(86 days)
Use TheraCem to cement the following:
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- Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
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- Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
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- Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
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- Metal (prefabricated or cast) and non-metal/fiber endodontic posts
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- Implant supported restorations
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- Orthodontic Appliances (brackets, bands)
TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.
The provided text is a 510(k) summary for the dental cement TheraCem. It describes the device, its indications for use, technological characteristics, and performance data, but it does not contain the information you're looking for regarding acceptance criteria and study details for an AI/CADe device.
Specifically, the document focuses on demonstrating substantial equivalence to predicate dental cements based on physical and mechanical properties, not on AI-assisted diagnostic or decision-making capabilities. Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The document provides a table of physical/mechanical properties tested for TheraCem and states its equivalence to predicates or compliance with ISO standards, but these are not "acceptance criteria" in the context of an AI device's diagnostic performance (e.g., sensitivity, specificity, AUC).
- Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a dental cement, "ground truth" would relate to its physical properties (e.g., bond strength, setting time), which are measured according to established standards (e.g., ISO).
- The sample size for the training set: Not applicable, as there's no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
The document is for a medical device (dental cement) that does not involve AI or diagnostic imaging. The performance data presented is about the product's physical and chemical characteristics, which are compared to predicate devices for substantial equivalence.
§ 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.