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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

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The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to

The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body. The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass. All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides. NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.

The provided 510(k) summary for the Novalung® GmbH NovaPort® One Vascular Access device primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance criteria through a detailed clinical or standalone performance study as would be seen for AI/ML devices.

Here's an analysis based on the information provided, emphasizing what is present and what is absent from the request's specific questions regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical device (a vascular access cannula) and not an AI/ML diagnostic tool, there are no specific diagnostic "performance metrics" like sensitivity, specificity, or AUC. Instead, the acceptance is based on demonstrating equivalence to predicate devices across various attributes. The "acceptance criteria" here implicitly refer to meeting the expectations for functional and safety performance that allow for declaration of substantial equivalence.

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