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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 Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.

The provided text describes the 510(k) premarket notification for the BioCardia Morph DNA Steerable Introducer Sheath (K242169). This document does not include information about acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as the product is a physical medical instrument (a steerable introducer sheath), not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a machine learning model, as this content is not present in the provided document.

The document details the device's technical specifications, comparison to predicate devices, and various benchtop and simulated use tests conducted to demonstrate that modifications did not affect product specification requirements. These tests are focused on the physical and functional performance of the catheter, not on an AI's diagnostic or predictive capabilities.

Here's a breakdown of what the document does provide in relation to performance testing, which is different from an AI/ML performance study:

Device Performance Testing (Not AI/ML Study)

The document lists performance tests conducted to confirm the device meets product specifications due to modifications from predicate/reference devices.

1. Acceptance Criteria and Reported Device Performance: This section is presented as a list of tests conducted, implying that successful completion of these tests (meeting internal product specifications for each test) is the "acceptance criteria" for this type of physical device. The specific quantitative acceptance criteria values or detailed reported performance values for each test are not explicitly stated in the provided text. Instead, it indicates that the tests were conducted "to confirm that the modifications... did not affect the ability to meet all product specification requirements."

2. Sample Size Used for the Test Set and Data Provenance: Not applicable for a physical device. Testing would involve a number of manufactured units, but this is not typically referred to as a "test set" in the context of data for AI. No information on data provenance (country, retrospective/prospective) is provided as there's no data being collected for an AI model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The "ground truth" for a physical device like this is its physical and functional performance according to engineering specifications and simulated use scenarios, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set: Not applicable for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study is relevant for AI/ML diagnostic or prognostic tools that assist human readers. This is a physical medical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.

7. The Type of Ground Truth Used: For this physical device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993, ASTM standards) and internal product specifications for attributes like tip deflection, catheter diameter, material properties, and functional performance in simulated use models.

8. The Sample Size for the Training Set: Not applicable, as there is no training set for an AI model.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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

PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure.

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. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The PathBuilder™ Steerable Introducer is a medical device designed for introducing various cardiovascular catheters into the heart, including into the left side of the heart through the interatrial septum. The device did not undergo clinical studies to prove these claims but a series of non-clinical, benchtop tests and analyses to establish substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer (K081645)).

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample sizes for each non-clinical test (biocompatibility, bench validation, cleaning and sterilization, shelf life). It states that "All samples were sterilized and aged prior to testing. All tested samples passed bench testing." As these are bench tests and not clinical studies, the data provenance is from laboratory testing performed by the manufacturer, Shanghai MicroPort EP MedTech Co., Ltd., presumably in China as that is their location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This was a non-clinical evaluation comparing device properties to established standards and a predicate device. There was no expert-derived "ground truth" for the test set in the way it would be for a diagnostic AI device. The ground truth was based on the performance standards themselves and the characteristics of the predicate device.

4. Adjudication method for the test set:
   Not applicable. There was no adjudication method described as it was not a study involving human interpretation of results. The tests measured physical and material properties against predefined specifications and 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:
   No. This device is a steerable introducer (a physical medical device), not an Artificial Intelligence (AI) device, and thus an MRMC comparative effectiveness study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used:
   The "ground truth" in this context refers to established national and international standards (e.g., ISO 10993-1, ISO 11135, ISO 11070, AAMI TIR 28) and the characteristics of the legally marketed predicate device (Agilis™ NxT Steerable Introducer K081645). The device's performance was compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set:
   Not applicable. As this is not an AI/machine learning device, there is no training set.

9. How the ground truth for the training set was established:
   Not applicable. There is no training set for a physical medical device.

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The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU.

The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.

The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).

Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.

The provided text does not contain any information about:

1. AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
2. Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
3. Experts for Ground Truth/Adjudication: This concept is not applicable here.
4. MRMC Comparative Effectiveness Study: Not relevant for a physical device.
5. Standalone AI Algorithm Performance: There is no AI algorithm.
6. Type of Ground Truth: Not applicable.
7. Training Set Sample Size or Ground Truth Establishment: Not applicable.

The document focuses on:

• Device Description: Physical attributes and components.
• Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
• Technological Characteristics: How it operates (bi-directional steering, radiopacity).
• Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
• Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."

In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.

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The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.

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

The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.

The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

This document describes the Steerable Introducer 8.5F, a medical device for introducing cardiovascular catheters. The information provided focuses on the device's design, intended use, and the performance data submitted to the FDA for 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined with numerical targets in the provided text. Instead, the document states that the device was tested to "meet the device intended use and to ensure conformance to the product specifications" and "meets all its physical and performance specifications." The performance data section lists the types of tests conducted and generally states that the device "passed" or "meets" these specifications.

Therefore, the table can be constructed as follows:

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

The document does not specify the sample sizes used for any of the tests listed (e.g., shaft deflection, simulated use, leak testing). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench testing and laboratory studies conducted as part of the device development and regulatory submission.

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

This information is not provided in the document. The studies described are primarily performance and safety tests for a physical medical device, not diagnostic or AI-driven systems requiring ground truth established by medical experts in the traditional sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment where disagreements in interpretation need to be resolved. The studies described are engineering and biological performance tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic aids (like AI algorithms) by comparing human readers' performance with and without the aid. The Steerable Introducer 8.5F is a physical medical device, not a diagnostic AI system.

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

No, a standalone study in the context of an "algorithm only without human-in-the-loop performance" was not done. This device is a physical tool, not an algorithm. The performance data relates to the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance studies would be the objective measurements and engineering standards (e.g., a shaft deflecting to a certain angle, a guidewire fitting, no leaks under specific pressure) that define whether the device meets its specifications and intended function. These are inherent physical properties or design requirements.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device. The device's design is based on engineering principles and similarities to predicate devices, not data-driven machine learning.

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

This information is not applicable and not provided for the same reasons as point 8.

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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 Flextra™ Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Flextra Steerable Introducer set contains a steerable introducer, integrated vessel dilator/transseptal needle (component branded as Lancer"), guidewire, and ECG adapter cable. The set is designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy. The Flextra introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various cardiac catheters. The shaft has a proximal handle with a rotating actuator that allows the user to change the degree of curvature on the distal tip of the shaft (referred to as steerable tip, deflectable tip, or dynamic tip). Rotating the actuator can deflect the tip, in a planar fashion, +/- 180°. The handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. The Lancer integrated dilator/needle combines the dilator and transseptal needle into a single component. The needle is used to puncture the interatrial septum to gain access to the left atrium. The Lancer consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional dilators. The lumen of the Lancer is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the Lancer handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector to monitor an ECG from the needle while in the heart, utilizing the ECG adapter cable. The guidewire included in the kit is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The ECG adapter cable included is manufactured by Bioconnect (RF Industries, Inc.), is one (1) meter long, and has male/female DIN 0.080 inch touchproof connectors on the ends.

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the Flextra Steerable Introducer. It focuses on demonstrating substantial equivalence to the predicate device through various non-clinical tests.

Since this document describes a medical device undergoing premarket notification (510(k)) for substantial equivalence, the "acceptance criteria" are generally established regulatory standards and the "study that proves the device meets the acceptance criteria" refers to the comprehensive non-clinical testing performed to show the device functions as intended and is safe, effective, and performs as well as or better than the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that it pertains to a device, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device, "acceptance criteria" are typically defined by recognized standards and performance specifications derived from these standards or from the predicate device's performance. The "reported device performance" are the results of tests against these criteria.

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

• Biocompatibility: Various numbers per test, e.g., "2 canines" for thrombogenicity.
• Sterilization, Packaging, Shelf Life, Performance Testing: The document refers to "samples" or "test devices" but does not specify the exact number of units used for each test. For accelerated aging, it mentions "test devices."
• Animal Study: "A single animal study was performed that combined the evaluation of another device... to limit the number of animals required." The thrombogenicity test also used "2 canines."
• Data Provenance: The tests were conducted by various vendors and labs primarily in the USA (Minneapolis, MN; Salt Lake City, UT; Franklin, WI; Eden Prairie, MN). The studies are prospective evaluations of the manufactured device.

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

Not applicable to this type of device submission. The "ground truth" for device performance is established by objective measurements against engineering specifications and validated test methods (e.g., ASTM, ISO standards), or by comparison to a predicate device in an animal model. There is no mention of human experts establishing ground truth in the context of diagnostic performance or image interpretation.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if disagreement) are typically used in clinical studies or diagnostic performance evaluations for subjective assessments. This document describes objective engineering tests and an animal study.

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 device is a steerable introducer catheter, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI-assisted human reader improvement assessment was performed.

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

Not applicable. The device is a physical medical instrument, not an AI algorithm.

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized international and national standards (e.g., ISO, ASTM IEC) for physical, mechanical, chemical, and biological properties.
• Direct measurement and verification against pre-defined engineering specifications.
• Comparison to a legally marketed predicate device (SJM Agilis™ NxT Steerable Introducer, K061363) in an animal model for functional and performance aspects, demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. See point 8.

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