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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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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 < 6 hours.

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.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The NovaPort® One Vascular Access was subjected to numerous tests and comparisons to the predicate device: testing included pressure/burst, simulated use, kink resistance, tensile strength, flow characteristics, hemolysis, biocompatibility, and validation testing to coating."

• Sample Size: The specific sample sizes for these various engineering and bench tests are not provided in the 510(k) summary. These would typically be detailed in the full test reports submitted to the FDA, not in the summary.
• Data Provenance: The tests are described as "numerous tests," indicating they were likely benchtop/laboratory studies conducted by Novalung GmbH (likely in Germany, given the company's location) rather than human clinical trials. There is no mention of country of origin for any human data (as no human data appears to be used for acceptance) or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this 510(k) summary. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices where human expert interpretation is the gold standard for comparison (e.g., in AI/ML tasks). For this vascular access cannula, the "truth" is established through physical and material property testing, and comparison to the known performance of predicate devices. There's no mention of expert review panels for determining ground truth in the way described.

4. Adjudication Method for the Test Set

This question is not applicable for the reasons stated above. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts in diagnostic ground truth establishment, which isn't part of this device's acceptance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to assess how a device (often with AI assistance) impacts human reader performance. The NovaPort® One is a physical medical device (cannula), not a diagnostic tool requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This concept is entirely specific to AI/ML or autonomous diagnostic algorithms. The acceptance testing for the NovaPort® One involves physical performance evaluations and material characterization, not algorithmic performance.

7. The Type of Ground Truth Used

For the NovaPort® One Vascular Access, the "ground truth" for its acceptance testing is based on:

• Engineering specifications and regulatory standards: For tests like pressure/burst, tensile strength, kink resistance, and flow characteristics.
• Established biocompatibility standards: For biocompatibility testing.
• Predicate device performance: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. This "ground truth" is therefore derived from the established safety and efficacy profiles of the predicate devices (Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K052524 and One Piece Pediatric Arterial Cannula 7000 Models K024069).

8. The Sample Size for the Training Set

Not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical medical instrument, not an AI/ML algorithm, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the NovaPort® One Vascular Access device.

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