(54 days)
BioPorta Solder 1020 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.
BioPorta Solder 1020 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold and Silver: 98,5%). BioPorta Solder 1020 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as a solder before ceramic firing for ceramic dental alloys with appropriate melting ranges and compositions, especially AGC® Speziallegierung and BioPorta G, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. BioPorta Solder 1020 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text describes a 510(k) premarket notification for a dental brazing alloy called "BioPorta Solder 1020." It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML or diagnostic device. The document is a regulatory submission for a dental material, focusing on its composition, intended use, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
Specifically, the document does NOT include:
- A table of acceptance criteria and reported device performance: This type of information is common for AI/ML or diagnostic devices where performance metrics (e.g., sensitivity, specificity, accuracy) are evaluated against pre-defined thresholds. For a dental alloy, performance is typically assessed against material standards (like ISO 9333 in this case) rather than clinical performance metrics in a study as you describe.
- Sample size for test set and data provenance: No test sets or patient data are mentioned as this is a dental material, not a diagnostic or AI device.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable.
- Type of ground truth used: Not applicable. The "ground truth" for a dental alloy would be its material properties meeting specified standards.
- Training set sample size: Not applicable.
- How ground truth for training set was established: Not applicable.
Instead, the document states that "BioPorta Solder 1020 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This indicates that compliance with established material standards (ISO 9333 and EC directive) serves as the basis for its safety and effectiveness, rather than a clinical trial or AI performance study.
In summary, the provided text does not contain the information required to answer your query, as it pertains to a different type of medical device (a dental alloy) than what your questions are designed for (AI/ML or diagnostic devices).
§ 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.