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The Novalung System is indicated for long-term (> 6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults 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. These may include:

• · Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• · ECMO-assisted cardiopulmonary resuscitation in adults

The Novalung ultimate kit (US) is a single use, ethylene oxide (EO) sterilized device comprised of a disposable tubing set and accessories. The Novalung ultimate kit (US) contains a disposable tubing set, pump head, oxygenator with heat exchanger, and accessories (gas line, priming line, stopcocks, luer caps, Christmas tree connector, tubing clamps, cable ties). The tubing set is pre-connected to a hollow fiber membrane oxygenator and blood pump head (Deltastream DP3 3/8"), which forms an extracorporeal circuit. All blood-contacting surfaces of the tubing set, except for the blood pump head, are coated with x.ellence coating. The Novalung ultimate kit (US) tubing set has three (3) integrated pressure sensors (IPS) that connect to the Novalung System sensor box. The flow sensor detects air bubbles in the extracorporeal circuit and measures blood flow. The Novalung ultimate kit (US) provides treatment for a blood flow range of 1-6.5 L/min and has a total extracorporeal priming volume of 670 mL ± 10%. In the Novalung ultimate kit (US), blood flows from the patient through the tubing set with IPSs, through the pump head and the oxygenator, and back to the patient. Blood flow is driven through the oxygenator by the pump head that is powered by the Novalung System console's pump drive.

The provided document is a 510(k) premarket notification for a medical device called the "Novalung ultimate kit (US)". This device is an extracorporeal circuit and accessories used for long-term respiratory/cardiopulmonary support. There is no mention of Artificial Intelligence (AI) or machine learning (ML) in this document, so it does not contain the information needed to answer your questions about AI device acceptance criteria or performance studies.

The document primarily focuses on demonstrating the substantial equivalence of the Novalung ultimate kit (US) to a legally marketed predicate device (Novalung System XLung kit, K191407) through non-clinical performance testing and biocompatibility assessments.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample sizes used for a test set, data provenance, or details about training sets for an AI/ML device.
3. Number of experts, qualifications, or adjudication methods for establishing ground truth for an AI/ML device.
4. MRMC studies or effect sizes for human readers with and without AI assistance.
5. Standalone performance of an algorithm.
6. Type of ground truth used for an AI/ML device.

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