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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.

AI/ML Overview

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

Test	Acceptance Criteria (Internal/ISO Standard)	Reported Device Performance for BIO-C REPAIR ION+
Physical/Chemical Properties
Setting Time (ISO 6876:2012)	90-120 minutes	90-120 minutes
Solubility (ISO 6876:2012)	Not explicitly stated in the document as a numerical acceptance criterion, but implied as meeting the standard's requirements for "insoluble".	Meets the standard's requirements for being insoluble
Radiopacity (ISO 6876:2012)	Not explicitly stated as a numerical acceptance criterion in the text, but the reported performance for the predicate deviceBIO-C SEALER ION+ is "≥ 7 mm Al," and for BIO-C REPAIR and BIO-C REPAIR ION+ it's "~ 7 mm Al". It is implied that BIO-C REPAIR ION+ meets comparable radiopacity.	~ 7 mm Al
Injectability	Incorporated into product acceptance criteria (no specific value provided).	Test performed and reported to meet criteria.
X-ray diffraction	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
Particle size distribution	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
Color determination analyses	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
pH	> 10	> 10
Biocompatibility (ISO 10993-1:2009)
Sensitization	Non-sensitizing	Non-sensitizing
Irritation	Non-irritant	Non-irritant to oral mucosa of hamsters
Mutagenicity (Genotoxicity)	Non-mutagenic and did not induce genotoxic effects to bone marrow cells of mice. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Acute Systemic Toxicity	Absence of acute systemic toxicity after single oral administration. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Local and Systemic Toxic Effects upon Implantation	Did not demonstrate local and systemic toxic effects when implanted. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Overall Biocompatibility	Biocompatible according to ISO 10993-1:2009	Biocompatible according to ISO 10993-1:2009

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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