(237 days)
- Class III and V restorations
- Restoration of primary teeth
- Core build-up
- Cases where radiopacity is required
- Base material for Class I and Class II cavities using a sandwich laminate technique.
GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to include all your requested points:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (ISO 9917-2:2010) | Reported Device Performance (GC Fuji Direct) |
|---|---|---|
| Appearance | No visible sign of extraneous matter, Free of any gelation | Conforms to requirements |
| Working time | The indenter shall make a complete circular indentation. | Conforms to requirements |
| Setting time | The indenter shall fail to make a complete circular indentation. | Conforms to requirements |
| Flexural strength | More than 25 MPa | Conforms to requirements |
| Radiopacity | More than equivalent thickness of aluminum | Conforms to requirements |
| Shade and color stability | Shade: Shall match with the manufacturer's nominated shade guide; Color stability: No significant change from the reference specimen | Conforms to requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing against ISO standards and biocompatibility assessments. Therefore, there isn't a "test set" in the context of a clinical study with human or biological samples in the way this question typically implies for AI/diagnostic devices. The data provenance is related to laboratory testing, likely conducted by or for GC America Inc., a US-based company, referencing the specified international standards. No country of origin for the specific test data is given beyond the company's location. The testing appears to be prospective (as part of the 510(k) submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a bench test and biocompatibility assessment against technical specifications rather than an evaluation requiring expert-established ground truth on a test set (e.g., medical image interpretation). The "ground truth" for these tests is the quantitative and qualitative requirements of the ISO standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This is a bench test against technical specifications, not a study requiring adjudication of expert interpretations.
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
N/A. This device is a dental cement, not an AI software/diagnostic device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a dental cement, not an algorithm, so this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing is adherence to the technical specifications defined in ISO 9917-2:2010 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the protocols outlined in ISO 10993-1:2009, ISO 10993-5, and ISO 10993-10 for biocompatibility. These are objective, predefined standards for material properties and biological response.
8. The sample size for the training set
N/A. This is a dental material, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
N/A. As there is no training set for an AI model, this question is not applicable.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.