(224 days)
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.
Ezfil is indicated for Class I , II, IV, V restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.
The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
The document provided details for a traditional medical device (dental resin) and not a medical device with AI/ML components. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, expert qualifications, MRMC studies) is not applicable or available in this document.
However, I can extract the acceptance criteria and performance data for the non-clinical tests performed on the Ezfil device, which are relevant to its substantial equivalence determination.
1. A table of acceptance criteria and the reported device performance
The document states that performance tests were conducted "according to EN ISO 4049:2009" and other ISO standards. Conformance to these standards serves as the acceptance criteria. The document explicitly states that the device "Conformed to ISO 4049" and that "the test results provided in this submission supports that it is substantially equivalent to the primary predicate." While specific numerical performance values are not provided in this summary, the acceptance is that the device meets the requirements of these standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| EN ISO 10993-1:2009 (Biocompatibility) | Yes |
| EN ISO 10993-3:2014 (Biocompatibility) | Yes |
| EN ISO 10993-5:2009 (Biocompatibility) | Yes |
| EN ISO 10993-10:2013 (Biocompatibility) | Yes |
| ISO 10993-11:2009 (Biocompatibility) | Yes |
| EN ISO 4049:2009 (Dental Polymer-Based Restorative Materials) | Conformed |
| ISO 3107:2011 (Dental Zinc Oxide/Eugenol Cements and Zinc Phosphate Cements) | Conformed |
| ISO 6507-1:2005 (Metallic Materials - Vickers Hardness Test) | Conformed |
| Shelf Life (3 years) | 3 years |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical, likely laboratory-based, and performed on material samples rather than clinical patient data. The manufacturer is based in South Korea (Meta Biomed Co., Ltd.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a non-clinical device that does not involve expert interpretation or ground truth establishment in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical device.
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 is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference standard would be the defined physical, chemical, and biological properties as specified in the referenced ISO and EN ISO standards. For biocompatibility, this refers to the absence of adverse biological reactions. For performance tests (depth of cure, flexural strength, etc.), it refers to meeting the quantitative limits or qualitative descriptions set by the standards.
8. The sample size for the training set
Not applicable. This is a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is a non-AI/ML device.
§ 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.