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The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO™ 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V8.1 consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO™ 3 system V8.1 are the same as those found in the predicate device.

The provided FDA 510(k) clearance letter for the CARTO™ 3 EP Navigation System V8.1 does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device (CARTO™ 3 EP Navigation System V8.0) and outlines the V&V testing performed at a high level.

Specifically, the document does not report specific quantitative acceptance criteria or reported device performance metrics in a readily extractable table format. It states that "All tests were successfully completed and met the acceptance criteria" for various testing phases, but the acceptance criteria themselves are not provided. Similarly, actual performance metrics (e.g., accuracy values, false positive rates, etc.) are not listed.

Regarding the "study that proves the device meets the acceptance criteria," the document describes verification and validation testing, but this is not presented as a single, comprehensive "study" with a specific design (like an MRMC study or a standalone performance study) and reported results in the same way one might describe a clinical trial. Instead, it's a summary of different types of engineering and software testing.

Given these limitations, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available in the document.

Overview of Device Acceptance and Performance (Based on Available Information)

The acceptance of the CARTO™ 3 EP Navigation System V8.1 is broadly based on the successful completion of various verification and validation (V&V) tests, ensuring the device meets its design specifications and performs as intended, especially with new features and existing functionalities. The primary "proof" of acceptance is the statement that "All tests were successfully completed and met the acceptance criteria," even if those criteria are not quantitatively detailed.

Since quantitative acceptance criteria and reported numerical performance are not explicitly provided, a table with specific metrics cannot be generated. The document focuses on conceptual and functional "acceptance."

Detailed Breakdown of Available Information:

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

Not explicitly provided in the document in a quantitative, tabular format.

The document states:

• "All tests were successfully completed and met the acceptance criteria" for "Proof of Design."
• "All system features were found to perform according to specifications and met the tests acceptance criteria" for "Functional verification."
• "All tests were successfully completed and met the acceptance criteria" for "Unit Tests."
• "All testing performed were successfully completed and met the acceptance criteria" for "Retrospective Validation Tests."
• "All test protocol steps were successfully completed and expected results were achieved" for "Animal Testing."

While these statements confirm the device met its internal acceptance criteria, the specific numerical values of these criteria (e.g., "accuracy > X mm," "sensitivity > Y%") and the actual measured performance values are not disclosed in this 510(k) letter.

Inferred Performance Claims:

• The device maintains "identical magnetic location sensor and ACL location accuracy" as the predicate device (V8.0). However, the specific accuracy values are not stated for either version.

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

• Test Set Sample Size: Not explicitly stated.
  • For "Retrospective Validation Tests," it mentions "clinical recorded data from historic EP procedures." The number of procedures or specific data points is not provided.
  • For "Animal Testing," it indicates "animal testing was conducted," but the number of animals or specific test cases is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated. The company Biosense Webster has facilities in Irvine, CA, USA, and Yokneam, Israel. The data could originate from clinical sites globally.
  • Retrospective or Prospective:
    • "Retrospective Validation Tests" explicitly used "clinical recorded data from historic EP procedures." This indicates retrospective data.
    • "Animal Testing" would be considered prospective in the context of controlled experimental animal studies.

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

Not explicitly stated. The document does not describe the process of establishing ground truth for any of the V&V tests, nor the involvement or qualifications of experts for this purpose.

4. Adjudication method for the test set

Not explicitly stated. Given that expert involvement for ground truth is not detailed, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, an MRMC comparative effectiveness study was NOT done or reported. The document focuses on demonstrating substantial equivalence through technical V&V testing and software feature improvements, not on comparative effectiveness with human readers. The CARTO™ 3 System is a navigation system, not an AI for image interpretation that typically undergoes MRMC studies.

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

Yes, aspects of standalone performance were evaluated, though not explicitly labeled as such.

• "Proof of Design" and "Unit Tests" would inherently involve evaluating the device's (or its software components') performance against design specifications in a standalone manner, without direct human-in-the-loop interaction beyond setup and execution of the tests.
• The statement "identical magnetic location sensor and ACL location accuracy" implies a standalone assessment of the system's core navigational accuracy.

However, specific quantitative metrics for this standalone performance (e.g., location accuracy in mm, precision, etc.) are not provided.

7. The type of ground truth used

Not explicitly stated for specific tests.

Inferred types of ground truth based on the nature of the device and tests:

• Engineering Specifications/Reference Standards: For "Proof of Design," "Functional verification," and "Unit Tests," the ground truth would likely be defined by internal engineering design specifications, simulated environments, and established reference measurements. For accuracy testing of location, highly precise physical measurement systems or phantoms would be used as ground truth.
• Retrospective Clinical Data: For "Retrospective Validation Tests," ground truth would presumably come from existing clinical records of "historic EP procedures," although how this ground truth was established within those records (e.g., confirmed diagnoses, procedural outcomes, expert review) is not detailed.
• Direct Observation/Measurement in Animal Models: For "Animal Testing," ground truth would be based on direct measurements and observations within the animal during the simulated procedures.

8. The sample size for the training set

Not applicable/Not mentioned. The CARTO™ 3 System is described as a navigation system with improved software features (e.g., catheter support, legacy feature enhancements). It is not presented as an AI/ML model that undergoes a distinct "training set" development phase in the typical sense of deep learning models requiring large datasets for training. The changes appear to be more in line with traditional software development and feature integration.

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

Not applicable/Not mentioned (as it's not described as an AI/ML system with a training set).

Summary of Limitations of the Document for this Request:

The provided FDA 510(k) clearance letter serves its purpose of demonstrating substantial equivalence based on the provided V&V testing summary. However, it is not a detailed technical report or clinical study publication that would typically include the specific quantitative acceptance criteria, full performance metrics, detailed sample sizes, expert qualifications, or ground truth methodologies you are requesting for a comprehensive analysis of a device's proven performance. The document implies successful adherence to internal specifications without detailing those specifications or the resultant performance values.

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The NUVISION™ Ultrasound Catheter is indicated for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NUVISION™ NA V Utrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NUVISION™ Catheters are sterile, single use ultrasound catheters. They intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of patients. The catheters are intended for imaging guidance only, not treatment or therapy delivery, during cardiac interventional percutaneous procedures.

The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are sterile, single-use, disposable intracardiac echo (ICE) ultrasound imaging catheters. The distal end of the catheter has an ultrasound transducer with 2D acoustic element array on ASIC enabling real time 2D, 3D, and multiplane imaging. NUVISION Ultrasound Catheter is compatible with GE Vivid™ S70N and GE E95 Ultrasound System to enable 4D intra-cardiac imaging. While the NUVISION NAV Ultrasound Catheter's grid transducer combines the processing power of the GE Vivid™ S70N Ultrasound System to enable 4D intra-cardiac imaging and when coupled with a 3D location sensor enables location mapping in a compatible CARTO 3 System. The transducer array can be rotated independently of the deflection plane of the catheter shaft. The NUVISION NAV Ultrasound Catheter adds integration into the CARTO environment.

The provided text is a 510(k) Summary for the NUVISION™ Ultrasound Catheter and NUVISION™ NAV Ultrasound Catheter. This document is focused on demonstrating substantial equivalence to predicate devices, not on proving that the device meets specific performance criteria through a study with a test set, ground truth, experts, and statistical analysis as would be done for a software or AI/ML device.

Therefore, the requested information regarding acceptance criteria, device performance, sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set cannot be found in this document.

This document states:

• "Both catheters met all acceptance criteria in accordance with appropriate test criteria and standards." (Page 7, section 1.6 Performance Testing)
• "The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are substantially equivalent to its currently cleared predicate devices based on the successful completion of nonclinical bench testing, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use." (Page 7, section 1.7 Conclusion on Safety and Effectiveness)

These statements indicate that some internal testing (bench testing) was performed to ensure the device met its design specifications and regulatory standards for substantial equivalence, but it does not detail the type of clinical or performance study that would be associated with the questions asked, especially for an AI/ML device. The device is an ultrasound catheter, not explicitly stated as an AI/ML device from this document.

Therefore, I cannot populate the table or provide the requested details based on the given text.

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The SOUNDSTAR™ CRYSTAL Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO™ 3 EP Navigation Systems, the catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.

The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.

The provided text is a 510(k) premarket notification for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. It does not describe a study involving acceptance criteria and device performance in the context of AI/algorithm performance.

The document states: "The SOUNDSTAR™ CRYSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence." This indicates that the regulatory submission primarily relies on demonstrating equivalence to a previously cleared device through non-clinical testing, rather than presenting a study proving performance against specific acceptance criteria with human or AI assessment.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (especially a clinical or AI-centric one) is not included in this submission. The "Performance Testing" section lists various engineering and safety standards (e.g., ISO, ANSI/AAMI, IEC) that the device complies with, but these are not presented as acceptance criteria for performance in the way described in your prompt (e.g., sensitivity, specificity, or human reader improvement with AI).

If you have a different document that details a clinical study or AI algorithm performance, I would be happy to analyze that.

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The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTOTM 3 System provides information about the electrical activity of the heart and about catheter location the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.

The system has no special contraindications.

The CARTOTM 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTOTM 3 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTOTM 3 System V8.0 consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO™ 3 system V8.0 are the same as those found in the predicate device.

The provided document describes the CARTO™ 3 EP Navigation System Software V8.0 and its modifications. It details the various tests performed (software verification and validation, bench testing, animal testing, and clinical testing) to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate device. However, the document does not provide specific acceptance criteria or detailed study results in the format requested. It generally states that "All testing performed were successfully completed and met the acceptance criteria" and "All system features were found to perform according to specifications and met the tests acceptance criteria" without listing the metrics or the numerical outcomes.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Effect size of how much human readers improve with AI vs without AI assistance," and specific numerical results for performance, the information is not present in the provided text.

Based on the available text, here's a breakdown of what can be extracted:

Device: CARTO™ 3 EP Navigation System Software V8.0

No AI/ML Specific Performance Study (MRMC or Standalone) provided in the document for the new AI/ML features that show a quantitative acceptance criteria and the actual performance. The document broadly states that tests met acceptance criteria and performs as expected.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document broadly states that all tests successfully met acceptance criteria without providing specific performance metrics or numerical thresholds for acceptance. It is a general statement of compliance.

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

• Complex Signals Identification (CSI) module:
  • Data Provenance: Medical Centers in Europe and the United States of America.
  • Data Type: Control database created using input from multiple stable atrial typical and atypical flutter cases. Included data from different catheters, with complex signals, single activations, noisy signals, and so on.
  • Sample Size: Not specified.
  • Retrospective/Prospective: "Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTOTM 3 System." This applies to all new modules including CSI.
• CARTOSOUND™ FAM Module:
  • Data Provenance: Diverse locations and populations.
  • Data Type: Collected using a variety of ultrasound system settings, scanners, and Catheters.
  • Sample Size: Not specified.
  • Retrospective/Prospective: "Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTOTM 3 System." This applies to all new modules including CARTOSOUND™ FAM.
• Clinical Testing (REAL AF Registry Sub-Study):
  • Sample Size: The "REAL AF Registry population" is mentioned, but the specific number of patients is not provided.
  • Data Provenance: Not explicitly stated beyond "REAL AF Registry Sub-Study."
  • Retrospective/Prospective: Not explicitly stated, but "Registry Sub-Study" often implies a prospective or retrospective observational study on existing patient data.

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

• For the Complex Signals Identification (CSI) module, it states that "a control database was created using input from multiple stable atrial typical and atypical flutter cases." It does not specify the number or qualifications of "experts" if involvement extends beyond clinical data collection.
• For the CARTOSOUND™ FAM Module, no information provided about experts involved in ground truth establishment for the test set.
• For the Clinical Testing (REAL AF Registry Sub-Study), the ground truth is clinical outcomes and safety endpoints, which are typically established by clinical professionals as part of the study protocol, but specific numbers or qualifications of adjudicators are not provided.

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

• No specific adjudication method for establishing ground truth is described for any of the modules or studies.

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) comparative effectiveness study to evaluate human reader improvement with AI assistance. The AI/ML algorithms are described as components of the system to aid specific tasks (e.g., automatically tagging fractionated IC ECG signals, reconstructing 3D volumes) rather than an AI-assisted interpretation by human readers.

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

• The document indicates that the "Complex Signals Identification (CSI) module is a machine learning locked algorithm that automatically tags fractionated IC ECG signals." Similarly, "The CARTOSOUND™ FAM Module incorporates a Deep Learning (DL) algorithm" for automatic reconstruction and segmentation.
• "Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures" for newly introduced modules. This suggests standalone performance evaluation on historic data, but specific performance metrics (e.g., accuracy, sensitivity, specificity) for these algorithms are not provided in the document. The document only states that "All testing performed were successfully completed and met the acceptance criteria."

7. The type of ground truth used:

• Complex Signals Identification (CSI) module: "Control database created using input from multiple stable atrial typical and atypical flutter cases." This implies clinical ground truth based on real patient data.
• CARTOSOUND™ FAM Module: Training and validation data collected from diverse clinical settings with ultrasound systems. Ground truth for 3D segmentation would likely be based on expert manual segmentation or a consensus method, though not explicitly stated.
• Clinical Testing (REAL AF Registry Sub-Study): Clinical outcomes (safety and acute effectiveness endpoints) based on patient data.

8. The sample size for the training set:

• Complex Signals Identification (CSI) module: Not specified.
• CARTOSOUND™ FAM Module: Not specified, only mentioned that "Data for training and validation of the DL algorithm was collected from diverse locations and populations."

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

• Complex Signals Identification (CSI) module: "a control database was created using input from multiple stable atrial typical and atypical flutter cases." This suggests the ground truth was derived from the characteristics of these cases, likely based on established clinical criteria or expert review of the EP data. The exact method (e.g., expert consensus, independent review) is not detailed.
• CARTOSOUND™ FAM Module: Not specified. For 3D segmentation, ground truth is typically established by manual annotation by trained professionals or a consensus of multiple annotators, but this is not confirmed in the document.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through various V&V activities and broad statements of meeting acceptance criteria. It introduces new AI/ML components but does not delve into detailed quantitative performance metrics for these AI components or comparative studies with human readers.

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PENTARAY® NAV ECO High Density Mapping Catheter:
The PENTARAY® NAV ECO High Density Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV ECO High Density Mapping Catheter provides location information when used with compatible CARTO®3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to version 3.x).

DECANAV® Mapping Catheter:
The DECANAV® Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the coronary sinus. In addition, the catheter is used with compatible CARTO® 3 System to provide catheter tip location information.

Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology and Auto ID:
The Webster® CS Catheter is indicated for electrophysiological mapping of cardiac structures i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

PENTARAY® NAV eco High Density Mapping Catheter:
The PENTARAY® NAV eco High Density Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.

DECANAV® Mapping Catheter:
The DECANAV® Catheter has been designed to be used with the CARTO® 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals.

The DECANAV® Catheter has a single proximal electrode that can be used for unipolar recording signals. The DECANAV® Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.

The DECANAV® Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.

Webster® CS Catheter with Auto ID:
The Webster® Coronary Sinus Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 6 FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a deflectable tip selection containing an array of platinum electrodes that can be used for stimulation and recording.

Standard features of this catheter include a braided 6 FR deflectable tip section with an array of platinum electrodes that includes a 2 mm tip dome. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in a various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate position of the catheter tip at the desired site.

The catheter is equipped with Electronically Erasable Programmable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.

The catheter interfaces with CARTO® EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors.

Webster® CS Catheter with EZ Steer Technology:
The Webster® CS Catheters with EZ Steer Bi-directional Technology (D-1263-04-S and D-1263-05-S) are diagnostic. 7F, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:

• D-1221-21
• D-1221-26
• D-1221-25

Webster® CS Catheter with EZ Steer Technology and Auto ID:
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06-S and D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06-S & D-1263-07-S) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO 3 EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information. The catheters interface with CARTO 3 EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

Here's a breakdown of the acceptance criteria and study findings based on the provided text.

The provided text describes modifications to existing electrophysiology mapping catheters, primarily concerning a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation.

The submission does not describe an AI/ML-driven device or study. Instead, it focuses on demonstrating the substantial equivalence of modified catheters to their predicate devices, with the main change being the allowed use of direct imaging guidance. Therefore, many of the requested categories related to AI/ML performance, such as test set size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (modifications to existing medical devices to allow for direct imaging guidance during use), the "acceptance criteria" are based on demonstrating that these modifications do not adversely affect the safety and effectiveness of the devices, and that they remain substantially equivalent to their predicates. The primary evidence presented is a clinical study focused on the safety and effectiveness of the updated workflow (zero/low fluoroscopy) rather than the inherent performance of an AI component.

As this submission is for modifications to existing non-AI/ML devices, the following inquiries are largely not applicable:

2. Sample size used for the test set and the data provenance: The document mentions a "Real-World Evidence study (REAL AF Registry Sub-Study)" but does not specify a distinct "test set" in the context of algorithm evaluation. It describes a clinical study population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical study evaluated procedural outcomes and safety, not an algorithm's performance against expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" equivalent would be the clinical outcomes and safety endpoints observed in the "Real-World Evidence study (REAL AF Registry Sub-Study)."
8. The sample size for the training set: Not applicable, as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML algorithm.

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The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with compatible CARTO® EP Navigation Systems.

The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy.
The steerable sheath is fitted with a hemostatis valve to minimize blood loss during catheter introduction and/or exchange. A sideport
with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the
tip clockwise ≥ 180° and counterclockwise ≥ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize
cavitation and a radiopaque tip marker to allow fluoroscopic visualization. The steerable sheath is coated with silicone lubricant on the
entire shaft and dilator surface to help minimize friction at the insertion site.

The sheath has electrodes on the outer surface to allow interface with compatible CARTO® 3 EP Navigation Systems.

Based on the provided text, the device in question is a CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath. It is a catheter introducer. The submission is not for a new AI/ML device but rather a modification to the Instructions For Use (IFU) of an existing device to allow for additional imaging guidance and to update labeling based on FDA guidance. Therefore, the detailed questions about AI model acceptance criteria, ground truth, training and test sets, and multi-reader studies are not applicable to this submission.

Here's a breakdown of why this is the case based on the provided document:

• Device Type: This is a physical medical device (catheter introducer), not a software or AI/ML diagnostic tool.
• Purpose of Submission: The 510(k) summary explicitly states: "The sole purpose of this submission is to revise the instructions for use (IFU) to (1) allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation, and (2) to adhere to FDA Guidance 'Intravascular Catheters, Wire, and Delivery Systems with Lubricious Coatings -Labeling Considerations' (October 2019)."
• Technological Comparison: "The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is identical in technological characteristics with the predicate device, as there are no changes in the materials, design, or other from those of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath cleared under K170997."
• Clinical Study Data (Mentioned): The text mentions: "The safety and performance of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath with the additional workflow has been validated through clinical study data." And "The clinical study data demonstrated that the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is as safe and effective as the predicate device." However, no details about this "clinical study data" (e.g., sample size, design, endpoints) are provided in the excerpt. This study would not be for an AI model.

Therefore, it is impossible to answer the specific questions about AI/ML acceptance criteria, test sets, ground truth establishment, or MRMC studies because the submission is not for an AI/powered device. The acceptance criteria for this type of submission would relate to demonstrating that the change in IFU does not negatively impact the safety or effectiveness of the physical device, likely through non-clinical (bench) testing and review of existing clinical data, rather than AI model performance metrics.

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The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or simulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology has been designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. The OPTRELL™ Mapping Catheter with TRUEref™ Technology is deployed in the heart through an 8.5 F guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has six (6) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 6 (6x6) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo clinical effectiveness against a set of performance metrics as one might see for a completely novel device or an AI/ML product where clinical performance (e.g., accuracy, sensitivity, specificity) is a key outcome. This 510(k) is for a physical medical device (mapping catheter). Therefore, the "acceptance criteria" and "study" described herein are primarily related to bench and animal testing to show that the modified device performs similarly to its predicate and doesn't raise new safety or effectiveness concerns.

Given the nature of the device and the submission type, there is no mention of AI/ML or human reader studies (MRMC). The "metrics" are mechanical, electrical, and physiological performance in a simulated environment or animal model, not diagnostic accuracy based on human interpretation.

Acceptance Criteria and Device Performance

Study Details (Bench and Animal Testing)

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated numerically. The document states "Testing included mechanical integrity, deflection, device functionality, simulated use, electrical properties, visualization, shelf life, device maneuverability and signal quality, and animal testing". This implies a series of tests, each likely with its own sample size of devices or animal subjects, sufficient to meet engineering and GLP (Good Laboratory Practice) standards.
   • Data Provenance: The studies were conducted by Biosense Webster, Inc. (the manufacturer). The animal testing would be prospective. Location of testing is not specified beyond the manufacturer's address in Irvine, California, and a manufacturing site in Juarez, Mexico.

2. Number of Experts and Qualifications for Ground Truth:

   • This type of submission for a physical device, especially for bench and animal testing, typically relies on objective measurements, engineering specifications, and established biological responses in animal models. There's no indication of human "experts" establishing a subjective "ground truth" for classification or diagnosis as there would be for an AI diagnostic device. The "ground truth" for mechanical and electrical properties is typically defined by the device's design specifications and accepted industry standards, while for animal studies, it would be physiological responses evaluated by qualified veterinarians/scientists.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of bench and animal testing metrics. The results would be objectively measured and compared against defined thresholds or the predicate device's performance.

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

   • No, an MRMC study was not done. This device is a mapping catheter, not an AI/ML diagnostic tool that assists human readers in interpretation. The study evaluates the physical and electrical performance of the catheter itself.

5. Standalone Performance Study (Algorithm Only):

   • Not applicable. This device does not contain a standalone algorithm. Its function is to obtain electrograms, which are then used by the CARTO™ 3 System. The "performance" described is of the catheter's ability to achieve its physical and electrical functions, not an algorithm's diagnostic performance.

6. Type of Ground Truth Used:

   • Engineering Specifications/Bench Standards: For mechanical integrity, deflection, electrical properties, etc., the ground truth would be defined by pre-determined engineering specifications, design requirements, and established industry standards.
   • Physiological/Biological Outcomes (in Animal Model): For animal testing, the ground truth relates to the physiological responses within the animal model, observed and measured by qualified personnel, demonstrating the device's intended function (obtaining electrograms) and safety (e.g., lack of adverse tissue reactions).
   • Predicate Device Performance: A key aspect of this 510(k) is demonstrating that the modified device performs "as well as or better than" the predicate device in these tests, making the predicate's established performance a de facto "ground truth" for comparison.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set" in the computational sense. The design and development of the device would rely on engineering principles, material science, and prior knowledge from the predicate device, not machine learning training data.

8. How Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set for a machine learning model, this question does not apply.

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The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances.

I am sorry, but the provided text does not contain the specific information required to answer your request. The document describes a medical device (NUVISION™ NAV Ultrasound Catheter) and its substantial equivalence to predicate devices for FDA clearance. However, it does not include details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML development and validation.

The document primarily focuses on:

• Indications for Use
• Device Description
• Comparison to predicate devices (physical characteristics, intended use, technical specifications)
• General performance testing categories (bench, biocompatibility, animal testing)

Therefore, I cannot generate the requested table and information as it is not present in the provided text.

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The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

CARTO® The 3 EP Navigation System with CARTOSOUND™ 4D, software V7.4, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO® 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System with CARTOSOUND™ 4D consists of the following hardware components:

• . Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• . Wide-Screen monitors, keyboard, and mouse
• . Intracardiac In Port
• Intracardiac Out Port ●
• . Power Supply
• Patches Connection Box and Cables (PU)
• Pedals ●
• Location Pad (LP) ●
• Signal Processing Unit (SPU) ●

All hardware components of the CARTO® 3 system with CARTOSOUND™ 4D are the same to those found in the predicate device.

The provided document focuses on the 510(k) summary for the CARTO® 3 EP Navigation System with CARTOSOUND™ 4D version 7.4. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria with performance values, sample sizes for test and training sets, expert qualifications, or multi-reader, multi-case (MRMC) comparative effectiveness studies.

The document primarily describes functional and performance verification rather than a study validating a specific AI algorithm's diagnostic performance against ground truth (as would be typical for an AI/ML medical device). The "CARTOSOUND™ 4D" module appears to be a feature that combines and processes ultrasound and mapping data, not a standalone diagnostic AI algorithm.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria and corresponding numerical performance results for the device's diagnostic accuracy or AI performance. Instead, it states that:

Important Note: The document describes engineering and system verification tests, not a clinical study involving diagnostic AI performance metrics like sensitivity, specificity, or AUC, which would typically have specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not specified. The document mentions "Bench testing," "Animal Testing," and "Summative Usability testing" but does not give specific numbers of cases, patients, or animals used in these tests.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. Animal testing is mentioned, which is by nature prospective for the animal portion.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It is implied that qualified personnel conducted and assessed the engineering and animal tests, but no details are given. This device processes and displays information for a human user (physician) to interpret; it does not itself make a diagnostic decision that requires establishing a "ground truth" through expert consensus in the typical AI sense.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Given the nature of the described tests (functional, image quality, animal functionality, usability), there's no mention of a traditional expert adjudication process for establishing ground truth for diagnostic accuracy, as the device's primary function is data acquisition and display, rather than automated diagnosis.

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

• MRMC Study: No. The document does not describe any MRMC study comparing human readers with and without AI assistance. The device is a navigation system that provides information, not an assistive AI diagnostic tool for image interpretation.
• Effect Size of Human Reader Improvement: Not applicable, as no such study was performed or described.

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

• The document implies that the "performance data" refers to the device's functional performance in acquiring and processing data to specification. It does not describe a standalone study of an AI algorithm making diagnostic interpretations without human intervention. The device is a "Navigation System" that "provides information" to the user, not an autonomous diagnostic AI.

7. Type of Ground Truth Used

• Type of Ground Truth: The concept of "ground truth" in the traditional sense of a diagnostic outcome (e.g., pathology, clinical outcome, expert consensus on a diagnosis) is not explicitly discussed for the device's performance validation. The "truth" in this context refers to whether the system functions according to its engineering specifications and accurately displays the acquired data. For instance:
  • Bench Testing: Verification against internal system specifications and accurate data display.
  • Animal Testing: Verification of functionality in a simulated physiological environment.
  • Usability Testing: Assessment of the user interface's safety and effectiveness.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a medical device upgrade, not a de novo AI model that requires a distinct "training set" in the machine learning sense. The software updates described are improvements to an existing system, including a new module (CARTOSOUND™ 4D) and various other enhancements, for which "training data" is not a relevant concept as it would be for a deep learning model.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Was Established: Not applicable. As there's no mention of an AI model with a training phase, the concept of establishing ground truth for a training set does not apply.

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The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO® 3 EP Navigation System with AFM, software V7.3, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheters location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO® 3 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System with AFM consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO® 3 system with AFM are identical to those described for the predicate device.

The provided text describes a 510(k) premarket notification for the CARTO® 3 EP Navigation System with Advanced Focus Mapping (AFM). While the document outlines performance testing, it does not provide detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the format requested.

The document discusses:

• Bench Testing:
  • Proof of Design – "CARTO® 3 System AFM algorithms were verified to meet specifications." "All testing performed met the acceptance criteria."
  • Functional verification – "All system features were found to perform according to specifications and met the tests acceptance criteria."
  • Unit Test – "performed to verify isolated software components that were modified."
• Animal Testing: "conducted to evaluate the CARTO® 3 System with AFM functionality under simulated clinical workflow and conditions." "All test protocol steps were successfully completed and expected results were achieved."

However, the specific quantitative acceptance criteria (e.g., "accuracy must be > 95%") and the detailed results against these criteria are not disclosed in this regulatory summary. Similarly, the study design elements like sample size, data provenance, expert qualifications, or detailed ground truth establishment methods for these specific validation tests are not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on identical intended use, fundamental scientific technology, hardware platform, and core mapping technology, with software modifications undergoing verification and validation.

Therefore, based on the provided text, I cannot fill out the requested table or answer most of the detailed questions regarding acceptance criteria and study specifics. The document confirms that testing was done and acceptance criteria were met, but it does not describe those criteria or the exact study details.

Limitations based on the provided text:

• Acceptance Criteria Table: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided in the text. It only states that "All testing performed met the acceptance criteria" and "All system features were found to perform according to specifications and met the tests acceptance criteria."
• Sample Size and Data Provenance: Not specified for the bench or animal testing. The animal testing implies prospective data collection in a controlled setting.
• Number/Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned. The focus is on a "human-in-the-loop" system, but a comparative effectiveness study with/without AI assistance is not described.
• Standalone Performance: Not explicitly detailed as a separate study. Performance is likely intertwined with the system's overall function during bench and animal testing.
• Type of Ground Truth: For the bench testing, ground truth would be the known, expected outputs based on specifications. For animal testing, it would be the direct physiological measurements and observations during the procedures. No mention of expert consensus, pathology, or outcomes data for validation.
• Training Set Sample Size/Ground Truth Establishment: No information about a training set for machine learning models is provided. The new features appear to be software-driven calculations and displays (CLM, PDM, Ripple Frequency, PASO™ Module Improvement) rather than AI models requiring extensive training data and ground truth labeling in the traditional sense of deep learning. The testing described is verification and validation of these new features and regression testing for existing ones.

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