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The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

The AcQGuide® VUE Steerable Sheath, Model 900201 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. There is a cable exiting from the handle of the sheath to provide connection for the distal electrodes. This cable terminates with four standard 2mm pins that are connected to the Auxiliary Interface Box or Auxiliary Catheter Cable of the AcQMap High Resolution Imaging and Mapping System, Model 900100 or 900000. The pin connections are assigned by the user for electrode identification (D1, 2, 3, 4) to the corresponding channel on the AcQMap System 900100. No designated order of pin connection is required. The AcQGuide® VUE Steerable Sheath includes a valve bypass tool as an optional accessory to facilitate the insertion of a loop or circular catheter.

The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

Some of the key design attributes of the Steerable Sheath include:

• Deflectability
• Hemostasis
• Kink-resistance
• Visibility under fluoroscopy
• Easily flushed during the procedure
• Single-handed operation
• Biocompatible materials
• Sterile, single use
• Combined three-way stopcock

The AcQGuide® VUE Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. Its deflection facilitates catheter positioning, and its electrodes aid in visualization with a compatible localization system like the AcQMap System.

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

1. A table of acceptance criteria and the reported device performance

Based on the provided information, the acceptance criteria are largely implied by successful completion of various nonclinical tests, demonstrating the device's conformance to specifications and comparable safety and effectiveness to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes nonclinical (bench) testing. For these tests, specific sample sizes are not explicitly provided in the summary. The studies are prospective in nature, as they involve testing newly manufactured devices to verify their performance against established specifications. The data provenance is Acutus Medical, Inc., Carlsbad, CA, U.S.A., implying the testing was conducted or overseen by the company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish a "ground truth" for the nonclinical test sets in the way it would for a clinical study with image interpretation or disease diagnosis. The "truth" for these bench tests is derived from engineering specifications, industry standards (e.g., ISO, IEC), and established medical device testing protocols. The "physician simulated use in an animal model" likely involved qualified medical professionals, but their specific number, qualifications, and their role in establishing a "ground truth" (beyond observing performance) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is mentioned. For the nonclinical bench tests described, the outcomes are objective and based on meeting predefined specifications, rather than subjective interpretations 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

No MRMC study was conducted or mentioned. The device described is a steerable sheath with electrodes for visualization, not an AI-powered diagnostic tool for human readers.

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

This refers to a medical device's performance without direct human intervention, especially applicable to AI algorithms. The AcQGuide® VUE Steerable Sheath is a physical medical device that inherently requires human-in-the-loop operation by a physician. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated in relation to its mechanical, electrical, and material properties, and its interaction with a compatible localization system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the nonclinical testing described, the "ground truth" is defined by:

• Engineering Specifications: For dimensional, mechanical, and functional tests.
• International Standards: Such as ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR28 for sterilization, and IEC 60601-1/1-2 for electrical safety and EMC.
• Predefined Performance Metrics: For tests like leak testing, torque, and compatibility.
• Physiological Response: In the animal model for physician simulated use.

8. The sample size for the training set

This question is not applicable. The AcQGuide® VUE Steerable Sheath is a physical medical device, not a software algorithm that requires a training set in the context of machine learning or artificial intelligence.

9. How the ground truth for the training set was established

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

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