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BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.

BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.

This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.

The document discusses:

• Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
• Processing: It's processed by selective laser melting (SLM).
• Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
• Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
• Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
• Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.

Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.

If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.

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BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.

BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy called "BegoPal 300". It states that the device is substantially equivalent to legally marketed predicate devices and is classified as a Class II medical device.

However, this document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established. It is purely a regulatory approval document.

Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving device performance based on the provided input.

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BegoPal is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with 93/42 EEC. Class IIa according to Annex IX.

BegoPal is a crown and bridge metal to ceramic type 4 alloy.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that demonstrates a device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental alloy named BegoPal, indicating its substantial equivalence to a predicate device. It discusses regulatory matters such as classification, general controls, and marketing authorization.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided text.

Ask a specific question about this device