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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 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 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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