(281 days)
- · 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
| 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.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.