(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Palladium based casting alloy
This document is a 510(k) summary for the Palceram 82SF dental casting alloy, asserting its substantial equivalence to the legally marketed device Argipal. The information provided heavily emphasizes a direct comparison of the new device to the predicate device, rather than defining independent acceptance criteria with separate performance goals.
Therefore, the "acceptance criteria" and "device performance" are presented as a comparison to the predicate device, Argipal, arguing that because Palceram 82SF has "practically identical technological characteristics" it meets the necessary standards. There is no explicit and distinct set of predetermined acceptance criteria independent of the predicate device for this submission.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for Palceram 82SF are implicitly defined by its substantial equivalence to the Argipal alloy. The "reported device performance" for Palceram 82SF is presented as being nearly identical to Argipal.
| Characteristic | Acceptance Criteria (Implied by Argipal's Performance) | Reported Palceram 82SF Performance |
|---|---|---|
| Composition (weight%) | ||
| Palladium (Pd) | 81.5 | 81.6 |
| Tin (Sn) | 14.5 | 14.6 |
| Gallium (Ga) | 3.5 | 3.4 |
| Ruthenium (Ru) | 0.5 | 0.6 |
| Physical & Mechanical Properties | ||
| Melting point range (°C) (solid.) | 1220 | 1220 |
| Melting point range (°C) (liquid) | 1250 | 1250 |
| Hardness (Vickers 5/30) (soft) | 240 | 230 |
| Hardness (Vickers 5/30) (hard) | 245 | 245 |
| Yield strength (MPa) (soft) | 560 | 560 |
| Yield strength (MPa) (hard) | 660 | 660 |
| Elongation (%) (soft) | 15 | 15 |
| Elongation (%) (hard) | 10 | 10 |
| CTE (x10-⁶/°C) | 14.1 | 14.1 |
| Density (g/cm³) | 11.2 | 11.2 |
2. Sample size used for the test set and the data provenance
The document states that "Test methods applied: as in ANSI/ADA 5 and ISO 9693." However, it does not specify the sample size for any of the tests performed or the data provenance (e.g., country of origin, retrospective or prospective). The data presented appears to be summary statistics rather than raw data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns a dental casting alloy, and performance is determined by physical and chemical property testing, not expert interpretation of outputs.
4. Adjudication method for the test set
Not applicable. This submission concerns a dental casting alloy, and performance is determined by physical and chemical property testing, not subjective adjudication.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The testing described is for material properties.
7. The type of ground truth used
The "ground truth" for the performance claims is based on standard laboratory measurements of chemical composition as well as physical and mechanical properties, conducted according to ANSI/ADA 5 and ISO 9693 standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a training set. The data presented is for the characterization of the material.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device, this question is not relevant.
§ 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.