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The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of the following components based on the model#:
Size and Working Length: 14FR 65 and 85 CM, Included Accessories: Dilator, Stylet, Tear-away introducer sheath
Size and Working Length: 14Fr 105 CM, Included Accessories: Dilator, NA, Tear-away introducer sheath
Size and Working Length: 9Fr 65CM, Included Accessories: NA, Curved Stylet, NA
The Dexterity steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in various diameters and working lengths. The device is provided sterile and is intended for single use only.
The purpose of this submission is to add an additional device working length, 105 CM, to the 14Fr Introducer product offering. In addition the intended use statement is modified to include the term percutaneous for clarification only. This change is not a change to the intended use of the device.

This document describes the Cardiosolutions Dexterity™ Steerable Introducer, a medical device designed for the introduction of cardiovascular catheters into the heart. The information provided outlines the acceptance criteria and the summary of testing performed to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical study on human subjects with ground truth established by experts.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, implying these are the acceptance criteria, and states that "All test results demonstrate that the properties and performance of the device are substantially equivalent to the predicate device and suitable for its intended use." Specific quantitative performance values are not provided in this summary.

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

The document describes design verification testing on the modified device, specifically a 14Fr 105 CM Dexterity™ Steerable Introducer. It does not specify the sample size for each test. The testing is described as occurring in a laboratory setting (in vitro simulated use), and therefore the data provenance is laboratory testing, not human subject data from a specific country or retrospective/prospective study.

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

Not applicable. This device is a steerable introducer catheter, and the evaluation is based on engineering and performance specifications, not on expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests would be the established engineering specifications and standards (e.g., ISO 10555).

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective engineering and performance tests, not subjective assessments requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to existing predicate devices through engineering and performance testing, not on assessing the improvement of human readers with or without AI assistance. The device itself is an introducer, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical instrument (catheter introducer), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the design verification tests, the ground truth is based on engineering specifications, international standards (ISO 10555), and FDA guidance documents for intravascular catheters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The device is evaluated based on its physical and mechanical properties.

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

Not applicable, as there is no training set for this type of device.

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