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The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.

Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.

The provided text is a 510(k) premarket notification for a medical device (Steerant Super Stiff Guidewire). It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets individual acceptance criteria for an AI/software component through a study.

Therefore, the information required to answer your prompt, specifically concerning acceptance criteria, study design for AI performance, sample sizes for training and test sets, expert involvement, and ground truth establishment, is not present in the provided document.

The document details the device's physical characteristics, indications for use, and a comparison to predicate and reference devices. It mentions "Non-Clinical Performance Data" and states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence." However, it does not elaborate on what those criteria were for the performance of the device (e.g., accuracy, sensitivity, specificity for an AI algorithm), nor does it describe a study involving humans and AI assistance or algorithm-only performance.

The "Non-Clinical Performance Data" section lists various engineering and regulatory tests such as:

• Design Verification Testing
• Design Validation Testing
• Sterilization Validation per requirements of ISO 11135
• Biocompatibility Testing per the requirements of ISO 10993-1
• Packaging Design Verification Testing per requirements of ISO 11607
• Shelf Life Testing

These are standard tests for a physical medical device and do not involve AI or software performance evaluation in the manner described in your prompt.

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study data for an AI-powered medical device.

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