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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.
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 document, a 510(k) premarket notification letter from the FDA regarding the EnSite™ X EP System, does not contain the detailed information typically required to answer your specific questions about device acceptance criteria and a study proving those criteria were met for an AI/ML medical device.

The document describes the device as a "Programmable Diagnostic Computer" for electrophysiology (EP) studies and notes software revisions for the subject device (EnSite™ X EP System v3.0) compared to its predicate (EnSite™ X EP System v2.0.1). However, the software updates described are primarily workflow enhancements, minor display updates, and data import/export expansions, not features that would typically involve a large-scale AI/ML performance study with specific acceptance criteria like sensitivity, specificity, or AUC as you described.

The "Non-Clinical Testing Summary" mentions "Software Verification at unit, software and system level," "Performance testing of updated feature functionality," "Preclinical Validation Testing to confirm the system could meet user requirements," and "Human Factors Evaluations." While these are tests, they are framed in the context of ensuring the updated software functions as intended and meets user requirements, rather than demonstrating a performance benefit against a specific clinical outcome with an AI algorithm.

Therefore, based solely on the provided text, I cannot extract the information required for your questions.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI algorithm, nor reported device performance against such criteria. The "acceptance criteria" mentioned are more general for software verification and validation.
2. Sample sizes used for the test set and the data provenance: There is no mention of a specific test set, its size, or the provenance of any data used for performance evaluation in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and qualifications: This information is absent as no detailed performance study with a test set requiring ground truth is described.
4. Adjudication method for the test set: Not applicable, as no such test set or study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document does not describe any MRMC study or any study evaluating human reader improvement with AI assistance. The device is a "Programmable Diagnostic Computer" for EP studies, not explicitly an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned in the context of a standalone AI algorithm performance. The device itself is a system that assists in EP studies.
7. The type of ground truth used: No ground truth for an AI algorithm's performance is described.
8. The sample size for the training set: Not applicable, as there's no mention of an AI model's training set.
9. How the ground truth for the training set was established: Not applicable, as there's no mention of an AI model's training set.

In summary, the provided document is a regulatory approval letter and a summary of the device's technical specifications and non-clinical testing. It does not elaborate on an AI/ML component meeting specific performance criteria through a clinical validation study as implied by your questions. The software changes are presented as enhancements to an existing system, rather than the introduction of a new AI-driven diagnostic capability requiring a comprehensive AI performance study.

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