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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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The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is intended to be used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is a sterile device for single use only and it is not intended to be resterilized by the user. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is used to deliver oxygen into the blood and remove carbon dioxide from the blood. It is intended to be used as a component in an extracorporeal circuit for patients undergoing cardiopulmonary bypass. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane and has a 1.3 m² surface area. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has a nominal flow range from 0.5 L/min. to 4.5 L/min and is suitable for patients weighing >20kg.

The provided text describes a medical device submission (K072362) for the Novalung® surgical Lung Assist (sLA) Membrane Lung™. This is a 510(k) premarket notification for a new oxygenator device, aiming to demonstrate substantial equivalence to a predicate device.

Crucially, the provided text describes a submission for a physical medical device (an oxygenator), not a software or AI-driven diagnostic device. Therefore, many of the requested categories related to acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training sets are not applicable.

Below is an attempt to answer the relevant questions based on the provided text, with explanations for the questions that are not applicable to this type of device submission.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance against those criteria in a quantitative manner as would be expected for an AI/software device. Instead, it describes general performance testing and a comparison to a predicate device.

2. Sample size used for the test set and the data provenance

Not Applicable for this type of physical medical device. This device undergoes bench testing and in-vitro evaluation, not a "test set" with human data provenance in the context of an AI/software submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device does not rely on expert-established ground truth for a test set in the way an AI/software diagnostic device would. Its performance is evaluated through physical and chemical testing.

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

Not Applicable. There is no "test set" and no human or expert adjudication involved in the evaluation of this physical medical device.

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

Not Applicable. This is a physical medical device (oxygenator), not an AI diagnostic tool. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation.

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

Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a concept relevant to its evaluation.

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

The "ground truth" for this device's performance would be established through principles of physics, chemistry, and established clinical performance standards for oxygenators. This would involve:

• Bench Test Results: Measurements of oxygen transfer, CO2 removal, pressure drops, blood compatibility, and other physical/chemical parameters.
• Predicate Device Performance: The established performance characteristics of the "Jostra Quadrox D Safeline Diffusion Membrane Oxygenator" serve as a benchmark for substantial equivalence.
• FDA Guidance: Adherence to recognized FDA guidance for oxygenator testing.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not Applicable. As there is no AI model or training set, this question is irrelevant.

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