailing how the true apex location was established for either device or if experts determined this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This is not applicable. The device, "Detect," is an electronic apex locator, not an AI system designed to assist human readers (e.g., radiologists interpreting images). The study compares the performance of one device to another, not human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance test was done. The "Detect" device's performance was evaluated independently during the ex-vivo test and then compared to the "BINGO PRO" device. The document describes the device's automatic operation ("fully automatic, no manual calibrations or adjustments are required") which supports the idea of a standalone assessment of its measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document implies that the ground truth was established by comparing "Detect" to the results obtained from the "BINGO PRO" apex locator, which is an FDA-cleared device. Therefore, the ground truth is essentially comparison against a predicate device with established performance, rather than an independent gold standard like direct anatomical measurement or pathology results.
8. The sample size for the training set:
This information is not provided in the document. The document describes an ex-vivo test for performance evaluation, but does not detail any internal training sets for the device's development.
9. How the ground truth for the training set was established:
This information is not provided in the document, as no training set details are given.
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