(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Medium gold palladium based casting alloy
The provided text is a 510(k) summary for a dental casting alloy named HIPALLAUR 51. This document describes the device and compares it to a legally marketed predicate device (Jelenko Cameo) based on composition and physical/mechanical properties to demonstrate substantial equivalence. It does not describe an AI/ML device or a study with acceptance criteria and device performance in the way requested in the prompt.
Therefore, many of the requested categories are not applicable to the provided text. I will address the relevant information that can be extracted.
Not Applicable:
- A table of acceptance criteria and the reported device performance: This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, predefined acceptance criteria for a new AI/ML device performance. The "performance" here is comparison to a predicate.
- Sample size used for the test set and the data provenance: There isn't a "test set" in the context of an AI/ML device. The comparison is based on material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a dental alloy.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a dental alloy.
- The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for this submission is established chemical composition and physical properties measured by standard methods.
- The sample size for the training set: Not applicable for a dental alloy.
- How the ground truth for the training set was established: Not applicable for a dental alloy.
Applicable Information (based on interpretation of the prompt for a non-AI/ML device):
The "acceptance criteria" for a 510(k) submission like this are implicitly demonstrating substantial equivalence to a legally marketed predicate device. The "device performance" is presented through direct comparison of material properties.
1. Table of Acceptance Criteria and the Reported Device Performance
For this 510(k) submission, the implicit "acceptance criteria" are that the new device (HIPALLAUR 51) has a composition and physical/mechanical properties that are sufficiently similar to the legally marketed predicate device (Jelenko Cameo) to ensure equivalent safety and effectiveness.
Here's a table synthesizing the comparison presented:
| Property | Acceptance Criteria (Predicate: Jelenko Cameo) | Reported Device Performance (HIPALLAUR 51) | Discussion/Outcome (Substantial Equivalence) |
|---|---|---|---|
| Composition (weight%) | |||
| Au | 52.5 | 50.6 | Difference |
§ 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.