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The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License:

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit:

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.The EnSite™ X EP System TactiFlex™ Ablation Catheter Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and EnSite™ X EP System, TactiFlexTM Ablation Catheter, Sensor EnabledTM, Software License:

The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided text is a 510(k) summary for the EnSite™ X EP System, which is a catheter navigation and mapping system. The submission describes a software upgrade that enables compatibility with a new ablation catheter (TactiFlex™ Ablation Catheter, Sensor Enabled™). However, it does not provide specific acceptance criteria or a detailed study proving that the device meets those acceptance criteria.

Instead of specific acceptance criteria and detailed study results, the document generally states that "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." It also lists various types of testing performed and the standards followed.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text:

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

The document does not provide a table of acceptance criteria with corresponding performance metrics. It indicates that "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications" but does not give details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a "Programmable Diagnostic Computer" for electrophysiology, assisting in catheter navigation and mapping, not an AI for image interpretation or diagnosis that would typically involve human readers.

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

The document states, "Software Verification at a software and system level to test the new software features added for the display of the TactiFlex™ Ablation Catheter, Sensor Enabled™ Force Number Refresh Rate Force Direction Indicator". This indicates software-level testing, which could be considered standalone performance for the specific software features implemented. However, detailed performance metrics are not given.

7. The type of ground truth used

The document does not explicitly state the "ground truth" used for testing, but given the nature of the device (catheter navigation and mapping, force display), it would likely involve:

• Engineering validation/simulations: For verifying force number refresh rates and direction indicator accuracy (implied by "Software Verification").
• User requirements and intended use: For "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use."
• Safety standards: For "Electrical Safety Testing."

8. The sample size for the training set

The document does not mention a training set, as the changes described are software adaptations for a new catheter, rather than the development of a machine learning model that would require a training set.

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

Not applicable, as no training set is mentioned in the context of the described software upgrade.

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