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The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombous formation associated with catheterization.

The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension lines, luer hubs, and clamps. It is essentially the same in appearance and function to the Arrow multi-lumen predicate catheters except for the larger size to accommodate rapid fluid administration in emergency critical care situations in the hospital.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arrow-Howes™ Large Bore Multi-lumen central venous catheter:

This submission is for a device, not an AI/software product, so many of the common fields related to AI/software performance studies (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set data, etc.) are not applicable in this context. The evaluation focuses on the physical and functional characteristics of a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a physical device evaluation based on laboratory and bench testing, not a study involving patient data or a "test set" in the context of an AI algorithm. No patient samples or clinical data sets were used for performance evaluation. All testing was laboratory-based.

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

• Not Applicable. Ground truth in the context of AI/software performance is not relevant here. The "ground truth" for a physical device like this is established by engineering standards and validated laboratory testing procedures for mechanical integrity, biocompatibility, and fluid dynamics. Experts involved would be engineers, material scientists, and toxicologists conducting the specified tests.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of a "test set" was part of this regulatory submission, as it relates to physical device performance.

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. An MRMC study is relevant for AI-assisted diagnostic or interpretative tasks. This is a physical medical device (catheter) and does not involve AI or human "readers" in its primary function or evaluation.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Laboratory Measurements: The "ground truth" for this device's performance is based on established engineering principles, material science properties, and direct measurements from standardized laboratory tests (e.g., flow rate measurements, tensile strength measurements, pressure endurance measurements, established biocompatibility protocols). The comparison is made against the performance of legally marketed predicate devices with known safety and effectiveness profiles.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of a physical device. Design and manufacturing might involve iterations and testing of prototypes, but that doesn't align with the concept of a training set for an AI algorithm.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study was a desk-based review of laboratory and bench testing performed on the Arrow-Howes™ Large Bore Multi-lumen central venous catheter. The primary goal was to demonstrate substantial equivalence to existing legally marketed predicate devices.

• Study Type: Non-clinical laboratory and bench testing.
• Purpose: To demonstrate the device's safety and effectiveness are comparable to predicate devices, particularly highlighting the larger size and greater fluid flow rates while maintaining essential technological characteristics.
• Key Finding: The device is "safe, and as effective as the legally marketed predicate devices" based on the performed laboratory tests.
• Clinical Testing: No clinical testing was performed for this submission.

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