(21 days)
Ionofil Plus AC is intended for the restoration of deciduous teeth; Ionofil Plus AC is intended in the restoration of documents in the dental Repair of cuneiform defects and enamel, as well as root erosions in the dental neck area, including class V fillings; Cavities with carious lesions; Filling of class III and small fillings of class I (including extended fissure sealing), and a Filing of class in and omall millings on s cavity lining.
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This document is a 510(k) premarket notification decision letter from the FDA for a dental cement named "Ionofil Plus AC." It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about the acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not available in the provided text as it pertains to AI/ML device evaluation.
However, I can extract the "Indications for Use" from the document, which outlines what the device is intended for. This can be seen as a form of "acceptance criteria" for the device's intended use, rather than performance metrics from a clinical study for an AI/ML product.
Here's a breakdown of what can be extracted based on the provided text, and what cannot due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a regulatory approval letter for a dental cement, not an AI/ML device. It does not report performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" in this context are the "Indications for Use":
| Acceptance Criteria (Indications for Use) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Restoration of deciduous teeth | The device is deemed substantially equivalent for this use. |
| Repair of cuneiform defects and enamel, as well as root erosions in the dental neck area, including class V fillings | The device is deemed substantially equivalent for this use. |
| Cavities with carious lesions | The device is deemed substantially equivalent for this use. |
| Filling of class III and small fillings of class I (including extended fissure sealing) | The device is deemed substantially equivalent for this use. |
| Cavity lining | The device is deemed substantially equivalent for this use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. This information is not provided in a 510(k) clearance letter for a dental material. Clinical study details (sample size, data provenance) are typically found in the 510(k) submission itself or related study reports, not the FDA's decision letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a study involving human experts establishing ground truth for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a study involving expert adjudication for an AI/ML device.
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 document is for a dental cement, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a dental cement, not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. This document is for a dental cement, not an AI/ML device. The "ground truth" for a dental cement would be its physical and chemical properties and clinical efficacy, which are evaluated through different types of studies (e.g., in-vitro tests, clinical trials for safety and effectiveness), not typically by expert consensus on data interpretation.
8. The sample size for the training set
Not applicable. This document is for a dental cement, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This document is for a dental cement, not an AI/ML 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.