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The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature.

The fundamental mechanism of action is temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration through a guide catheter. The sheath provides vessel access. The occlusion balloon catheter is intended for temporary vessel occlusion and the guide catheter functions to remove emboli and thrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the 510(k) submission for "The ICHOR Panacea Vascular Embolectomy Catheter System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing. However, the document does not provide the detailed information required for the questions regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

Here's why and what's missing:

• This device is a physical medical device (catheter system), not an AI/algorithm-based diagnostic or therapeutic device. The questions posed are highly relevant to AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, etc., are crucial, and the "ground truth" establishment, expert adjudication, and human reader comparative studies are standard.
• The "testing" mentioned is for a physical device. The "Summary of Testing" section lists various in vitro tests (e.g., "Balloon performance and dimensions," "Tensile testing," "Clot capture," "Biocompatibility," "Sterilization," "Animal testing"). These are standard for clearing a physical medical device and ensure its mechanical properties, safety, and functionality. They are not about the performance of an AI algorithm.
• There is no mention of "acceptance criteria" in the context of an AI's diagnostic performance. The "acceptance criteria" referred to in the document would be pre-determined specifications for the physical properties and performance of the catheter (e.g., balloon burst pressure, tensile strength limits, successful clot removal percentage in an in vitro model).
• No "study" is described that involves human readers, ground truth established by experts, or AI performance metrics. The document states "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements," referring to the physical tests.
• No data provenance, sample sizes for AI test/training sets, or expert qualifications are discussed. These concepts are not applicable to the premarket notification for this physical device.

Therefore, I cannot answer the questions based on the provided text, as the text describes the submission for a physical medical device and not an AI/ML-driven device.

To answer your questions, I would need a 510(k) summary or clinical study report for an AI-based medical device that performs a diagnostic or prognostic task.

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