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The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.

Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction. rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

The Vdrive™ with V-Sono™ is comprised of three major components,

1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure
2. Vdrive™ User Interface - combination of software driven 1) Tableside Controller and 2) dedicated Vdrive™ Controller
3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices.

This 510(k) summary describes a medical device, the Vdrive™ with V-Sono™, which is a system intended to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters during cardiac procedures.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria for the device's performance nor does it report detailed performance metrics against such criteria in a table format.

Instead, it indicates that the device's performance was evaluated through:

• Comparative preclinical study: Conducted in animals with manual versus Vdrive™ manipulation of an ICE catheter using the V-Sono™ disposable.
• Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing.

The conclusion drawn is: "Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Sono™ device is safe and effective for its intended use." This is an overall statement of efficacy and safety rather than a report against specific, numerical acceptance criteria.

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

• Test Set Sample Size: The document mentions a "comparative preclinical study ... in animals." However, the exact number of animals (sample size) used in this preclinical study is not specified.
• Data Provenance: The study was a "preclinical study ... in animals." This suggests the data is preclinical/animal data, not human clinical data. The country of origin is not specified. It can be assumed to be prospective as it's a study designed to evaluate the device.

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

This information is not provided in the document. As it was an animal preclinical study, "ground truth" might refer to direct observation, imaging, or post-mortem analysis by veterinary or lab experts, but no details are given.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not explicitly mentioned or described. The study mentioned is a "comparative preclinical study in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter." This is a comparison between two methods of catheter manipulation, but not a human reader study evaluating improved performance with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The Vdrive™ with V-Sono™ is a system that physically manipulates catheters and has a user interface. It is described as remotely controlling catheter advancement, retraction, rotation, and deflection. Therefore, it inherently involves human interaction for operation and is not a standalone algorithm in the sense of an AI-only diagnostic tool. Its performance is tied to its mechanical and software functions under human control.

7. Type of Ground Truth Used

For the "comparative preclinical study in animals," the "ground truth" would likely be established through:

• Direct observation of catheter manipulation and visualization of cardiac structures.
• Imaging (e.g., the ICE images themselves, or other imaging modalities used to confirm catheter position/movement).
• Potentially pathological examination or other scientific methods to assess any adverse effects or successful manipulation in the animal models.

The document does not detail this, but the context of a preclinical animal study suggests these types of 'ground truth' would be relevant.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is primarily a mechanical and software-controlled system, not an AI/machine learning device that typically requires extensive training data for its core function of catheter manipulation. The "software driven" user interface would involve verification and validation testing, but not a "training set" in the common AI sense.

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

As no training set is mentioned in the context of AI/machine learning, this information is not applicable/provided. The "ground truth" for the device's functional and safety testing would be based on engineering specifications, regulatory standards, and established medical principles.

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