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The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy.

An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly).

A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s).

The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

This document, a 510(k) Summary for the RadialSeal™ Introducer Kit (K181855), focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria specific to algorithm performance. Therefore, many of the requested categories related to AI model evaluation will not be applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabular format for each test, nor does it provide specific numerical results for the RadialSeal™ Introducer Kit for most tests. Instead, it generally states that "results indicated that no new issues of safety and effectiveness were raised and the results were within the predetermined acceptance criteria" and that "The devices performed equivalently."

However, it does list the types of performance tests conducted and the standards they followed. A summary of the reported performance is general equivalency to the predicate device.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench or animal test. It mentions that "side by side testing between the predicate device and RadialSeal was performed" and implicitly suggests multiple units were tested to demonstrate equivalency.
• Data Provenance: The bench testing refers to compliance with ISO standards and internal standards. The animal study was a "GLP Acute Animal Porcine study" conducted at "American Preclinical Services." This implies the animal data is from a controlled, prospective animal study conducted in the USA (presumably, given "American Preclinical Services"). All data appears to be prospective as it was generated to support the 510(k) submission.

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

This is not applicable as this is a medical device (introducer kit) and not an AI/software device that requires ground truth derived from expert consensus for performance evaluation. The "ground truth" for this type of device is defined by passing established physical, chemical, and biological performance standards and demonstrating equivalence to a predicate device.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. The "adjudication" is compliance with international and internal standards, and comparison to a predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable as this is a physical medical device, not an AI or software device.

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

This is not applicable as this is a physical medical device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by:

• Compliance with established international and national standards (e.g., ISO 11070, ISO 10993-1, ISO 594-1, ISO 594-2, ASTM, USP).
• Demonstrating functional equivalence to a legally marketed predicate device (Terumo Glidesheath Slender® K142183) through direct comparative testing.
• The safety and effectiveness of the device as assessed through non-clinical (bench) and pre-clinical (animal) testing to ensure it raises no new issues compared to the predicate.

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device and not an AI/software device that requires a training set. The "training" in manufacturing would relate to process validation and quality control, not data training.

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

Not applicable as this is a physical medical device and not an AI/software device.

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