(26 days)
Nexus 2 Modified is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.
Nexus 2 Modified is a dual cured, chemical and light cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and encdodontic posts. Nexus 2 Modified is a two-part, base/catalyst - paste/paste, system.
The provided text is a 510(k) summary for a dental luting cement, Nexus 2 Modified. It focuses on establishing substantial equivalence to a predicate device based on its intended use and functional similarities, rather than presenting a study with acceptance criteria and device performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given document.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The 510(k) summary for Nexus 2 Modified describes the device and its intended use, focusing on demonstrating substantial equivalence to a predicate device (Nexus 2). It does not present specific acceptance criteria or quantitative performance data from a prospective study to assess the device's performance against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document. The submission focuses on functional characteristics and intended use for substantial equivalence, not a clinical or performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided document. No test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
This information is not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. The submission is for a dental luting cement, which typically does not involve human readers interpreting images, and thus an MRMC study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/available. The device is a dental luting cement, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
This information is not applicable/available. There is no ground truth, expert consensus, pathology, or outcomes data described in relation to a study in this document. The "ground truth" in the context of this 510(k) is the established performance and safety of the predicate device, which Nexus 2 Modified aims to be substantially equivalent to.
8. The Sample Size for the Training Set
This information is not applicable/available. As the device is a dental cement, not an AI or algorithm, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/available.
Summary of available information from the document:
The 510(k) summary for Nexus 2 Modified focuses on demonstrating substantial equivalence to the original Nexus 2 formulation manufactured by Kerr Corporation. The device is a dual-cured, resin-based dental cement for luting inlays, onlays, crowns, bridges, porcelain veneers, and endodontic posts. The document does not describe any studies with acceptance criteria, performance metrics, test sets, or ground truth establishment typically associated with medical device performance evaluations or AI/algorithm submissions. The FDA's letter states that the device is substantially equivalent based on the indications for use.
§ 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.