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The principal use for Core it Dual is as a core material either with adhesives or with pins or posts. Core it Dual can also be used for: Luting of abutments to dentures; Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials; Repair material for provisionals; Bite registration material; Build up material for plastic bite rails (occlusal individualisation); Cement for pins and posts; Semipermanent restorative material (e.g., in childrens' teeth)

The Core it Dual is a dual-cured composite resin designed for the fabrication of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. It has two shades (Blue, yellow).

This looks like a 510(k) summary for a dental product, specifically a core build-up resin. These types of summaries rarely contain detailed clinical study information in the way you've outlined. They primarily focus on demonstrating substantial equivalence to a predicate device through material properties and intended use.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or statistical format often seen for performance outcomes in clinical studies for AI/software devices. Instead, it discusses the similarity of mechanical properties to the predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not mentioned. The document primarily focuses on material properties testing, not a clinical test set in the traditional sense.
• Data Provenance: Not mentioned. The testing was likely conducted in a lab setting, possibly by the manufacturer or a contracted lab. The country of origin for the company is Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device and study. Ground truth established by experts is typically relevant for diagnostic or image analysis software. For a dental material, the "ground truth" is typically established by standardized material testing methods.

4. Adjudication method for the test set:

This is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This device is a dental material, not an AI or software device that assists human readers.

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

This is not applicable. This is a dental material, not an algorithm.

7. The type of ground truth used:

For dental materials, "ground truth" is typically established by:

• Standardized material testing: Using recognized international (e.g., ISO) or national (e.g., ADA) standards for mechanical properties like compressive strength, flexural strength, wear, etc.
• Biocompatibility testing: According to standards like ISO 10993.

The document implicitly refers to this through statements like: "The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience" and "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049."

8. The sample size for the training set:

This is not applicable. There is no training set in the context of an AI/software device. This refers to the development and testing of a physical material.

9. How the ground truth for the training set was established:

This is not applicable.

Summary of the Study/Testing:

The "study" described in the 510(k) summary is primarily focused on demonstrating substantial equivalence of the Core it Dual dental composite resin to a legally marketed predicate device (LuxaCore Dual). This demonstration relies on comparing:

• Intended Use: "The Core it Dual is similar to other commercially available products based on the intended use..."
• Technology/Material Composition: "The Core it Dual is similar to other commercially available products based on the ...material composition employed..." and "...material, chemical composition, design and use concept are similar [to the predicate device]."
• Performance Characteristics/Mechanical Properties: "The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience." These properties were likely assessed through in-vitro laboratory testing according to relevant dental material standards.
• Safety/Biocompatibility: "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049."

The document states, "The Core it Dual has been subjected to extensive safety, performance, and product validations prior to release." This indicates that laboratory testing was performed to establish its properties and confirm its similarity to the predicate device, rather than a clinical study with human subjects, expert readers, or AI algorithms.

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