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The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are identical to those already marketed by Exel International, Inc. under K895768. Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles 3/4 to 11/4 inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.

This document is a 510(k) summary for a medical device called "Nipro Safelet Cath," an intravascular catheter. It explicitly states that the device is identical to a previously marketed and cleared device, the "Exel Safelet Catheter" (K895768).

Therefore, the acceptance criteria and study data provided here are not for the Nipro Safelet Cath itself, but rather rely on the substantial equivalence to the predicate device. In such cases, no new performance studies are typically required for the new device if it is identical.

Given this, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone studies) specifically for the Nipro Safelet Cath from this document because it defers to the predicate device for all technical characteristics and equivalence.

The relevant section states:
"The Nissho and Exel devices are exactly the same devices, therefore, all technical characteristics are identical."

This means that the "study that proves the device meets the acceptance criteria" refers to the prior clearance of the Exel Safelet Catheter (K895768), and no new, independent study for the Nipro Safelet Cath is presented in this summary.

Therefore, I cannot populate the requested table and details based on the provided text, as this summary explicitly states the device is identical to a predicate and does not present new study data.

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