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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

The provided text is a 510(k) Summary for a medical device (CROSSLEAD Tracker, a guide wire) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance or human reader improvement.

The document details non-clinical laboratory testing performed to demonstrate substantial equivalence to predicate and reference devices, focusing on physical and material properties of the guide wire. These tests are standard for medical devices and are not related to AI/ML or a comparative effectiveness study involving human readers.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML performance and human reader studies because this information is not present in the provided document.

The "Non-clinical testing/performance data" section (Page 8) lists various physical tests:

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Catheter Compatibility
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radio-Detectability
• Dimensional Verification
• Coating Integrity / Acute Particulate Characterization

And "Biocompatibility" tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Systemic Toxicity
• USP Rabbit Pyrogen, Material Mediated
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Sc5b-9 Complement Activation

The document states: "The in vitro bench tests demonstrated the CROSSLEAD Tracker met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide the specific numerical acceptance criteria or the reported performance for each of these physical and biocompatibility tests. It also does not discuss any computational or AI-driven aspects, nor does it mention a study involving human readers, sample sizes for test/training sets, or expert ground truth establishment for such studies.

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