Search Results

ViewFlex™ Xtra ICE Catheter
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart.

ViewFlex™ Eco Reprocessed ICE Catheter
The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode 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.

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode 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.

Agilis™ NxT Steerable Introducer
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Agilis™ NxT Steerable Introducer Dual-Reach™
The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This FDA 510(k) clearance letter (K251211) and its accompanying 510(k) summary pertain to a change in workflow for several existing cardiovascular catheters, specifically allowing for a "Zero/Low Fluoroscopy Workflow."

The key phrase here is "Special 510(k) – Zero/Low Fluoroscopy Workflow". This type of submission is for modifications to a previously cleared device that do not significantly alter its fundamental technology or intended use, but rather introduce a change in how it's used or processed.

Crucially, this submission does NOT describe a new AI/software device that requires extensive performance testing against acceptance criteria in the manner you've outlined for AI/ML devices. Instead, it's about demonstrating that existing devices, when used with a new, less-fluoroscopy-dependent workflow, remain as safe and effective as before.

Therefore, many of the questions you've asked regarding acceptance criteria, study details, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) document. The document explicitly states:

• "Bench-testing was not necessary to validate the Clinical Workflow modifications."
• "Substantial Equivalence of the subject devices to the predicate devices using the zero/low fluoroscopy workflow has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods."

This indicates that the "study" proving the device (or rather, the new workflow) meets acceptance criteria is a summary of existing clinical data where alternative visualization methods were already employed, rather than a prospective, controlled study of a new AI algorithm.

Based on the provided document, here's what can be answered:

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

• Acceptance Criteria: The implicit acceptance criterion is that the devices, when used with "zero/low fluoroscopy workflow," maintain substantial equivalence to their predicate devices in terms of safety and effectiveness. This means they must continue to perform as intended for visualizing cardiac structures, blood flow, mapping, or introducing catheters.
• Reported Device Performance: The document states that "Substantial Equivalence... has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods." This implies that the performance (e.g., adequate visualization, successful mapping, successful catheter introduction) was maintained. Specific quantitative metrics of performance (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for a diagnostic AI) are not provided or applicable here as this is not an AI/ML diagnostic clearance.

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

• Sample Size: Not specified. The document refers to "a summary of clinical data across multiple studies." This suggests an aggregation of results from existing (likely retrospective) patient data where alternative visualization techniques (allowing for "zero/low fluoroscopy") were already utilized clinically. It's not a new, single, prospectively designed test set for an AI algorithm.
• Data Provenance: Not specified regarding country of origin or specific patient demographics. It is implied to be clinical data collected from studies where these types of procedures were performed using alternative visualization. The data would be retrospective as it's a "summary of clinical data" that already exists.

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

• Not applicable in the context of this 510(k). Ground truth in an AI/ML context typically refers to adjudicated labels for images or signals. Here, the "ground truth" is inferred from standard clinical practice and outcomes in the historical data summarized. There's no mention of a specific expert panel for new ground truth establishment for a diagnostic AI.

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

• Not applicable. This is not a study requiring adjudication of diagnostic outputs by multiple readers.

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. This is not an AI-assisted diagnostic device. The workflow change is about using alternative non-fluoroscopic imaging modalities (e.g., intracardiac echocardiography, electro-anatomical mapping systems), not about AI improving human reader performance.

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

• No. This is not an AI algorithm. The predicate devices are physical catheters.

7. The type of ground truth used:

• The "ground truth" is inferred from clinical outcomes and established clinical practice using the devices with alternative visualization methods in real-world scenarios. It's not a specific, adjudicated dataset for an AI algorithm. The performance of the devices (such as successful navigation, visualization, and mapping) under the "zero/low fluoroscopy" workflow is assumed to be equivalent to their performance under full fluoroscopy, as demonstrated by prior clinical use where such methods were employed.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. No training set for an AI model.

In summary:

This 510(k) is for a workflow modification for existing medical devices (catheters), not for an AI/ML diagnostic or assistive software. Therefore, the detailed data performance evaluation typically required for AI models against specific acceptance criteria (as requested in your template) is not presented or relevant in this clearance letter. The "proof" relies on the concept of substantial equivalence to previously cleared predicate devices, supported by a summary of existing clinical data that used alternative visualization methods, implying that the devices function safely and effectively even with reduced fluoroscopy.

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The ViewFlex™ X ICE Catheter Sensor Enabled™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.

The ViewFlex™ X ICE Catheter Sensor Enabled™ (SE) is a sterile, single use, temporary, radiopaque, intracardiac ultrasound catheter. The catheter shaft is a 9 French (F) catheter constructed with flexible tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64‑element linear phased array transducer. The distal portion of the shaft is deflectable utilizing two handle mechanisms which create four deflection directions including left, right, anterior and posterior. The distal tip contains an ultrasound transducer and 3-D location sensor providing 2-D imaging and 3-D location and orientation information when used with a compatible ultrasound system and the EnSite X Cardiac Mapping System.

This document is a 510(k) clearance letter for the ViewFlex™ X ICE Catheter, Sensor Enabled™. The provided text does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, especially in the context of an AI/ML-enabled device as implied by the prompt's request for information about human readers, AI assistance, ground truth, and training sets.

The device described is an intracardiac ultrasound catheter that provides 2-D imaging and 3-D location/orientation information. The mention of "Sensor Enabled™" and "3-D location sensor" suggests a technological upgrade, but there is no indication that this involves the use of artificial intelligence or machine learning for diagnostic interpretation.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are all relevant to the evaluation of AI/ML-enabled medical devices, which is not what this 510(k) summary describes.

In summary, the provided document explains the ViewFlex™ X ICE Catheter, Sensor Enabled™ as a traditional medical device (an intravascular ultrasound catheter) with an added 3-D location sensor for mapping systems. It details the substantial equivalence to a predicate device based on non-clinical testing (bench design verification, biocompatibility, mechanical integrity, etc.). It does not mention any AI or ML components, nor does it describe studies with human readers, AI assistance, or data sets for machine learning model evaluation.

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The VeriSight/VeriSight Pro ICE catheter is 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 adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.
The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.
The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

Based on the provided FDA 510(k) clearance letter for the Philips VeriSight Intracardiac Echocardiography Catheters, the device is not an AI/ML-based device. The submission focuses on adding pediatric indications to an existing, cleared device, and thus, the information requested about acceptance criteria and a study proving an AI device meets those criteria is not applicable to this specific submission.

The document explicitly states:

• "The purpose of this submission is solely to add pediatric indications to the currently cleared VeriSight/VeriSight Pro ICE catheters (cleared under K200812)." (Page 6)
• "No additional non-clinical performance testing was executed for this change." (Page 6)
• "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 6)

Therefore, the document does not contain details regarding acceptance criteria, performance data, test sets, ground truth establishment, or any other aspects related to the validation of an AI/ML device. The clearance is based on the substantial equivalence to a predicate device for the expanded indications, rather than a new technological performance validation.

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

VERAFEYE Imaging System: The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies. The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen. The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.

This appears to be a 510(k) Pre-market Notification document for the VERAFEYE System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence, rather than detailing a study used to prove the device meets specific acceptance criteria in the context of an AI/ML study.

Therefore, the requested information points (1-9) which are typically associated with performance evaluations of AI/ML devices, are not directly addressed in this document. The document focuses on regulatory comparison and safety/effectiveness based on non-clinical data and equivalence to existing devices.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document doesn't provide a table of acceptance criteria for AI performance or reported device performance in that context. It focuses on functional and technological comparisons with predicate devices.
• Sample Size and Data Provenance (Test Set): Not applicable as this is not an AI/ML performance study.
• Number of Experts and Qualifications (Ground Truth): Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data."
• Standalone Performance Study (Algorithm Only): Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily makes a case for substantial equivalence based on technical characteristics, intended use, and non-clinical performance data, rather than reporting on an AI/ML specific performance study. It lists various safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1) that the device was tested against to demonstrate safety and effectiveness for regulatory clearance.

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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 Provisio™ SLT IVUS™ System is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature.

The Provisio™ SLT IVUS™ System is designed for use as an adjunct to conventional angiographic procedures to evaluate the vessel lumen and provide dimensional measurements.

The SLT IVUS™ Support Crossing Catheter also guides and supports a guidewire during access of the vasculature and provides a conduit for the delivery of saline solutions or radiopaque contrast agents.

The Provisio™ Sonic Lumen Tomography Intravascular Ultrasound ("SLT IVUS™") System is an IVUS system that utilizes A-mode ultrasound operation to evaluate the vessel lumen and provide dimensional measurements in real time. The Provisio™ SLT IVUS™ System comprises the SLT IVUS™ Support Crossing Catheter and the SLT IVUS™ P1 System, which includes the Pulser Receiver Unit, the Display Unit, and a Cart.

The SLT IVUS™ Support Crossing Catheters, provided sterile for single use, are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end. The information from the echoes is used to generate real-time dimensions and representations of the peripheral vessel's flow lumen. If required clinically, the SLT IVUS™ Support Crossing Catheter also functions as a support crossing catheter and may be used for the infusion of saline or radiopaque contrast agents.

The Provisio™ SLT IVUS™ System may be used in peripheral vascular procedures to generate real-time measurements of the vessel flow lumen dimensions, while also providing the functionality of the support crossing catheter in the same procedure. The cross-sectional parameters of diameter and area are displayed as numbers; additionally, the diameter measurement is graphically displayed as a representation of the flow lumen. The cross-sectional area measurements are displayed over time on a timeline display. As the catheter is moved by the operator through the vessel lumen, new crosssectional measurements are obtained and displayed. Adjacent cross-sectional measurements can be compiled and displayed over a period of time to create an orthogonal graphical display of the vessel lumen (called RunView™).

Here's a breakdown of the acceptance criteria and the study information for the Provisio™ SLT IVUS™ System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document provides a general statement about meeting performance specifications and specific non-clinical tests, but it does not contain a table explicitly defining numerical acceptance criteria (e.g., "Accuracy must be >X%"). Instead, it describes comparative testing against a predicate device and states that the device meets "all performance specifications necessary to achieve its intended use."

However, based on the non-clinical testing summary, we can infer some of the performance aspects that were evaluated and determined to be acceptable:

Study Information

The document focuses on non-clinical testing rather than a large-scale clinical trial.

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

   • Agar Phantoms: The sample size for the agar phantom study is not explicitly stated. The provenance is likely a laboratory setting, as phantoms are simulated environments.
   • Human Cadaver Study: The sample size (number of cadavers or vessels) is not explicitly stated. The data provenance is human cadaveric peripheral vessels. This is considered a retrospective use of biological material.
   • GLP Animal Study: The sample size (number of animals) is not explicitly stated. The provenance is an animal model, likely for pre-clinical evaluation.

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

   • This information is not provided in the document. For the agar phantom study, ground truth would typically be established by precise physical measurements. For the cadaver study and animal study, it would likely involve established metrology techniques or histological analysis, but the specific experts and their qualifications are not detailed.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the studies (benchtop, cadaver, animal), formal adjudication by multiple experts (like 2+1, 3+1) is less common than in clinical image interpretation studies. Ground truth would likely be established through direct measurement or pathological assessment.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers improving with AI assistance was not mentioned or conducted. The device is an IVUS system that provides measurements and visual representations, but the document does not describe an AI interpretation component where human readers would interpret images with AI assistance and without AI assistance.

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

   • The document implies standalone performance testing for the measurement accuracy of the device's algorithms in the agar phantom and cadaver studies. The SLT IVUS System "analyzes ultrasound signal reflections (echoes) from the vessel wall to yield vascular morphology information" and displays "cross-sectional parameters of diameter and area." These are algorithmic outputs that would have been evaluated directly. The human factors study evaluates the usability of the system by human users, not their diagnostic performance with the system's output.

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

   • Agar Phantoms: Likely precise physical measurements based on known phantom dimensions.
   • Human Cadaver Study: Likely high-precision measurements (e.g., calipers, micro-CT, or histological assessment) of the actual vessel dimensions.
   • GLP Animal Study: Likely histological analysis and pathology reports to assess vascular damage and tissue reaction.

7. The sample size for the training set:

   • The document does not specify a training set size. This type of device, based on A-mode ultrasound, may rely more on physics-based algorithms and signal processing rather than extensive machine learning models that require large training datasets in the conventional sense. If machine learning was used for measurement extraction or image enhancement, the training data details are not provided.

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

   • Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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The catheter is intended 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 AcuNav 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 provided text is a 510(k) summary for the AcuNav Crystal Ultrasound Catheter. It outlines the device's characteristics and its substantial equivalence to a previously cleared predicate device. However, it explicitly states that clinical data was not required to establish substantial equivalence because the new device uses the same intended use, technology, and principles as the predicate device.

Therefore, the document does not contain information regarding a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (e.g., sensitivity, specificity). It only lists non-clinical tests related to safety and manufacturing standards.

Consequently, I cannot provide the requested information about acceptance criteria for device performance, given that no such performance study was conducted or presented in this 510(k) summary.

Here's what can be inferred from the document regarding non-clinical acceptance criteria:

• Acceptance Criteria for Non-Clinical Performance (Implicit): The device is expected to conform to various safety and manufacturing standards. The "acceptance criteria" for these would be successful adherence to the requirements of the listed standards.

• Study Proving Device Meets Acceptance Criteria (Non-Clinical): The document states: "The device has been evaluated for acoustic output, biocompatibility, sterilization, packaging, shelf life as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards." This is the "study" proving it meets these non-clinical acceptance criteria.

Specifically, the document does NOT contain the following information that would be relevant to a clinical performance study:

• A table of acceptance criteria and reported device clinical performance (e.g., diagnostic accuracy metrics).
• Sample size used for a test set (clinical).
• Data provenance (e.g., country of origin of clinical data, retrospective or prospective).
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set (as no AI algorithm requiring a training set is mentioned for performance).
• How the ground truth for the training set was established.

In summary, based on the provided text, no clinical performance study was conducted or described because the device demonstrated substantial equivalence through technological comparison and adherence to non-clinical safety standards.

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This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The OptiCross HD and OptiCross 6 HD 60 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.

All catheters consist of two main assemblies:

1. Imaging Core
2. Catheter Body

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 60 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUS™) Instrument. The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection.

The catheter body is comprised of three sections:

1. Distal Imaging Window Lumen
2. Proximal Shaft Lumen
3. Telescope Section

The distal imaging window lumen and proximal shaft lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the quiding catheter.

The catheter body has a distal imaging window lumen with proximal exit at 1.6 cm from the distal end. A radiopaque (RQ) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, two insertion depth markers are located on the proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in estimating catheter position relative to the distal quide catheter tip. The proximal shaft lumen is attached to the telescoping section via a strain relief connection.

The telescoping shaft (section) allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the quidewire exit port to the proximal end of the distal imaging window lumen. The telescope section has proximal markers for lesion length assessment, consisting of a series of marks spaced 1 cm apart on the telescope body.

A flush port with a one-way check valve is used to flush the interior of the catheter body and maintain a flushed condition. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way check valve helps retain saline in the catheter during use.

The Coronary Imaging Catheter, 17.78 cm (7 in) extension tube, 3 cm³ (3 cc) and 10 cm³ (10 cc) syringes, and 4-way stopcock are provided in a single use sterilized package. The MDU5 PLUS Sterile Bag is provided in a separate sterile pouch within the finished carton along with the catheter package.

The provided document is an FDA 510(k) clearance letter and summary for the OptiCross™ HD Coronary Imaging Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a new AI/imaging algorithm.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Here's why and what the document does say:

• Substantial Equivalence: The core purpose of this 510(k) submission is to show that the new OptiCross™ HD catheter is substantially equivalent to a previously cleared predicate device (OptiCross HD and OptiCross 6 HD Coronary Imaging Catheter K213593). This means the FDA determined it's as safe and effective as the predicate.
• Device Changes: The "modified device includes a protective packaging component. There are no other design changes with this 510(k)." This is a very minor change, which is why extensive new clinical studies or detailed performance metrics are not required.
• Non-Clinical Performance Data: "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data." This bench testing evaluated "imaging quality robustness and packaging integrity." No specific performance metrics or acceptance criteria for imaging quality are provided beyond this general statement.
• Clinical Testing: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters." This explicitly states that clinical studies (which would typically involve human readers, ground truth, etc.) were not done for this submission.

In summary, the provided document does not contain the information to answer your specific questions because it's a 510(k) clearance based on substantial equivalence for a minor device modification, not a study introducing and validating a new imaging algorithm against specific performance metrics involving human interpretation or AI.

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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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