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The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.

The provided text is a 510(k) summary for the medical device "ENDOCEM MTA PREMIXED REGULAR," which is a root canal filling material. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study involving AI, human readers, or a test set with ground truth established by experts, as typically seen in submissions for AI-powered diagnostic devices.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the content provided. I can, however, extract information regarding the acceptance criteria for the device itself and the tests performed to meet them.

Here's the information based on the provided text:

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

The document states that "All the test results met the preset test criteria." However, it does not explicitly list the specific acceptance criteria (e.g., "setting time must be between X and Y minutes") or the exact numerical results obtained for each test. It only lists the tests performed and implies that the performance was satisfactory.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The type of testing performed (bench and biocompatibility) generally does not involve "test sets" in the context of clinical or AI studies, but rather samples of the material for physical, chemical, and biological evaluation.

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 applicable to the provided document, as it describes the testing of a medical material, not a diagnostic device requiring expert interpretation of results for ground truth.

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

This information is not applicable to the provided 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

There is no mention of an MRMC study or AI in the provided document.

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

This information is not applicable to the provided document. The device is a root canal filling material, not an algorithm.

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

This information is not applicable in the traditional sense for this type of device submission. For the physical and chemical tests, "ground truth" would be established by the adherence to specified standards (e.g., ISO 6876) and validated testing methodologies. For biocompatibility, "ground truth" is determined by established biological safety endpoints and accepted testing protocols (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device with a training set.

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

This information is not applicable as this is not an AI/machine learning device with a training set.

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