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The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.

The Fogarty Arterial Embolectomy Catheter with Gate Valve provides a means of clearing emboli and thrombi from vessels in the arteries of the peripheral vasculature through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 2F and is available in 45 cm length. The catheter contains a latex balloon at the distal end and a gate valve at the proximal end for connection to a syringe for balloon inflation.

The provided document details a 510(k) premarket notification for the Fogarty Arterial Embolectomy Catheter with Gate Valve. This document is a regulatory submission to the FDA for a medical device. Based on the content, it does NOT describe an AI/ML-driven medical device or a study involving human readers or expert panels for ground truth establishment.

Instead, the device is a physical medical instrument (a catheter) for removing blood clots. The information provided focuses on the substantial equivalence of this new device to a predicate device, primarily through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. The document explicitly states:

• "Device Testing: Biocompatibility testing was performed in accordance with ISO 10993-1: 2018... Bench testing was performed in accordance with Edwards’ current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria."
• "Conclusion: Based on the performance testing and the technological characteristics, the Fogarty Arterial Embolectomy Catheter with Gate Valve meets the established performance criteria and is substantially equivalent to the predicate device Fogarty Arterial Embolectomy Catheters."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert involvement, and reader studies as these are not relevant to the type of device and submission described in the provided text. The document describes a traditional medical device submission, not an AI/ML diagnostic or assistive device.

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