Search Results

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Endoscopic Applicator, 41 cm

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a medical device called "Endoscopic Applicator, 41 cm." It primarily discusses regulatory aspects, such as substantial equivalence, general controls, and compliance with federal regulations.

Therefore, I cannot provide the requested table and study summary based on the given input.

Ask a specific question about this device

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Not Found

This document is a 510(k) premarket notification from the FDA regarding a medical device called the "Endoscopic Applicator". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets that criteria.

Specifically, the document:

• Identifies the manufacturer (Micromedics Inc. d/b/a Nordson Medical).
• States the device name, regulation number, and product code.
• Confirms the device is substantially equivalent to legally marketed predicate devices.
• Outlines general controls and regulations the device must comply with.
• Provides contact information for various FDA divisions.
• States the Indications for Use for the Endoscopic Applicator: "The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar."

Therefore, I cannot provide the requested information as the document does not contain details about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device