Search Results

Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers.

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, a study, or any of the specific details you requested regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

The document is a clearance letter from the FDA for Alliance Medical Corporation's Reprocessed Unipolar Laparoscopic/Endoscopic Instruments. It confirms that the supplemental validation data for these reprocessed single-use devices has been reviewed and that the devices are substantially equivalent to legally marketed predicate devices. It lists the devices cleared and their indications for use.

The letter explicitly states: "After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the FDA has assessed the equivalence of the reprocessed devices to existing ones, rather than evaluating a standalone study with defined acceptance criteria and performance metrics against a medical condition for a novel device.

Therefore, I cannot provide the requested table or answer the specific questions about a study's methodology as this information is not present in the provided text.

Ask a specific question about this device