(265 days)
C&B 5.0 Hybrid resin is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer , and curing lightequipment.
The C&B 5.0 Hybrid is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
The C&B 5.0 Hybrid is made from Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1 wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. The subject device is liquid photo-curable material that is polymerized by UV laser at 405nm. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use DLP/LCD 3D Printer equipment using UV light source and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16 um.
The provided text describes a 510(k) premarket notification for a dental resin, "C&B 5.0 Hybrid." This document focuses on demonstrating the substantial equivalence of this new device to an existing predicate device rather than presenting a study proving a device meets specific acceptance criteria related to AI or clinical performance. Therefore, most of the requested information regarding AI studies, sample sizes, expert ground truth, and adjudication methods is not applicable or cannot be extracted from this particular document.
However, I can extract information related to the performance data and the standards it meets.
1. A table of acceptance criteria and the reported device performance
The document references ISO standards as the "Referenced Standard" for various tests, which implicitly define the acceptance criteria for these physical and biological properties. The reported device performance is that it "Meets" these standards.
| Test Item | Referenced Standard (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Shelf-Life Validation Tests | ||
| Visual Inspection | - | Test Performed |
| Packaging | ISO 10477 | Test Performed |
| Flexural Strength | ISO 10477 | Test Performed |
| Biocompatibility Tests | ||
| Cytotoxicity | ISO 10993-10 | Meets ISO 10993 |
| Sensitization | ISO 10993-10 | Meets ISO 10993 |
| Acute Toxicity | ISO 10993-11 | Meets ISO 10993 |
| Oral Mucosal Irritation | ISO 10993-10 | Meets ISO 10993 |
| Performance Tests | ||
| Visual Inspection | - | Test Performed |
| Packaging | - | Test Performed |
| Capacity | - | Test Performed |
| Color Consistency | - | Test Performed |
| Color Stability | ISO 10477 | Meets ISO 10477 |
| Flexural Strength | ISO 10477 | Meets ISO 10477 |
| Water Absorption | ISO 10477 | Meets ISO 10477 |
| Solubility Test | ISO 10477 | Meets ISO 10477 |
Regarding the other requested information:
- 2. Sample sized used for the test set and the data provenance: Not specified in the document. The document refers to "the following tests were performed," but details about sample sizes for each test are not provided. The data provenance is implied to be from the manufacturer's testing (Arum Dentistry Co., Ltd., South Korea), but no country of origin of patient data or retrospective/prospective nature is applicable as this is a material science and biocompatibility study, not a clinical study involving patients.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for material properties and biocompatibility is established by adherence to recognized international standards (ISO), not by expert consensus in the context of clinical interpretation or image analysis.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.
- 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 document does not describe an AI medical device or an MRMC study.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on established scientific and engineering principles and adherence to international standards (e.g., ISO 10477 for dental polymer materials, ISO 10993 for biological evaluation of medical devices).
- 8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.