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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

C-Root BP Bioceramic Root Repair Material (C-Root BP) is a convenient ready-to-use premixed bioceramic paste developed for permanent root canal repair and surgical applications. C-Root BP is an insoluble, radiopaque and aluminum-free material based on a strontium silicate composition, which requires the presence of water to set and harden. C-Root BP does not shrink during setting and demonstrates excellent physical properties. C-Root BP is packaged in a Preloaded syringe.

The provided document is a 510(k) summary for a medical device called "Bioceramic Root Repair Material (C-Root BP)". This document outlines the non-clinical testing performed to demonstrate that the subject device is substantially equivalent to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides two tables summarizing non-clinical performance testing.

Table 1: Summary of non-clinical performance testing according to the ISO 6876:2012

Table 2: Summary of non-clinical performance testing according to the Technical Requirements of "Bioceramic Root Repair Material" provided by our company

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

The document does not explicitly state the sample sizes used for the non-clinical performance tests. The data provenance is implied to be from laboratory testing conducted within the context of the manufacturer (Beijing C-Root Dental Medical Devices Co., LTD.) for both the subject device and the predicate device. It is therefore retrospective data collected specifically for this submission. The country of origin of the data is China, as the manufacturer is based in Beijing, China.

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

This information is not provided in the document. The "ground truth" for these tests refers to the objective measurement against established standards (ISO 6876:2012 and internal technical requirements), rather than expert consensus on clinical cases. Therefore, experts in dental product testing and metrology would be implied, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not applicable as the non-clinical tests involve objective measurements against specific criteria rather than subjective assessments requiring adjudication.

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

This is not applicable. The device is a "Bioceramic Root Repair Material," not an AI-powered diagnostic or decision-support tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This is not applicable. The device is a physical material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical performance tests comprises defined standards and criteria:

• ISO 6876:2012: An international standard for root canal sealing materials.
• Technical Requirements of "Bioceramic Root Repair Material": Internal company-defined standards.
  This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical and chemical property measurements against established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical material, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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