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The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III , IV.

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This looks like a 510(k) clearance letter for the Ultroid™ Hemorrhoid Management System. It's a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, not a study report detailing acceptance criteria and performance data.

Therefore, the prompt's request for information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text.

The document only states the intended use of the device: "coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, IV."

To answer your request, you would need access to the actual 510(k) submission, which would likely include pre-clinical or clinical data to support the substantial equivalence claim.

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The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III, IV.

Not Found

This document is a 510(k) clearance letter for the Ultroid™ Hemorrhoid Management System. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) would for novel devices.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device