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This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.

Jel-20 is a white Type III Crown & Bridge alloy.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental alloy, stating its substantial equivalence to a predicate device. It does not include a scientific study report or clinical trial results. Therefore, I cannot fulfill your request based on this input.

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Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.

Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and study information you requested. The document appears to be an FDA 510(k) clearance letter for a dental alloy, "Jel Bios 18." It confirms substantial equivalence to pre-amendment devices and outlines regulatory obligations, but it does not detail:

• Acceptance Criteria or Device Performance: There is no table or description of specific performance metrics or thresholds for the device.
• Study Design Information: The document does not mention any studies conducted to prove the device meets acceptance criteria, nor does it provide details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results.
• Training Set Information: No information regarding a training set for an AI/algorithm is present, as this appears to be a material device clearance.

The document's focus is on the regulatory clearance of a physical medical device (dental alloy), not a software or AI-driven device that would typically involve the type of study and performance metrics you've asked about.

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