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The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Each ProtekDuo Veno-Venous Cannula Set includes a dual lumen cannula and an introducer. The introducer is designed to accept a standard 0.038-inch guidewire. The ProtekDuo Veno-Venous Cannula Sets are intended as single patient, single use, sterile devices.

Each ProtekDuo Veno-Venous Cannula consists of two (2) distinct lumens, each made of polyurethane with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body is the smaller diameter lumen with six (6) side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal of the cannula from the extracorporeal circulatory support equipment. A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8-inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has two suture wings that can be used for securing the cannula in place to the patient. The cannulas also have printed insertion depth markings measured from the distal tip.

Each introducer consists of a tube and hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque polyvinyl chloride material for visualization under fluoroscopy.

This document describes the premarket notification (510(k)) for the ProtekDuo Veno-Venous Cannula Sets, asserting their substantial equivalence to legally marketed predicate devices. The information provided outlines the device's technical characteristics, its intended use, and the non-clinical testing performed to demonstrate its performance.

However, the provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the context of an AI/human reader performance study. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to existing devices, primarily through non-clinical testing and an in vivo animal study. It does not mention any AI component or human reader performance evaluation.

Therefore, I cannot fulfill the request to provide information based on the input about:

• A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
• Sample sized used for the test set and data provenance (for an AI/human reader study)
• Number of experts used to establish ground truth and qualifications (for an AI/human reader study)
• Adjudication method (for an AI/human reader study)
• MRMC comparative effectiveness study, effect size
• Standalone (algorithm only) performance study
• Type of ground truth used (for an AI/human reader study)
• Sample size for the training set (for an AI)
• How ground truth for the training set was established (for an AI)

The document's "acceptance criteria" are related to regulatory conformity (e.g., biocompatibility, sterility, mechanical integrity) and "performance" refers to the device's physical and functional characteristics (e.g., flow rates, tensile strength) demonstrated through non-clinical bench testing and an animal study, not human or AI diagnostic performance.

Based on the provided document, here's what can be extracted regarding the device's acceptance criteria and proof of performance:

The acceptance criteria for the ProtekDuo Veno-Venous Cannula Sets are primarily defined by the Special Controls outlined in 21 CFR 870.4100 for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. The study proving the device meets these criteria is a series of non-clinical tests (bench tests) and an in vivo animal study.

1. Table of Acceptance Criteria (Special Controls) and Reported Device Performance:

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

• Test Set (Non-Clinical/Bench Testing): Specific sample sizes for each non-clinical test (e.g., number of cannulas tested for tensile strength, number of setups for pressure/flow) are not detailed in this summary. However, these would be standard engineering test sample sizes to ensure statistical validity for the specific tests performed (e.g., according to ISO standards or internal validation protocols).
• Test Set (In Vivo): The summary mentions a "14-day in vivo evaluation" in a "biologic test system." The specific number of animals used for this study is not provided in this document.
• Data Provenance: The testing appears to be conducted by the manufacturer or contract research organizations as part of their regulatory submission for the device. The country of origin for the data is implied to be related to the applicant's location (Pittsburgh, PA, USA) or its testing facilities. It is a prospective set of tests and studies specifically performed for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as this submission is for a medical device (cannula) based on physical and biological performance, not an AI or diagnostic imaging device requiring expert reader ground truth.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by physical measurement standards, engineering specifications, and established biological/material compatibility protocols (e.g., ISO standards for biocompatibility, flow dynamics equations for pressure/flow).
For the in vivo animal study, the "ground truth" would be the observed physiological function and integrity of the device within the biologic system over the 14-day period.

8. The Sample Size for the Training Set: Not applicable, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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The Quantum Perfusion Single Lumen Cannula 22F is designed to drain blood from the patient through the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

The Quantum Perfusion Dual Lumen Cannula 27F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

The Quantum Perfusion Dual Lumen Cannula 31F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Quantum Perfusion Single Lumen Cannula:
Quantum Perfusion Single Lumen Cannula is a single use device intended to be used in medical procedures providing cardiac and respiratory support up to 6 hours. The device is characterized by a single lumen drainage catheter and is designed to be coupled with an extracorporeal circuit, allowing for blood oxygenation and carbon dioxide removal.
The device exploits a percutaneous insertion procedure, which reduces the invasiveness of extracorporeal procedures. It is intended to be inserted in the right internal jugular vein.
The device features multiple inflow openings, allowing to drain blood from the vena cava., providing drainage during extra-corporeal medical procedures.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. Blood contact surfaces of the device are coated with a stable biocompatible surface.

Quantum Perfusion Dual Lumen Cannula:
Quantum Perfusion Dual Lumen Cannula is a single use device intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. The device is characterized by two coaxial catheters and is designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.
The device exploits a single site insertion which reduces of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter, and returned through the lumen of the inner catheter.
The device features multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the device surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.

The provided text describes a medical device submission (K203067) for several Quantum Perfusion Cannulas. This document is a 510(k) summary, which outlines the device's characteristics and demonstrates substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against those criteria in the context of an AI/ML device.

The entire submission focuses on non-clinical testing to establish substantial equivalence for physical medical cannulas, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device cannot be extracted from this document.

The document explicitly states:

• "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." (Page 10)
• "In-vitro performance tests have been performed in order to substantial equivalence determining that proposed devices do not raise any new issues in terms of product's safety or effectiveness if compared to currently cleared predicate and reference products." (Page 9)

The non-clinical testing performed includes evaluations of: Device Pressure Drop, Mechanical Integrity, Kinking resistance, Dynamic Blood Damage, Infusion/drainage recirculation, Air aspiration, Marker radiopacity, Pad printing resistance, product shelf life, EtO Sterilization process validation, Packaging Validation tests, and Biocompatibility. These are typical engineering and material tests for physical medical devices.

Therefore, I cannot provide the requested information for an AI/ML device based on this document because it is not about an AI/ML device.

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