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i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

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

i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe.

The provided document is a 510(k) premarket notification for a medical device called "CeraPutty," which is a root canal filling resin. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory filing and does not contain information about a study proving the device meets acceptance criteria in the way a clinical or diagnostic performance study would. It presents information regarding the device's technical characteristics and non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study against a specific performance benchmark for diagnostic accuracy or effectiveness with human subjects.

Therefore, many of the requested elements regarding acceptance criteria for a diagnostic device performance study, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and training set details are not applicable or available in this type of regulatory submission. The document focuses on showing that the new device (CeraPutty) is similar enough to an already approved device (iRoot BP Plus) to be considered safe and effective for the same indications.

Here's the information that can be extracted or inferred from the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the typical sense of a diagnostic performance study (e.g., minimum sensitivity, specificity). Instead, it compares the performance of the subject device (CeraPutty) to the predicate device (iRoot BP Plus) based on performance standards (ISO 6876) and specific physical properties. The implicit "acceptance criterion" is that the subject device's performance is comparable to or better than the predicate device for these properties, and within the bounds of the standard.

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

• Sample Size: Not explicitly stated. The document refers to "Performance tests" and "Biocompatibility Tests" but does not provide details on the number of samples or specimens tested for these non-clinical evaluations.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from patients. The manufacturer is Meta Biomed Co., Ltd. in South Korea.

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):

Not applicable. This is not a study requiring expert ground truth in the diagnostic sense. The "ground truth" for the performance tests would be the results obtained from calibrated laboratory equipment according to the specified ISO standards.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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:

Not applicable. This device is a material for dental procedures, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a material for dental procedures, not an algorithm.

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

The "ground truth" for the non-clinical performance tests mentioned (setting time, solubility, radio-opacity) would be derived from measurements obtained via standardized laboratory protocols according to ISO 6876:2012. For biocompatibility, it would be results from standardized biological tests according to ISO 10993 series.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device 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 device.

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