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The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.

K-VAC is a sterile, single-use aspiration-irrigation catheter that is designed to assist in the removal of stone fragments during standard ureteroscopy. K-VAC is a dual-lumen catheter with two concentric lumens. The outer lumen is the irrigation lumen that accommodates delivery of irrigation/contrast solution. The larger, inner lumen is the aspiration lumen through which the stone fragments are removed. The inner diameter of the aspiration lumen is 2.5 mm. The distal 5 cm of the K-VAC tip is soft with a steering mechanism on the catheter handle and embedded wires to actuate the tip. In this way, stones and debris in the renal calyces can be fluidized with irrigation and aspirated.

An additional component to the device is a radiopaque introducer, which is 0.035" and 0.038" guidewire compatible. The tip of the introducer has a soft tapered tip.

The design of K-VAC allows the trained operator to maneuver and position K-VAC via a standard 12/14F ureteral access sheath under fluoroscopic guidance, followed by controlled irrigation and aspiration of stones and debris from the renal pelvis and calyces.

K-VAC is composed of well-characterized biocompatible materials commonly used in urinary catheters. The catheter is mechanical and contains no electrical components.

The provided text is a 510(k) summary for the Kalera Vacuum Aspiration Catheter (K-VAC), a medical device. It does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. Instead, it details the process for demonstrating substantial equivalence of a mechanical medical device to a predicate device, focusing on performance testing, biocompatibility, sterilization, and packaging/shelf life.

Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for AI performance (like sensitivity, specificity), sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, because this document pertains to a physical, non-AI medical device.

The study described is a demonstration of equivalence to a predicate device (ClearPetra Suction-Evacuation Sheath, K161110) for a mechanical device, not the performance of an AI/ML algorithm.

Here's a breakdown of why this document doesn't fit your prompt's requirements for an AI/ML device:

• Device Type: The K-VAC is described as a "sterile, single-use aspiration-irrigation catheter" and "mechanical and contains no electrical components." This clearly indicates it's a physical medical device, not an AI/ML system.
• Performance Testing: The "Performance Testing" section outlines bench testing (dimensional conformance, flow, product cycling, tortuous path, actuation, torque, bond), animal studies (fluoroscopy, irrigation, aspiration in a porcine model), usability assessment, biocompatibility, sterilization, and packaging/shelf life. These are typical tests for mechanical medical devices, not AI/ML algorithms.
• "Acceptance Criteria" Context: The document refers to meeting "product specifications" and "design input requirements" related to the mechanical performance of the catheter. It does not mention any statistical thresholds for AI performance metrics (e.g., AUC, sensitivity, specificity).
• No AI/ML Specifics: There is no mention of algorithms, models, training data, test data, ground truth established by expert consensus for image interpretation, or any other elements common in AI/ML device validation.

In summary, the provided text is irrelevant to the prompt, as it concerns a mechanical medical device, not an AI/ML product.

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