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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 MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure 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.

The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

This document is a 510(k) Summary for the MC3 Crescent™ Jugular Dual Lumen Catheter. It outlines the device's indications for use, description, comparison to a predicate device, and how it conforms to Class II Special Controls.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one might expect for diagnostic accuracy or clinical outcomes. Instead, it discusses conformance to "Special Controls" and mentions various types of testing to demonstrate "substantial equivalence."

Based on the information provided, the "acceptance criteria" can be inferred from the "Class II Special Controls" and the general requirements for substantial equivalence. The "device performance" is described qualitatively as meeting these controls.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (Jugular Dual Lumen Catheter K180151) rather than proving novel clinical efficacy or diagnostic accuracy as might be seen for AI-driven diagnostic devices. The performance metrics are related to safety, material compatibility, and engineering design rather than clinical outcome improvements attributable to the device itself beyond its function in ECMO.

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

The document describes various types of testing but does not provide specific sample sizes for each test mentioned (e.g., "non-clinical performance," "in vivo evaluation," "biocompatibility").

• Non-clinical Performance: Mentions "bench" testing, "mechanical integrity," and "30-day durability." No specific sample size is given.
• In vivo Evaluation: Mentions "7-day in vivo thrombogenicity evaluation." No specific sample size is given, nor is the species used.
• Biocompatibility: Refers to ISO 10993-1:2009 and GLP (21 CFR 58). These are standards for testing, but they don't specify the sample size used in this particular submission.

Data Provenance: The data is generated from various tests (bench, in vivo, etc.) conducted by the manufacturer (MC3 Incorporated). The document does not specify the country of origin for the data or if it's retrospective or prospective, as these are typically controlled laboratory and animal studies, not patient data in the context of this device.

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

This information is not provided in the document. The tests described are laboratory and animal studies, not typically involving human expert adjudication for "ground truth" in the way a diagnostic AI would.

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

This information is not provided and is not applicable to the types of engineering and biocompatibility tests described for this 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a physical medical device like a catheter.

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

This question is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy is not directly applicable here. For the various tests performed, the "truth" is established through:

• Bench Test Results: Measured physical and mechanical properties against pre-defined specifications.
• Biocompatibility Standards: Adherence to established ISO and GLP guidelines.
• In vivo Evaluation: Biological responses (e.g., thrombogenicity) observed in an animal model, measured against expected safety profiles.

8. The sample size for the training set

This is not applicable. The MC3 Crescent™ Jugular Dual Lumen Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure 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.

The MC3 Jugular Dual Lumen Catheters are bi-caval dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous surgical methods (Seldinger type approach). The introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The introducer hub provides an area for grasping the introducer during insertion and when fully seated, indicates that the introducer is fully inserted. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. The catheters remain intact throughout the duration of use and withstand the forces associated with insertion, securement, connection to perfusion line, clamping, blood pressures, and removal.

This document describes the premarket notification for a medical device and provides information on its performance evaluations, but it does not contain acceptance criteria or a study proving the device meets those criteria in the context of diagnostic or AI-driven performance.

The document is a 510(k) summary for the MC3 Jugular Dual Lumen Catheter, which is a physical medical device (a catheter) used for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). The "performance evaluations" mentioned are for the physical characteristics and safety of the catheter itself (e.g., durability, flow, kink resistance, biocompatibility, sterility), not for a diagnostic algorithm or AI system's output.

Therefore, I cannot provide the requested information from the provided text, as it pertains to a different type of device and different evaluation criteria than what your questions imply (e.g., questions about ground truth, expert consensus, MRMC studies, standalone algorithm performance, training/test sets are relevant for AI/diagnostic devices, not for a physical catheter's mechanical performance).

If you have a document related to an AI/diagnostic device, please provide that.

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The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 31/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 QuickFlow Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature by normal access techniques. The introducer is designed to follow a pre-positioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The catheter is wire-reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter has radiopaque markers at the tip and most proximal set of drainage holes.

The devices are comprised of two separate thin-walled catheters made of silicone and polyurethane polymer and reinforced with a spring wire. The dual lumen design involves two catheters of different diameters joined together in a co-axial configuration. An arrangement of side holes in the outer (drainage) catheter allows for egress of blood. An open tip on the inner (return) catheter allow s for blood ingress. Unreinforced tube extensions with barbed connectors, allowing clamping and connection to the extracorporeal circuit, are joined to the wye junction. A tapered tip introducer is included to facilitate placement of the catheter into the blood vessel over a standard guide wire (not included). Securement of the device may be accomplished via a groove designed in the Y-connector to accept a suture and a suture around a 3/8" barb connector.

The provided text describes the MC3 QuickFlow Dual Lumen Catheter and its equivalency to a predicate device, focusing on its physical characteristics, intended use, and performance evaluations. However, it does not contain information related to an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

The document is a 510(k) premarket notification for a medical device (a catheter), and the performance evaluations listed are typical for such hardware devices (durability, pressure/flow, kink resistance, etc.). There is no mention of "AI", "algorithm", "human readers", "MRMC", "ground truth" in the context of an AI-driven study, or any other terms that would suggest an AI/ML component.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text, as the text pertains to a non-AI medical device.

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