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1. Sealing the root canal of permanent teeth;

2. Internal reabsorption treatment;

BIO-C SEALER ION* is a ready-to-use injectable bioceramic root canal sealer, developed for sealing the root canals and for the treatment of internal reabsorption. The product is a single paste provided in a syringe with disposable intracanal tips to be applied directly into the root canal system. BIO-C SEALER ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root canal sealer materials.

The document describes the non-clinical performance testing for the BIO-C SEALER ION+ device. Here is the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria versus reported performance for each specific test. Instead, it states that tests were performed "according to ISO 6876:2012 Dental root canal sealing materials" and that "additional tests are also performed and incorporated into the product acceptance criteria." For biocompatibility, it states the device "has met the requirements." Based on the comparison table and the text, we can infer some details.

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

The document explicitly states: "NON-CLINICAL PERFORMANCE TESTING: BIO-C SEALER ION* has undergone extensive bench testing." It lists various tests. However, the exact sample size for each specific test (e.g., how many units were tested for setting time, or how many animals for each biocompatibility test) is not specified in the provided text.

The data provenance is non-clinical/bench testing and animal testing for biocompatibility. No human data is mentioned. The manufacturer is Angelus Indústria de Produtos Odontológicos S/A, based in Brazil. Therefore, the data provenance for non-clinical testing would be from their labs or contracted facilities. The study is prospective in the sense that the device was specifically tested to meet the standards.

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

This section is not applicable to the provided text. The performance assessment relied on established international standards (ISO 6876:2012 for physical/chemical properties and ISO 10993-1:2009 for biocompatibility). These standards define test methodologies and criteria, rather than requiring expert consensus on a test set's ground truth in the way a diagnostic AI tool would. The experts involved would be those performing and interpreting the ISO standard tests, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic devices where multiple human readers assess cases. This document describes non-clinical performance and biocompatibility testing against international standards, not a clinical trial requiring human adjudication of results.

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:

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a root canal filling material, and the evaluation is non-clinical, focusing on its physical, chemical, and biological properties, not its impact on human reader performance.

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

This section is not applicable. The device is a physical dental material, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by conformance to international standards (ISO 6876:2012 for dental root canal sealing materials and ISO 10993-1:2009 for biological evaluation of medical devices). For biocompatibility, this means the device did not elicit mutagenic, irritant, sensitizing, or acute systemic toxic effects as defined by the standard's methodologies. For physical properties, it means the device's setting time, solubility, flow, film thickness, and radiopacity fell within the acceptable parameters or demonstrated comparability to predicates as assessed by the standard's tests.

8. The Sample Size for the Training Set:

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This section is not applicable as there is no training set for a physical medical device.

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• 1. Sealing the root canal of permanent teeth;
• 2. Internal reabsorption treatment.

BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.

The provided text describes a 510(k) premarket notification for a dental device called BIO-C SEALER. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing clinical efficacy studies with specific acceptance criteria as might be found for a novel device or drug.

Therefore, the supplied text does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance in a clinical context. The performance data is for physical-chemical properties to show equivalence to the predicate.
• Sample size used for a test set (clinical data).
• Data provenance for a test set (clinical data).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only without human-in-the-loop performance).
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical efficacy.
• Sample size for a training set (clinical data).
• How ground truth for the training set was established (clinical data).

Instead, the document highlights non-clinical (bench) testing to support substantial equivalence.

Here's what can be extracted from the document regarding "performance criteria" in the context of a 510(k) and the "study" (bench tests) that proves them:

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

The document states: "BIO-C SEALER has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP. Bench tests performed are: flow, setting time, film thickness, solubility and radiopacity. Both devices have comparable flowability, setting time, film thickness, solubility and radiopacity."

This implies that the acceptance criteria for BIO-C SEALER's physical-chemical properties were to demonstrate comparability or substantial equivalence to the predicate device (iRoot SP) for these specific metrics. The reported performance is that they are comparable.

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "extensive bench testing." The sample size would refer to the number of samples of the material tested for each physical-chemical property.
• Data provenance: Bench test results; conducted by Angelus Indústria de Produtos Odontológicos S/A. It's non-clinical, so country of origin for patients/data is not relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was bench testing of physical properties, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set

Not applicable. This was bench testing.

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 is a dental material, not an AI diagnostic device.

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

Not applicable. This is a dental material, not an AI algorithm.

7. The type of ground truth used

For physical-chemical properties, the "ground truth" is measured by standard laboratory methods according to relevant ISO or ASTM standards, against which the test device's performance is compared to the predicate device's established performance or regulatory requirements. For biocompatibility, the ground truth would be established by validated tests for mutagenicity, allergenicity, and general tolerance.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. This device does not use machine learning or require a training set.

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