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510(k) Data Aggregation
(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Low gold palladium based casting alloy
- Acceptance Criteria and Reported Device Performance:
| Property | Acceptance Criteria (Predicate Device: Legacy XT) | Reported Device Performance (Palaurex 76KF) |
|---|---|---|
| Melting point range (solid.) | 1190 °C | 1115 °C |
| Melting point range (liquid) | 1300 °C | 1285 °C |
| Hardness (Vickers 5/30) - soft | 245 | 220 |
| Hardness (Vickers 5/30) - hard | (Not specified for predicate) | 260 |
| Yield strength (MPa) - soft | 552 | 630 |
| Yield strength (MPa) - hard | (Not specified for predicate) | 865 |
| Elongation (%) - soft | 30 | 18 |
| Elongation (%) - hard | (Not specified for predicate) | 4 |
| CTE (x10-6/°C) | 14.3 | 14.1 |
| Density (g/cm3) | 10.8 | 10.6 |
| Composition (weight%) | ||
| Au | 2 | 2 |
| Ag | 10 | 7.5 |
| Pd | 75.4 | 75.6 |
| Sn | 0 | 2.9 |
| In | 6 | 6.2 |
| Ga | 6 | 5.5 |
| Ru | <1 | 0.3 |
The "acceptance criteria" here are defined by the properties of the legally marketed predicate device, Jelenko Legacy XT. The study demonstrates that the Palaurex 76 KF, while having some differences, is considered substantially equivalent based on the listed physical and mechanical properties and composition. The discussion indicates that the differences, such as Sn compensating for lower Ag, were deemed acceptable.
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Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test beyond the comparative tables showing single values for each property. The tests were run according to ANSI/ADA 5 and ISO 9693 standards, which would define the number of samples required for each specific test (e.g., hardness, tensile).
- Data Provenance: Not explicitly stated, but the submission is from "Aurex Precious Metal Industries (PTY) LTD." in the "Republic of South Africa." The data likely originated from their internal testing or accredited labs in support of their submission. The data is retrospective in the context of the 510(k) submission, as it was generated prior to the submission for pre-market notification.
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Number of Experts and Qualifications:
- Not applicable. This is a submission for a dental casting alloy, and the evaluation relies on objective physical and chemical property comparisons, not expert interpretation of images or clinical outcomes.
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Adjudication Method:
- Not applicable. This is not a study involving human interpretation or clinical adjudication. Properties are measured against standard test methods.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a material science comparison, not a study evaluating human readers' performance with or without AI assistance.
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Standalone (Algorithm Only) Performance:
- Not applicable. This is not a software device or an algorithm. The "performance" refers to the intrinsic physical and chemical properties of the alloy.
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Type of Ground Truth Used:
- The "ground truth" for the new device's performance is based on measurements taken according to established international standards (ANSI/ADA 5 and ISO 9693).
- The "ground truth" for the comparison/acceptance criteria is the reported properties of the legally marketed predicate device, Jelenko Legacy XT.
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Sample Size for Training Set:
- Not applicable. This is a materials comparison, not a machine learning model.
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How Ground Truth for Training Set was Established:
- Not applicable. This pertains to machine learning models, which is not relevant here.
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