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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.

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Intended Use: Ariston pHc filling material is intended to be used for Intended USE. Allscon pho firming indeciduous and permanent teeth with Crass I and if reparations and for an amalgam substitute.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental filling material called "Ariston pHc", indicating it has been found substantially equivalent to a predicate device.

The letter mentions the device's intended use and regulatory classification, but it does not detail specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a performance study.

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Intended Use: ProCad is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental device called "ProCad". It does not contain information about acceptance criteria, study details, or performance data for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which are "inlays, onlays, veneers, and anterior/posterior crowns."

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