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FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Polystim Nerve Stimulator." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter is primarily a regulatory approval stating that the device can be marketed. It does not include the technical study details one would expect to find when describing acceptance criteria and a study proving device performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, as this information is not present in the provided text.

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The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetic and/or analgesic solutions into the epidural or Caudal space for up to 72 hours.

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I am sorry. This document is a 510(k) clearance letter from the FDA to Te Me Na S.A.R.L. for their Model C20900-03 Polymedic Epidural Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain information about any AI/ML device, clinical study, acceptance criteria for an AI/ML device, or device performance metrics. Therefore, I cannot provide the requested information based on this text.

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The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves (when used with a nerve stimulator) and administration of anesthesia drugs.

Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles

I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for nerve stimulation needles, confirming "substantial equivalence" to previously marketed devices. It does not include a scientific study report or data on performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED FOR THE DETECTION AND CONFIRMATION OF THE PLACEMENT OF THE EPIDURAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPIDURAL ANESTHESIA. THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY. IT IS NOT INTENDED FOR ASPIRATION OR INJECTION.

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The provided documents are a 510(k) premarket notification approval letter and the "Indications For Use" statement for the TE ME NA Loss of Resistance Syringe, 10CC. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means that the FDA determined the new device is as safe and effective as a legally marketed predicate device, without requiring extensive clinical trials or performance studies that would typically be detailed in a Device Performance section.

Therefore, I cannot provide the requested information based on the given input.

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