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

Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

The provided text describes the regulatory clearance of a dental root canal filling material, Vista BC Putty. It references non-clinical performance testing but does not include information about clinical studies, expert-based ground truth, or MRMC studies that are typically associated with AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 6876 standards for dental root canal sealing materials. The reported performance indicates compliance with these standards and comparability to predicate devices.

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 provided in the document. The document refers to "benchtop testing" and "accelerated shelf-life testing" for non-clinical performance but does not specify sample sizes or data provenance.

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 information is not applicable and not provided. The testing described is non-clinical (benchtop, shelf-life, etc.) for a dental material, not an AI/ML device requiring expert ground truth for interpretation of medical images or other data.

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

This information is not applicable and not provided. The testing described is non-clinical and does not involve adjudication by experts.

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, an MRMC comparative effectiveness study was not done. The device is a dental material, not an AI/ML-based diagnostic or assistive technology for human readers.

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

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

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

The "ground truth" for the non-clinical performance evaluation appears to be established by the specifications and measurement methodologies defined in the ISO 6876 standard and other relevant international standards (e.g., ISO 10993 for biocompatibility) that govern dental materials. For example, set time is measured according to a defined procedure in ISO 6876.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. The device is a dental material, not an AI/ML algorithm.

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