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510(k) Data Aggregation
(225 days)
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.
The device in question is GC ACRYLIC PRIMER, a resin tooth bonding agent.
Here's a breakdown of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Requirements (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Appearance | No contamination of foreign matter. | Conforms to specification. |
| Application characteristics (coating properties) | Equivalent to reference standard. | Conforms to specification. |
| Refractive index | 1.398 ± 0.003 | Conforms to specification. |
| Bond strength | > 10 MPa | Conforms to specification. |
| Biocompatibility | Not considered to have a cytotoxic effect (per ISO 10993-5 guidelines) | Meets requirements of the test. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI. The performance bench tests appear to be conducted on the device itself.
- Sample Size for Test Set: Not explicitly stated for performance bench tests, but implied to be sufficient to demonstrate conformity to specifications.
- Data Provenance: Not applicable in the context of a "test set" as typically understood for AI/clinical studies. The performance data is generated from laboratory bench testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing involves laboratory measurements and assessments against predefined physical and chemical specifications, not expert-derived ground truth on clinical data.
4. Adjudication method for the test set
Not applicable. The performance testing involves objective measurements rather than expert adjudication.
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 MRMC comparative effectiveness study was conducted. This device is a dental material (primer) and not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance criteria is based on:
- Predefined physical and chemical specifications: For appearance, application characteristics, refractive index, and bond strength. These are objective laboratory measurements.
- Biocompatibility standards: ISO 10993-5 guidelines for cytotoxicity.
8. The sample size for the training set
Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set or associated ground truth establishment.
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