Search Results

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.

Ask a specific question about this device

Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture.

The Acrylic Block is a solid block of an acrylic polymer block that includes small quantities of color pigments. This Acrylic Block is a high polymer material made from quality poly methyl methacrylate. Poly (methyl methacrylate) is commonly used for thermopolymerizable acrylic resin denture bases because of its properties, including color and durability. In vitro tests have also shown its biocompatibility and enhancement of flexural behavior properties.

To fabricate the denture base, the Acrylic Block is milling machine utilizing the CAM data. After a 3D denture image is structured using the 3D CAD software, the artificial teeth are factored out, and a 3D denture base image is obtained. The Acrylic Block is then milled to the shape of the denture base. The artificial teeth are then bonded to the milled denture base using a bonding material and polished.

The provided document is a 510(k) Pre-market Notification for the "Acrylic Block" device, a cured base acrylic resin used to fabricate dentures. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study purely on the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable in the context of this traditional medical device submission. The submission relies on non-clinical (bench) testing and established standards for materials.

However, I can extract and present the relevant information that is available, framed within the context of a traditional device submission.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Acrylic Block (K143265)

The "Acrylic Block" device is a cured base acrylic resin intended for fabricating dentures. Its regulatory submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device (Yamahachi Denture Base Resins - K131036) by showing comparable material properties and biocompatibility, rather than assessing diagnostic performance or clinical effectiveness through human reader studies.

The acceptance criteria for this device are established through compliance with recognized international and national standards for dental materials, specifically focusing on biocompatibility and mechanical properties. The "study" proving the device meets these criteria consists of a series of non-clinical, bench-top tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical "sample size" in terms of patients or independent data points originating from specific cases, as would be common for AI/ML or clinical studies. Instead, samples refer to material specimens created and tested according to the requirements of the cited ISO and ANSI/ADA standards. These standards typically define the number of test specimens required for each specific mechanical or biological test (e.g., a certain number of flexural bars, cytotoxic extracts, etc.). The exact number for each test is not detailed in this summary.
• Data Provenance: Not applicable in the traditional sense of patient data. The data originates from laboratory testing (bench testing) performed on material specimens of the Acrylic Block. The location of these testing facilities is not explicitly stated but would typically be in certified labs in Japan (Sun Medical Co. Ltd.'s country of origin) or elsewhere. The testing is prospective in the sense that it was conducted specifically for this submission against established standards.

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

• Number of Experts & Qualifications: Not applicable. For material science and biocompatibility testing, "ground truth" is established by adherence to validated standardized test methods (e.g., ISO, ANSI/ADA) and objective measurements by trained laboratory personnel, rather than expert consensus on interpretive tasks. The results are quantitative measurements or assessments of biological reactions.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Material testing results are typically objective measurements or observations (e.g., cell viability; flexural strength in MPa, absence/presence of irritation) and do not involve human interpretation or adjudication in the way clinical image analysis might.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess if the device improves reader performance. The Acrylic Block is a material used for fabrication, not a diagnostic tool.

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

• Standalone Performance: Not applicable. The Acrylic Block is a physical material, not an algorithm or software device. Its "performance" is assessed through its inherent physical, chemical, and biological properties, not a standalone algorithmic output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's evaluation is derived from objective, quantitative measurements and standardized biological assays as defined by the referenced international and national standards (ISO, ANSI/ADA, JIS). For example:
  • Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity as determined by specific, validated lab tests (e.g., MEM Elution, Guinea Pig Maximization, Intracutaneous Reactivity, Chromosome Aberration Test, AMES Test).
  • Mechanical Properties: Quantitative values for flexural strength, flexural modulus, sorption, solubility, etc., measured against specified thresholds in the standards like ISO 20795-1 and ANSI/ADA 12.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The Acrylic Block is not an AI/ML device that requires a "training set" to learn from data.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device