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PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) premarket notification summary. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details of a novel device's performance validation. Therefore, many of the requested categories (especially those related to AI/MRMC studies, ground truth establishment for large datasets, and clinical trials) are not applicable or detailed in this type of submission.

1. A table of acceptance criteria and the reported device performance

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 for test set: The document does not specify the sample size for the surface tension test.
• Data provenance: Not specified. The tests were "Non-Clinical Tests," implying laboratory-based.

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)

• Not applicable. The "ground truth" for non-clinical performance tests like pH and surface tension would be based on standard scientific measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for non-clinical laboratory tests.

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

• No. This device is a chemical solution (root canal cleanser), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a chemical solution, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the performance characteristics (pH, appearance, composition, surface tension), the "ground truth" is derived from standard analytical chemistry and physical property measurements.

8. The sample size for the training set

• Not applicable. This is not a machine learning device; there is no training set.

9. How the ground truth for the training set was established

• Not applicable. There is no training set.

Study Proving Device Meets Acceptance Criteria:

The document describes a Non-Clinical Performance Test to demonstrate that PacEndo™ EDTA is substantially equivalent to its predicate device, EDTA Plus (K072555).

• Name of Study: "Surface tension test using contact angle measurement" was performed in comparison to the predicate device.
• Outcome: "The subject device was found to have similar surface tension compared to the predicate device and can be used as intended."
• Biocompatibility: A biocompatibility assessment and risk analysis were conducted. The results "demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use."
• Conclusion: The summary states, "non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use."

The entire submission focuses on showing substantial equivalence through direct comparison of technological characteristics (Indications for Use, Composition, Performance properties like pH and appearance) and a targeted non-clinical test (surface tension) rather than a comprehensive, independent validation against specific performance targets. No clinical testing was provided or deemed necessary for this 510(k) submission.

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