(78 days)
- For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite. resin, acrylic denture base and artificial acrylic teeth.
Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.
The provided text describes the 510(k) premarket notification for "Optiglaze Color," a light-cured glazing and characterizing material for dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.
Here's an analysis of the provided information relative to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical trial report would. Instead, it lists performance bench tests conducted to confirm conformity to specifications. These are implicit acceptance criteria.
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| Appearance | Confirmed to required specifications and suitable for intended use. |
| Depth of cure | Confirmed to required specifications and suitable for intended use. |
| Color stability after irradiation | Confirmed to required specifications and suitable for intended use. |
| Surface hardness | Confirmed to required specifications and suitable for intended use. (Noted as "higher" than predicate in differences section) |
| Application characteristics | Confirmed to required specifications and suitable for intended use. |
| Packaging | Confirmed to required specifications and suitable for intended use. |
| Shelf Life (3 years) | Confirmed (implied by shelf life evaluation). |
| Storage Conditions (4-25°C) | Confirmed (implied by shelf life evaluation). |
2. Sample size used for the test set and the data provenance
The document describes bench tests rather than a clinical study with a "test set" of patient data. Therefore, specific sample sizes for a clinical test set are not applicable or provided. The data provenance is laboratory-based testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations mentioned are performance bench tests of the material properties, not interpretations requiring human expert "ground truth" in the diagnostic sense.
4. Adjudication method for the test set
This information is not applicable for bench tests.
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 such study was conducted or reported. This document pertains to a dental coating material, not an AI software/device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical dental material, not an algorithm.
7. The type of ground truth used
For the bench tests, the "ground truth" would be established by standardized testing methodologies and specifications for material properties common in dental material science (e.g., ISO standards for depth of cure, hardness measurements, colorimetry for color stability).
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
Summary of the Study and Device Proof:
The submitted information is a 510(k) premarket notification for a dental material. The "study" described is a series of performance bench tests designed to demonstrate that the Optiglaze Color material meets required specifications for a dental glazing and characterizing agent. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices (specifically, G-Coat from GC Corporation).
The document states:
- "It is confirmed that the device conforms to the required specifications and is suitable for its intended use." (Page 2)
- The device complies with all requirements of ISO 10993-1 for biological evaluation.
- The curing mechanism is substantially equivalent to predicate devices, implying similar function, composition, and intended use.
Therefore, the "proof" the device meets acceptance criteria is through successful completion of these internal bench tests (appearance, depth of cure, color stability, surface hardness, application characteristics, packaging, shelf life) and the FDA's determination of substantial equivalence, rather than a clinical trial or algorithm performance study.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.