(79 days)
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips.
Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. §872.3275[b]) because it is a device composed of various materials other than zinc oxideeugenol. Unicem is intended to affix dental :.cvices such as crowns and bridges. Unicem currently is available in two single dose delivery systems called Unicem Aplicap™ and Unicem Maxicap™. The existing and 510(k) cleared device Unicem is modified as follows: A multi-dose handmix version of Unicem, called Unicem HM, will be added to the single dose delivery systems. Unicem HM is considered as a modification to its predicate device Unicem. Unicem HM consists of a base and catalyst base and will be available in 3M ESPE's multi-dose device Clicker™. The intended use of Unicem HM is the same as cleared for Unicem, and the slight differences in chemical composition have been assessed for any effects regarding biocompatibility. The physical and chemical properties of Unicem HM were compared to those of Unicem. Furthermore, the physical-chemical property to release fluoride ions is added to the product description of Unicem. For this purpose, the fluoride release rates of Unicem have been measured following the guidance document: "Dental Cements - Premarket Notification" issued by CDRH on August 18, 1998, section 6.0.
The provided text is a 510(k) summary for a dental cement called Unicem. This document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance using the requested metrics.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Type of Device: Unicem is a dental cement, a physical material used to affix dental devices. It is not an AI/ML-driven diagnostic or image analysis device, which are the types of devices typically associated with "acceptance criteria," "reported device performance" in terms of accuracy/sensitivity/specificity, "sample sizes for test sets," "expert ground truth," "adjudication methods," "MRMC studies," or "standalone performance."
- Regulatory Focus: The 510(k) summary primarily focuses on demonstrating "substantial equivalence" of a modified version (Unicem HM, a multi-dose handmix version) to a previously cleared predicate device (Unicem). This involves comparing chemical composition, physical properties, and intended use, rather than clinical performance metrics in the way you've described for AI/ML devices.
- "Study" Mentioned: The only "study" mentioned is the measurement of fluoride release rates for Unicem, following a guidance document. This is a chemical/physical properties test, not a clinical trial or performance study against a ground truth in the context of an AI/ML device.
Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain that type of information for this kind of device.
If the request was for an AI/ML-driven diagnostic medical device, the information provided in such a 510(k) summary or associated study reports would typically include these details. However, for a dental cement, the "performance" is assessed through material properties and biocompatibility, not through diagnostic accuracy metrics or human reader studies.
The closest one could get to "acceptance criteria" and "reported device performance" from this document would be related to the physical and chemical properties compared with the predicate. For example, if the predicate device had specific benchmark values for flexural strength, bond strength, or setting time, the new device would need to meet those, and the study would show the measured values. However, these specific benchmarks are not detailed in this summary.
§ 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.