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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 Introducer 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. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and 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 tubing with 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. There is no radiocontrast agent on the dilator.

The document provided is a 510(k) premarket notification for a medical device called the "Shoocin™ Introducer Kit." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets acceptance criteria related to AI/ML or diagnostic performance studies.

Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and a study proving device performance (specifically, a diagnostic performance study for an AI/ML device) is not present in this document.

The document primarily focuses on:

• Substantial Equivalence: Comparing the modified device (Shoocin™ Introducer Kit) to its predicate (also Shoocin™ Introducer Kit, K123475) to demonstrate that changes (e.g., adding models, changing radiocontrast agent) do not alter its fundamental nature, intended use, or safety and effectiveness.
• Biocompatibility Testing: Results from tests performed according to ISO 10993 standards (e.g., cytotoxicity, intracutaneous study, sensitization, systemic toxicity, complement activation, hemolysis, pyrogen study, partial thromboplastin time, in vivo thromboresistance). These are biological safety tests.
• Performance Testing (Bench Tests): A list of physical and chemical bench tests performed on components of the introducer kit (sheath introducer, 3-way stopcock/valve, dilator, puncture needle, guidewire, particulate evaluation, chemical performance, biological sterility, bacterial endotoxin). These are engineering/material performance tests.
• Sterilization: The method used and the Sterility Assurance Level.

This document does not describe an AI/ML-based device, a study involving human readers, ground truth establishment for diagnostic images, or any of the other criteria relevant to the prompt's request for AI/ML device performance and acceptance criteria.

To directly answer your numbered points based on the provided document, I must state that the information is absent:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists performance tests for physical properties and biocompatibility, not diagnostic or AI performance.
2. Sample sizes used for the test set and the data provenance: Not applicable. The tests are bench tests and biocompatibility studies, not diagnostic studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an introducer kit, not a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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