(44 days)
For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.
Metapaste is intended for use by qualified healthcare personnel trained in its use.
Metapaste calcium hydroxide with Barium Sulfate is a device consisting of a temporary root canal sealer paste contained within a plastic syringe, packaged with disposable applicator tips and a plastic ring rotator for direction control of the tip. It is a device intended for use by qualified healthcare personnel trained in its use.
The Metapaste device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
The provided document is a 510(k) summary for a dental device (Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with a test set.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. The submission relies on a comparison of characteristics and compliance with existing standards (ISO 6876 and ISO/TR 7405) to establish equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific acceptance criteria in a quantitative table format that a study would aim to meet. Instead, it compares the "Physical Properties" and "Biocompatibility" of Metapaste with its predicate devices, indicating that Metapaste meets the standards required of such devices. The "performance" is implicitly stated as being equivalent to the predicate devices and compliant with the listed ISO standards.
| Characteristic | Acceptance Criteria (Implied by Standards & Predicate) | Metapaste Reported Performance |
|---|---|---|
| Physical Properties: | ISO 6876 (Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & Disintegration) | Complies with ISO 6876 for Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & disintegration |
| Biocompatibility: | ISO/TR 7405 Agar diffusion test (Freedom from toxicity), ISO 10993-11 Acute intervenous application (Biocompatible) | Freedom from toxicity per ISO/TR 7405 Agar diffusion test. Biocompatible per ISO 10993-11 Acute intervenous application. |
| Labelling: | Temporary root canal sealer | Temporary root canal sealer |
| Intended Use: | Similar to predicate | Similar to predicate |
| Human Factors: | Dispensed ready to use | Dispensed ready to use |
| Design, Construction, Components: | Premixed paste, packaged in plastic syringe, disposable tips | Premixed paste, packaged in plastic syringe, disposable tips |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to compliance with ISO standards, which would involve testing, but the sample sizes for these tests are not provided in this summary.
- Data Provenance: Not specified, but implied to be from laboratory testing conforming to ISO standards. The country of origin of the data is not mentioned. The studies would be considered prospective in the context of validating performance against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" here is compliance with established international standards (ISO). The standards themselves are developed by expert consensus in their respective fields, but there's no mention of specific experts establishing ground truth for Metapaste's individual tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable and not provided. This type of adjudication is typically for image-based or clinical diagnostic studies, not for material property testing or biocompatibility assessments against defined standards.
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 material science and biocompatibility assessment, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used is adherence to international standards for dental materials (ISO 6876) and biocompatibility (ISO/TR 7405, ISO 10993-11). These standards define acceptable ranges for physical properties and methods for assessing safety.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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.