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The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

This balloon-tipped left ventricular vent is intended to drain the left ventricle and left atrium of air, blood, and solid particles generated during surgery. The balloon-tipped IV vent is intended to be inserted through the open left atrium or through the right superior pulmonary vein and across the mitral valve into the left ventricle. In addition, it can be introduced directly into the left ventricle during mitral valve surgery. The design of the balloon-tipped LV vent focuses on ease of passage, position and safety. The soft balloon will inflate in the left ventricle, keeping the catheter tip below the mitral valve to ensure drair, debris and blood from the left ventricle. In addition, the proximal holes will drain air, particulate debris, and blood from the left atrium.

I am sorry, but the provided text does not contain information regarding the acceptance criteria of a device or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Michler-Kapp Cardiovascular Vent Catheter), outlining its intended use, design, and comparison to a predicate device to establish substantial equivalence.

It includes:

• Indications for Use: The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.
• Device Description and Attributes: Detailed description of the catheter's features, dimensions, and materials.
• Comparison to a Predicate Device: A table comparing the technological characteristics of the proposed device to the Medtronic/DLP 16 Fr Vent Catheter, Model 12116 (K834352), highlighting similarities and differences.
• Non-Clinical Testing: A list of non-clinical tests performed, including liquid and air leakage, tubing tensile force, balloon inflation, suction, kink testing, flexibility testing, and hemolysis.
• Biocompatibility Testing: A list of biocompatibility tests performed, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity (including pyrogenicity assessment), and hemocompatibility.
• No Clinical Testing: Explicitly states that no clinical testing was performed for this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than defining specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and a study to meet those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth was established for the training set.

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