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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

• No Sensitization: Considered to cause no sensitization per ISO 10993-10, IIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
• Not Irritant: Caused no signs of irritation and met requirements per ISO 10993-10, JIS T 6001, and Yakushokukihatsu No. 0301-20.
• No Significant Systemic Toxicity: Considered to not cause significant systemic toxicity per ISO 10993-11, JIS T 6001, Yakushokukihatsu No. 0301-1. And Yakushokukihatsu No. 0301-20.
• Non-clastogenic: Considered non-clastogenic per ISO 10993-3, JIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
• Non-mutagenic: Considered non-mutagenic per ISO 10993-3, JJST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. |
  | Mechanical Properties | EN ISO 1567:1995: Denture Base Polymers.
  ISO 20795-1: Dentistry -- Base polymers -- Part 1: Denture base polymers.
  ANSI/ADA Specification No. 12:2002 (Reaffirmed 2008): Denture Base Polymers (including surface characteristics, color, translucency, freedom from porosity, flexural strength, flexural modulus, residual methyl methacrylate monomer, sorption and solubility). | - Met all acceptance criteria for denture base polymers as outlined in ISO 20795-1 and ANSI/ADA Specification No. 12:2002.
• Demonstrated substantially similar performance to predicate denture base resins during non-clinical bench testing. |
  | Risk Management | ISO 14971: Medical devices - Application of risk management to medical devices. | - Risk analysis conducted. Outcomes considered acceptable, and all potential risks mitigated to the lowest form. |
  | Quality Systems | ISO 9001:2007
  ISO 13485:2002 | - Confirmed compliance (as listed for both subject and predicate device). |

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.

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