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The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Fathom™-16 Steerable Guidewires are hydrophilic coated, steerable guidewires intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. They are not intended for use in the cerebral or coronary vasculatures. The devices provided are non-pyrogenic, sterile, and intended for one procedure only. The device shaft is coated with a thin hydrophilic coating over the distal section to provide lubricity, which aids in the navigation of distal, tortuous vasculature. Accessories include a torque device, guidewire introducer and torque device. They are not intended to enter the body and have no patient contact.

The provided document is a 510(k) summary for the Boston Scientific Fathom™-16 Steerable Guidewire. This type of submission is for medical devices, specifically guidewires, not for AI/ML-driven diagnostic or assistive software. Therefore, the document does not contain information related to acceptance criteria, ground truth, expert consensus, or study designs like MRMC or standalone performance evaluations as they would apply to an AI device.

The "Performance Data" section in the document indicates that the testing was conducted to demonstrate equivalence to a predicate device, focusing on physical and mechanical properties of the guidewire. The tests listed are:

• Total Length
• Particulate
• Tip Shape Retention
• Torsional Strength
• Pre-Shape Tips

The document states, "The Fathom™-16 Steerable Guidewires met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing." However, it does not provide the specific "acceptance criteria" values or the "reported device performance" values for these tests.

Therefore, I cannot populate the requested table or answer the questions related to AI/ML device study methodologies using the provided text. The information is simply not present in this type of regulatory submission for a physical medical device like a guidewire.

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