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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 Reprocessed 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.

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

This document is a 510(k) Premarket Notification from the FDA for a reprocessed medical device, specifically a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It details the device, its indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the functional and safety testing was conducted "to demonstrate performance (safety and effectiveness)" and the conclusion is that the device is "substantially equivalent," implying that all these tests met their respective acceptance criteria. Specific quantitative acceptance criteria (e.g., "electrical continuity must be X ohms") are not detailed in this summary.

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

The document does not provide specific sample sizes for the functional and safety testing mentioned.
Therefore, the sample size for the test set is not specified.
The data provenance is from bench and laboratory testing conducted by Innovative Health, LLC. The country of origin of the data is implicitly the United States, as Innovative Health, LLC. is based in Scottsdale, Arizona, and is interacting with the U.S. FDA. The testing conducted is likely prospective in nature, as it was performed to support the 510(k) submission for the reprocessed device.

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

This document does not describe the establishment of a "ground truth" in the sense of expert consensus on diagnostic imaging or clinical findings, as it pertains to a physical medical device (a catheter) and its reprocessing. The "testing" involved demonstrating physical, electrical, and sterilization performance. Therefore, this section is not applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

This section is not applicable as the tests performed are objective measurements (e.g., electrical continuity, dimensional verification) or validations (e.g., sterilization, cleaning), not subjective assessments requiring expert adjudication.

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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is established by:

• Engineering specifications and standards: These define acceptable dimensional tolerances, electrical properties, and mechanical characteristics for a functional catheter.
• Biocompatibility standards: Defines acceptable levels of biological response to materials.
• Sterilization and cleaning validation protocols: These define validated processes to ensure sterility and cleanliness, often with established microbial reduction or residue limits.
• Predicate device performance: The reprocessed device is compared to the performance characteristics of the original cleared device and other predicate reprocessed devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device. The device is a physical product, not an algorithm that requires training data.

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

This section is not applicable for the same reasons as point 8.

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The Reprocessed 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.

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated, steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

The provided text describes the 510(k) premarket notification for a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It is important to note that this document is for a reprocessed medical device, meaning it is a device that has been previously used, cleaned, sterilized, and prepared for re-use. The testing conducted primarily focuses on ensuring the reprocessed device performs comparably to the original new device and meets safety standards, rather than testing new clinical efficacy.

Based on the provided information, I can extract the following details regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various functional and safety tests performed but does not explicitly state quantitative acceptance criteria or detailed numerical performance results for most of them. It generally states that testing was conducted "to demonstrate performance (safety and effectiveness)".

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

The document does not specify the sample sizes used for any of the functional and safety tests.

Regarding data provenance:

• The tests are described as "Bench and laboratory testing".
• The data is retrospective in the sense that it relies on demonstrating equivalence to an already marketed device (the predicate device). It's not a prospective clinical trial generating new outcome data directly on patients.
• The location of the testing is not explicitly stated, but it would have been conducted by Innovative Health, LLC, which is based in Scottsdale, Arizona, USA.

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

This information is not provided in the document. For a reprocessed device and the types of engineering and safety tests described, ground truth would typically be established by internal engineering specifications, regulatory standards, and comparison to the original device's performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes bench and laboratory testing to ensure the safety and effectiveness of the reprocessed device itself, not a study assessing human reader performance with or without AI assistance.

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

No, this is not an AI/algorithm-based device. The device is a physical electrophysiology catheter. Therefore, "standalone algorithm performance" is not applicable. The core of the submission is about the reprocessing process and ensuring the physical device's performance after reprocessing.

7. The type of ground truth used:

For the functional and safety testing, the ground truth is primarily based on:

• Engineering specifications and standards: For dimensional, electrical, and mechanical tests.
• Regulatory standards: For biocompatibility, cleaning, sterilization, and electrical safety.
• Performance of the original predicate device: The reprocessed device is demonstrated to have "identical" purpose, design, materials, function, and intended use to the predicate device, implying its performance should match the original.

8. The Sample Size for the Training Set:

This is not applicable. This is a reprocessed physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable. As there is no training set for an AI model.

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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.

The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.

The provided text describes the St. Jude Medical Advisor HD Grid Mapping Catheter, Sensor Enabled. It mentions several types of testing conducted to demonstrate substantial equivalence to predicate devices, including bench, in vivo, and biocompatibility testing. However, the document does NOT contain a study that establishes acceptance criteria and provides specific device performance data in the format requested.

The document lists various performance characteristics that were tested (e.g., irrigation pressure, electrical resistance, magnetic resistance, and compliance to various ISO and ANSI/AAMI/IEC standards), as well as a "GLP safety study" and an "Accuracy study" as part of in vivo testing. It states that "The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices."

However, it does not provide the acceptance criteria for these tests, nor does it present the reported device performance against those criteria in a quantitative manner. Therefore, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Based on the provided text, I can only state that an "Accuracy study" was performed as an in vivo test, but no details about its methodology, results, or how it proved the device met specific acceptance criteria are given.

The information regarding acceptance criteria and a study proving their fulfillment is absent from the provided FDA 510(k) clearance letter and associated indications for use and device description.

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