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The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only.

IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.

The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types.

The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design.

All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.

This looks like a 510(k) premarket notification for a guiding catheter, not a study describing the acceptance criteria and performance of an AI/ML device.

Therefore, the requested information fields (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training) are not applicable to the provided text.

The document discusses substantial equivalence to predicate devices based on:

• Intended Use, Indications for Use: Similar to predicate devices.
• Materials and Design: Similar to predicate devices.
• Technical Characteristics: Do not introduce new questions regarding safety or effectiveness.
• Labeling: Similar to predicate devices.
• Biocompatibility and Physical Performance Testing: These tests demonstrate the device to be safe and effective, though specific acceptance criteria and results are not detailed in this summary.

In summary, there is no AI/ML device described in this document, and thus no AI/ML performance study to analyze for acceptance criteria.

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