(4 days)
DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture02 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
DIOnavi-Denture02 is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer, which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.
The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
The provided text is related to a 510(k) submission for a dental device (DIOnavi-Denture02), which is a light-curable resin for fabricating and repairing dentures. The document details the regulatory review process and the basis for the FDA's substantial equivalence determination.
However, the provided text does not describe a study that uses AI/ML or performs human reader improvement studies (MRMC study) or standalone AI performance. The studies mentioned are non-clinical performance tests (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization) to demonstrate that the new device is substantially equivalent to a predicate device based on material properties and performance characteristics relevant to dental resins.
Therefore, many of the requested points regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone AI performance, cannot be extracted from this document as they are not relevant to the type of device and study described.
The document specifically states: "No clinical testing was performed for this submission." This further reinforces that the type of study typically associated with AI/ML device approval (which often involves clinical data and human reader performance analysis) was not conducted or required for this dental resin.
Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study" as applicable to this type of medical device submission:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests in accordance with ISO 20795-1 and states that the "results have met the criteria of the standards." It does not provide a table with specific acceptance values and corresponding device performance values.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Non-clinical Performance | Visual inspection (ISO 20795-1) | Met criteria of the standards |
| Weight (ISO 20795-1) | Met criteria of the standards | |
| Package inspection (ISO 20795-1) | Met criteria of the standards | |
| Dimensions (ISO 20795-1) | Met criteria of the standards | |
| Surface characteristics (ISO 20795-1) | Met criteria of the standards | |
| Shape capability (ISO 20795-1) | Met criteria of the standards | |
| Translucency (ISO 20795-1) | Met criteria of the standards | |
| Color stability (ISO 20795-1) | Met criteria of the standards | |
| Flexural strength (ISO 20795-1) | Met criteria of the standards | |
| Flexural modulus (ISO 20795-1) | Met criteria of the standards | |
| Water sorption (ISO 20795-1) | Met criteria of the standards | |
| Water solubility (ISO 20795-1) | Met criteria of the standards | |
| Form porosity test (ISO 20795-1) | Met criteria of the standards | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Addressed (implied criteria met for clearance) |
| Sensitization (ISO 10993-10) | Addressed (implied criteria met for clearance) | |
| Irritation reactivity test (ISO 10993-10) | Addressed (implied criteria met for clearance) | |
| Genotoxicity test (ISO 10993-3) | Addressed (implied criteria met for clearance) | |
| Sub-acute toxicity (ISO 10993-11) | Addressed (implied criteria met for clearance) | |
| Material-mediated pyrogenicity (ISO 10993-11) | Addressed (implied criteria met for clearance) | |
| Shelf Life | Bench tests from ISO 20795-1 on aged samples | 2 years (subject device has a shelf life of 2 years) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for non-clinical or biocompatibility tests. These are typically material property tests, not patient data tests.
- Data Provenance: Not applicable in the context of patient data, as the tests relate to the physical and chemical properties of the resin itself, not clinical outcomes from human subjects. The manufacturer is based in Republic of Korea.
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. Ground truth in this context refers to the defined standards (e.g., ISO 20795-1, ISO 10993 series) for material properties and biocompatibility, not expert consensus on medical images or clinical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or clinical interpretation.
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. The document explicitly states: "No clinical testing was performed for this submission." This type of study is not relevant to the approval of a dental resin as a material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standards are the international standards for dental materials (ISO 20795-1) for physical and mechanical properties and biocompatibility standards (ISO 10993 series) for biological safety. This is a material science and biocompatibility assessment, not a diagnostic accuracy assessment.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, and no training set was involved.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.