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Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the femoral artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wres, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.

The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.

The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.

Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.

The provided text describes a 510(k) submission for the INT Introducer Set. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific acceptance criteria for AI or diagnostic accuracy, which is what your request implies.

Therefore, many of the requested categories related to AI performance, expert ground truth, multi-reader studies, and training sets are not applicable to this type of device and document.

Below is a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable.

Acceptance Criteria and Study Details for INT Introducer Set

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like an introducer set, "acceptance criteria" are typically defined by engineering specifications and relevant ISO/ASTM standards, rather than diagnostic performance metrics. The "reported device performance" is the result of testing against these engineering criteria.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of devices) used for each individual bench or biocompatibility test. It lists the tests performed, implying that appropriate sample sizes were used according to the referenced standards.
Data provenance is for the device being submitted (INT Introducer Set), manufactured by Shanghai Kindly Medical Instruments Co., Ltd. The studies are non-clinical (bench and lab-based biocompatibility studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical medical instrument (introducer set), not an AI/diagnostic software. "Ground truth" in this context refers to objective measurements and adherence to engineering and biocompatibility standards, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review. This document describes bench and biocompatibility testing of a physical device.

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
This question is not applicable. This is a physical medical device, not an AI or imaging diagnostic software that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is 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 performance is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) for physical and material properties, sterility, and biocompatibility. The tests performed are designed to objectively measure these properties against predefined specifications from these standards.

8. The sample size for the training set
This question is not applicable. There is no AI component or algorithms that require a training set for this device.

9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.

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