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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "CROSSLEAD 0.018inch" guide wire. This document primarily focuses on establishing substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not contain information about a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with the evaluation of artificial intelligence (AI) or software-based medical devices.

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance in the context of an AI/software study. The document lists non-clinical tests and states they met acceptance criteria, but these are for the physical device, not an AI.
• Sample size used for a test set (in the context of an AI study).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the physical characteristics and performance of a medical guide wire, not a software or AI device that would require such studies. The "non-clinical testing/performance data" section refers to bench tests for the physical guide wire's properties (e.g., tensile strength, torqueability, coating integrity, biocompatibility), not an algorithm's performance on a dataset.

In summary, the provided text does not describe the kind of study you are asking about, which typically pertains to the evaluation of AI/software in medical devices.

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