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The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated.

• When used with the EnSite® Catheter, the EnSite 3000® 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.
  OR
• When used with the EnSite NavX™ Surface Electrode Kit, the EnSite 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters

The provided text is a 510(k) Summary for the EnSite 3000® System. It describes the device, its intended use, and a general statement about non-clinical performance data. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a comprehensive analysis of the device's performance against defined criteria.

Therefore, I cannot fully complete the requested table and answer all questions. Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "a battery of bench and user tests" for non-clinical performance data. However, no specific sample size for a test set (e.g., number of patients or cases) is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). The tests appear to be internal validation steps rather than a formal clinical study with a specified test set.

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 document. There is no mention of experts establishing ground truth for any test set.

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

This information is not present in the document. No adjudication method is mentioned, as there's no described test set with ground truth established by experts.

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 document. The EnSite 3000® System is described as a "computerized storage and display system" that aids electrophysiologists. It facilitates mapping and visualization but isn't explicitly described as an AI system that improves human reader performance in the context of an MRMC study. No MRMC study or effect size data is provided.

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

The device is described as assisting human operators ("electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy"). There is no mention of a standalone algorithm-only performance study. The system is intended to be used with human intervention.

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

This information is not present in the document. There is no detailed description of ground truth establishment for any performance evaluation.

8. The sample size for the training set

The document describes "bench and user tests" for non-clinical performance data but does not mention a training set or its sample size. This suggests that if machine learning was involved (which isn't explicitly stated but could be inferred from "computerized system"), the details of its development and validation are not included in this summary.

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

As no training set is mentioned, this information is not present in the document.

Summary of what the document does state regarding performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Endocardial Solutions EnSite 3000® System, K012926). The non-clinical performance data mentioned refers to "a battery of bench and user tests" conducted internally ("in-house procedures"). The conclusion states that the device is "as safe and effective as the previously marketed device" and "does not raise any new issues of safety and effectiveness." This indicates that the performance evaluation was likely focused on verifying that the changes made did not negatively impact the established performance of the predicate device, rather than establishing new, quantitative performance metrics against specific acceptance criteria.

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The EnSite® Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation 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 (i.e., linear mapping catheters).

The EnSite 3000 System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000 Electrophysiology Workstation connected to the EnSite Catheter utilizes proprietary software algorithms to reconstruct and display right atrial electrograms detected by the EnSite Catheter. This information can be presented as color-coded three-dimensional maps to provide global electrical activation patterns of the heart chamber. The EnSite 3000 System may also be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads, and other analog or digital inputs.

The EnSite 3000 System also incorporates a navigational tool to provide real-time feedback regarding the position of an auxiliary catheter for creation of a geometrical model of the heart chamber or for guiding therapy to a designated location.

This 510(k) notification describes a device modification, making it a "Special 510(k)". The core assertion is that the modified device is as safe and effective as its predicate. Therefore, the study presented focuses on demonstrating equivalence rather than establishing new performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a standalone AI or a human-in-the-loop scenario. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device performs comparably to the predicate device without introducing new risks.

The study described is focused on validating the changes made to the EnSite 3000 System.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states "a battery of bench and user tests." It does not specify the sample size for these tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions "in-house procedures" for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information about "experts" or the establishment of "ground truth" in the context of clinical performance evaluation. The testing appears to be focused on engineering validation (bench and user tests) to confirm the modified device's functionality and safety equivalent to the predicate.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This type of methodology is usually relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study described is not a clinical effectiveness study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "bench and user tests" for the system, not specifically a standalone algorithm performance test. The EnSite 3000 System itself is a computerized system with proprietary software algorithms, but the testing reported is for the system's operational equivalence to the predicate, not a standalone AI performance.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, expert consensus, outcomes data) is not explicitly stated or described. The validation appears to be against established functional specifications of the predicate device and safety standards.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This type of information is typically relevant for machine learning model development, and while the EnSite 3000 System uses "proprietary software algorithms," the submission focuses on device modification validation rather than algorithm development or training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth was established.

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The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation 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 (i.e., linear mapping catheters).

EnSite 3000® System Components

EnSite® Multi-electrode Diagnostic Catheter

The EnSite® Multi-electrode Diagnostic Catheter (EnSite® catheter) is a single use, 9 French, percutaneous catheter. The EnSite® catheter is designed for use only with the EnSite 3000® System in an electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.

EnSite 3000® Electrophysiology Workstation

The EnSite 3000® Electrophysiology Workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multi-electrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac clectrograms. The EnSite 3000® may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.

The EnSite 3000® System is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.

Acceptance Criteria and Study Details for EnSite 3000® System

Based on the provided 510(k) summary, the EnSite 3000® System did not include specific quantitative acceptance criteria or a detailed clinical study demonstrating its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified. The document mentions "a battery of bench and user tests," but does not provide details on the number of cases or subjects involved in these tests.
• Data Provenance: Not specified. The tests were "conducted in accordance with in-house procedures," suggesting an internal testing environment rather than a specific country or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of the device (electrophysiology cardiac mapping), "user tests" would likely involve electrophysiologists or cardiac technicians, but their number and specific qualifications are not detailed.

4. Adjudication Method:

• Adjudication Method: Not applicable or not specified. The document does not describe a process for establishing ground truth through expert adjudication. The focus was on demonstrating functionality and safety during bench and user testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. The device is a diagnostic tool for mapping cardiac arrhythmias, and the study as described focused on demonstrating its functionality and substantial equivalence, not comparing its effectiveness with and without AI assistance for human readers.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study with AI assistance was performed.

6. Standalone Performance Study (Algorithm Only):

• Standalone Performance Study: Yes, to some extent. The "Non-clinical performance data" section refers to "proprietary software algorithms to reconstruct and display right atrial endocardiograms." While not a formal "standalone performance study" as understood in modern AI/ML device evaluations, the bench and user tests inherently assessed the performance of the system's algorithms in reconstructing and displaying data, albeit within a simulated or controlled environment. However, specific metrics for the algorithm's standalone accuracy are not provided.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated or defined beyond the context of "bench and user tests." For a device that maps intracardiac electrograms, ground truth would typically involve comparing the device's output to known electrical activity (e.g., from a simulator or a highly accurate reference mapping system) or clinical outcomes. The document does not specify how "ground truth" was established for validating the accuracy of the reconstructed endocardiograms during these tests.

8. Sample Size for Training Set:

• Sample Size for Training Set: Not applicable. The document describes the EnSite 3000® System as utilizing "proprietary software algorithms." There is no indication that these algorithms were developed using machine learning or required a "training set" in the contemporary sense. The focus is on the functionality and accuracy of the pre-programmed algorithms rather than a learned model.

9. How Ground Truth for Training Set was Established:

• How Ground Truth for Training Set was Established: Not applicable, as there is no indication of a training set being used for machine learning.

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The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation 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 (i.e., linear mapping catheters).

EnSite 3000 System Components
EnSite Multi-electrode Diagnostic Catheter
The EnSite Multi-electrode Diagnostic Catheter (EnSite catheter) is a single use, 9 French, percutaneous catheter. The EnSite catheter is designed for use only with the EnSite 3000 electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.

EnSite 3000 electrophysiology workstation
The EnSite 3000 electrophysiology workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multielectrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac electrograms. The EnSite 3000 may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.

The EnSite 3000 is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary for the EnSite 3000 System, does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics. Instead, it describes a foundational approach to demonstrating substantial equivalence through various tests and comparisons.

The "reported device performance" is described qualitatively as:

• Non-clinical performance data:
  • The EnSite catheter underwent "a battery of in vitro tests including tensile, torsion, inflation, deflation testing."
  • Biocompatibility was confirmed "in accordance with ISO 10993."
  • The EnSite 3000 was tested and conforms to "IEC 601-1 and IEC 601-2-27 international standards."
  • "Device validation testing was conducted in accordance with in house procedures."
  • "Animal studies were utilized to show initial catheter and system safety of the catheter."
• Clinical Data:
  • "Clinical studies were conducted which demonstrate that the EnSite 3000 System is as safe and effective as EP mapping catheter systems presently marketed."
  • "The results indicate that it can map complex atrial arrhythmias."

Therefore, while no specific numerical acceptance criteria are given, the overarching acceptance criterion appears to be "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias."

Study Details

Here's the breakdown of the study information based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   As noted above, no quantitative table is provided. The acceptance criterion is broadly defined as "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states "Clinical studies were conducted," but neither the specific sample size nor the data provenance (country, retrospective/prospective) is mentioned for these clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The text only vaguely refers to "EP mapping catheter systems" for comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not provided 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:
   No MRMC study is mentioned. The device is an electrophysiology cardiac mapping system, not specifically described as an AI-assisted diagnostic tool that human readers would interact with in a 'before-and-after' scenario to measure improvement. The comparison is between the EnSite 3000 System and "EP mapping catherer systems presently marketed" in terms of safety and effectiveness, implying a direct comparison of device performance rather than human reader performance with and without AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   The clinical studies assess the "EnSite 3000 System," which includes the hardware and proprietary software algorithms. The statement "The EnSite 3000 connected to the EnSite catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms" indicates the algorithm's direct role in the device's function. The clinical studies would inherently be evaluating this standalone performance as part of the system's overall function in diagnosing arrhythmias.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   While the clinical studies demonstrate the system "can map complex atrial arrhythmias," the specific method for establishing the "ground truth" (i.e., definitive diagnosis of these arrhythmias against which the device's mapping was compared) is not detailed. It's implied that conventional EP mapping techniques or expert clinical judgment would have served as the benchmark, but this is not explicitly stated.

8. The sample size for the training set:
   The document describes "proprietary software algorithms" but does not mention a "training set" in the context of machine learning or AI that would typically be associated with such a term. This submission predates the widespread regulatory focus on AI/ML training data.

9. How the ground truth for the training set was established:
   As no training set is explicitly mentioned, this information is not provided.

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