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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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• Permanent obturation of the root canal following vital pulpextirpation.
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
  C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.

C-Root SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. C-Root SP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. C-Root SP does not shrink during setting and demonstrates excellent physical properties. C-Root SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. C-Root SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
C-Root SP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in2g; 1g; 0.5g. The only difference between the types are the net weight.

Based on the provided text, the device in question is an "Injectable Root Canal Bioceramic Sealer" and the submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, not necessarily a claim of improved performance or a direct clinical efficacy study. Therefore, a significant portion of the requested information, particularly regarding AI performance, MRMC studies, and detailed ground truth establishment for a diagnostic AI, is not applicable to this type of medical device submission.

Here's the breakdown of the information that can be extracted and applied, with N/A for criteria that are not relevant to this submission:

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

For a 510(k) submission, "acceptance criteria" are typically defined by recognized standards (like ISO 6876:2012) and comparability to the predicate device. The performance is assessed through non-clinical testing.

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

This information is not applicable as the provided document details a 510(k) submission for a root canal sealer, which relies on non-clinical performance and biocompatibility testing, not a clinical study involving human patient data or a diagnostic AI's test set. The tests performed are laboratory-based assays on the material itself.

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 is not applicable. Ground truth establishment by experts relates to diagnostic device performance evaluation, particularly for AI/image analysis. This document describes a material-based device.

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

This is not applicable as there is no diagnostic test set requiring expert 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. This submission is for a material (root canal sealer), not an AI-assisted diagnostic device.

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

This is not applicable. There is no algorithm or standalone AI performance to evaluate.

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

For this device, "ground truth" refers to the established scientific and engineering principles and the performance standards outlined in ISO 6876:2012, as well as biocompatibility standards (e.g., ISO 10993 series). The "truth" is whether the material meets these specified physical, chemical, and biological properties in laboratory settings.

8. The sample size for the training set

This is not applicable. There is no machine learning model or "training set" for this type of device.

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

This is not applicable. There is no machine learning model or "training set" for this type of device.

Ask a specific question about this device