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EP navigator is intended to provide navigation support for cardiovascular devices for heart rhythm disorders, such as catheters and guidewires, by superimposing 3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan over intra-procedural X-ray images of the same anatomy.

EP navigator Rel. 5.0 is a software medical device that contains image processing algorithms that are executed on a PC-based hardware platform. EP navigator Rel. 5.0 can perform the following functions: view previously acquired 3D anatomical image data in a slice viewer, such as CT, MRI, or 3D rotational scan, segment previously acquired 3D anatomical image data, register the segmented 3D dataset and landmarks with intra-procedural X-ray images, superimpose the segmented 3D dataset and landmarks on intra-procedural X-ray images of the same anatomy, position visual markers such as tag points, and visualize the inside of the 3D volume (EndoView).

The provided text describes EP navigator Rel. 5.0, a software medical device that offers navigation support for cardiovascular devices by superimposing 3D anatomical image data (CT, MRI, 3D rotational scan) over intra-procedural X-ray images. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, ground truth establishment for test or training sets, expert qualifications, adjudication methods, or MRMC studies.

The document states:

• "Verification and validation tests have been performed to address intended use, the technical claims, requirement specifications and the risk management results."
• "a system verification test was performed to ensure that the modifications are properly introduced; verification and validation testing was conducted to ensure the proper introduction of the individual modifications listed; sample clinical images as well as conformance to IEC standards and guidance documents were provided."
• "The test results in this 510(k) premarket notification demonstrate that EP navigator Rel. 5.0 complies with the aforementioned international and FDArecognized consensus standards and FDA guidance document, meets the acceptance criteria, and is adequate for its intended use."
• "EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial equivalence to the currently marketed and secondary predicate devices..."

Based on the provided text, the following information can be extracted or explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the device "meets the acceptance criteria," but it does not detail what those specific quantitative or qualitative criteria were for each function or claim, nor does it provide specific performance metrics beyond a statement of compliance.

2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The text mentions "sample clinical images" were used, but no details on size, country of origin, or whether they were retrospective or prospective.

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.

4. Adjudication Method for the Test Set:
This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed, or at least not described. The document explicitly states: "EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial equivalence..." This suggests that human-in-the-loop performance studies were not a requirement for this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study:
The document primarily focuses on non-clinical performance testing for verification and validation of features and compliance with standards. It performed "system verification test" and "verification and validation testing" of individual modifications using "sample clinical images." However, it does not explicitly provide a separate, detailed "standalone performance study" with specific metrics (e.g., accuracy, precision) for its algorithms in isolation. The testing appears to be focused on ensuring functional correctness and compliance with design controls and standards.

7. Type of Ground Truth Used:
This information is not provided in the document. It mentions "sample clinical images," but how ground truth was established for these images is not detailed. Given the device's function (overlaying 3D data on X-ray), ground truth might involve accurate registration and anatomical landmark identification, but the method for validating this ground truth is not described.

8. Sample Size for the Training Set:
This information is not provided in the document. The device uses "image processing algorithms" and is capable of "automatic segmentation of MR datasets" and "automatic segmentation of a 3D EP rotational scan," which implies machine learning or complex image processing that might involve training. However, no details on training data are given.

9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document.

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