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The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The puncture needle incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The flexible stainless steel guide wire is utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The provided text describes a medical device, the Shoocin™ Introducer Kit, and its substantial equivalence to a predicate device (Pinnacle Precision Access System). The acceptance criteria and the study proving the device meets them are primarily focused on biocompatibility and performance testing, rather than an AI/ML-based diagnostic or prognostic device study.

Here's an analysis of the provided information, structured according to your request, with an emphasis on what is and is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be meeting the standards of the predicate device and relevant ISO standards. The document explicitly lists performance tests and biocompatibility tests from ISO standards as criteria. The reported performance is that the device "successfully passed all" these tests.

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

• Sample Size for Test Set: Not explicitly stated for each performance or biocompatibility test. The document indicates that the tests were conducted, and results are reported as "non-hemolytic," "no evidence of causing cell lysis or toxicity," "met the requirements," etc. This suggests that the sample sizes were sufficient for the specific tests based on their respective ISO standards.
• Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. The tests appear to be laboratory-based evaluations of the device's physical and biological properties.

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

This question is not directly applicable to the type of device and study described. The "ground truth" for a medical introducer kit is established by objective measurements against engineering specifications and biological standards (e.g., ISO 10993 for biocompatibility), not by human expert opinion like in an AI/ML diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. As this is a physical medical device being evaluated against engineering and biological standards, there isn't a need for expert adjudication in the way it would be applied to, for example, medical image interpretation. The testing results are objective measurements.

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. The Shoocin™ Introducer Kit is a physical medical device, not an AI/ML-based diagnostic or prognostic tool involving human readers and AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• Adherence to relevant international standards: ISO 10993 for biocompatibility and ISO 11070 for shelf life.
• Meeting engineering specifications: Implied for dimensions (Sheath ID/OD, Lengths, Guide Wire OD, Needle OD/ID) and mechanical properties (Fracture Strength, Flexibility, Joint Strength).
• Absence of manufacturing defects: (e.g., "Sheath Introducer should be free of defects," "Surface free from impurity").
• Comparison to a predicate device: The overall claim is substantial equivalence to the Pinnacle Precision Access System (K111606).

8. The Sample Size for the Training Set

Not applicable. This document describes the evaluation of a physical medical device, not the development or training of an AI/ML algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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