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Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.

RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D Resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes a medical device, RODIN Titan 3D Resin, and its acceptance criteria, along with performance data to demonstrate substantial equivalence to predicate devices. The study conducted is primarily a set of performance tests against established standards and comparisons to existing products, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with international standards (ISO, ASTM) and performance comparable to predicate devices. The "Specification" column in Table 1 represents the acceptance criteria for most physical properties, usually a minimum or maximum value. For some parameters, "N/A" is listed, indicating that there is no specific quantitative acceptance criterion listed in the table, but the result is provided.

Note: For properties listed as N/A under "Specification", their acceptance is often implied by demonstrating comparable performance to predicate devices or simply reporting the value without a specific threshold stated within the document. The comparability to predicate devices is shown in Table 2.

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

The document does not explicitly state the numerical sample size (e.g., number of specimens tested for flexural strength). It refers to the tests being conducted according to specific ISO and ASTM standards, which would define the required sample sizes for each test method.

• Data Provenance: The data appears to be from laboratory testing performed by the manufacturer, or a contracted lab, to characterize the material properties. There is no information provided regarding the country of origin of the data or whether it is retrospective or prospective, but it is characteristic of premarket submission data based on physical and chemical testing.

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

This type of study does not involve expert readers establishing ground truth in the way a diagnostic imaging AI would. The "ground truth" for the performance tests outlined here is defined by:

• Established physical and chemical test methods: The performance data (e.g., flexural strength, water sorption) are objective measurements derived from standardized laboratory tests (ISO, ASTM protocols).
• Predicate device data: The "ground truth" for substantial equivalence comparison is the performance of legally marketed predicate devices, which have already been deemed safe and effective.

Therefore, there were no human experts (e.g., radiologists) establishing ground truth for the test set in this context. The "experts" would be the scientists and engineers who conducted the material characterization tests and those who established the ISO/ASTM standards.

4. Adjudication Method for the Test Set

Not applicable for this type of material characterization study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy, where there is subjective interpretation of findings (e.g., by multiple radiologists) requiring a consensus mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers' Improvement with AI vs. without AI Assistance

Not applicable. This device is a dental resin material, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This is a physical material, not an algorithm. The performance data presented are "standalone" in the sense that they are intrinsic properties of the material itself, measured in laboratory settings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device's performance is based on:

• Standardized Physical and Chemical Characterization: Data derived from established and validated laboratory test methods (ISO, ASTM standards). This is the primary ground truth for material properties.
• Predicate Device Performance: Performance data from already cleared predicate devices serve as a comparative ground truth to establish substantial equivalence.
• Biocompatibility Standards: Compliance with ISO 10993 provides the ground truth for biological safety.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a material or a traditional AI model discussed.

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