(426 days)
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.
| Acceptance Criteria (from ISO 6876:2012) | Reported Device Performance (DIA-PROSEAL) |
|---|---|
| Setting time | Conforms |
| Film Thickness | Conforms |
| Radio-opacity | Conforms |
| Solubility | Conforms |
| Flow | Conforms |
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:
| Biocompatibility Test (from ISO 10993 series) | Reported Device Performance (DIA-PROSEAL) |
|---|---|
| Bacterial Reverse mutation (Genotoxicity) | Conforms |
| Cytotoxicity | Conforms |
| Sensitization | Conforms |
| Irritation/Intracutaneous reactivity | Conforms |
| Acute systemic toxicity | Conforms |
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.
§ 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.