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The PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.

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I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (PerioView Model DV-1 Fiberscope and Window Sheath), but it does not contain any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily focuses on:

• Confirming the substantial equivalence of the device to legally marketed predicates.
• Outlining regulatory responsibilities and contacts.
• Stating the intended indications for use.

Therefore, I cannot extract the specific technical details about device performance tests and validation studies from this document.

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The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called the "Dentalview Perioview System." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The letter primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data typically found in a study summary or clinical trial report.

Ask a specific question about this device