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The PERCEPTOR® Compensator MORSE® Manifold, like its predicates, the MORSE® DT Manifold and the Stand Alone Transducer, is a physiological blood pressure transducer. Both devices are intended for invasive pressure monitoring, catheterization procedures, fluid delivery and/or blood access maintenance.

A device which integrates a physiological pressure transducer directly into the side port lumen of a manifold. A catheter provides a fluid column which communicates pressure in the heart from the tip of the catheter to the transducer. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The signal is communicated to the monitor via the cable.

The provided text is a 510(K) summary for a medical device called the PERCEPTOR® Compensator MORSE® Manifold, which is a physiological blood pressure transducer. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. It does not contain information about a study involving acceptance criteria, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any form of AI/algorithm performance.

The document addresses compliance with engineering standards rather than clinical performance metrics in the way you've outlined for AI or diagnostic devices.

Therefore, I cannot populate the requested table or answer the subsequent questions based on the input provided. The summary is about a physical device's design, materials, and compliance with general transducer standards, not about a study assessing its diagnostic or interpretive accuracy.

Here's a breakdown of what can be inferred from the text, and why the other information is missing:

What's available in the text:

• The device is a physiological blood pressure transducer.
• It's intended for invasive pressure monitoring, catheterization procedures, fluid delivery, and/or blood access maintenance.
• It's expected to conform to specifications in ANSI/AAMI BP22-1994 "Blood Pressure Transducers."
• Biocompatibility testing was performed on predicate devices (implying the new device, using identical materials, doesn't need new biocompatibility testing).
• The fundamental design principles are outlined (integrates transducer into manifold, catheter communicates pressure, gel acts as vibratory membrane).
• Differences from predicates are described: redirected lumen for accurate zero balancing and pressure monitoring at any height, and discontinuation of an Over Pressure Protection Band.

Why the requested information is absent:

The 510(k) summary is for a physical medical device (a blood pressure transducer) that measures a physiological parameter. The "performance" in this context refers to its ability to accurately measure blood pressure according to established engineering standards (like ANSI/AAMI BP22-1994), not its ability to interpret images, diagnose conditions, or provide AI-assisted insights.

Therefore, there are no:

• "Acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic task. The acceptance criteria would be conformance to the ANSI/AAMI standard.
• "Reported device performance" in terms of diagnostic metrics. Performance is implied by adherence to the ANSI/AAMI standard.
• "Sample sizes for test set" related to diagnostic accuracy.
• "Experts" establishing ground truth for a diagnostic task.
• "Adjudication method."
• "MRMC comparative effectiveness study" involving human readers and AI.
• "Standalone algorithm performance."
• "Type of ground truth" (pathology, expert consensus, etc.).
• "Training set" or "how ground truth was established for training" because this isn't an AI/algorithm-driven device.

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