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DiaFil & DiaFil Capsule composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations

The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.

The provided document is a 510(k) summary for the Diafil & Diafil Capsule, a tooth shade resin material. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI software. Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or not available in this specific document.

The document primarily focuses on non-clinical performance and substantial equivalence based on material properties and intended use.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance metrics of a device, but rather conformity to standards and comparability to predicate devices. The "Performance Standard conformance" in the comparison table serves as the closest equivalent to acceptance criteria for the material.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. The document describes non-clinical bench testing and conformance to standards, not a specific "test set" in the context of clinical or AI performance evaluation. The data provenance is implied to be from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was not done. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not provided. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Standardized material property testing. The "ground truth" for this type of device is established through adherence to international standards (e.g., ISO 4049 for physical/chemical properties, ISO 10993 for biocompatibility). The testing involves measuring specific properties (e.g., flexural strength, water sorption, cytotoxicity) and comparing them against the requirements defined in these standards.

8. The sample size for the training set:

• Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.

Summary from the document:

The 510(k) submission for Diafil & Diafil Capsule primarily relies on non-clinical performance data demonstrating conformance with harmonized international standards, specifically:

• ISO 4049: Dentistry -- Polymer-based restorative materials
• ISO 7405: Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-3, 10993-5, 10993-10, 10993-11: Specific parts of ISO 10993 related to genotoxicity, cytotoxicity, irritation/sensitization, and systemic toxicity.

The document explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." The basis for substantial equivalence is the comparison of device characteristics, indications for use, construction, composition, human factors, shelf life, period of use, biocompatibility, and performance standard conformance with legally marketed predicate devices. The "Change is only a package addition of DiaFil Capsule" and this addition "does not affect to the original product," which had already demonstrated safety and effectiveness through its own 510(k) clearances.

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-Restoration of Class III, Class V, smaller Class IV

-Repair of resin, porcelain, and acrylic temporary materials

-Undercut blockout

The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. The subject device is packaged with the following: Syringe, Disposable Tip, Protective Cap, Shade Sheet

Here's a breakdown of the acceptance criteria and the study information for the DiaFil Flow device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for DiaFil Flow (K192284) primarily demonstrates substantial equivalence through non-clinical performance data and comparison to a predicate device. The "acceptance criteria" are therefore framed around adherence to harmonized standards and showing similar properties to the predicate.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of discrete samples for performance evaluation beyond conformity to standards. The evaluation is primarily based on bench testing against harmonized standards and a comparison to a predicate device. No specific number of items tested for each characteristic (e.g., strength, wear) is provided in the summary.
• Data Provenance: The studies are described as "non-clinical performance data" and "non-clinical bench testing." This implies internal laboratory testing conducted by the manufacturer, DiaDent Group International, located in Cheongju-si, Chungcheongbuk-do, Republic of Korea. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a continuous monitoring process.

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

• The summary does not mention "experts" in the context of establishing ground truth for a test set in the way one might for an AI/device diagnostic study. This is a dental material, and the "ground truth" is established by adherence to the objective criteria laid out in international standards (e.g., ISO for dental materials, ISO 10993 for biocompatibility). There is no mention of human expert consensus or radiologists in this context.

4. Adjudication Method for the Test Set

• No adjudication method is described, as the evaluation is based on objective measurements against harmonized standards, not on subjective interpretations requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices. DiaFil Flow is a dental restorative material, and its evaluation focuses on material properties and biocompatibility, not diagnostic performance.

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

• Not applicable/Not done. This device is a physical material, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The performance evaluated is the physical and chemical properties of the material itself.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical performance data is defined by the specifications and acceptable ranges/pass criteria within the referenced harmonized ISO standards (e.g., ISO 4049 for material properties, ISO 10993 series for biocompatibility). These standards define objective, measurable physical, chemical, and biological endpoints. The "Biological Safety Assessment Report (#BSA-2018-14)" also contributed to establishing the safety ground truth.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" for a material like this involves formulation development and manufacturing process controls, not data-driven algorithm training.

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

• Not applicable. As a dental restorative material, the concept of a "training set" and associated ground truth establishment for a training set does not apply.

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A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations

The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.

Here's a breakdown of the acceptance criteria and study information based on the provided text, where applicable:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance data and biocompatibility tests. It does not specify the exact sample sizes for each of these tests, nor the country of origin of the data. It is implicitly retrospective as it's a submission for regulatory clearance based on completed tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests described are non-clinical, laboratory-based performance and biocompatibility studies, not studies involving expert interpretation or "ground truth" derived from human assessment in the way that would apply to, for example, medical imaging or diagnostic devices.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental restorative material (tooth shade resin), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a dental restorative material, not an algorithm.

7. The type of ground truth used:

For the non-clinical performance tests, the "ground truth" is established by the specifications and acceptance criteria defined in the harmonized standards (e.g., ISO 4049). For biocompatibility, the "ground truth" is determined by meeting the specified endpoints and requirements of the relevant ISO 10993 standards (e.g., no cytotoxicity, no irritation, etc.).

8. The sample size for the training set:

Not applicable. This is a material device, not a machine learning model.

9. How the ground truth for the training set was established:

Not applicable. This is a material device, not a machine learning model.

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