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Nexus 2 Clear 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 Clear is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 Clear is a two-part, base/catalyst - paste/paste, system.

This document is a 510(k) premarket notification for a dental luting cement, Nexus 2 Clear. It does not contain information on acceptance criteria for a device's performance, nor does it describe a study proving such criteria are met. The document focuses on establishing substantial equivalence to a predicate device based on similar materials, intended use, and functional characteristics, which is a regulatory pathway, not a performance study as typically understood for AI/ML or diagnostic devices.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and its regulatory submission, not a study evaluating a device's performance against pre-defined acceptance criteria in the context of clinical outcomes or AI model accuracy.

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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.

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Nexus 2 is a dual cured, resin-based, dental cement designed to be used for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.

The device is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 is a two-part, base/catalyst - paste/paste, system.

The provided text is a 510(k) Summary and an FDA clearance letter for a dental cement called Nexus 2. This document does not describe any clinical study or acceptance criteria for device performance in the way typically required to assess risk and efficacy for more complex medical devices.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Kerr Corporation, Nexus Universal Luting Cement) based on similar intended use and functional characteristics. Dental cements like Nexus 2 are generally evaluated based on material properties (e.g., bond strength, solubility, film thickness) through bench testing, rather than extensive clinical trials with human subjects.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided document.

The relevant information from the document is:

• Device Name: Nexus 2 (Luting Cement)
• Intended Use: Luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.
• Substantial Equivalence Claim: Nexus 2 is substantially equivalent to other legally marketed devices, specifically "Kerr Corporation, Nexus Universal Luting Cement," in its function and intended use.
• Device Description: Dual cured, chemical and light cured, two-part (base/catalyst - paste/paste) resin-based dental cement.

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