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

• When used with the EnSite Catheter, the EnSite 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 System is intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 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 Array does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 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 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 does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, nor does it detail a standalone or MRMC study.

Instead, the document is a 510(k) premarket notification for a modification to an existing device, the EnSite System (Model EE3000). The key statements relevant to performance are:

• "The changes made to the EnSite System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."
• "An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness."

This indicates that the changes were validated internally against established procedures, and the conclusion is that the modified device performs comparably to the predicate device. However, no specific performance metrics, acceptance criteria, or study details (like sample size, ground truth, or expert qualifications) are provided in this document.

Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.

Here's a summary of what can be inferred or directly stated from the text, with the understanding that detailed performance criteria and study results are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "bench and user tests," implying internal testing.

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

• Not specified.

4. Adjudication method for the test set:

• Not specified.

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:

• Not mentioned. The device is an electrophysiology mapping system, not specifically an AI-driven image analysis tool, though it is a "programmable diagnostic computer." The document only refers to "user tests" without specifying their nature or comparative effectiveness.

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

• Not mentioned. The document describes a "computerized storage and display system" used in conjunction with catheters and for clinicians to identify arrhythmia sources. It does not describe a standalone algorithm performance evaluation.

7. The type of ground truth used:

• Not specified. As the device is an electrophysiology mapping system, ground truth would typically relate to accurate identification of arrhythmia sources or catheter positions, likely established by electrophysiology study results, clinical outcomes, or expert consensus during the "user tests," but this is not detailed.

8. The sample size for the training set:

• Given this is a 510(k) for a modification to an existing device, and the description does not suggest a machine learning model from scratch, there is no mention of a "training set" in the context of typical AI/ML development. The "training" would have been part of the initial development of the predicate device (K070902), if applicable.

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

• Not applicable/Not specified, as there is no mention of a training set for a new algorithm in this document.

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

• When used with the EnSite™ Catheter, the EnSite 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 System is . intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 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 Array does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System is a system that facilitates mapping and treatment of arrhythmias.

The provided text appears to be a 510(k) summary for the St. Jude Medical EnSite System (Model EE3000), along with its associated components. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria based on detailed performance studies with clinical endpoints.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The 510(k) process relies on demonstrating that the new device has "the same technological characteristics" and is "as safe and effective as the previously marketed device" based on a comparison to a predicate device.

Here's what can be extracted based on the provided text, and what is explicitly not available:

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

The document states: "The changes made to the EnSite System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures." and "An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness."

This document does not provide a table of
specific, quantifiable acceptance criteria or reported device performance metrics against such criteria. The focus is on demonstrating equivalence to a predicate device.

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

The document mentions "a battery of bench and user tests" and "device validation testing," but does not specify the sample size, data provenance (country of origin), or whether the data was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth or their qualifications. Testing appears to be primarily bench and user-based as part of internal validation.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) study or any comparison related to human readers improving with or without AI assistance. The EnSite system described is an electrophysiology cardiac mapping system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for assessing reader improvement.

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

The document does not provide details on standalone algorithmic performance. The system is described as a "computerized storage and display system for use in electrophysiology studies" which implies human interaction.

7. The type of ground truth used

The document does not specify the type of ground truth used. Given the context of comparing to a predicate device and internal validation, the "ground truth" would likely be based on established engineering and clinical standards for electrophysiology systems or direct comparison to the predicate device's output.

8. The sample size for the training set

The document does not mention a training set sample size. This type of 510(k) submission generally does not involve machine learning "training sets" in the way that AI/ML devices do.

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

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

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The EnSite System is indicated for patients for whom electrophysiology studies are indicated.
When used with the EnSite* Catheter, the EnSite 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 System is . intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 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.

This 510(k) summary does not contain the level of detail necessary to answer all the questions about acceptance criteria and the study proving the device meets them as typically presented for AI/ML-based medical devices. This document predates the widespread use of sophisticated AI/ML in medical devices and therefore focuses on traditional medical device validation.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format requested for an AI/ML device. Instead, it relies on a qualitative assessment of "safety and effectiveness" compared to a predicate device.

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

This information is not provided in the document. The abstract mentions "bench and user tests," but details on sample size, data type, or provenance are omitted.

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)

This information is not provided. Given the nature of the device (an electrophysiology cardiac mapping system and its components), ground truth would likely be established through physician observation during electrophysiology studies, but the specifics are absent.

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

This information is not provided.

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 as typically understood for AI/ML evaluation was not performed or reported. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI efficacy study. The concept of "human readers improve with AI vs without AI assistance" is not applicable here as it is not an AI/ML device in the modern sense.

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

This concept is not applicable to this device. The EnSite System is a computerized storage and display system that supports electrophysiology studies, not a standalone AI algorithm producing diagnoses or interpretations without human involvement. Its "performance" is inherently linked to its use by an electrophysiologist in conjunction with catheters or surface electrodes.

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

The document does not specify the type of ground truth. For an electrophysiology mapping system, "ground truth" would likely relate to accurate identification and visualization of cardiac activation patterns and catheter positions, validated through clinical observation and established electrophysiological principles, rather than pathology or outcomes data in the traditional sense of a diagnostic AI device.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this traditional medical device submission. The device is not an AI/ML system that undergoes "training" in the computational sense.

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

This information is not provided and is not applicable.

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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 Endocardial Solutions EnSite 3000® System. It describes the device, its intended use, and states that it has "the same technological characteristics as the legally marketed predicate device."

However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. Instead, it states that "The changes made to the EnSite 3000® System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."

Therefore, I cannot provide the requested information from the given text. The 510(k) summary is a declaration of substantial equivalence to a predicate device, and for such submissions, detailed performance data, especially clinical study results with specific metrics and acceptance criteria, are often not included in the publicly available summary if they are considered proprietary or have already been established for the predicate device.

Based on the provided text, the answer is: The document does not contain the specific acceptance criteria or details of a study that proves the device meets acceptance criteria.

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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 describes a 510(k) summary for the EnSite 3000® System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics. Therefore, many of the requested sections about acceptance criteria, study sizes, and ground truth establishment cannot be fully populated from the given information.

However, based on the non-clinical performance data section, some inferences and summaries can be made regarding testing.

Here's an attempt to populate the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states, "The changes made to the EnSite 3000® System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures." It does not explicitly define specific numerical acceptance criteria or detail the quantitative performance of the device against such criteria. The conclusion simply states, "An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness." This implies that the device met internal performance benchmarks consistent with the predicate device, but these are not specified.

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

The document refers to "bench and user tests" but does not specify the sample size (e.g., number of cases, number of subjects, or number of test scenarios) for these tests.
The data provenance is not specified (e.g., retrospective or prospective, country of origin).

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

The document does not mention the use of experts to establish a "ground truth" for a test set. The evaluation seems to be focused on comparing the new device against the predicate and against internal validation procedures.

4. Adjudication method for the test set

Not applicable, as no external expert adjudication for a test set is described.

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 such MRMC study is mentioned. The device described is an electrophysiology mapping system, not an AI-assisted diagnostic tool that would typically involve human "readers" in the context of image interpretation.

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

The document does not describe a "standalone" algorithmic performance study in the context of AI. The testing described involves "bench and user tests" for a medical device system, which inherently includes the device's integrated functionalities.

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

The concept of "ground truth" in the context of evaluating a diagnostic/mapping system's accuracy (e.g., against true anatomical locations or arrhythmia sources) is not explicitly detailed in the provided summary. The evaluation focuses on the safety and effectiveness relative to a predicate device and adherence to internal validation procedures.

8. The sample size for the training set

Not applicable. The document does not describe an AI/machine learning model that would require a "training set." The device is a "computerized storage and display system" and mapping system, not a learning algorithm that is "trained."

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

Not applicable, as there is no mention of a training set or AI/machine learning model.

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