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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 (a) Tableside Controller and (b) 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.

The provided text describes a 510(k) summary for the Vdrive™ with V-Sono™ device. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data related to electrical safety, EMC compatibility, and software verification and validation. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested for AI/diagnostic devices.

Based on the provided text, here's what can be answered:

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

The provided document describes the device as being substantially equivalent to a predicate device (Vdrive™ with V-Sono™ K122659). The "Performance data" section states: "Changes were made under Design Controls to ensure that the modified device is as safe and effective as the predicate device and that the design outputs of the modified device meet the design input requirements. Performance testing for electrical safety, EMC compatibility and software verification and validation testing were performed."

This indicates that the acceptance criteria are implicitly tied to meeting the design input requirements and demonstrating safety and effectiveness comparable to the predicate device through:

• Electrical safety performance
• EMC compatibility performance
• Software verification and validation performance

The document does not provide specific quantitative acceptance criteria (e.g., specific thresholds for electrical leakage or EMC emissions) or detailed performance results (e.g., measured values) for these tests. It only states that these tests were "performed" and that the device was deemed "safe and effective for its intended use" based on the documentation.

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

Not applicable. The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. It refers to "performance testing for electrical safety, EMC compatibility and software verification and validation," which are engineering and software testing activities, not clinical trials with patient samples.

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)

Not applicable. As noted above, this document describes engineering and software testing, not a clinical study involving expert interpretation of medical data to establish ground truth.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

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

Not applicable. This device is a mechanical system for controlling intracardiac echocardiography catheters, not an AI or diagnostic imaging device that would typically undergo an MRMC study related to human reader performance with or without AI assistance.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and software functions to control the catheter.

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

Not applicable. The performance testing mentioned (electrical safety, EMC, software V&V) uses engineering standards and software validation methods as their "ground truth," rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI device that would have a training set.

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

Not applicable. As this is not an AI device, there is no training set or associated ground truth.

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