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The VitalFlow™ Console controls the VitalFlow™ Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.

The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal life support (ECLS) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for ECLS circuit data only; no patient data are stored or exported.

The VitalFlow Emergency Handcrank (drive unit) can be used in emergency situations to manually drive the centrifugal pump in the case of console and or motor drive failure.

The provided text describes the VitalFlow™ Console, an extracorporeal circuit component, and its FDA 510(k) clearance (K230364). The document outlines the device's indications for use, description, and the performance evaluations conducted to demonstrate substantial equivalence to a predicate device.

However, the document does not contain the detailed information necessary to answer all parts of your request, specifically regarding acceptance criteria for an AI/ML model, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details for an AI model. This is likely because the VitalFlow™ Console is a mechanical/electronic medical device, not an AI/ML-driven diagnostic or assistive device that would typically undergo such evaluations.

The "Bench Performance Evaluations" section lists various studies (Hydraulic performance, Reliability, EMC, Electrical Safety, Software Validation, Usability Studies), but these are standard engineering and regulatory tests for hardware and software functionality, not AI model performance.

Therefore, I cannot provide a table of acceptance criteria for an AI model or details about AI-specific testing from this document.

If you are looking for information regarding an AI/ML-driven medical device, this document does not seem to pertain to such a device.

From the provided text, I can infer the following about the device and its testing:

• Device Type: The VitalFlow™ Console is an extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure (Product Code: QNR, Regulation Number: 21 CFR 870.4100). It controls features like pump motor speed (RPM), flow, and bubble detection.
• Purpose of Studies: The studies were conducted to demonstrate "substantial equivalence" of the VitalFlow™ Console to a predicate device (TandemHeart Escort Controller, K202751) and to meet the "Special Controls" described in 21 CFR 870.4100.
• Nature of Studies: The studies were primarily "Bench Performance Evaluations" and included aspects like hydraulic performance, reliability, EMC, electrical safety, software validation, and usability studies. These are typical engineering and functional performance tests for a physical device.
• Ground Truth: For a physical device like this, "ground truth" would be established through calibrated instruments and established engineering principles for parameters like flow rate, RPM, pressure, and electrical safety. It's not based on expert consensus on image interpretation or pathology.
• No AI Component: There is no mention of an AI/ML component or algorithm within the VitalFlow™ Console. Therefore, concepts like training sets, test sets for AI models, expert adjudication, or MRMC studies are not applicable to the information provided.

In summary, the provided document does not contain the information requested about AI/ML device acceptance criteria and study details because the VitalFlow™ Console appears to be a physical medical device, not an AI-driven one.

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