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Adhesive cementation of:

• 1. ceramic, porcelain, or composite inlays/onlays, veneers, or crowns;
• 2. all metal crowns, bridges, inlays/onlays including precious, semi-precious, and non-precious metals;
• 3. PFM (porcelain fused to metal) crowns and bridges;
• 4. prefabricated and cast posts; and
• 5. resin-bonded retainer bridges (Maryland bridges)

CALIBRA™ CEMENT is a visible light cured (VLC), dual-cured, or self-cured high strength cement that, with compatible dentin/enamel adhesive systems, adhesively bond and lute indirect restorations to tooth structure.

CALIBRA™ CEMENT consists of VLC base paste and catalyst paste. The base paste is mixed with the catalyst paste to form a dual-cured cement. This mixed version of the cement will self-cure or can be light-cured, or both.

CALIBRA™ CEMENT also includes a set of try-in pastes. These try-in pastes are highly water-soluble and easily rinsed away, and are used to mimic the shade of the cured cement prior to final cementation in order to ensure a good match to the adjacent dentition.

This 510(k) summary (K040906) for CALIBRA™ CEMENT describes the device and its intended use but lacks specific details regarding quantitative acceptance criteria and a detailed study report that proves the device meets those criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document DOES NOT provide a table of acceptance criteria or specific quantitative performance metrics. It makes a general statement about the device's characteristics and its equivalence to a predicate device.

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

The document DOES NOT specify any test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The approval is based on "prior use of the components" and a general statement about "performance data provided," without detailing what that data entails.

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

The document DOES NOT mention any experts being used to establish a ground truth for a test set. This type of analysis (experts establishing ground truth) is typically associated with diagnostic or image-based devices, not material components like dental cement where performance is often measured through physical or chemical property testing.

4. Adjudication Method for the Test Set:

Not applicable, as no test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. CALIBRA™ CEMENT is a dental cement, not a diagnostic tool requiring human interpretation in this context.

6. Standalone (Algorithm Only) Performance:

Not applicable. CALIBRA™ CEMENT is a physical material, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance would be related to material properties (e.g., bond strength, setting time, solubility), which are not detailed here.

7. Type of Ground Truth Used:

The document implies that the ground truth for establishing "safety and effectiveness" is based on:

• Predicate Device Equivalence: The primary basis for approval appears to be substantial equivalence to the predicate device, Enforce™ with Fluoride Cement (K940459). This suggests that the ground truth is established by the known performance and safety of legally marketed, similar devices.
• Performance Data (unspecified): The submission mentions "performance data provided," but does not explicitly state the nature of this data (e.g., in-vitro studies, mechanical testing, clinical trials, etc.) or how ground truth was established within these studies. For dental cements, ground truth is typically derived from standardized testing methods for properties like bond strength, compressive strength, film thickness, water sorption, solubility, and biocompatibility.

8. Sample Size for the Training Set:

Not applicable. As a material component (dental cement), there is no 'training set' in the context of artificial intelligence or machine learning algorithms. Its "training" would be analogous to product development and formulation testing, which are not detailed with specific sample sizes.

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

Not applicable, as there is no 'training set' in the AI/ML sense. The "ground truth" for the material's properties would be established through standard material testing protocols and clinical evaluations over the product development lifecycle, but these details are not provided in the 510(k) summary.

In summary:

This 510(k) summary represents a premarket notification for a dental material (cement) and relies heavily on substantial equivalence to a predicate device. It does not contain the types of detailed performance study information, acceptance criteria, or ground truth methodologies typically found in submissions for diagnostic or AI-powered devices. The focus is on the known characteristics of the components and the general safety and effectiveness statement rather than presenting specific quantitative study results.

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