Search Results

DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.

DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.

The provided document describes the DIA-PROSEAL root canal filling resin and its substantial equivalence to a predicate device, AH Plus Root Canal Sealer. The focus is on non-clinical performance and there is explicitly no clinical performance data.

Here's a breakdown of the requested information based on the provided text:

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

The document details the conformance of DIA-PROSEAL with ISO 6876:2012 (Dentistry — Root canal sealing materials). This standard sets the acceptance criteria for root canal sealing materials. The device's reported performance is its conformance to these tests, implying that the results obtained for DIA-PROSEAL met the specifications outlined in ISO 6876:2012.

Additionally, the device demonstrates conformance to biocompatibility standards: ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. Specific biocompatibility tests performed include:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the non-clinical tests (e.g., number of samples tested for setting time, film thickness, etc.). It only states that the device "demonstrated conformance" with the listed standards. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the provided document. The ground truth for this medical device is established through compliance with international standards for material properties and biocompatibility, not expert consensus on anatomical images or clinical outcomes. The "ground truth" is defined by the measurable parameters and limits set in the ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes in clinical studies or image interpretation, which are not detailed here. The conformance to standards is based on physical and chemical testing.

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. The document explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no MRMC study, AI assistance, or human reader improvement data is present.

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

Not applicable. This device is a root canal filling resin, a physical material, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The ground truth used for proving the device's performance is conformance to established international standards for dental materials, specifically ISO 6876:2012 for root canal sealing materials, and the ISO 10993 series for biological evaluation of medical devices (biocompatibility). The success of the device is measured against the physical, chemical, and biological requirements outlined in these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device (a resin), not an AI algorithm or model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device