(184 days)
- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
- Suitable for use in single cone and lateral condensation technique.
EDS Bioceramic sealer (Bioseal) is a ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. EDS Bioceramic Sealer (Bioseal) is an insoluble, radiopaque material based on a calcium silicate and calcium phosphate composition, which requires the presence of water to set and harden. EDS Bioceramic Sealer (Bioseal) does not shrink during setting. EDS Bioceramic Sealer (Bioseal) is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with ISO standards and specifications for performance and biocompatibility. The acceptance criteria are implicit in meeting these standards. The device performance is reported as meeting these standards.
| Acceptance Criteria Category | Specific Criteria (Implicitly met by compliance with standard) | Reported Device Performance (Summary from text) |
|---|---|---|
| Performance | ISO 6876:2012 (Flow, Setting time, Solubility, Radiopacity, Film thickness) | EDS Bioceramic Sealer (Bioseal) demonstrated equivalence in performance to the predicate device (EndoSequence BC Sealer) based on testing to these standards. |
| ANSI / ADA Specification No. 57 (Endodontic Sealing Materials) | EDS Bioceramic Sealer (Bioseal) demonstrated equivalence in performance. | |
| Biocompatibility | ISO 10993-1:2018 (Biological evaluation of medical devices) | EDS Bioceramic Sealer (Bioseal) is non-mutagenic, non-cytotoxic, does not elicit an allergenic response, and exhibits excellent tolerance by subcutaneous tissue. |
| ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity) | Non-mutagenic. | |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | Non-cytotoxic. | |
| ISO 10993-6:2016 (Local effects after implantation) | Excellent tolerance by subcutaneous tissue. | |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Does not elicit an allergenic response. | |
| ISO 10993-11:2017 (Systemic Toxicity) | (No specific detail, but implied as part of overall biocompatibility) | |
| Safety | ISO 14971:2007 (Application for risk management) | Equivalence in safety to the predicate device demonstrated through biocompatibility testing. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test (Flow, Setting time, Solubility, Radiopacity, Film thickness) or for the biocompatibility tests. It broadly mentions "extensive bench (ISO 6876:2012) and biocompatibility testing."
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. These were non-clinical, bench-top tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For non-clinical, bench-top tests, the "ground truth" is typically established by the testing methodology itself (e.g., measuring flow according to ISO 6876). Expert consensus in the traditional medical imaging sense (e.g., radiologists) is not applicable here.
4. Adjudication method for the test set
Not applicable. This device underwent bench and biocompatibility testing, not human reader studies 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 a root canal filling material, a medical device, and not an AI-powered diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a root canal filling material, not an algorithm.
7. The type of ground truth used
For performance tests (Flow, Setting time, Solubility, Radiopacity, Film thickness), the ground truth is based on physical measurements and established parameters defined by the relevant ISO and ANSI/ADA standards.
For biocompatibility tests, the ground truth is derived from the results of the specific biological assays (e.g., cytotoxicity assays, genotoxicity assays) as per ISO 10993 series. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm that requires a "training set." The materials and manufacturing processes are developed based on scientific principles and prior knowledge of similar materials, rather than iterative machine learning.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of 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.