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Nexus Universal Self-Cure is a bonded resin cementation of indirect restoration of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material.

Nexus Universal Self-Cure, manufactured by Kerr Corporation, is a two-component, auto-mixing, dual-cure bonded resin cement consisting of catalyst and base paste at a 4:1 ratio, packaged into a syringe extruded out with an automix tip prior to use. The cement is designed to simplify cementation of restorative substrate such that product can be used with adhesive/bonding agents without the need to light-cure the adhesive/bonding agent on the tooth structure and to eliminate the need for primer treatment on the substrate prior to cement applications. Nexus Universal Self-Cure will be available in various shades.

The provided document is a 510(k) summary for a dental cement (Nexus Universal Self-Cure), which is a device used for restorative dentistry. The document focuses on demonstrating substantial equivalence to a predicate device (Suglue-10) through technological characteristics, performance testing, and biocompatibility.

It does not describe a study involving an AI/Medical Device that processes images or requires human expert adjudication for ground truth, Multi-Reader Multi-Case (MRMC) studies, or the performance of an algorithm. The context of the original request seems to be geared towards diagnostic or assistive AI devices, whereas this document pertains to a physical dental material.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, training set sample size, how ground truth was established) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this dental material.

Acceptance Criteria and Device Performance (Dental Cement - Nexus Universal Self-Cure)

The acceptance criteria here are established by comparing the performance of the proposed device (Nexus Universal Self-Cure) to a legally marketed predicate device (Suglue-10) and relevant ISO standards. Substantial equivalence is demonstrated by showing that the new device performs "similar to" or "at least as good as" the predicate, or meets established standard thresholds.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" values independently but presents a comparative table (Table 5.1) where the predicate's performance serves as a de facto benchmark for the subject device to achieve substantial equivalence. The "Subject" values are the reported device performance. ISO standards provide the basis for the criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample sizes (number of tests/specimens) used for each performance test (e.g., film thickness, flexural strength, shear bond strength). It refers to "various tests" and "the data analyzed from the various tests."
• Data Provenance: The tests are non-clinical performance tests conducted by the manufacturer, Kerr Corporation, in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission. They are laboratory bench tests, not clinical retrospective/prospective studies on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This is a physical dental material, and the "ground truth" is established through standardized laboratory testing (bench testing) against ISO standards and comparison to a predicate device, not through human expert interpretation of images or clinical outcomes that require expert consensus or adjudication.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing involves objective measurements of material properties, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic or imaging device. No human-in-the-loop study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical dental cement; there is no algorithm. The "standalone" performance refers to the intrinsic material properties measured in lab tests.

7. The Type of Ground Truth Used:

• Bench Test Results / ISO Standards / Predicate Device Performance: The "ground truth" for the performance evaluation is derived from the results of standardized non-clinical (bench) tests according to ISO standards (e.g., ISO 1641, ISO 1041, ISO 7405, ISO 29022, ISO 14971, ISO/TS 16506, ISO 10993-1, ISO 11405). The measured properties of the new device are directly compared to the established properties of the predicate device and the thresholds set by these international standards.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. This device is a physical product, not an AI model that requires a training set or corresponding ground truth for training.

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