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The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.

The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. The RAP FV cannula is provided with a flexible obturator to assist with the placement. The RAP FV cannula can be guided over a 0.035" guidewire. The RAP FV cannula has depth markers to assist the physician with placement. The RAP FV cannula ranges in outside diameter from 18 - 26 Fr, and in length from 60 -76 cm.

The provided document is a 510(k) premarket notification for a medical device (ESTECH Remote Access Perfusion FV Catheter). The information requested pertains to the acceptance criteria and the study proving the device meets those criteria, which is typical for AI/ML device submissions. However, this document does not contain any information about an AI/ML device.

The document describes a physical medical device (a cardiopulmonary bypass cannula) and its substantial equivalence to predicate devices. It discusses:

• Device Description: A sterile, single-use, open-ended, hollow polymer tube with multiple perforations.
• Intended Use: As a venous drainage cannula during cardiopulmonary bypass.
• Comparison to Predicate Device: Substantially equivalent in terms of sterile, single-use, open-ended, hollow polymer tubes inserted into the vena cava via the femoral vein.
• Supporting Data: Biocompatibility testing consistent with ISO 11193 and preclinical performance data to demonstrate labeled performance claims and substantial equivalence.

Therefore, I cannot provide the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) because these concepts are not applicable to the non-AI/ML device described in the provided text.

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