(283 days)
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Sealing the root canal of permanent teeth;
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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.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance (BIO-C Sealed ION+) |
|---|---|
| Physical/Chemical Properties (ISO 6876:2012) | |
| Setting time (range) | 120-240 minutes (Equivalent to predicate K172701) |
| Solubility | Tested according to ISO 6876:2012 (Insoluble, similar to predicates) |
| Flow | Tested according to ISO 6876:2012 (Comparable to predicate K172701) |
| Film thickness | Tested according to ISO 6876:2012 (Comparable to predicate K172701) |
| Radiopacity | $\ge 7$ mm Al (Equivalent to predicate K172701) |
| Additional Tests (Incorporated into acceptance criteria) | |
| X-ray diffraction analysis | Performed |
| Particle size analysis | Performed |
| Viscosity and thixotropy tests | Performed |
| Color determination analysis | Performed |
| Biocompatibility (ISO 10993-1:2009) | |
| Non-mutagenic | Met requirements (demonstrated to be non-mutagenic) |
| Non-irritant to oral mucosa of hamsters | Met requirements (demonstrated to be non-irritant) |
| Non-sensitizing | Met requirements (demonstrated no sensitizing effects) |
| Absence of acute systemic toxicity after single oral administration | Met requirements (demonstrated absence of acute systemic toxicity) |
| pH | 10.5 (Equivalent to predicate K172701, for which pH is 12.5; within acceptable range for bioceramic sealers, inferred as acceptable although a specific range isn't stated). The document states "Equivalent to BIO-C SEALER" for pH, even though the values are different. This implies the difference is considered acceptable. |
| Insoluble | Stated in Principle of Operation, implying it meets the expectation for root canal sealers. |
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.
§ 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.