(34 days)
Gold Core 75 is a, high noble, yellow alloy, to be used for inlays, onlays, single crown bridges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indicret restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.
Gold Core 75 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. The chemical composition of Gold Core 75 is as follows: Au - 75% Ag - 17% Pt-4.5% Rh - 0.5% Balance Amounts of: Zn, Ta, In, Ir
The provided text is a 510(k) summary for a dental alloy named "Gold Core 75". It states that the device is substantially equivalent to a previously marketed device, BIO74-PF Crown and Bridge Alloy (K943487). This type of submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific performance metrics and ground truth establishment as would be seen for novel or high-risk devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving device performance is not present in this document. The document primarily focuses on chemical composition and intended use to establish substantial equivalence.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to a predicate device (BIO74-PF Crown and Bridge Alloy, K943487).
- Reported Device Performance: The document lists the chemical composition of Gold Core 75: Au - 75%, Ag - 17%, Pt - 4.5%, Rh - 0.5%, Balance (Zn, Ta, In, Ir). It also implicitly states its performance by declaring its intended uses (inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites). The basis of "performance" in this context is its chemical composition and intended use closely matching the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The 510(k) does not describe a clinical study with a test set of data. Substantial equivalence is often based on material characterization and comparison to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set requiring adjudication is described.
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/Not provided. This is a material (dental alloy), not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth in the context of a clinical study is described. The "truth" for this submission is the established performance and characteristics of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. This is a material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a material, not a machine learning model.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.