(90 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURELUX Bio Y85PF. The primary study presented is a comparison between the new device and a legally marketed predicate device (Argen Argedent Bio Yellow PF) based on composition and physical/mechanical properties. The overall conclusion is that the new alloy is "substantially equivalent" to the predicate, implying it meets similar performance characteristics.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a numerical threshold that must be met. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. The performance is reported as a direct comparison of physical and mechanical properties and composition. The implication is that if the new device's properties are comparable to the predicate, it meets the "acceptance criteria" for substantial equivalence.
| Property/Test Method | Predicate Device (Argedent Bio Y PF) | New Device (Aurelux BioY85PF) | Implicit Acceptance Criteria (Comparative) |
|---|---|---|---|
| Composition (weight%) | |||
| Au | 86.5 | 84.5 | Similar (% within reasonable range for the type of alloy) |
| Pt | 10.4 | 12 | Similar |
| Zn | 1.5 | 1.8 | Similar |
| Ta | 0.3 | 0 | Similar (absence noted, considered insignificant due to oxidation/elimination) |
| In | 0.2 | 0.5 | Similar |
| Ir | 0 | 1.2 | Similar |
| Rh | 0.9 | 0 | Similar |
| Mr | 0.1 | 0 | Similar (absence noted, considered insignificant due to oxidation/elimination) |
| Physical/Mechanical Properties | |||
| Melting point range (solid.) | 1040 °C | 1027 °C | Comparable |
| Melting point range (liquid) | 1130 °C | 1079 °C | Comparable |
| Hardness (Vickers 5/30) (soft) | 180 | 120 | Comparable |
| Hardness (Vickers 5/30) (hard) | 250 | 220 | Comparable |
| Yield strength (MPa) (soft) | 650 | 280 | Comparable |
| Yield strength (MPa) (hard) | 750 | 460 | Comparable |
| Elongation (%) (soft) | 8 | 17 | Comparable |
| Elongation (%) (hard) | 5 | 7 | Comparable |
| CTE (x10^-6/°C) | 14.5 | 14.4 | Comparable |
| Density (g/cm³) | 18.6 | 18.8 | Comparable |
Note on "Acceptance Criteria": For an equivalence study like this, the "acceptance criteria" are implicitly that the measured properties of the new device are sufficiently close to those of the predicate device to justify the claim of substantial equivalence. The document concludes: "On the basis of the very high noble metal content and essentially same constitution it may be expected that the new alloy perform very similarly to Argident B Y PF." This statement serves as the justification for meeting the implicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of manufactured devices tested. Instead, it presents specific compositional percentages and physical/mechanical property values, which are likely derived from laboratory testing of material samples. The number of samples per test is not detailed.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the address of the applicant (Aurex Precious Metal Industries, Republic of South Africa), it's reasonable to infer the testing was conducted there or by a contracted lab. The data is retrospective, as it compares the new device's properties to a pre-existing, legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study does not involve expert evaluation of clinical images or diagnostic outcomes. The "ground truth" here is objective material science data (composition, physical/mechanical properties) as measured by standard test methods (ANSI/ADA 5 and ISO 9693).
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study requiring expert consensus or multiple readings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is a material science comparison for a dental casting alloy, not a diagnostic device involving human readers or cases.
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.
7. The Type of Ground Truth Used
The ground truth used is objective material science data derived from standardized laboratory test methods (ANSI/ADA 5 and ISO 9693) for:
- Elemental composition (weight percentage of metals)
- Physical properties (melting point range, density, CTE)
- Mechanical properties (hardness, yield strength, elongation)
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or algorithm-based device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.