(70 days)
Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations. Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, II, III and V cavities and cervical erosions; a final restorative for Class I and II of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings.
Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations, for Minimal Intervention (MI) dentistry.
This document describes a 510(k) premarket notification for the "GlasIonomer FX-II" dental cement. The key information regarding performance and testing is found in the "Biocompatibility" section.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Passed) |
|---|---|
| Acute oral toxicity | Acute oral toxicity |
| Bacterial reverse mutation | Bacterial reverse mutation |
| In vitro cytotoxicity | In vitro cytotoxicity |
| Subcutaneous implantation | Subcutaneous implantation |
| Sensitization | Sensitization |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each biocompatibility test. It also does not provide information on the data provenance (e.g., country of origin, retrospective/prospective). Dental cements are typically tested in vitro and in vivo (animal models) for biocompatibility, but the details are not included here.
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 in the document. Biocompatibility testing itself generates objective results (e.g., cell viability, mutation rates) rather than relying on expert interpretation for "ground truth" in the way an imaging AI model might. The interpretation of these results against established standards would be done by qualified toxicologists or biologists, but their number and specific qualifications are not mentioned.
4. Adjudication method for the test set
This is not applicable as the biocompatibility tests produce objective results, not requiring an adjudication method like those used for human-reviewed data sets in AI studies.
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
An MRMC comparative effectiveness study is not mentioned because this document is describing a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a dental cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for the biocompatibility tests is based on objective biological and toxicological measurements obtained through standard laboratory protocols. For example:
- Acute oral toxicity: Measured physiological responses in test subjects after oral exposure.
- Bacterial reverse mutation: Observation of bacterial colony growth on specific media.
- In vitro cytotoxicity: Measurement of cell viability or death in culture.
- Subcutaneous implantation: Histopathological examination of tissue reaction at the implant site.
- Sensitization: Observation of allergic reactions in test subjects.
These are established scientific methods with defined endpoints, not expert consensus or pathology reports in the diagnostic sense.
8. The sample size for the training set
This is not applicable as the document describes a dental cement, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a dental cement.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.