(114 days)
The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point. The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
The APX21 is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
Acceptance Criteria and Study Details for APX21 Electronic Apex Locator
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Range | Reported Performance (APX21) |
|---|---|---|
| Accuracy of apex localization | ±0.5 | Achieved "high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5." |
| Stability | Unconditionally stable | "proved to be unconditionally stable" |
| Improved accuracy (narrowed range) | ±0.2 | "accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2." |
2. Sample Size and Data Provenance
The document does not specify the exact sample size for the In-Vitro and In-Vivo studies for the APX21 or the Root ZX.
The data provenance is not explicitly stated in terms of country of origin, but the contact person for the submitter is located in Israel, suggesting the studies likely occurred there or under the oversight of individuals in Israel.
The studies were retrospective or prospective is not specified.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish the ground truth for the test set.
It mentions "Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics," tested the APX21 device in his clinic and noted observations, but it is not explicitly stated that he was the sole or primary expert for establishing objective ground truth for the comparative studies.
4. Adjudication Method
The adjudication method for the test set is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compares the APX21 against a predicate device (Morita's Root ZX) in terms of accuracy and stability, but not directly on how human readers' performance improves with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for the APX21. The "In-Vitro and In-Vivo studies" evaluated the performance of the APX21 and compared it to the predicate device, the Root ZX, specifically focusing on "accuracy and stability." The reported accuracy rates are directly attributable to the device itself.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly defined in the provided text. It can be inferred that the "accuracy" measurements were based on a definitive endpoint for the apex, likely established through either physical measurements in vitro or direct visualization/measurement in vivo (e.g., radiography, direct measurement during surgical exposure if applicable, or a highly reliable gold standard method in endodontics).
8. Sample Size for the Training Set
The document does not specify a training set sample size or mention the use of a training set for the device, as electronic apex locators typically rely on bio-impedance principles rather than machine learning models that require explicit training data.
9. How the Ground Truth for the Training Set Was Established
As the device described (APX21) relies on bio-impedance principles and not a machine learning model, a "training set" in the conventional sense is not applicable, and therefore, how its ground truth was established is not relevant to its design.
N/A