(63 days)
ADHESIVE HYBRID IONOMER CEMENT is used for:
- Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals
- Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins
- Adhesive cementation of gold inlays and onlays
- Adhesive cementation of prefabricated and cast posts.
- Adhesive cementation of porcelain/ceramic/composite substrate crowns
- Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns)
- Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins
- Adhesive liner for bonding freshly placed direct amalgam restorations
ADHESIVE HYBRID IONOMER CEMENT is a two-component, dualcure, high-strength hybrid ionomer dental cement used for permanent cementation of crowns and bridges, and for adhesive bonding of fresh direct amalgam to tooth structure. The cured product demonstrates adhesion to dentin and enamel, releases fluoride, and has suitable physical properties required for a dental luting cement, as well as a protective barrier.
The provided text is a 510(k) summary for a dental cement, "ADHESIVE HYBRID IONOMER CEMENT." This document focuses on demonstrating substantial equivalence to a predicate device based on material properties and biocompatibility, rather than assessing the performance of a diagnostic device requiring clinical studies with acceptance criteria, sample sizes, and ground truth established by experts.
Therefore, many of the requested categories in your prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable points and note where information is not available due to the nature of this submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical "acceptance criteria" in the way one might for diagnostic accuracy or clinical efficacy. Instead, it relies on demonstrating comparable physical properties and biocompatibility to a predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties | "The physical properties of ADHESIVE HYBRID IONOMER CEMENT are comparable to Advance® Hybrid Ionomer Cement (K940914)." |
| Biocompatibility | - MEM Elution Test: Found to be non-cytotoxic. |
- Ames Mutagenicity Test: Found to be non-mutagenic.
- Histopathologic Study (sub-human primates): "All responses were found to be acceptable." |
| Component Safety | "All of the components found in ADHESIVE HYBRID IONOMER CEMENT have either been used in legally marketed devices or have been found safe for dental use." |
2. Sample Size Used for the Test Set and Data Provenance
- MEM Elution Test & Ames Mutagenicity Test: The specific sample sizes for these in-vitro tests are not mentioned in the summary.
- Histopathologic Study: The number of sub-human primates used is not specified.
- Data Provenance: The location or retrospective/prospective nature of the biocompatibility studies is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here relates to safety and material properties, assessed through standardized laboratory tests and a histopathologic study, not through expert consensus on diagnostic interpretations. For the histopathologic study, it's implied that qualified personnel (e.g., pathologists/veterinary pathologists) would interpret the results, but their number and specific qualifications are not stated.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for expert review of images or clinical cases to establish a ground truth. Here, the assessment is based on laboratory test results and histopathological findings.
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 device is a dental cement, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental cement; there is no algorithm or AI component involved.
7. The Type of Ground Truth Used
- Laboratory Test Results: For non-cytotoxicity (MEM Elution) and non-mutagenicity (Ames Test).
- Histopathological Findings: For the in-vivo study, the "ground truth" would be the observed tissue reactions assessed by trained experts (likely pathologists).
- Component Safety: Established by prior use in legally marketed devices or general recognition of safety for dental use.
8. The Sample Size for the Training Set
Not applicable. As a material, there is no "training set" in the context of machine learning or AI. The development of the cement would involve formulation and testing, but not a dataset used for algorithm training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 872.3275 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.