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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 System is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support. The following therapies are available with the Novalung System:

• Extracorporeal CO2 removal (ECCO2R)
• Extracorporeal membrane oxygenation (ECMO) ●
  The Novalung System consists of the Novalung console and XLung kit. The Novalung console is composed of the following components:
• Control panel ●
• Power supply ●
• Sensor box ●
• . Pump drive
  The Novalung console powers and monitors the operation of the blood pump head in the extracorporeal circuit. The control panel has a touchscreen display on which all data, parameters, and values are displayed. Parameters can be selected and adjusted by pressing the touchscreen as well as by using the control panel function keys and the center knob. The control panel is attached to the power supply, which provides power to the console. The console also provides two (2) battery packs that supply power to the console if there is a power failure.
  The sensor box allows data to be transferred to the console and displayed on the control panel. It has connectors for pressure sensors that connect to the XLung kit tubing set and a flow sensor.
  The XLung kit contains a disposable tubing set 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 (XLung 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 XLung kit tubing has 3 integrated pressure sensors (IPS) that connect to the sensor box. The flow sensor detects air bubbles in the extracorporeal circuit and measures blood flow. The XLung kit provides treatment for a blood flow range of 1-7 L/min and has a total extracorporeal priming volume of 605 mL ± 10%.
  The blood pump head is pre-connected to the XLung kit tubing set, which is provided sterile. Blood flow in the XLung kit tubing set is driven by the pump drive when it is connected to the blood pump head.
  The following accessories are available with the Novalung System:
• Bracket and rail connector
• Flow sensor ●
• Pressure sensor connecting cables
• System cart ●
• Compact holder spike and bracket
• Pump drive holders ●
• . Infusion holder

The provided text describes the Novalung System, an extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. It outlines the device's indications for use, its components, and various tests conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present a table of specific acceptance criteria alongside reported device performance for these tests. Instead, it generally states that "All testing met predetermined acceptance criteria" and provides summaries of the types of tests performed and their overall conclusions.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, and ground truth establishment cannot be extracted directly from this document.

Here's a summary of the information that can be extracted or inferred from the provided text, and an explanation for what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "All testing met predetermined acceptance criteria." However, it does not provide a specific table with numerical or qualitative acceptance criteria for each test (e.g., "Oxygen transfer rate > X mL/min," "Pressure drop < Y mmHg") nor does it list specific reported numerical performance values for each criterion. It broadly summarizes the outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Animal Study:
  • Sample Size: 5 sheep were specifically used to evaluate the Novalung System (out of a total of 15 sheep in the study).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it's an animal study.
  • Retrospective or Prospective: Prospective (an 18-day animal study was conducted).
• Clinical Studies:
  • Sample Size: 148 patients (100 veno-venous (VV) ECMO patients and 48 veno-arterial (VA) ECMO patients).
  • Data Provenance: Retrospective analysis of clinical data from the Regensburg ECMO Registry. The country of origin (Germany) is implied by "Regensburg ECMO Registry."
  • Retrospective or Prospective: Retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The general phrase "predetermined acceptance criteria" suggests internal validation against established standards for the non-clinical tests. For the clinical and animal studies, "ground truth" would be established by the physiological measurements and clinical outcomes observed, interpreted by the clinicians and researchers involved, but the document does not specify the number or qualifications of these individuals involved in "establishing ground truth".

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the Novalung System is a medical device for extracorporeal support, not an AI-assisted diagnostic or interpretation tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the Novalung System is a physical medical device, not an algorithm. Its performance is inherent to its design and function, not dependent on human-in-the-loop interaction in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Non-clinical/Bench Testing: The "ground truth" for these tests would be defined by engineering specifications, safety standards (e.g., electrical safety, EMC), and existing biocompatibility standards (e.g., ISO 10993-1). The document refers to "predetermined acceptance criteria."
• Animal Study: The "ground truth" would be the observed physiological parameters, device performance, and adverse events in the animal subjects over the study duration.
• Clinical Study: The "ground truth" was established by the patient outcomes (e.g., survival, mortality), physiological status, and incidence of device-related complications as recorded in the Regensburg ECMO Registry. These were compared to data from the Extracorporeal Life Support Organization (ELSO) Registry, effectively using historical, aggregated outcomes data as a comparative "ground truth" or benchmark.

8. The sample size for the training set

This is not applicable. The Novalung System is a physical medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device would be its design, engineering, and manufacturing processes, along with component testing.

9. How the ground truth for the training set was established

This is not applicable, as explained in point 8.

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