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This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature. The catheter should not be used in the cerebral vessels.

The SwiftNINJA® Microcatheter is a 2.9 Fr (proximal) / 2.4 Fr (distal) microcatheter with a steerable/articulating distal tip. Articulation is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions. The steering dial and steerable tip are connected via two operating wires. The wires are located on both lateral walls of the catheter shaft with a connection point on the distal catheter. Tension is applied to either one of the wires by turning the steering dial for manipulation of the tip direction. Once the direction of steerable tip is determined, the steering dial lock may be used for maintaining the intended direction. The outer surface of the distal segment of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the microcatheter into the vasculature.

The provided text is a 510(k) Pre-Market Notification for the SwiftNINJA Microcatheter. This document details the device's characteristics and its substantial equivalence to previously cleared devices, but it does not describe a study meant to prove the device meets specific acceptance criteria in the context of AI/ML performance.

Instead, the document focuses on bench testing and biocompatibility testing to demonstrate the device's physical and biological safety and performance, comparing it to predicate devices. There is no mention of an AI/ML component in the SwiftNINJA Microcatheter.

Therefore, I cannot extract information related to:

1. A table of acceptance criteria and reported device performance in an AI/ML context. The document lists various performance tests for mechanical properties and biocompatibility, but these are not set as acceptance criteria for AI performance metrics (e.g., accuracy, sensitivity, specificity).
2. Sample size used for the test set and data provenance for AI/ML.
3. Number of experts used to establish ground truth for an AI/ML test set.
4. Adjudication method for an AI/ML test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and its effect size for human readers with/without AI assistance.
6. Standalone (algorithm-only) performance for an AI/ML device.
7. Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
8. Sample size for the training set for AI/ML.
9. How ground truth for the training set was established for AI/ML.

The document explicitly states: "No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of this device." This further confirms that no studies for performance in the sense of clinical effectiveness or AI model evaluation were performed. The "performance data" mentioned refers to the results of the bench and biocompatibility tests.

In summary, the provided document is for a medical device (microcatheter) and details its physical and biological testing for regulatory clearance, not the performance evaluation of an AI/ML component.

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