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Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.

These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25℃ (77°F).

The provided text is a 510(k) summary for the Medtronic Bio-Medicus Life Support Catheter and Introducer. It details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.

The information provided pertains to a traditional medical device (a catheter and introducer) with a material formulation change, and the "performance testing" described is bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device. There is no mention of AI, machine learning, or software performance in terms of diagnostic accuracy or effect on human readers.

Therefore,Based on the provided text, it is not possible to describe the acceptance criteria or a study that proves a device meets acceptance criteria for an AI-powered device. The document pertains to a traditional medical device (catheter and introducer), specifically addressing a material change to a component (luer cap). There is no mention of AI, machine learning, or any form of algorithm-driven performance evaluation.

The "Summary of Performance Testing" section focuses on demonstrating substantial equivalence of the modified luer cap through risk-based testing, functional testing, and biocompatibility assessment, which are standard for physical medical devices.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No AI Component: The device described (Bio-Medicus Life Support Catheter and Introducer) is a physical medical device. The document explicitly states the "device modification was made to the predicate device: Luer cap material formulation change (vented connector models)." This is a hardware change, not a software or AI change.
• No Diagnostic or Classification Task: The device's function is to facilitate extracorporeal support procedures (CPB, ECMO, ECLS), not to interpret data, diagnose conditions, or assist human readers in a diagnostic capacity.
• No Performance Metrics for AI: The "performance testing" described is for the physical integrity and biocompatibility of the luer cap ("functional testing and biocompatibility assessment"), which are not the types of metrics (e.g., sensitivity, specificity, AUC, human reader improvement) that would be used for AI device acceptance criteria.

To directly answer your request based on the provided text, I must state that the information is not present:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes bench testing to qualify a material change, not AI performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components for bench testing, not a dataset for AI evaluation.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI validation (e.g., for image interpretation) is not established for this physical device.
4. Adjudication method: Not applicable. There is no interpretive task requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for AI-assisted human performance, which is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document is for a traditional medical device (catheter) and does not contain any information related to AI acceptance criteria or AI performance studies.

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The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients 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.

The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.

These devices are sterile, nonpyrogenic, disposable, intended for single use only. Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Do not store the product above 25°C (77°F).

The provided document is a 510(k) summary for the Medtronic Bio-Medicus Life Support Catheter and Introducer. It describes a medical device, specifically a catheter and introducer for use in ECMO/ECLS, and assesses its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (catheter and introducer), not an AI/ML device or a software device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML devices (e.g., standalone performance, MRMC studies, expert ground truth for image analysis, etc.) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests and regulatory requirements for a physical medical device. They are focused on mechanical properties, biocompatibility, sterility, shelf-life, and in vivo performance in an animal model, rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot populate the requested table and answer the questions in the context of an AI/ML device. The document does not contain information on:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample size for a "test set" or "training set" in the AI/ML sense.
• Number of experts for ground truth or adjudication methods for an AI/ML model.
• MRMC studies or effect sizes for human readers with/without AI assistance.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML context.
• How ground truth for a training set was established for an AI/ML model.

What the document does provide relevant to device acceptance is:

• Acceptance Criteria (Special Controls for the device type): These are outlined under "Comparison to Predicate (Special Controls)" on page 5 and include:
  • Technological Characteristics (geometry, design, compatibility)
  • Biocompatibility (ISO 10993-1:2009 compliance)
  • Sterility and Shelf-life (demonstrates sterility, integrity, durability, reliability)
  • Non-clinical Performance (bench, mechanical integrity, durability, reliability testing)
  • In vivo Evaluation (performance over 7-day duration of use)
  • Labeling (detailed summary of non-clinical and in vivo evaluations, instructions, compatibility, maintenance)
• Study Proving Device Meets Criteria (Summary of Performance Data): This is detailed on pages 5-6 under "Summary of Performance Data" and includes:
  • Pre-clinical bench testing: Used to verify performance characteristics.
    • 21-day Simulated use durability testing (Tensile strength after life conditioning, Pressure test after life conditioning)
    • Blood trauma testing
    • Kink testing
    • Birds Mouth testing
    • ID occlusion due to suture ring
    • Suture Collar Slide Force
    • Introducer removal and insertion forces
  • In vivo animal testing: 7-day GLP in vivo study.

In conclusion, the requested information pertains to AI/ML device validation, which is not the subject of this 510(k) submission. This document describes the testing and regulatory compliance for a physical medical device.

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