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EnSite™ X EP System

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 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.

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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 procedures.

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.

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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 procedures.

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 FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

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

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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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.
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.
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 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.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance.

Important Note: The provided document is an FDA 510(k) clearance letter and a 510(k) Summary. It does not contain detailed information about a comprehensive clinical study to establish performance, especially not in the depth typically seen for AI/ML device clearances (e.g., MRMC studies, specific performance metrics against ground truth for diagnostic accuracy). This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for software updates to an existing system. Therefore, many of the requested details, particularly those related to a new AI/ML model's performance validation, are not present in this type of submission.

Based on the provided document, here's what can be inferred and what information is missing:

The device in question is the EnSite™ X EP System, and the 510(k) (K242016) is a "Special 510(k)" for software updates (Version 3.1) to an already cleared predicate device (EnSite™ X EP System, K231415). Special 510(k)s are typically used for changes that do not alter the fundamental technology or indications for use.

The "study" referenced in this context is primarily software verification and validation testing to ensure the updated software maintains the safety and effectiveness of the previously cleared predicate device. It's not a clinical performance study in the sense of evaluating a new diagnostic algorithm's accuracy against a clinical ground truth with human agreement.

1. Table of Acceptance Criteria & Reported Device Performance

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

• Sample Size: Not specified in terms of clinical cases or data points. The "test set" here refers more to the scope of software testing rather than a clinical dataset for diagnostic performance.
• Data Provenance: Not specified. Given it's a software update to an existing system, the "data" would likely be the system's internal functions, compatibility with hardware, and simulated/recorded electrophysiology data used for testing. It's not a retrospective or prospective clinical study on patient data in the typical sense of evaluating a new AI/ML diagnostic model.

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

• Number of Experts: Not specified. Given the nature of a software update, ground truth for software functionality would be established by software engineers, quality assurance personnel, and potentially subject matter experts (e.g., electrophysiologists) for clinical workflow and output validity, but not in the context of diagnostic "ground truth" derived from patient-specific interpretations.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified in this type of submission. The "ground truth" is based on system specifications and expected software behavior, not human interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed as described for AI assistance. This submission is for software updates to a diagnostic system, not a new AI-powered diagnostic algorithm designed to assist human readers directly in interpreting images or data.
• Effect Size of Improvement: Not applicable, as no such study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not directly applicable in the typical sense of evaluating an AI algorithm's diagnostic performance. The device is a "Programmable Diagnostic Computer" used in electrophysiology procedures. Its performance is evaluated by ensuring its internal computations, mapping, and display functions are accurate and consistent with its design specifications and the predicate device. It's not a standalone "algorithm" providing a diagnosis independent of human interaction.

7. Type of Ground Truth Used

• Type of Ground Truth: For software verification, the ground truth is primarily based on design specifications, established functional requirements, and the expected behavior of the system as defined by its engineers and clinical subject matter experts. This is not clinical "ground truth" like pathology, expert consensus on imaging, or outcomes data, as this is a functional system, not an AI diagnostic algorithm.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of a new AI/ML model. The updates are to existing software components (bug fixes, compatibility, minor enhancements).

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

• Establishing Ground Truth for Training Set: Not applicable, as no new AI/ML training data or process is described.

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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.

Ask a specific question about this device

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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