(43 days)
Auropal 60 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays and Onlays, and Crowns
Auropal 60 is a dental gold-silver casting alloy (63,7% noble metals), intended for dental technicians to fabricate dental restorations. On the basis of it's mechanical properties, Auropal 60 is a Type 3 casting alloy, according to ISO 8891. The indications of Auropal 60 comprise inlays/onlays and crowns. Auropal 60 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is a 510(k) summary for a dental alloy, Auropal 60. It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria, a study that proves the device meets those criteria, or any of the detailed aspects of a device performance study (like sample sizes, ground truth establishment, or expert qualifications).
The document primarily focuses on establishing substantial equivalence to a predicate device based on its composition and mechanical properties conforming to an international standard (ISO 8891).
Therefore, I cannot provide the requested information based only on the input text. The information below reflects what could be inferred or is explicitly stated, but much of it will be marked as "Not provided in the text."
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties (according to ISO 8891 for Type 3 casting alloy): | Auropal 60 is a Type 3 casting alloy, according to ISO 8891. |
| - High corrosion resistance | Auropal 60 is highly corrosion resistant. |
| Compliance with European Directive: | It fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. |
| Indications for Use: | Auropal 60 is intended for manufacturing Inlays, Onlays, and Crowns. |
Note: The text states the device "fully complies" and "is highly corrosion resistant" but does not provide specific numerical criteria or measurement results for these properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the text. This document is a 510(k) summary focused on substantial equivalence to a predicate device, not a detailed study report.
- Data provenance: Not provided in the text. The device manufacturer is from Germany.
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. This device is a dental alloy, not an AI/medical image analysis device that requires expert review for ground truth establishment in the traditional sense. Its performance is based on material properties and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device is a dental alloy.
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 or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be the International Standard ISO 8891 for dental casting alloys and the European directive 93/42/ECC concerning medical devices. The device's performance is asserted to comply with these established standards for material properties and safety.
8. The sample size for the training set
- Not applicable. This is a material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. 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.