(104 days)
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the QMix™ 2in1 Endodontic Irrigating Solution:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device is a "Cleanser, Root Canal" and its indication for use is to "cleanse and disinfect the root canal system after endodontic instrumentation." The core of the submission relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | - All components have been used in legally marketed devices and found safe for dental use. |
| - Biocompatibility data provided. | |
| Effectiveness/Performance | - Efficacy demonstrated via non-clinical in vitro and ex vivo studies. |
| - Device "cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation," similar to the predicate device. | |
| Substantial Equivalence | - Believed to be substantially equivalent to the cleared and marketed BioPure MTAD root canal cleanser based on prior use of components, performance, and biocompatibility data. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical studies were conducted, meaning no test set of patient data was used.
- Data Provenance: Not applicable. The studies mentioned are non-clinical (in vitro and ex vivo).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical studies were performed requiring expert ground truth establishment for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical studies with a test set were conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states: "No clinical studies were conducted on this device." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in a sense, but not for an "algorithm" in the context of an AI device. The efficacy of the chemical solution itself was demonstrated through non-clinical in vitro and ex vivo studies. These studies evaluate the direct performance of the device (the irrigating solution) without human interpretation of images or data in a diagnostic context.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical in vitro and ex vivo studies, the "ground truth" would be established by scientific methods appropriate for laboratory assays, such as:
- Microbiological assays: To quantify bacteria killing.
- Electron microscopy or other imaging techniques: To assess smear layer removal.
- Chemical analysis: To confirm component presence, stability, and reaction kinetics.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a chemical solution, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data used to train an AI model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.
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