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The WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

The Boston Scientific WATCHMAN TruSteer™ Access System is composed of an Access Sheath and Dilator. The WATCHMAN TruSteer Access System is a steerable Access System intended to provide vascular and transseptal access specifically for the family of WATCHMAN™ FLX™ Left Atrial Appendage Closure Devices with Delivery Systems. The WATCHMAN TruSteer Access System will be used by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures.

The provided document is a 510(k) summary for the Boston Scientific WATCHMAN TruSteer Access System. It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device (WATCHMAN FXD Curve Access System, K212228).

However, this document does not contain information about a study proving that an AI-driven device meets acceptance criteria. It describes the verification testing for a physical medical device (an access system for cardiac procedures), not a software or AI-based device.

Therefore, I cannot provide the requested information, such as acceptance criteria for an AI device, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, because this information is not present in the provided text.

The document explicitly states under "Clinical Testing": "Clinical evaluation was not required for this device." This confirms that no clinical study (which would typically involve test sets, human readers, and expert ground truth for AI performance evaluation) was conducted or reported for this submission.

The "Non-Clinical Performance Data" section lists various physical performance tests for the access system (e.g., Dimensional Characterization, Kink Resistance, Torque Transmission, Biocompatibility tests), which are typical for hardware medical devices, not AI software.

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