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The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System [MNS]. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

The Cardiodrive® advances or retracts a compatible magnetic electrophysiology [EP] mapping catheter, through a hemostasis introducer, remotely via a User Interface (UI) located either at the patient table or in the control room.

The Stereotaxis Cardiodrive® consists of an electrical controller, motor assembly, and user controls, plus sterile, single-use advancer unit, patient mounting bracket, flexible drive shaft, and hemostasis valve adapter.

The provided document K042850 is a 510(k) summary for the Stereotaxis Cardiodrive® Catheter Advancer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results or extensive performance data against specific acceptance criteria.

Based on the information provided, here's what can be extracted and what is not available in the document:

This 510(k) summary does not include a detailed study that proves the device meets specific acceptance criteria in the format of a clinical trial with human subjects. Instead, it relies on demonstrating equivalence to an existing predicate device through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not provide specific quantitative acceptance criteria or detailed device performance metrics beyond a statement of equivalence. The "acceptance criteria" here are implied by the performance of the predicate device, which the new device is stated to match.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing," which implies testing of the device itself rather than a patient-based test set or a dataset for an AI model.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable, as no human data or AI training/test data are mentioned for this submission. The testing was bench testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is a mechanical system, and its performance was assessed via bench testing, not through expert review of diagnostic outputs or images.

4. Adjudication Method for the Test Set

• Not applicable. No expert review or adjudication process is described for bench testing of a mechanical device.

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

• No, an MRMC comparative effectiveness study was not done or reported. This device is a mechanical system for catheter manipulation, not a diagnostic imaging or AI-assisted interpretation device that would typically undergo MRMC studies.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic product.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This is not an AI algorithm. The device operates as a standalone mechanical system controlled by a user.

7. Type of Ground Truth Used

• Bench Testing Performance: The "ground truth" for this submission is the established performance and safety profile of the predicate device, against which the new device demonstrated equivalence through bench testing.

8. Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Not applicable. This is not an AI or machine learning device. The "ground truth" for comparison was the predicate device's established performance.

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