(137 days)
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.
| Acceptance Criteria (Performance Standard Conformance) | Reported Device Performance |
|---|---|
| Meet ISO 4049 standard (Dentistry -- Polymer-based restorative materials) | Conforming (Subject device is stated to "Meet ISO 4049 standard") |
| Conforming to ISO 10993-1 (Biological evaluation of medical devices - Part 1) | Conforming (Subject device is stated to "Conforming to ISO 10993-1") |
| Other ISO 10993 standards (Part 3, 5, 10, 11) for biocompatibility | Conforming (Implied by stating conformance to ISO 10993-1 and listing other parts) |
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.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.