(251 days)
Liquid used for root canal rinsing during endodontic treatment. During mechanical canal widening it removes the non-vital pulp debris. it cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.
Liquid for root canals rinsing
This document is a 510(k) summary for the medical device "CHLORAXID 3%" and "CHLORAXID 5,25%", which are liquids used for root canal rinsing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no specific, quantitative acceptance criteria or corresponding reported device performance metrics listed in a table format as would be typical for a new device claiming superiority or specific performance targets.
Instead, this submission is a Substantial Equivalence (SE) claim. The acceptance criterion for this type of submission is that the device is "substantially equivalent in safety and effectiveness" to legally marketed predicate devices.
The reported device performance, in this context, is the demonstration that CHLORAXID 3% and CHLORAXID 5,25% are substantially equivalent to their respective predicate devices based on:
- Similar intended use.
- Similar technological characteristics (main active substance is Sodium Hypochlorite as the standard of care for root canal irrigation).
- Chemical composition.
- Literature evidence for the biological effect of the chemical compounds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The non-clinical performance and biocompatibility data provided in this submission was based on professional literature by comparison with reference device and its chemical composition. Realistic study of biological effect of device CHLORAXID 3 % and CHLORAXID 5,25% has been abandoned because sufficient literature evidence exists for confirmation biological effect of device contained chemical compounds specified in their composition."
Therefore:
- Sample Size for Test Set: Not applicable, as no new clinical or non-clinical studies were conducted for this submission. The "test set" effectively refers to the existing body of scientific literature on Sodium Hypochlorite.
- Data Provenance: The data provenance is "professional literature," implying global scientific publications, not specific to one country or a retrospective/prospective study on this particular device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no new studies were performed, there were no "experts" establishing a ground truth for a specific test set related to this submission. The "ground truth" for the efficacy and safety of Sodium Hypochlorite as a root canal cleanser is established by the long-standing scientific and clinical consensus reflected in "professional literature."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new studies were performed or test sets created.
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
Not applicable. This device is a chemical liquid for root canal rinsing, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical liquid, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is expert consensus and accumulated scientific evidence published in professional literature regarding the efficacy and safety of Sodium Hypochlorite as a root canal cleanser. The document emphasizes that Sodium Hypochlorite "is the standard of care for root canal irrigation," which strongly points to an established expert consensus.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device (a chemical solution) or for a Substantial Equivalence submission purely based on literature review.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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