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The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ Precision System interfaces to either the MediGuide™ Technology system or the EnSite Precision Module to combine and display magnetic processed patient positioning and navigation mapping information.

When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

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When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite Precision™ Cardiac Mapping System with version 2.0 software is a new module that is designed to allow the system to interface to the EnSite Precision™ Module, Sensor Enabled, which is an alternative magnetic field-based medical positioning hardware kit for magnetic field scaling functionality.

This document does not contain the detailed acceptance criteria and study results in the format requested. While it outlines the device, its intended use, and that verification/validation activities were performed, it does not provide specific metrics or performance tables.

Here's what can be extracted and what is missing:

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

• Missing. The document states "Design verification/validation activities were performed with their respective acceptance criteria to ensure that the modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not specify what those acceptance criteria were or what the measured performance results were against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Partially Missing. The document mentions "Dynamic Wetlab Bench Comparative and Preclinical Animal testing."
  • Sample Size: Not specified.
  • Data Provenance: "Wetlab Bench" and "Preclinical Animal testing" suggest laboratory/animal studies, which are prospective. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable / Missing. This device is a cardiac mapping system for electrophysiology studies. The "ground truth" in this context would likely be precise catheter location measurements, which are typically established through highly accurate measurement systems, not expert consensus in the same way an image diagnosis would be. The document describes "magnetic field-based catheter localization" and "impedance locations" as mechanisms for determining position, suggesting instrumental ground truth rather than expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable / Missing. As the ground truth is instrumental (catheter position) rather than interpretive (e.g., diagnosing an image), adjudication methods by human readers are not relevant here.

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:

• No. This document describes a K160210 submission for a cardiac mapping system, focusing on its technical performance and equivalence to predicate devices, not on AI assistance for human readers in diagnostic interpretation. The testing involved comparisons of model rendering and catheter electrode localization between the subject and predicate devices, and workflow performance.

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

• Yes, implicitly. The testing described ("Electrical, Mechanical, Accuracy and Repeatability, Packaging, shelf life, Biocompatibility, Preclinical Animal Studies") focuses on the device's technical performance. The "accuracy testing for use with the magnetic field scaling feature" and comparisons of "model rendering and location of catheter electrodes" are examples of standalone performance evaluation of the system's ability to accurately map and localize.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth would be based on highly accurate physical measurements for catheter positions in the wetlab/animal studies. The document states "magnetic field-based catheter localization used for field scaling during model creation involves sensing of the magnetic fields generated through small coil sensors embedded inside the enabled device." This implies a physical, instrumental ground truth for position validation.

8. The sample size for the training set:

• Not Applicable / Missing. This document describes a device approval, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to the device's development and validation, which uses various engineering and animal studies.

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

• Not Applicable / Missing. See point 8. The ground truth for validation testing (such as catheter position) would be established through precise physical measurement techniques in the wetlab or animal models.

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The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

MediGuide Technology enables navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3D visualization and precise navigation to pre-recorded 2D X-ray images and can be used by the physician to perform complex electrophysiology procedures and CRT implants. MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure. MediGuide creates a real-time clinical environment by compensating for patient motion, respiration and heart rate variability

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document describes the "MediGuide Technology System (Version 17.0)" and its regulatory clearance (K162643) by the FDA. It outlines the device's intended use and briefly mentions non-clinical testing.

However, it does not include:

• A specific table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, ground truth establishment, or sample size for a training set.
• Information on the number and qualifications of experts or the adjudication method used.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone (algorithm only) performance study.

The document primarily focuses on regulatory aspects, comparison to a predicate device, and compliance with standards, rather than the specifics of a clinical or technical performance study in the way implied by your request. The "Summary on Non-Clinical Testing" section notes that "design verification activities for functional testing were performed with their respective acceptance criteria to ensure that software modifications and hardware addition do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not detail these acceptance criteria or the specific results.

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