(135 days)
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.
Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.
The provided text describes the acceptance criteria and the study for "Dentsoll - High Dental Denture Resins." However, it focuses on non-clinical performance and biocompatibility testing, not on clinical studies with human readers or AI algorithms. As such, many of the requested fields are not applicable to the information given.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Properties | ISO 20795-1 Denture Base Polymers | Passed all tests in accordance with ISO 20795-1 |
| Physical appearance | ISO 20795-1 | Passed |
| Surface property | ISO 20795-1 | Passed |
| Hue stability | ISO 20795-1 | Passed |
| Transparency | ISO 20795-1 | Passed |
| Presence of air bubbles | ISO 20795-1 | Passed |
| Flexural strength | ISO 20795-1 | Passed |
| Flexural elasticity | ISO 20795-1 | Passed |
| Bonding strength | ISO 20795-1 | Passed |
| Presence of residuals | ISO 20795-1 | Passed |
| Water sorption | ISO 20795-1 | Passed |
| Solubility | ISO 20795-1 | Passed |
| Biocompatibility | ISO 10993 | Passed all tests in accordance with ISO 10993 |
| Cytotoxicity | ISO 10993-5 (Pass/Fail) | Pass |
| Sensitization | ISO 10993-10 (Pass/Fail) | Pass |
| Systemic Toxicity | ISO 10993-11 (Pass/Fail) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests, but the device undergoes general "device testing" and "biocompatibility analysis." The standards (ISO 20795-1, ISO 10993) would define the specific sample sizes required for each test.
- Data Provenance: Not explicitly stated, but implies laboratory testing performed by Dentsoll, Inc. (or a contracted lab) in accordance with international standards. There is no mention of country of origin of the data or if it's retrospective or prospective in the clinical study sense. It's non-clinical, laboratory data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is relevant for clinical studies involving expert interpretation, typically in diagnostic imaging or similar fields. The provided document describes non-clinical, laboratory-based performance and biocompatibility testing against defined international standards. Ground truth is established by objective measurements against these standards, not by expert consensus in the human interpretation sense.
4. Adjudication method for the test set:
- Not applicable. This concept applies to clinical studies where human readers might disagree, requiring a method to reach a consensus ground truth. For non-clinical tests, results are typically objective measurements against a standard.
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 resin, not an AI software or a diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used:
- Non-clinical Standard Compliance: The ground truth for performance testing is established by the specified international standards: ISO 20795-1 for physical properties and ISO 10993 for biocompatibility. The "ground truth" is that the material meets the quantitative and qualitative requirements set forth in these standards.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model. The device is a manufactured material.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set mentioned or relevant for this type of device.
§ 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.