(141 days)
Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental cement called "Hy-Bond Resiglass." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the document:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document does not list any specific acceptance criteria or performance metrics for the device. The FDA's determination is based on substantial equivalence to predicate devices, not on the demonstration of meeting specific performance criteria detailed here.
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Sample size used for the test set and the data provenance:
- Cannot be provided. The document does not describe any test sets or studies performed by the manufacturer to establish performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The document does not describe any test sets or expert involvement in establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. The document does not describe any test sets or adjudication methods.
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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:
- No MRMC study was done, nor is this an AI device. This device is a dental cement, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a dental cement, not an algorithm, so the concept of standalone performance does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document does not describe any ground truth establishment for performance testing. Substantial equivalence for this type of device typically relies on demonstrating similar physical and chemical properties and intended use to existing marketed devices.
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The sample size for the training set:
- Cannot be provided. The document does not describe any training sets.
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How the ground truth for the training set was established:
- Cannot be provided. The document does not describe any training sets or ground truth establishment for them.
§ 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.