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Temporary fillings; Temporary management of inlay and onlay preparations; Temporary closure of implant screw holes; Relining of temporary pre-made crowns and bridges

CAVIT® LC is classified as a tooth shade resin material (21 C.F.R. § 872.3690) becaus it is a device composed of methacrylates intended to restore carious lesions o · structural defects in teeth.

The provided 510(k) summary for CAVIT® LC is for a temporary light-cured filling material, which is a medical device and not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically applied to AI/ML software (e.g., performance metrics like sensitivity, specificity, AUC) does not directly apply here.

Instead, the submission focuses on biocompatibility and material effectiveness for a physical product. The "acceptance criteria" in this context would be related to meeting regulatory standards for material safety and performance for a medical device.

Therefore, many of the requested points regarding AI/ML clinical studies will not be present in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable to AI/ML software. The testing was laboratory-based for material properties and biocompatibility.

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

• Not applicable to AI/ML software. However, the document mentions: "clinical testing to verify efficacy and material characteristics of the new formulation. This product was shown to exhibit advantages in some indications compared to the predicate device and other devices." This suggests some form of clinical evaluation, but details like the number or qualifications of clinicians are not provided in this summary. The old formula's issues were identified by "consultant dentists."

4. Adjudication Method for the Test Set:

• Not applicable to AI/ML software. The evaluation of material properties would involve standardized laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• Not applicable to AI/ML software. This is a physical, not an AI, device.

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

• Not applicable to AI/ML software.

7. The Type of Ground Truth Used:

• For Biocompatibility: likely established through standardized biological tests (e.g., cytotoxicity, sensitization, irritation) as per ISO 10993 series or similar standards for dental materials.
• For Effectiveness/Material Characteristics: established through physical and mechanical property laboratory tests (e.g., setting time, strength, wear resistance, handling properties) as per relevant ISO standards for temporary restorative materials.

8. The Sample Size for the Training Set:

• Not applicable. This refers to a physical product, not an AI model.

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

• Not applicable. This refers to a physical product, not an AI model.

Summary relevant to AI/ML questions:

This submission is for a traditional medical device (temporary dental filling material), not an AI/ML-powered device. Therefore, the detailed AI/ML-specific study design elements (such as test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details) are entirely irrelevant to this submission and are not present in the provided text. The "study" mentioned is laboratory testing for biocompatibility and material effectiveness.

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