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GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.

GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

This document describes the acceptance criteria and study proving the device meets those criteria for the GuttaSil, a root canal filling material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test within the non-clinical testing. It only generally refers to "the following testing was conducted." The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but it is implied to be laboratory testing conducted by or for Meta Biomed Co., Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The tests conducted are non-clinical, primarily physical, chemical, and biocompatibility tests based on ISO standards. These types of tests typically do not involve human expert adjudication of results in the way clinical performance studies do.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical performance and biocompatibility tests against quantitative ISO standards, not evaluations requiring human rater adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance and biocompatibility testing. The device is a material for root canal filling, not an AI-assisted diagnostic or treatment planning tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This device is a material (gutta-percha with a sealer) used in a medical procedure, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the ISO 6876:2012 standard for root canal sealing materials.

For the biocompatibility tests, the "ground truth" is adherence to the biocompatibility criteria specified in the relevant ISO 10993 series standards.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical material, not an AI algorithm or model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable, as there is no training set for this type of device.

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