(152 days)
- Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
- Cementation of metal, ceramic, fiber posts, and cast post and cores.
GAM-200 is a dual-cured self-adhesive resin cement. The mixed cement is hardened through the polymerization activated by redox or photo initiator system. The adhesiveness to tooth structure develops with phosphoric ester monomers which form ionic bonds with calcium ions. The acidic monomers also can polymerize with frame-forming monomers. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip and directly applied to restorations or the prepared cavity.
The provided text describes a 510(k) premarket notification for a dental cement device, GAM-200. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through clinical studies that would involve acceptance criteria and performance metrics in the way a medical AI/CAD device would.
Therefore, the information requested in your prompt (e.g., acceptance criteria, sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) is not applicable to this type of device and submission.
The document discusses the technical characteristics and equivalence of the GAM-200 dental cement to predicate devices based on material properties and in vitro tests, not on clinical performance in diagnosing or assisting with interpretation in a human-in-the-loop setting.
However, I can extract the relevant information that is present in the document related to how the device's characteristics were assessed against established standards and predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (compared to) | Reported Device Performance (GAM-200) |
|---|---|---|
| Curing Mechanism | Same as predicate devices (polymerization of uncured methacrylate ester monomers, redox or photo initiator system). | Same as predicate devices (polymerization activated by redox or photo initiator system). |
| Adhesive Mechanism | Same as predicate devices (acidic ester monomer developing adhesiveness to tooth structures by forming ionic bonds with calcium ions). | Same as predicate devices (phosphoric ester monomers forming ionic bonds with calcium ions; acidic monomers polymerize with frame-forming monomers). |
| Setting Time | Within the same range as comparative (predicate) devices. | In the same range as comparative devices. |
| Depth of Cure | Equivalent to comparative (predicate) devices. | Equivalent to comparative devices. |
| Flexural Strength | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Water Sorption | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Solubility | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Biological Evaluation (Cytotoxicity) | Equivalent to predicate devices (tested in accordance with MTT Assay method). | Equivalent to predicate devices. |
| ISO 4049: 2009 | Compliance with all requirements for Dentistry Polymer-based restorative materials. | Complies with all requirements. |
| ISO 11405: 2003 (Bond Strengths) | Equivalent bond strengths to predicate devices (in accordance with the standard). | Equivalent bond strengths to predicate devices. |
2. Sample size used for the test set and the data provenance: Not applicable. The evaluations are primarily in vitro material science tests against standards and predicate devices, not clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized testing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is a dental cement, not an AI/CAD system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is based on established international standards (ISO 4049: 2009, ISO 11405: 2003) and laboratory test results for material properties and biological evaluation (cytotoxicity via MTT Assay). The comparison is against the performance of legally marketed predicate devices.
8. The sample size for the training set: Not applicable. There is no machine learning "training set" for this device.
9. How the ground truth for the training set was established: 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.