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The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The system displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.

This document does not contain the detailed information necessary to answer all parts of your request. It is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with acceptance criteria and performance metrics in the way you've outlined.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the provided document. The 510(k) summary states "Testing demonstrated that the modified ECVUE Mapping System is substantially equivalent to the original (predicate) system." and "Full system, integration, unit regression testing was performed." However, it does not specify what the acceptance criteria for these tests were or report specific performance metrics against those criteria.

2. Sample sized used for the test set and the data provenance:

This information is not present in the provided document. The document states "No clinical testing was conducted." The non-clinical testing ("Full system, integration, unit regression testing") does not specify a test set size or data provenance.

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

This information is not present in the provided document, as no clinical testing with a "test set" and "ground truth" established by experts is mentioned.

4. Adjudication method for the test set:

This information is not present in the provided document, as no clinical testing with adjudication is mentioned.

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:

This information is not present in the provided document. The device is a "mapping system" that "displays cardiac maps and virtual electrograms from real-time chest ECG signals... for analysis by a physician." It's not described as an AI-powered diagnostic tool that assists human readers in the context of an MRMC study.

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

This information is not present in the provided document, as no explicit performance study (standalone or otherwise) is detailed. The device is intended for "analysis by a physician," implying a human-in-the-loop system.

7. The type of ground truth used:

This information is not present in the provided document, as no clinical testing with a defined ground truth is mentioned.

8. The sample size for the training set:

This information is not present in the provided document. The document refers to "updates to the software based on internal/user feedback and maintenance updates to the OTS," but does not describe a training set for an algorithm.

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

This information is not present in the provided document, as no training set or its ground truth establishment is mentioned.

Summary of what is available from the document:

• Device Name: ECVUE Mapping System, Model AT200
• Intended Use: Acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
• Regulatory Status: Class II, Product Code DOK (Programmable Diagnostic Computer).
• Predicate Device: ECVUE Mapping System (K140497) - implying the current device is an updated version of an already cleared device.
• Changes from Predicate: Software updates based on internal/user feedback and maintenance updates to OTS (Off-The-Shelf) components. These changes are described as "very small and do not change the functionality or technological characteristics of the device. The Intended Use of the device is not affected."
• Testing Performed: "Full system, integration, unit regression testing was performed."
• Clinical Testing: "No clinical testing was conducted."
• Conclusion: The modified system is "substantially equivalent to the original (predicate) system and the changes did not affect the safety and effectiveness of the device when it is used as labeled."

The document focuses on demonstrating that the changes made to the device (mostly software updates) do not affect its safety and effectiveness, thus maintaining substantial equivalence to its predicate. It does not provide performance data or acceptance criteria for an initial clearance study of the device's efficacy in the way a new, de novo device might.

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