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Cementation of Gutta-Percha in root canal using the single cone technique.

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This document is a 510(k) clearance letter from the FDA for a dental cement, Premier EndoCem Glass Ionomer Cement, and does not contain the detailed study information typically found in a clinical study report or a premarket approval (PMA) application. Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment is not available in this document.

The primary purpose of this letter is to state that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Here's what can be extracted, and what is explicitly not available:

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

• Not available in this document. The FDA letter grants clearance based on "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a similar device already on the market. It does not provide specific performance metrics or acceptance criteria for a new study.

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

• Not available in this document. This letter does not describe any specific test set or study methodology.

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 available in this document.

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

• Not available in this 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:

• Not applicable and not available. This device is a dental cement, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems with human readers.

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

• Not applicable and not available. Again, this is a physical dental cement, not an algorithm.

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

• Not available in this document. If a comparison was made for substantial equivalence, it would likely involve in vitro testing or perhaps clinical data demonstrating similar mechanical properties, biocompatibility, or sealing capabilities to the predicate device. The exact "ground truth" for showing equivalence is not detailed here.

8. The sample size for the training set:

• Not applicable and not available. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable and not available.

Summary of available information related to the device:

• Device Name: Premier EndoCem Glass Ionomer Cement
• K Number: K042215
• Regulation Number: 21 CFR 872.3275(b)
• Regulation Name: Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Indications for Use: Cementation of Gutta-Percha in root canal using the single cone technique.

To obtain the detailed information requested, one would typically need to review the original 510(k) submission (which is usually not publicly available in its entirety due to proprietary information) or a specific clinical study report if one was conducted and published. The FDA clearance letter itself is a summary of their decision, not the full scientific dossier.

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