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The MicroSlide™ Tearaway Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

The MicroSlide™ Tearaway Introducer is constructed using identical processes and materials as the predicate devices; Tearaway Introducer Sheath, Galt Medical, K000313 with the addition of smaller sizes 2 & 3French, and the Galt VTI™ Valved Tear-away Introducer, K112398 without the hemostasis valve.

The MicroSlide™ Tearaway Introducer device consists of two components; a dilator and an outer sheath. The outer sheath is a one piece, molded hub/sheath "tearaway" design that with minimal force will break and separate at the hub/wing to facilitate the removal of the sheath tube from the patient by peeling/splitting the tub longitudinally down its length. The dilator tube is an open plastic tube with an integral molded luer hub for guidewire insertion. The dilator is longer than the outer sheath with a tapered distal tip. The sheath hub and dilator hub lock together using a rotating motion to add in insertion of the device into the vasculature.

The provided document describes the MicroSlide™ Tearaway Introducer, a medical device for introducing catheters and other intravascular devices. The document outlines substantial equivalence to predicate devices based on functional testing and other characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance specifications of the subject device and compared against predicate devices. The document explicitly lists performance specifications under the "Performance Specifications" row in the comparison table on page 2.

Study Proving Acceptance Criteria:

Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. The document states: "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements." (Page 3)

The functional tests included:

• Penetration (Insertion) Force Test Ref. XE-022
• Sheath Peel Force Test - Ref. XE-022
• Sheath Perpendicular Pull Test- Ref. XE-022
• Dilator Pull Test- Ref. XE-022

Additionally, sterilization validation, biocompatibility testing, and packaging/product shelf-life testing were performed to ensure the device's safety and effectiveness.

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

The document does not specify the exact sample sizes used for each functional test (e.g., number of devices tested for insertion force). It broadly states that "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications." (Page 3)

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, since the studies are described as "Functional testing" and "Biocompatibility testing" performed by Galt Medical and its contractors, it implies prospective, in-house testing rather than data from real-world usage or external retrospective studies.

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

This information is not applicable to this type of device and study. The testing described is functional and performance-based, not diagnostic, and therefore does not rely on expert interpretation of results to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical measurement of the device's performance against predefined engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the type of device and study. The tests involve objective physical measurements rather than subjective assessments requiring adjudication.

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 information is not applicable. The device is a physical medical instrument (catheter introducer), not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

This information is not applicable. The device is not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing process.

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

The "ground truth" for the performance specifications is based on engineering specifications and established performance ranges of legally marketed predicate devices. For example, the hub break force acceptance criterion of "2.0 lbs - 5.5 lbs" is derived from the performance of the predicate devices. The functional tests directly measure physical properties, and the results are compared to these pre-defined numerical thresholds.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable, as there is no "training set" for this device.

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