Search Results

The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.

The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each bench test. For the preclinical study:

• Sample Size: Not explicitly stated as a number, but refers to "one Test or one Control sheath in the animal." This suggests a comparative animal study.
• Data Provenance: Pre-clinical testing performed "under simulated clinical conditions" and "in the animal." This indicates an animal study, which is often considered prospective in nature. The country of origin is not specified.

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

• The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bench tests or the pre-clinical study. The "Pass" results for bench tests imply internal testing against predetermined specifications, while the pre-clinical study endpoints would typically be assessed by veterinary or medical professionals, but this is not detailed here.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method. For bench tests, it's likely a pass/fail against internal criteria. For the pre-clinical study, the endpoints imply an assessment by the study investigators.

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

• No, an MRMC comparative effectiveness study was not conducted or described. The device is a guiding sheath, not an imaging analysis algorithm that would typically involve human readers.

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 (a guiding sheath), not an algorithm or AI system. While it has "visualization capabilities" with a compatible navigation system (CARTO® 3 EP Navigation System), the performance data presented focuses on the physical sheath itself rather than the performance of an independent algorithm for interpretation.

7. The Type of Ground Truth Used

• For Bench Tests: The ground truth is implied to be predefined engineering specifications and performance criteria. Each test has a "Pass" result, indicating it met these criteria.
• For Pre-Clinical Study: The ground truth for safety and performance refers to direct observation of the animal model for damage, leakage, thrombus, and tissue injury during and after the procedure. This could be considered outcomes data or direct observational data from a controlled biological setting.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

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

Ask a specific question about this device