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Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are by a trained professional in the field of general dentistry.

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I am sorry, but the provided text from the FDA letter (K202674 for Medidenta High Speed Handpieces) does not contain the information necessary to describe acceptance criteria and a study proving a device meets acceptance criteria in the way you've outlined.

The document is an FDA 510(k) clearance letter for a dental handpiece, establishing its substantial equivalence to previously marketed devices. It details the regulatory process, product classification, and general controls applicable to the device.

Specifically, it lacks any information regarding:

• Performance metrics (sensitivity, specificity, accuracy, etc.)
• Studies conducted to prove performance
• Acceptance criteria for these metrics
• Sample sizes for test or training sets
• Ground truth establishment methods
• Expert qualifications or adjudication methods
• MRMC studies or human reader improvement with AI assistance (as this is not an AI/software device)
• Standalone algorithm performance (again, not an AI/software device)

This letter is a regulatory document confirming clearance, not a clinical study report or a technical performance specification. Therefore, I cannot generate the requested table and study description based on the provided input.

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