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CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:

• Temporary disinfectant dressings in the obturation of root canals;
• Indirect pulp capping or management of deep caries lesions; or
• Direct pulp capping.

CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.

This document describes the premarket notification (510(k)) for CleaniCal, a Calcium Hydroxide Cavity Liner. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and comparison of characteristics, rather than a clinical study evaluating diagnostic accuracy or reader performance of an AI-powered device.

Therefore, many of the typical elements used to describe the acceptance criteria and the study proving an AI-powered device meets those criteria are not directly applicable or available in this type of submission. This premarket notification is for a dental material (calcium hydroxide paste), not an AI device.

Let's break down what can be extracted and what cannot, based on the provided text, in the context of your request for an AI device.

Observation: The provided document describes a medical device (a dental calcium hydroxide paste called "CleaniCal"), not an AI-powered device. Therefore, many of the questions related to AI-specific study designs (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size) will not be addressed in this document.

However, I will interpret the request as best as possible using the available information, mapping it to your bullet points where applicable, and highlighting where information is not present for this type of device.

Acceptance Criteria and Device Performance for CleaniCal (a Dental Material)

The acceptance criteria for "CleaniCal" are primarily defined by its ability to meet established ISO standards for dental root canal filling materials and its biocompatibility. The study proving the device meets these criteria is a series of non-clinical (bench and biocompatibility) tests.

1. A table of acceptance criteria and the reported device performance:

The document states: "All the test results met the preset test criteria." The "preset test criteria" are the specific requirements within the referenced ISO standards. The table below summarizes the types of tests performed and the general outcome as stated in the document. Specific numerical acceptance values or reported performance metrics for each test (e.g., exact flow rate, specific radio-opacity value) are not provided in this 510(k) summary, only that the device "met" them.

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

• Sample Size for Test Set: Not explicitly stated in the document. For non-clinical bench testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
• Data Provenance: The testing institution is MARUCHI itself (the manufacturer) or external labs contracted by MARUCHI, as implied by "Testing institution's method." The country of origin for the testing would likely be Republic of Korea as that is where MARUCHI is located. These are non-clinical, pre-market tests, so the retrospective/prospective distinction for clinical data doesn't apply here.

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

• Not Applicable. For this type of dental material, "ground truth" is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO 6876, ISO 10993). This does not involve clinical "experts" in the sense of radiologists reading images to establish ground truth for diagnostic AI. The tests are laboratory-based measurements.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy assessments where human readers interpret data that AI might also interpret. The tests performed for CleaniCal are objective laboratory measurements, not subjective evaluations requiring adjudication.

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 is not an AI-powered device. Therefore, no MRMC study, AI assistance comparison, or effect size calculation with human readers was performed or is relevant.

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

• Not Applicable. This is not an AI-powered device.

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

• For CleaniCal, the "ground truth" is based on objective measurements of material properties and biological responses as defined by international standards (ISO 6876, ISO 10993 series). This includes properties like pH, flow, radio-opacity, and results of various biocompatibility tests (cytotoxicity, systemic toxicity, genotoxicity, implantation). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is not an AI-powered device. There is no "training set" or "ground truth establishment" for a training set.

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1. Sealing the root canal of permanent teeth;

2. 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.

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.

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