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Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a medical device called "Bright MTA Sealer Plus." However, it is not an AI-driven device; it is a root canal filling material. Therefore, some of the requested information, such as details on AI acceptance criteria, expert ground truthing, MRMC studies, or training/test sets for an AI model, are not applicable and thus not present in the document.

The document primarily focuses on the biocompatibility and mechanical performance of the "Bright MTA Sealer Plus" in comparison to a predicate device.

Here's a breakdown of the available information based on your request, with an explanation for elements that are not applicable:

Device Name: Bright MTA Sealer Plus

Device Type: Root canal filling material (Non-AI device)

1. Table of Acceptance Criteria and Reported Device Performance

The closest information available is in the "Mechanical testing" section:

No.	Items	Standard & Method	Acceptance Criteria	Result
1	Visual test	ISO 4049 Bare eyes	No alien substance and suitable for using the product	No alien substance and suitable for using the product
2	Capacity test	ISO 4049 Weight difference	Standard weight ± 5%	1.50 %
3	Package test	ISO 4049 Bare eyes	No damages, cracks	The package was completely sealed, and there were no damages, cracks.
4	Extraneous matter test	ISO 4049 Bare eyes	No extraneous matter	No Extraneous Matter
5	Flow test	EN ISO 6876: 2012 5.2	Diameter ≥ 17mm	27mm
6	Setting time test	EN ISO 6876: 2012 5.4	≤ 360 min	Within 360min
7	Film thickness test	EN ISO 6876: 2012 5.5	≤ 50 μm	30 μm
8	Radio-opacity test	EN ISO 6876: 2012 5.7	More than 3mm	4.6mm
9	Solubility test	EN ISO 6876: 2012 5.6	≤ 3%	0.2%

In addition, Biocompatibility testing was performed with the following acceptance criteria and evaluation:

No.	Test	Standard & Method	Acceptance criteria	Evaluation
1	Cytotoxicity	EN ISO 10993-5 Agar diffusion assay	Non cytotoxic (Scale 0)	Scale 0 (Non cytotoxic)
2	Oral mucosal irritation	EN ISO 10993-23	Irritation index 0	Irritation index 0
3	Skin Sensitization	EN ISO 10993-10 GPMT	Sensitization score and rate 0	Sensitization score and rate 0
4	Acute systemic toxicity	EN ISO 10993-11 Single dose	No Acute systemic toxicity	No Acute systemic toxicity
5	Systemic toxicity	EN ISO 10993-11 Pyrogen test	No abnormal signs and dead	No abnormal signs and dead
6	Genotoxicity	EN ISO 10993-3 Back mutation.	No back mutation regardless of the presence or absence of a metabolic activation system	No back mutation
		Chromosomal aberration	No chromosomal aberration in CHL/IU cells	No chromosomal aberration in CHL/IU cells
7	Implantation	EN ISO 10993-6 Implantation	Biocompatible	Biocompatible
8	Sub-chronic toxicity	EN ISO 10993-11 Subchronic toxicity	No Subchronic toxicity	No Subchronic toxicity
9	Chronic toxicity	EN ISO 10993-11 Chronic toxicity	No chronic toxicity	No chronic toxicity
10	Carcinogenicity	EN ISO 10993-3 Carcinogenicity	No Carcinogenicity	No Carcinogenicity

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

Sample Size: Not explicitly stated in terms of number of samples/units tested for each mechanical or biocompatibility test, but the tests were performed on the device itself.
Data Provenance: The document implies in-house testing performed by or for Genoss Co., Ltd. The country of origin for the company is South Korea. The studies are assumed to be prospective tests on newly manufactured samples of the device.

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

Not Applicable. This is not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for this device's performance is derived from standardized physical and biological material testing.

4. Adjudication method for the test set

Not Applicable. As this is not an AI device involving human interpretation, there is no need for an adjudication method for a test set. The results are based on objective measurements from standardized tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study is relevant for AI systems that assist human readers in tasks like radiological interpretation. This device is a material, not an AI system, so an MRMC study would not be performed.

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

Not Applicable. This is not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used

The ground truth for this device's performance is based on objective measurements from internationally recognized standards (ISO and EN ISO) for dental materials and biocompatibility. For example, specific diameters for flow, time limits for setting, weight differences, and qualitative assessments of physical appearance and biological reactions are used as the "ground truth" against which the device's performance is measured. It's not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.

8. The sample size for the training set

Not Applicable. This is not an AI device that undergoes machine learning training.

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

Not Applicable. As it's not an AI device, there is no training set or associated ground truth establishment process.

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