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THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,

This guidewire has a 0.0175" diameter and is available in lengths of 45-120 cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.

This request requires the extraction of very specific information about acceptance criteria and study design, which is not present in the provided text. The document is a 510(k) summary for a medical device (guidewire) and primarily focuses on establishing substantial equivalence to predicate devices, not on detailed performance studies or specific acceptance criteria with reported device performance.

Therefore, I cannot provide the requested table or detailed study information. The text explicitly states: "NeoMetrics Access Wires and predicate devices were subjected to bench and biocompatibility testing to demonstrate equivalency in terms of safety and effectiveness." However, it does not provide:

• A table of acceptance criteria (e.g., minimum tensile strength, maximum friction) or reported device performance against those criteria.
• Details about the sample size for any test set, data provenance, or number/qualifications of experts used to establish ground truth.
• Information on adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, or training set specifics (as these are typically relevant for AI/software-based devices, not a physical guidewire).

The provided text focuses on the regulatory submission process and the determination of substantial equivalence for a physical medical device.

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