Search Results

The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.

The NMI MCs has an outside diameter of 2.8F and 2.4F and has a nominal inside diameter of 0.027" and 0.021", respectively, along the entire catheter length. The MC has a braided reinforced shaft, which transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located I mm from the distal end of the catheter to identify the location of the distal tip under fluoroscopic visualization. The MC has a hydrophilic coating applied to the outer surface of the distal end. The proximal end of the MC contains a Luer fitting and strain relief. The device is provided sterile and intended for single procedure use.

This document discusses a 510(k) submission for a microcatheter. However, it explicitly states that the submission is for a labeling change only, and no design, dimensional, or material changes have been made to the predicate device.

Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance. It only mentions infusate compatibility testing supporting the labeling change, which is not a performance study as typically understood for AI/ML devices.

Based on the provided text, I cannot complete the requested tables and sections because there is no detailed performance study or acceptance criteria information for the device itself.

Here's a breakdown of why each requested section cannot be fulfilled from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document is about a labeling change, not a new device or a change requiring re-evaluation of performance against acceptance criteria.
2. Sample size used for the test set and the data provenance: Not available. There is no test set or performance data mentioned for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth or expert review is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 device is a microcatheter, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:
The purpose of this 510(k) submission (K121954) is solely a labeling change for the NMI MC Microcatheter. The device itself is identical to previously cleared predicate devices (K112124 and K111368) in terms of intended use, materials, design, components, and technological characteristics. The performance data mentioned refers to "infusate compatibility testing" which supported the labeling change and demonstrated substantial equivalence, but this is not a study assessing the clinical performance or accuracy of the device in the way an AI/ML device would be evaluated.

Ask a specific question about this device