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

The devices we intend to market are intravascular catheters as described in 21 CFR 880.5200. The subject devices are similar to catheters currently marketed by Nipro Medical Corporation under K960051. Two types of catheters will be available: the container cases types L (long) and S (short). Type L catheters have needles 1 1/2 to 2 1/2 inches long and Type S have needles ¾ to 1 ¼ 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 is a premarket notification for a medical device (Nipro Safelet Cath), not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and studies proving performance for AI devices (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

The document is a 510(k) summary demonstrating substantial equivalence to a legally marketed predicate device (K960051), rather than presenting novel performance data against specific acceptance criteria for an AI algorithm.

However, I can extract information relevant to the device itself as presented in the document:

1. A table of acceptance criteria and the reported device performance:

This document describes a medical device (intravascular catheter) and focuses on demonstrating its substantial equivalence to a previously marketed device (K960051). It does not present specific quantitative acceptance criteria or detailed performance results in the way an AI diagnostic device submission would. Instead, the "performance" here is implied by the similarity in technical characteristics and intended use to the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device, and no "test set" in the context of algorithm performance is mentioned. The submission relies on comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication for ground truth is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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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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