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The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with the EnSite Array™ 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.
When used with the EnSite NavX™ Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
When used with the St. Jude Medical Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.

The EnSite Velocity System consists of the following:
Display Workstation
Amplifier

The provided text describes the EnSite Velocity System EnSite Contact Force Module and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a specific study proving those criteria were met, or detailed performance metrics in the format requested.

It primarily focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through bench testing and adherence to design control activities.

Therefore, many of the requested fields cannot be filled from the given text.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be provided. The document states "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." However, it does not specify what those design requirements (acceptance criteria) were or the quantitative results of the bench testing.

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

• Cannot be provided. The phrase "Bench testing" is too vague to determine sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. No information regarding human experts or ground truth establishment for a test set is mentioned. The testing described is "bench testing," implying laboratory-based or simulated environments, not involving clinical data with expert ground truth.

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

• Cannot be provided. No adjudication method is mentioned as there's no described process involving human review of a 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:

• Cannot be provided. The document describes a medical device (an electrophysiology mapping system), not an AI algorithm assisting human readers. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

• Cannot be provided. This device is an "Electrophysiology Mapping System with console and catheter," designed to be used by clinicians ("human-in-the-loop"). It's not a standalone algorithm in the sense of an AI model generating diagnoses without human intervention.

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

• Cannot be provided. No ground truth type is specified, as the testing mentioned is "bench testing" to confirm meeting "design requirements," not clinical validation against a gold standard.

8. The sample size for the training set:

• Cannot be provided. The device is a hardware/software system, not a machine learning model that would typically have a "training set."

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

• Cannot be provided. As above, no training set is mentioned as this is not an AI/ML algorithm requiring one.

Summary of available information:

The document focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through:

• Same fundamental scientific technology.
• All technological characteristics being substantially equivalent.
• Bench testing to confirm that "changes met design requirements and did not adversely affect the device's safety and effectiveness" where operational and performance differences exist.
• Compliance with Quality System Regulation design controls (21 CFR 820.30).

Essentially, the acceptance criteria are implied to be "meeting design requirements" and "not adversely affecting safety and effectiveness" compared to the predicate, verified through bench testing. Specific quantitative criteria and results are not detailed in this public disclosure summary.

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The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

VeriSense™ Technology is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI).

The EnSite Velocity System consists of the following:

• Display Workstation .
• . Amplifier

Here's an analysis of the provided text, focusing on acceptance criteria and study details, though it's important to note that the document is a 510(k) summary, which often provides less granular detail than a full clinical study report.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the VeriSense System Software. Instead, it refers to a "summary of the clinical study applicable to the diagnostic portion (VeriSense Software)" from the CONTACT AFL study, which supported the PMA supplement for the hardware. The closest to stated performance is the statement that the VeriSense Technology is intended for "monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact."

Without specific numerical targets for metrics like sensitivity, specificity, or accuracy, it's impossible to create a table of "acceptance criteria" and "reported device performance." The document relies on the fact that an "ECI Validation" was performed as part of a larger study, and the results were deemed sufficient for substantial equivalence.

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

• Sample Size for Test Set: The sample size for the "test set" (referring to the data used to evaluate the VeriSense Software specifically) is not explicitly stated in this document. It mentions the "CONTACT AFL study" as a "prospective, multi-center" study, but does not break down the number of patients or data points used specifically for the VeriSense Software validation within that study. It also mentions a "summary report of the Electrical Coupling Index (ECI) Validation that was collected from the CONTACT AFL Study." This implies the data used was a subset or specific analysis from the larger CONTACT AFL study.
• Data Provenance: The CONTACT AFL study was described as a "prospective, multi-center" study. The document does not specify the country of origin of the data, but "multi-center" usually implies data from various clinical sites.

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

The document does not specify the number of experts used, nor their qualifications, for establishing ground truth for the test set of the VeriSense System Software.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for the VeriSense System Software. The document describes the system as a "diagnostic tool" and "intended for monitoring catheter tip-to-tissue electrical coupling." This type of device focuses on providing information to the clinician, rather than directly replacing or augmenting human interpretation of complex images in a way that would typically warrant an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a form of standalone performance was implicitly done. The "ECI Validation" described as being collected from the CONTACT AFL study would represent the standalone performance of the VeriSense System Software in its function of "monitoring catheter tip-to-tissue electrical coupling." The document focuses on the software's ability to provide an Electrical Coupling Index (ECI) as an indication of contact, rather than its impact on clinician decision-making or patient outcomes directly in this 510(k) summary.

7. Type of Ground Truth Used

The document states that VeriSense Technology is intended for "monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact." The "ECI Validation" would likely have involved comparing the Electrical Coupling Index (ECI) generated by the VeriSense software against a direct or established method of determining actual catheter tip-to-tissue contact during the electrophysiology procedures.

While the document doesn't explicitly state the exact ground truth used (e.g., direct visual confirmation, pressure sensors, histological confirmation, etc.), it implies a comparison against a more definitive measure of "tip-to-tissue contact." This would fall under a form of empirical validation or a gold-standard comparison related to the physical phenomenon it's designed to detect.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. Given that this is a 510(k) summary for a "System Software Module" that is part of a larger mapping system, and the primary focus is on "substantial equivalence" to a predicate device, explicit details about AI model training (which is what a "training set" typically implies) are not provided. The term "software module" in this context might refer to an algorithmic component, but the document does not elaborate on its development methodology in terms of machine learning.

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

Since the document does not specify a training set or the use of machine learning in a way that requires explicit ground truth for training, it does not provide information on how ground truth for a training set was established.

Ask a specific question about this device

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation
• Amplifier
• Interconnects

The provided text is a 510(k) summary for the EnSite Velocity System v4.0. It describes the device, its indications for use, and its substantial equivalence to a predicate device (EnSite Velocity System v3.0). However, it does not contain any information about specific acceptance criteria, performance metrics, or details of a study that proves the device meets those criteria.

Instead, the document states:

• "Bench and animal testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This is a general statement and does not provide specific acceptance criteria or an evaluation of performance.
• The conclusion is based on substantial equivalence to a predicate device, meaning it has the same indications for use, intended use, and fundamental scientific technology, and all technological characteristics are substantially equivalent. This suggests that extensive new performance studies (like those with detailed acceptance criteria and expert evaluation for, e.g., image analysis algorithms) were not required for this particular submission because the changes were not significant enough to warrant them.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

Here's what can be inferred or stated based on the text:

Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided text)

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "bench and animal testing" but provides no details on sample sizes or data provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
4. 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 applicable. This device is an electrophysiology mapping system, not an AI-assisted diagnostic imaging device for human readers in the typical sense of an MRMC study. The document describes it as a "diagnostic tool" in patients. There is no mention of AI or human reader improvement.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a system involving hardware (workstation, amplifier, interconnects) and intended to be used with catheters, suggesting a physician interaction, not a standalone algorithmic performance test in the conventional sense.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
7. The sample size for the training set: Not applicable/Not specified. This is a medical device system update based on established technology, not a de novo AI algorithm requiring a training set in the machine learning context described.
8. How the ground truth for the training set was established: Not applicable/Not specified for the reasons above.

Ask a specific question about this device

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation
• Amplifier

The provided text is a 510(k) summary for the EnSite Velocity System v.3.0. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document states:

• "Bench testing and animal study testing (Appendix S) were performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product."
• "Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness."

However, it does not provide any details on:

1. Specific Acceptance Criteria: No quantitative or qualitative acceptance criteria are listed.
2. Reported Device Performance: No actual performance metrics are reported.
3. Study Details: There is no description of the methodology, results, or statistical analysis of any study. "Bench testing and animal study testing" are mentioned, but no specifics are given.
4. Sample Sizes: No sample sizes are provided for any tests.
5. Data Provenance: No information on the country of origin or whether data was retrospective/prospective.
6. Number/Qualifications of Experts: No experts are mentioned in the context of establishing ground truth for testing.
7. Adjudication Method: Not applicable as there's no mention of expert consensus.
8. MRMC Comparative Effectiveness Study: Not mentioned as being performed.
9. Standalone Performance Study: Not explicitly described for the algorithm itself.
10. Type of Ground Truth: Not specified.
11. Training Set Sample Size: No mention of a training set.
12. Ground Truth for Training Set: Not applicable.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, and the claim that differences do not adversely affect safety or effectiveness, rather than reporting a detailed study against pre-defined acceptance criteria.

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The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.
  When used with the v.1.5.1 MediGuide gMPS System Interface Module, the EnSite Velocity System interfaces to the MediGuide Guided Medical Positioning System II to combine and display gMPS II processed patient positioning and orientation Mapping information.

The EnSite Velocity System consists of the following:

• Display Workstation .
• Amplifier .

The provided text is a 510(k) summary for a medical device (EnSite Velocity System v.1.5.1 with MediGuide gMPS System Interface Module). It outlines the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not contain the detailed information required to describe specific acceptance criteria for performance, a comprehensive study proving those criteria, or details regarding ground truth establishment and expert involvement.

The document states:

• "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product."
• "The full software performance benchmarks which measure map and waveform display refresh rates, data rates, and time to display a frame of map and waveforms were conducted."
• "The performance of the EnSite Velocity System was observed during verification and integrated system testing to ensure performance was not severely impacted by the integration with the gMPS II (K102905)."

While these statements indicate that testing was performed to ensure the device met certain performance expectations and safety requirements, they do not provide quantitative acceptance criteria or the study data that validates them. The document primarily focuses on establishing substantial equivalence to a predicate device through modifications and integration with another system.

Therefore, I cannot populate the requested table and answer many of the questions because the necessary details are not present in the provided text.

Here's a breakdown of what can be inferred from the text and what cannot:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance (country, retrospective/prospective): Not specified. The testing described is "bench testing" and "software performance benchmarks," suggesting laboratory/simulated environments rather than patient data.

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)

• Number of Experts: Not applicable/not mentioned. This type of testing appears to be functional and performance-based against specifications, not reliant on expert interpretation of ground truth in a clinical context.
• Qualifications of Experts: Not applicable/not mentioned.

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

• Adjudication Method: Not applicable/not 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

• MRMC Study: No, an MRMC study was not done or mentioned. This device is an electrophysiology mapping system, not an AI-assisted diagnostic imaging device that would typically involve human "readers" interpreting cases.

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

• Standalone Performance: The described "software performance benchmarks" (map and waveform display refresh rates, data rates, and time to display a frame) represent a form of standalone performance testing for the system's core functions. However, "standalone" in the context of AI often refers to an algorithm making a diagnosis without human intervention, which is not the primary function or testing focus described here.

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

• Type of Ground Truth: Not explicitly stated. For bench testing and software benchmarks, the "ground truth" would likely be the defined design requirements and expected performance specifications derived from engineering principles and predicate device behavior.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a traditional medical device (electrophysiology mapping system) and its software integration, not a machine learning or AI algorithm that would typically involve a "training set" in the context of AI model development.

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

• How Ground Truth for Training Set was Established: Not applicable (see point 8).

Ask a specific question about this device

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation .
• Amplifier

The provided text describes a 510(k) summary for the EnSite Velocity System, a medical device. However, it does not contain information regarding detailed acceptance criteria or a study proving that the device meets such criteria.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. This often involves demonstrating that any differences do not adversely affect safety or effectiveness, which might be supported by bench testing.

Here's a breakdown of what is present and what is missing from your request based on the provided text:

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

• Not Available. The document states: "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." However, it does not provide specific acceptance criteria (e.g., "accuracy must be >90%") or a table of reported device performance against such criteria. The "changes" refer to modifications between version 1.3 and 2.0 of the EnSite Velocity System.

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

• Not Available. There is no mention of a "test set" in the context of clinical data or patient samples. The testing described is "bench testing," which typically involves simulated conditions or controlled environments, not patient data in the sense of sample size and provenance.

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. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No clinical 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

• Not Available. This document describes an electrophysiology mapping system, not an AI-assisted diagnostic tool for image interpretation or a system that modifies human reader performance in the way described. No MRMC study is mentioned.

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

• Not Available. The device is an "Electrophysiology Mapping System" which is an interactive tool used by clinicians (human-in-the-loop). Standalone algorithm performance is not discussed as it's not relevant to this type of device.

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

• Not Applicable. The testing mentioned is bench testing. For bench testing, "ground truth" typically refers to engineering specifications, reference standards, or expected outputs based on known inputs, not clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• Not Applicable. This document describes a medical device, not an AI model that undergoes a "training set" in the machine learning sense. The development of the device followed "St. Jude Medical's Quality System requirements" and "design controls requirements," which is a different process than AI model training.

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

• Not Applicable. See point 8.

In summary: The provided 510(k) summary focuses entirely on demonstrating "substantial equivalence" of the EnSite Velocity System v.2.0 to its predicate device (EnSite Velocity System v.1.3) through modifications meeting design requirements and bench testing. It does not provide the kind of detailed information about acceptance criteria, clinical study designs, sample sizes, expert ground truth, or AI performance metrics that your request specifies. Such information is typically found in PMAs (Premarket Approval applications) or specific clinical trial reports, not usually in a 510(k) summary focused on substantial equivalence.

Ask a specific question about this device

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation .
• Amplifier .

This 510(k) summary (K101667) describes a resubmission for the EnSite Velocity System with PRT, which is a modification to the previously cleared EnSite Velocity System (K093942). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a novel device. The document states that the new device has the same indications for use, intended use, and fundamental scientific technology as the predicate and that all technological characteristics are substantially equivalent.

Therefore, the provided document does not contain a detailed study proving the device meets specific performance acceptance criteria in the way one might expect for a new device submission. Instead, it relies on demonstrating that the changes made did not adversely affect the device's safety and effectiveness compared to the already cleared predicate.

Here's a breakdown of the information as requested, extrapolated from the provided text where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific quantitative acceptance criteria or a dedicated performance study for this modified device (EnSite Velocity System with PRT) are not included in this 510(k) summary. The summary focuses on equivalence to a predicate device. The "performance" assessment is based on ensuring the changes did not degrade performance.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," which implies some form of in-vitro or simulated testing, but details on sample size (e.g., number of test cases, number of runs) are not provided.
• Data Provenance: The testing was "bench testing," indicating it was likely conducted in a laboratory setting by St. Jude Medical. No information on country of origin for data or whether it was retrospective or prospective clinical data is mentioned, as this was not a clinical study.

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

• This type of detail is not applicable to the "bench testing" described. Bench testing typically involves engineering verification against specifications or design requirements, not expert-adjudicated ground truth as would be used in a clinical study of diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. This information is relevant for clinical studies involving human observers or diagnoses, where consensus among experts is often established. Bench testing does not involve adjudication in this sense.

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

• No. An MRMC comparative effectiveness study was not conducted for this 510(k) submission. This type of study would typically be performed for new diagnostic algorithms where human reader performance is a key metric, often with and without AI assistance to measure improvement (effect size). This submission focuses on engineering changes and equivalence.

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

• The EnSite Velocity System is a tool used by interventional electrophysiologists. Its function is to map cardiac activity and display catheter positions. It is inherently a "human-in-the-loop" device. Therefore, a standalone (algorithm only) performance assessment as might be done for an AI diagnostic algorithm is not applicable in the context described. The "bench testing" was likely verification of the system's ability to accurately perform its technical functions.

7. The Type of Ground Truth Used

• For the "bench testing" mentioned, the ground truth would typically be engineering specifications, known physical properties, or pre-defined validation targets established during the device's design and development. For instance, if a change affected how catheter position is displayed, ground truth could be the known, reference position of the catheter in a phantom or simulated environment. It would not be expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. The EnSite Velocity System, as described in this summary, is an electrophysiology mapping system, not an AI/machine learning device that relies on a "training set" in the conventional sense. The "PRT" refers to "Positional Reference Tool," which is an engineering-level feature, not an AI algorithm.

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

• Not applicable. As explained above, there is no "training set" for this type of device.

In summary, this 510(k) summary pertains to a modification of an existing device and leverages the concept of "substantial equivalence" to a predicate device. The "study" described is limited to "bench testing" to ensure the modifications do not negatively impact safety or effectiveness, rather than a comprehensive de novo clinical performance study with specific acceptance criteria, expert adjudication, or AI performance metrics.

Ask a specific question about this device

The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation
• Amplifier

The provided text is a 510(k) Summary for the EnSite Velocity System. It details the device's regulatory information, intended use, and comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of AI/ML performance evaluation.

The "Summary of Non-Clinical Testing" section states, "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." The "Summary of Clinical Testing" section states, "Cross-vendor interoperability testing sessions were conducted between EnSite Courier and 15 different PACS models/versions, seven vendors. This clinical test report can be found in Appendix S."

This submission appears to be for an update to an existing system (EnSite Velocity v.1.3 (K093942)) to include "EnSite Courier™" which is a networking software feature. The testing described is focused on interoperability and verifying that changes did not negatively impact safety or effectiveness compared to the predicate device, rather than establishing performance metrics against a defined acceptance criterion for a novel diagnostic accuracy claim.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can be inferred or confirmed:

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

   • Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic performance study, nor does it report such metrics. The non-clinical testing focused on "meeting design requirements" and not affecting safety/effectiveness. The clinical testing focused on "interoperability."

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

   • For the "Cross-vendor interoperability testing sessions," the "test set" consisted of "15 different PACS models/versions, seven vendors." No patient data sample size, provenance, or retrospectivity/prospectivity is mentioned as the testing was on interoperability, not clinical diagnostic performance.

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. This information is relevant for studies evaluating diagnostic accuracy against expert ground truth. The described testing was for interoperability and non-inferiority via bench testing.

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

   • Not applicable. See point 3.

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. An MRMC study was not described. The device is an electrophysiology mapping system, and the update involves networking software. This type of study is not relevant to the described testing.

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

   • The device is a "Cardiac Mapping System" and the update is for "EnSite Courier™" networking software. It is not an "algorithm only" device in the AI/ML sense. The testing described (bench testing and interoperability) is a form of standalone testing for the specific aspects evaluated (design requirements and data exchange).

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

   • For the non-clinical bench testing, the "ground truth" would be the engineering design requirements.
   • For the clinical interoperability testing, the "ground truth" would be successful data exchange with various PACS systems. No medical ground truth (pathology, expert consensus, outcomes) was established as this was not a diagnostic accuracy study.

8. The sample size for the training set:

   • Not applicable. This device and its update (networking software) are not described as using an AI/ML algorithm that would require a "training set" in the context of machine learning model development.

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

   • Not applicable. See point 8.

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The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

• When used with the EnSite Array™ 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 (EP) catheters in the heart.

The EnSite Velocity System consists of the following:

• Display Workstation .
• Amplifier

The provided text is a 510(k) summary for the EnSite Velocity System. It details the device's intended use and substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general "bench testing" to confirm design requirements.

Therefore, I cannot fulfill your request for the specific details outlined as the information is not present in the provided document.

Here's a breakdown of why I cannot answer each point based on the given text:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product," but no specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: 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: Not provided. This is a diagnostic mapping system, not specifically an AI-assisted diagnostic tool as described in the question.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document's primary focus is on establishing substantial equivalence to a predicate device based on similar indications for use, fundamental scientific technology, and the outcome of general bench testing. It does not delve into detailed performance studies with specific acceptance criteria as you've requested.

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