(59 days)
Permanent obturation of root canals of the permanent teeth in combination with root canal points
VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.
The provided text does not describe an AI/ML powered medical device or software. It pertains to a dental device, specifically a root canal filling resin. Therefore, the questions regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for an AI/ML device are not applicable to this document.
The document discusses the substantial equivalence of the VioSeal root canal filling resin to a predicate device based on non-clinical tests.
Here's the relevant information found in the document regarding the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ISO 6876) | Reported Device Performance (VioSeal) |
|---|---|---|
| Flowability | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Working Time | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Setting Time | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Film Thickness | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Solubility | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Radio-opacity | Meets ISO 6876 requirements | Meets ISO 6876 requirements |
| Biocompatibility | Good biocompatibility | Good biocompatibility |
2. Study that Proves the Device Meets Acceptance Criteria:
A non-clinical study investigated the performance of VioSeal according to ISO 6876 standards for root canal filling materials.
- Sample size used for the test set and the data provenance: Not explicitly stated, but implies laboratory testing of the material itself. It is a non-clinical study, not a study involving human or image data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a materials science characterization, not an expert-driven ground truth assessment.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML or diagnostic device.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: The "ground truth" or reference standard for these non-clinical tests is the established methodology and specifications outlined in the ISO 6876 standard.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.