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• · Furcation or root perforation treatment via canal;
• · Furcation or root perforation treatment via surgical;
• · Internal reabsorption treatment via canal or surgical;
• · External reabsorption treatment;
• · Retrofilling in parendodontic surgery;
• · Direct and indirect pulp capping;
  · Apexification;
• · Apexogenesis and Pulpotomy.

BIO-C REPAIR ION+ is a bioceramic reparative material ready-to-use suitable for furcation or root perforation treatment via canal, furcation treatment via surgical, internal reabsorption treatment via canal or surgical, external reatment, retrofilling in parendodontic surgery, direct and indirect pulp capping, apexification, apexogenesis and pulpotomy.
The product is a single paste provided in a syringe with blunt tips to be applied into the root canal system. BIO-C REPAIR 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 repair materials.

This document describes the marketing authorization for the Bio-C Repair Ion+ dental device. It does not contain information about the acceptance criteria or study details as typically associated with AI/ML-based medical devices. The device is a traditional dental material, not an AI or ML product. Therefore, I cannot provide an answer that includes details such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the information relevant to the non-clinical performance testing conducted for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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 as it pertains to a traditional material device, not software, AI, or ML. The document refers to "extensive bench testing" and biological evaluations according to ISO standards, which typically involve specific numbers of samples or animals as defined by those standards. The data provenance (country of origin or retrospective/prospective nature) is not specified.

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

This is not applicable as the document describes a material device and evaluates its physical, chemical, and biological properties, not diagnostic or predictive performance requiring expert ground truth setting like an AI/ML device.

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

Not applicable for a physical material device.

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 dental material, not an AI or ML system intended to assist human readers.

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

Not applicable. This device is a dental material.

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

For the non-clinical tests, the "ground truth" is defined by the objective measurements and methodologies outlined in the ISO standards (ISO 6876:2012 for physical properties and ISO 10993-1:2009 for biocompatibility). For example, setting time is measured by a specific physical method, and cytotoxicity is assessed via laboratory assays, not expert consensus or pathology in a clinical setting.

8. The sample size for the training set

Not applicable for a physical material device.

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

Not applicable for a physical material device.

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Reparative cement for endodontic complications.

1. Furcation or root perforation treatment via canal;
2. Furcation or root perforation treatment via surgical;
3. Internal reabsorption treatment via canal or surgical;
4. External reabsorption treatment;
5. Retrofilling in parendodontic surgery;
6. Direct and indirect pulp capping;
7. Apexification;
8. Apexogenesis and Pulpotomy.

BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.

The provided document is a 510(k) summary for the dental device BIO-C REPAIR. This document primarily focuses on establishing substantial equivalence to predicate devices based on comparisons of indications for use, technological characteristics, and performance data from bench testing. It does not describe a clinical study directly proving the device meets specific acceptance criteria in a clinical setting in the way an AI/ML device would.

However, based on the provided text, we can infer the acceptance criteria for various physical-chemical properties and present the reported device performance. No information is available regarding AI/ML specific criteria such as sensitivity, specificity, or accuracy, as this is a dental material, not an AI/ML diagnostic tool.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the ISO 6876:2012 standard for dental root canal sealing materials and the properties of the predicate devices. The "reported device performance" refers to BIO-C REPAIR's measured characteristics.

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

The document does not specify a "test set" in the context of human data or AI/ML model evaluation. The performance data is derived from bench testing of the material itself. Therefore, sample sizes for the bench tests would refer to the number of material samples tested for properties like setting time, pH, radiopacity, and solubility. This information is not provided in the document.

Data provenance: The testing was performed by the manufacturer, Angelus Indústria de Produtos Odontológicos S/A, based in Londrina, Brazil. The data is from laboratory (bench) testing, not clinical. It is retrospective in the sense that the tests were completed before the 510(k) submission.

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

This is not applicable as the device is a dental material, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for the material's properties is established through adherence to international standards (ISO 6876:2012) and comparison to predicate devices, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" requiring adjudication in the context of human expert review for a dental material. The performance measurements are objective laboratory tests.

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 dental filling material, not an AI-assisted diagnostic tool.

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

This is not applicable. The device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the properties of BIO-C REPAIR is established by objective laboratory measurements according to an international standard (ISO 6876:2012) and comparison to the characteristics reported for legally marketed predicate devices. This is analogous to "physical and chemical properties" ground truth.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML model and therefore does not have a "training set."

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

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

Ask a specific question about this device