(86 days)
Used for brazing dental alloys prior to porcelain application.
High Gold Palladium Free Ceramic Solder
This is a 510(k) premarket notification decision letter from the FDA regarding a dental solder, not a study report for an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document.
The letter confirms that the High Gold Palladium Free Ceramic Solder is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
To elaborate on why this information isn't available:
- Acceptance Criteria and Device Performance Table: The document states that the device is "substantially equivalent" to predicate devices. It doesn't provide specific performance metrics or acceptance criteria for the solder itself, as would be expected for a novel medical device like an AI algorithm.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): A 510(k) submission for a dental solder typically relies on material characterization, biocompatibility testing, and comparison to existing devices, not clinical studies in the same way an AI diagnostic tool would. Hence, there are no details about test sets, experts, or adjudication methods.
- Ground Truth: For a dental solder, "ground truth" would relate to its material properties and clinical performance (e.g., bond strength, corrosion resistance), which are established through laboratory testing and clinical experience with similar materials, not expert consensus or pathology on a dataset in the context of an AI device.
- Training Set Size and Ground Truth Establishment for Training Set: These concepts are entirely irrelevant for a dental solder because it's a physical material, not a machine learning algorithm that requires training data.
§ 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.