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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 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 consists 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 introduction and/or exchange. It has a sideport with a 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 document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based product.

The information provided describes design verification activities for a hardware medical device (steerable introducer), not an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable.

Here's an analysis based on the provided text, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." However, specific numerical acceptance criteria and their corresponding reported device performance values are not detailed in this summary. The document lists the types of testing performed and the standards met.

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

This is not applicable as the document describes physical device testing, not an AI/algorithm-based test set with data provenance. "Test set" here refers to the physical devices subjected to various engineering and biological tests. The sample sizes for each specific test (e.g., number of devices for durability, sterility, or biocompatibility) are not provided in this summary, but would be part of the full design verification report.

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

Not applicable. "Ground truth" in the context of expert consensus is relevant for AI algorithms interpreting medical images or data. For a physical medical device like an introducer, "ground truth" is typically established by engineering specifications, validated test methods, and biological safety standards. Experts involved would be engineers, microbiologists, and other technical specialists relevant to the specific tests performed (e.g., biocompatibility specialist, sterilization expert).

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for reconciling differing expert opinions on ground truth for AI algorithms. For device performance testing, adjudication involves comparing test results against predefined acceptance criteria from engineering specifications and regulatory standards.

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. This is a hardware device (catheter introducer), not an AI system that assists human readers.

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

Not applicable. This is a hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering specifications, international and national standards (e.g., ISO, ANSI AAMI listed), and regulatory requirements for mechanical performance, material compatibility, biocompatibility, and sterility. For example, for biocompatibility, the ground truth is that the materials do not elicit an adverse biological response as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This refers to AI/machine learning models.

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

Not applicable. This refers to AI/machine learning models.

Summary of Study Type:

The study referenced is a series of non-clinical design verification activities and laboratory tests. These tests were conducted to demonstrate that the modifications made to the Agilis NxT Steerable Introducer Dual-Reach™ (the subject device) did not adversely affect its safety and effectiveness and that it continues to meet established performance, biological safety, and sterility standards, making it substantially equivalent to its predicate device. This is typical for a 510(k) submission for a modified hardware device.

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The Agilis NxT Steerable Introducer Dual-Reach™ is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis™ NxT Steerable Introducer Dual-Reach™ set consists 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 13 F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction 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 ≥135° and counterclockwise ≥90°. Actual curve angles will vary. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text is a 510(k) premarket notification for a medical device, the Agilis™ NxT Steerable Introducer Dual-Reach™. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance in a clinical or diagnostic context.

The document states that the device is a catheter introducer and its indications for use are "introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum."

The "study" referenced in the document is a non-clinical testing summary for design verification to ensure substantial equivalence to a predicate device, not a performance study in the sense of accuracy, sensitivity, or specificity for a diagnostic algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or specific outcomes in patients) or report such performance metrics. Instead, it indicates that "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

The types of testing performed, which would have their own internal acceptance criteria, are:

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

Not applicable. This is a submission for a physical medical device, not a software algorithm tested on a data set. The "testing" refers to non-clinical laboratory or engineering tests.

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

Not applicable. This is a submission for a physical medical device. Ground truth, in the context of clinical expert review of data/images, is not relevant here.

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

Not applicable. This is a submission for a physical medical device.

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. This document is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This is a submission for a physical medical device, not an algorithm.

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

Not applicable. For this type of physical medical device, "ground truth" would be established through engineering specifications, material standards, and performance benchmarks for the physical properties and function of the device in a controlled environment.

8. The sample size for the training set

Not applicable. This is a submission for a physical medical device, not an AI/ML algorithm.

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

Not applicable. This is a submission for a physical medical device, not an AI/ML algorithm.

Summary from the document:

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a physical medical device. The "study" mentioned in the document is a series of non-clinical design verification activities, biocompatibility, sterility, and packaging tests conducted in accordance with industry standards and guidance documents. These tests were performed to demonstrate that the modified device is substantially equivalent to its predicate device (Agilis™ NxT Steerable Introducer) and that all associated risks with the modifications were mitigated. The device is not a diagnostic algorithm or AI software, and therefore, typical performance metrics, sample sizes for data sets, expert involvement for ground truth, or MRMC studies are not applicable or described in this document.

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The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided 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.

The provided text is a 510(k) premarket notification for a Reprocessed Agilis NxT Steerable Introducer. This document is for a medical device that facilitates the introduction of catheters into the heart. It is not an AI/ML medical device, and therefore the provided document does not contain information on acceptance criteria for AI models, nor studies that prove an AI device meets acceptance criteria.

The information requested in the prompt (acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is typically found in submissions for AI/ML-driven medical devices, especially those related to diagnostic imaging or analysis.

Since this document pertains to a reprocessed physical medical device (a catheter introducer), the "studies" mentioned are bench and laboratory testing to prove the device's physical and mechanical performance, biocompatibility, cleaning validation, sterilization validation, and packaging validation. These are standard tests for physical medical devices, not for AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device assessment.

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The Reprocessed Agilis NxT Steerable Introducing various cardiovascular cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided 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.

The provided document is a 510(k) summary for a reprocessed medical device, specifically the Reprocessed Agilis NxT Steerable Introducer. The focus of the acceptance criteria and study is on demonstrating that the reprocessed device is substantially equivalent to the predicate (original) device, meaning it is as safe and effective.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document describes several types of testing performed to demonstrate that the reprocessed device is equivalent to the original, but it does not provide a table with specific quantitative acceptance criteria or reported numerical performance data for the reprocessed device. Instead, it lists the categories of tests conducted.

The general acceptance criterion is that the reprocessed device must perform equivalently to the predicate and meet established safety and effectiveness standards for reprocessed medical devices.

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

The document does not specify the sample sizes used for any of the described tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The studies described are bench and laboratory tests, not clinical studies involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. The studies described are physical, mechanical, and sterilization validations, which rely on established engineering and scientific testing methodologies and standards rather than expert clinical interpretation for establishing ground truth. There is no mention of human experts evaluating the "ground truth" in the context of diagnostic interpretation.

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

This detail is not applicable to the type of bench and laboratory testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate cases and discrepancies are resolved.

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

There was no Multi-Reader Multi-Case (MRMC) comparative effectiveness study done. This submission is for a reprocessed physical medical device (a steerable introducer), not an AI/imaging diagnostic device. Therefore, questions about human readers or AI assistance are not relevant.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

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

For the types of tests performed:

• Biocompatibility, Cleaning, Sterilization: The ground truth is established through adherence to recognized standards and validated scientific methods for assessing these parameters (e.g., ISO standards for biocompatibility, validated cleaning protocols, sterilization cycle validation to achieve sterility assurance levels).
• Physical and Mechanical Testing: The ground truth is established by comparing the reprocessed device's performance against the original equipment manufacturer's specifications for the predicate device, or relevant industry standards. This includes objective measurements of dimensions, tensile strength, deflection, leak integrity, and radiopacity.
• Simulated Use: The ground truth is success in performing the intended function without failure or compromise in a simulated environment, based on pre-defined performance metrics.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

This question is not applicable as there is no training set for this type of device submission.

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The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.

The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

This document describes the acceptance criteria and the study for the 82cm Agilis NxT™ Steerable Introducer.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes bench testing for the device, not a human clinical trial involving a "test set" of patients or data in the typical sense for evaluating diagnostic accuracy or clinical outcomes. The "test set" here refers to the actual devices or components tested.

• Sample Size: The specific sample size for each individual bench test (e.g., how many devices underwent a Shaft Kink test) is not explicitly stated in the provided text. The results are simply reported as "Pass."
• Data Provenance: The tests are conducted by the manufacturer, St. Jude Medical, which implies internal testing. The data provenance is retrospective in the sense that these tests were performed on manufactured devices to verify their specifications. The country of origin of the data is implicitly the manufacturing or testing location of St. Jude Medical, likely the United States (Minnetonka, MN, as listed for the submitter).

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

This information is not applicable as the evaluation is based on bench testing of device specifications, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly for interpreting diagnostic images or clinical endpoints where multiple experts might disagree. Bench tests have objective Pass/Fail criteria based on predefined specifications.

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

No, an MRMC comparative effectiveness study was not performed. This type of study assesses the impact of a device (like an AI algorithm) on human reader performance, which is not relevant for a steerable introducer device's bench testing.

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

This information is not applicable. The device is an electro-mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests is the defined product specifications and performance requirements. For example, the "Curve Angle" test would have a specific angle tolerance as its ground truth, and the device either meets it ("Pass") or fails to. For biocompatibility tests, the ground truth is established by standards (e.g., ISO 10993) and the biological response observed meets the defined acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/ML algorithm. The device design and materials are based on engineering principles and previous predicate devices.

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

This information is not applicable for the same reasons as above.

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The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis NxT Steerable Introducer consists of a steerable sheath, plastic dilator and stainless steel guidewire, which is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. It is an 11F asymmetrical bi-directional steerable introducer with a small and medium curl at the distal tip and a useable length of 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

This 510(k) summary (K083402) describes a medical device, the Agilis™ NxT Steerable Introducer Catheter, which is a Class II device (21 CFR 870.1340, Product Code DYB) for introducing cardiovascular catheters into the heart. The regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer, K061363) rather than defining specific acceptance criteria and providing a detailed study report with performance metrics.

Therefore, the requested information elements related to device acceptance criteria and a study proving those criteria are largely not applicable in the context of this 510(k) submission as it is presented. This type of submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

However, I can extract what is provided and explain why other sections are not present in this document.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary of Information Provided in the 510(k) Document:

This 510(k) submission for the Agilis™ NxT Steerable Introducer Catheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Agilis™ NxT Steerable Introducer, K061363). The core argument is that the new device has the same intended use and fundamental scientific technology as the predicate and that testing confirmed its design meets product specifications and intended use, implying equivalence to the predicate's performance. Specific quantitative acceptance criteria with corresponding device performance metrics for novel functionalities are not explicitly detailed in this summary.

The "acceptance criteria" and "device performance" in this context are implicitly tied to demonstrating that the modifications made to the predicate device do not negatively impact its safety and effectiveness, and that the device performs as expected for its intended use, comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in this 510(k) summary. The "bench testing" performed would have involved a sample of manufactured devices.
• Data Provenance: Not explicitly stated. Bench testing is typically conducted internally by the manufacturer. It is not clinical data (e.g., country of origin, retrospective/prospective).

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

• Not Applicable. This submission describes a physical medical device, not an AI/software device requiring "ground truth" established by human experts for a test set in the same manner. The "ground truth" for a device like this is its performance against engineering specifications and its functional behavior in a simulated environment, typically evaluated by engineers and quality control personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not an AI/software device requiring a human-expert adjudication method for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a physical medical device submission, not an AI/software device requiring MRMC studies to assess human reader improvement with AI assistance. The evaluation is focused on the device's physical and functional properties.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Functional Performance Benchmarks. For a physical device, the "ground truth" is typically defined by:
  • Design Specifications: Quantitative and qualitative requirements established during the device's design phase.
  • Predicate Device Performance: The established performance characteristics of the legally marketed predicate device to which the new device is compared for substantial equivalence.
  • Industry Standards: Relevant ISO or ASTM standards that might apply to introducer catheters (though not explicitly mentioned for this specific testing).
  • Bench Test Results: Direct measurements and observations of the device's physical properties and functional behavior (e.g., deflection angles, material strength, flow rates).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of a physical medical device submission unless it refers to process validation or manufacturing controls, which are not detailed in this 510(k) summary. This is not an AI/machine learning device.

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

• Not Applicable. As above, there is no "training set" or "ground truth for a training set" as typically understood in AI/software device submissions.

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The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis NxT Steerable Introducer consists of a steerable sheath, plastic dilator and stainless steel guidewire, which is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

The provided text is a 510(k) summary for the Agilis™ NxT Steerable Introducer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria and a study proving the device meets those criteria in the format requested.

Specifically:

• No detailed acceptance criteria table: The document states "Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use," but it doesn't list the specific performance metrics or their acceptable limits.
• No specific study results: It mentions "Bench testing of the Agilis™ NxT Steerable Introducer was performed to verify the device modification," but doesn't provide any quantitative results or a breakdown of the study methodology (sample sizes, ground truth establishment, etc.).
• No information on clinical studies: The document focuses on "non-clinical testing" (bench testing) and substantial equivalence. There is no mention of human reader studies (MRMC), standalone algorithm performance, or clinical trial data.
  Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated from the document, and what is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The testing was "bench testing," meaning it was likely laboratory-based and not involving human data or clinical scenarios.

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

• This is not applicable as the testing was "bench testing" of a physical medical device (introducer catheter), not a diagnostic or AI-driven device requiring expert-established ground truth from images or other patient data. Ground truth would be based on engineering specifications and physical measurements.

4. Adjudication method for the test set

• Not applicable for bench testing of a physical device.

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. The document describes "non-clinical testing" (bench testing) of an introducer catheter. It does not involve AI or human readers.

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

• No. This is a physical medical device, not an algorithm, so this is not applicable.

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

• For "bench testing" of the Agilis™ NxT Steerable Introducer, the ground truth would be based on engineering design specifications and objective physical measurements (e.g., steerability angles, hemostasis valve integrity, material strength, radiopacity). This is inferred from the nature of the device and testing mentioned.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. (See #8)

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The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.

The St. Jude Medical Agilis™ NxT Stecrable Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counter-clockwise ≥ 90°15 The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This document, K083083, is a 510(k) summary for the Agilis™ NxT Steerable Introducer Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the St. Jude Medical Agilis™ NxT Steerable Introducer (K061363).

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Agilis™ NxT Steerable Introducer. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

Note: The acceptance criteria are largely implied by the statement of "substantial equivalence" and the general successful outcome of non-clinical testing. Specific numerical or threshold-based performance metrics are not detailed in this summary.

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

• Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" which typically involves testing a sample size of devices, but the specific number is not provided.
• Data Provenance: The testing appears to be non-clinical bench testing, meaning it was conducted in a laboratory setting, not with human or animal subjects. Details on the geographic origin are not mentioned, but it would typically be internal testing by the manufacturer (St. Jude Medical). It is retrospective in the sense that the test results confirm the design choices made.

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

This information is not applicable and therefore not available in the provided document. The study described is a non-clinical bench test. "Ground truth" in the context of expert review typically refers to clinical studies where human experts (e.g., radiologists, pathologists) interpret data (e.g., images, case files) to establish a correct diagnosis or outcome. For bench testing of a medical device like an introducer catheter, the "ground truth" is typically defined by engineering specifications, physical measurements, and established testing standards, not by expert human review in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not available. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers in clinical studies to establish a consensus ground truth. Since this study is a non-clinical bench test validating device performance against specifications, such a method would not be used.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this document. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to evaluate the performance of human readers with and without AI assistance. This document describes the substantial equivalence of a physical medical device (an introducer catheter) based on bench testing.

Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable and not provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this concept is not applicable to the device described. A "standalone" performance evaluation refers to the performance of an algorithm or AI model without human intervention. The Agilis™ NxT Steerable Introducer is a physical medical device. Its performance is evaluated through engineering tests, not as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this study would be derived from:

• Engineering Specifications: Pre-defined performance parameters and design requirements for the introducer catheter.
• Physical Measurements and Standards: Data obtained from bench tests (e.g., material strength, deflection angles, hemostasis valve integrity, flow rates) are compared against established industry standards, design tolerances, and the performance characteristics of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and therefore not available. A "training set" is used for machine learning algorithms. The Agilis™ NxT Steerable Introducer is a physical medical device, not an AI algorithm. Its development and validation are based on engineering design, manufacturing processes, and physical testing, not machine learning.

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

This information is not applicable. As stated above, there is no "training set" in the context of this device.

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The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis™ device is an 8.5 F steerable catheter introducer. The device has a small curl or medium curl at the distal tip which can deflect 90° in the counterclockwise direction and 180° in the clockwise direction. The device is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The proximal end of the device is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way store can is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheath is filled with radiopaque material for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) summary for a medical device (Agilis NxT Steerable Introducer) and the FDA's letter granting substantial equivalence.

Here's what can be extracted from the text:

• Device Name: Agilis NxT Steerable Introducer
• Intended Use: Introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
• Comparison to Predicate: The Agilis NxT introducer has similar design, materials, and technical requirements as its predicate devices (Agilis Steerable Catheter Introducer K042623 and Livewire Electrophysiology Diagnostic Catheter K022380).
• Testing Summary: "Testing has demonstrated that the new device is substantially equivalent to the predicate devices." However, no details about this testing (what tests were done, what the results were, what acceptance criteria were used) are provided.
• Conclusion: The proposed modifications are equivalent to the predicates with respect to intended use, technological characteristics, and performance specifications.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

To answer your request, I would need a different document that details the specific performance studies conducted for the Agilis NxT Steerable Introducer, including their methodology, results, and the acceptance criteria established for those studies.

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