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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz HLM is a modular heart-lung machine like its primary predicate Stöckert S5 System. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifuqal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Electrical venous occluder (EVO), Arterial Clamp/ Electric Remote Control, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

This FDA 510(k) summary for the Essenz HLM heart-lung machine does not contain information on acceptance criteria for device performance or a study proving that the device meets those criteria. In fact, it explicitly states "CLINICAL TESTING: None required" and "ANIMAL TESTING: None required."

The document details non-clinical testing for verification and validation, but these tests are against recognized standards for electrical safety, EMC, software, human factors, and mechanical performance, rather than specific, quantified device performance acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Here's why the document doesn't contain the requested information in the typical format for AI/ML device evaluations:

• Device Type: The Essenz HLM is a hardware medical device (a heart-lung machine console) used for cardiopulmonary bypass. The questions you've asked (acceptance criteria, study design, sample size, ground truth, expert consensus, MRMC studies, standalone performance) are highly relevant to AI/Machine Learning (AI/ML) driven medical devices, especially those involved in diagnostic or predictive tasks where performance metrics like sensitivity, specificity, or AUC are critical and need to be validated against expert ground truth.
• Regulatory Pathway: This is a 510(k) submission, which demonstrates substantial equivalence to a predicate device. For hardware devices like this, substantial equivalence is often established through detailed comparisons of technological characteristics, materials, and non-clinical performance (electrical safety, EMC, mechanical testing, software verification) against recognized standards, rather than clinical efficacy studies on patient outcomes or AI model performance.
• Focus of the Document: The document focuses on demonstrating that the Essenz HLM is as safe and effective as its predicate through engineering verification and validation testing, not through a study evaluating its diagnostic accuracy or predictive capability.

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