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Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

The Ultimum™ EV Hemostasis Introducer consists of a polyethylene introducer and dilator with a radiopaque marker band at the distal end. The introducer is fitted with a hemostasis valve for use during catheter introduction and/or exchange over a guidewire. The hub is located on the proximal end of the introducer, where a sideport with a three-way stopcock is provided for aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator is tapered at the distal tip with an internal lumen designed to accept guidewires that have a maximum diameter of 0.035" (0.889 mm).

The provided information describes a medical device, the Ultimum™ EV Hemostasis Introducer, and its regulatory submission (K140327). This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence through non-clinical testing. It does not describe an AI/ML-driven device or a clinical study involving human readers. Therefore, many of the requested categories related to AI performance, human reader improvement, and ground truth for deep learning models are not applicable or cannot be extracted from this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes non-clinical bench and biocompatibility testing. It does not involve a "test set" in the context of AI/ML or a clinical study with human patients. Thus, there is no information on sample size for a test set or data provenance related to country of origin or retrospective/prospective data.

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

Not applicable. The ground truth for device performance in this context would be defined by engineering specifications, safety standards, and physiological limits demonstrated through bench and biocompatibility testing. There's no indication of clinical experts establishing ground truth for a test set in the traditional sense of diagnostic accuracy.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This is not a study involving expert adjudication for diagnostic tasks.

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 not an AI-driven device.

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

Not applicable. This is not an AI-driven device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established through adherence to pre-determined engineering specifications, design requirements, and international standards (e.g., ISO 10993-1 for biocompatibility). Performance metrics are objectively measured in bench tests (e.g., break force, dimensions, hemostasis maintenance).

8. The Sample Size for the Training Set

Not applicable. This is not an AI-driven device. No training set was used.

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

Not applicable. This is not an AI-driven device. No training set was used, and therefore, no ground truth for a training set was established.

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