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LC MICROHYBRID is a light cure micro hybride composite for tooth fillings.

LC MICROHYBRID is a light cure micro hybride composite for tooth fillings. The chemical composition and use of LC MICROHYBRID material is the same as "ACORN", a product manufactured by S & C Polymer GmbH for Dent Zar International. The purpose of this material for use by the dentist is to clinically fill human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.

The provided text describes a 510(k) submission for a dental filling material called "LC MICROHYBRID." This document focuses on the regulatory submission process and the substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria typically associated with software or AI/ML medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI-specific details cannot be extracted from this document, as it pertains to a different type of medical device (dental filling material) and regulatory pathway.

Here's what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be inferred. The document does not specify quantitative acceptance criteria or detailed performance metrics. It focuses on the material's intended use and its substantial equivalence to a predicate device (ACORN), which implies that its performance is expected to be similar and acceptable for tooth fillings.

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

• Cannot be inferred. As this is a material rather than a diagnostic or AI device, the concept of a "test set" for performance evaluation in the typical sense (e.g., image data for AI) is not applicable. There's no mention of specific clinical studies with defined sample sizes.

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

• Cannot be inferred. This concept is not relevant to the regulatory submission of a dental filling material. Ground truth establishes for AI models by experts.

4. Adjudication Method for the Test Set:

• Cannot be inferred. Not applicable for a dental filling material's regulatory submission as described.

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

• Cannot be inferred. This type of study is specifically for evaluating diagnostic performance, often with human readers and AI assistance. It is not relevant to a dental filling material.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

• Cannot be inferred. This is relevant for AI algorithms. Not applicable here.

7. Type of Ground Truth Used:

• Cannot be inferred. The document heavily relies on substantial equivalence to a predicate device (ACORN, K960565). The "truth" in this context is that the new device has "the same chemical composition and use" and "substantially similar intended use, performance, indications, proposed labels and instructions" as the already cleared predicate. This isn't "ground truth" in the AI sense but rather a regulatory comparison.

8. Sample Size for the Training Set:

• Cannot be inferred. No training set is mentioned as this device is a material, not an AI model.

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

• Cannot be inferred. No training set for AI.

Summary of what can be extracted directly relevant to the submission:

• Device Name: LC MICROHYBRID
• Predicate Device: ACORN (manufactured by S & C Polymer GmbH for Dent Zar International), 510(k) K960565
• Basis of Acceptance: Substantial equivalence to the predicate device.
• Key Equivalence Claims:
  • Same chemical composition.
  • Same use (tooth filling material).
  • Substantially similar intended use, performance, indications, proposed labels, and instructions for use as the predicate device.
• Intended Use: Clinically fill human teeth (restoration in the case of mostly destroyed tooth structure). Placed against an applied adhesive system.
• Regulatory Class: II (as mentioned in the FDA letter, implying general and special controls may apply).
• Product Code: EBF (Resin, Composite, Dental Restorative)

In conclusion, the provided text is a 510(k) summary for a dental restorative material, not an AI/ML device. Therefore, the specific details requested regarding acceptance criteria and studies typical for AI software are not present and cannot be extracted. The acceptance criteria for this device revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of composition, intended use, and performance, rather than specific quantitative performance metrics tested in the context of an AI algorithm.

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