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Coating Material is a light-cured, transparent resin sealant for acrylic denture bases that produces a smooth, glossy surface finish on the denture.

Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.

This document describes a 510(k) premarket notification for a device called "Coating Material," which is a light-cured, transparent resin sealant for acrylic denture bases. The submission aims to demonstrate substantial equivalence to a predicate device, Heraeus Kulzer, Inc., Palaseal® (K892452).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the sample sizes for the individual biocompatibility tests or performance bench tests. It refers to "extending testing" and "experimental conditions."
• Data Provenance: The studies are described as "Non-Clinical Performance Data." The sponsor is Sun Medical Co., Ltd. in Japan, suggesting the studies were likely conducted or overseen in Japan, but this is not explicitly stated for each test. The studies appear to be prospective as they were conducted specifically to support this 510(k) submission.

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

This information is not provided in the document. For non-clinical lab tests like biocompatibility and bench testing, "ground truth" is typically established by adhering to standardized test protocols (e.g., ISO standards) and comparing results against predefined acceptance criteria outlined in those standards. The expertise would lie in the accredited laboratories and personnel performing these specific tests rather than a panel of clinical experts establishing a ground truth in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable in the context of these non-clinical, objective laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data where consensus among multiple reviewers is needed to establish a "ground truth" for a diagnosis or specific outcome.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

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

This question is not applicable. The "Coating Material" is a physical medical device (a resin sealant for dentures), not a software algorithm or AI-based device. Performance testing was conducted directly on the material itself.

7. The Type of Ground Truth Used

For the biocompatibility tests and performance bench tests, the "ground truth" used was adherence to established international standards and their predefined acceptance criteria. For example, for cytotoxicity, the ground truth for "non-cytotoxic" is defined by the criteria within ISO 10993-5. For physical properties like gloss and cracking, the "ground truth" is based on visual assessment against predefined quality metrics.

• Biocompatibility: Ground truth established by compliance with ISO 7405, ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11 test methodologies and their respective acceptance limits.
• Performance Bench Testing: Ground truth established by adherence to "required specifications" (which would be internal to the manufacturer, but validated against intended use) and visual/tactile assessment of "smooth, high gloss surface with no evidence of cracking or peeling."

8. The Sample Size for the Training Set

This question is not applicable. As stated previously, this is a physical medical device, not an AI or software device that uses training sets.

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

This question is not applicable as there is no training set for this device.

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