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The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

The EZ-Fill® Xpress Epoxy Root Canal Cement System is an obturation system for filling straight and minimally curved canals. The bi-directional spiral (cement carrier that fully coats the canal, but prevents excess cement form exiting apically) and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. The contents of the kit are identical except that '2 - Dual Chambered Syringes containing 9.5 gm of root canal sealer' and '20 - Mixing Tips' replace the '7.5 gm - Epoxy Root Canal Cement Gel, 8.0 gm - Powder (Epoxy Root Canal Cement), and 1 Measuring Scoop.' The full list of contents is as follows: 4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1 - 21mm length and 3 - 25 mm length), 2 - Dual Chambered Syringes containing 9.5 gm root canal sealer, 20 - Mixing Tips.

The provided document describes the EZ-Fill® Xpress Epoxy Root Canal Cement System and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence through:

• Comparison of device description, intended use, and technological characteristics to predicate devices.
• Bench testing to show compliance with international standards (ADA Specification No.57 and ISO 6876) for physical properties.
• Biocompatibility literature to show no new safety concerns compared to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are Not Applicable (N/A) based on the provided text, as a direct study demonstrating achievement of criteria is not presented.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only mentions "Bench Testing performed" without detailing the number of samples or tests conducted.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Bench testing against pre-defined physical property standards does not typically involve expert ground truth establishment in the same way clinical or diagnostic studies do. The "ground truth" here is the standard itself.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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. The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." This is a material testing for a root canal cement, not a diagnostic AI device.

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

• Not Applicable. This is not an AI/algorithm-based device.

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

• For physical properties, the ground truth is based on the requirements and methodologies outlined in ADA Specification No.57 and ISO 6876.
• For biocompatibility, the ground truth is established by biocompatibility literature and Material Safety Data Sheets, indicating that the materials do not raise new safety concerns compared to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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