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The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the perioheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

The NexGen Peripheral Expandable Catheter is a sterile single use catheter intended to facilitate the placement or removal of vascular catheters and devices including the NexGen Mechanical Retrieval Device (MRD).

The Device features a Pebax/HDPE catheter shaft attached Nitinol tip that expands as the device is deployed from the lumen of a guide catheter. The Nitinol braid passively expands to the contour shape of the vessel lumen and allows a separate medical device such as a catheter to be retracted into the Nitinol Braid. Both the Nitinol Braid and the other device are then retracted into the Guide Catheter. The retracted Expandable Catheter with the encapsulated device are then removed together via removal of the Guide Catheter.

The Expandable Catheter comes in multiple expanded profiles of 5mm, 7mm, 9mm and 11mm, each having a working length of 43cm and 116cm. The Expandable Catheter is packaged in a Tear Away Sheath (B. Braun 510(k) K000313) that is used to facilitate loading the catheter into a Guide Catheter.

Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

The provided text describes a medical device, the NexGen Peripheral Expandable Catheter, and its 510(k) submission to the FDA. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically applied to AI/ML medical devices.

Instead, this document details the regulatory clearance process for a physical medical device (catheter) based on its substantial equivalence to predicate devices. The "testing" mentioned refers to bench-top non-clinical tests to verify the device met design specifications and functional/structural integrity, not clinical performance acceptance criteria in the context of diagnostic accuracy or reader improvement that would be relevant for an AI study.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not applicable or present in this document.

Below is a table summarizing the information available in the provided text, while explicitly noting where the requested AI-relevant information is not present.

Acceptance Criteria and Device Performance (as presented for a physical medical device)

Study Details (as applicable to a physical medical device submission, not AI)

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

   • Not Applicable / Not Provided for AI-style "test set." The testing described is non-clinical bench testing of the physical device. The documents do not mention clinical studies with human participants that would have a "test set" in the context of an AI/ML device evaluation.

2. 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)

   • Not Applicable / Not Provided. This is a physical device submission, not an AI/ML device requiring expert-established ground truth for performance evaluation in the diagnostic sense.

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

   • Not Applicable / Not Provided.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This document describes a physical medical device, not an AI/ML algorithm that would assist human readers.

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

   • No. This is not an algorithm.

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

   • Not Applicable. For the bench-top tests, "ground truth" was likely defined by engineering specifications and measurements (e.g., a specific tensile strength requirement, a maximum leak rate).

7. The sample size for the training set

   • Not Applicable / Not Provided. This is a physical device, not an AI/ML algorithm requiring a training set.

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

   • Not Applicable / Not Provided.

Conclusion:

The provided 510(k) summary is for a physical medical catheter and details non-clinical bench testing to demonstrate compliance with design specifications and substantially equivalence to predicate devices, as required for FDA clearance of such devices. It does not provide information relevant to the typical acceptance criteria and study designs used for AI/ML-driven medical devices, as it is not an AI/ML device.

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The NexGen Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

The MRD is a member of a family of sterile, single use, catheter-based devices that are intended to mechanically remove blood clots and other obstructions from blood vessels in the human body. The MRD is designed to be used for peripheral vascular applications.

The Device design is intended to allow easier access into anatomically difficult endovascular locations because it is pushed out of a small profile guide catheter. Other devices such as those delivering laser, ultrasound, or photo-acoustical energy may be too stiff to access tortuous blood vessels, and too large.

The MRD consists of a stainless steel coil that is inserted into a standard 4F guide catheter. The guide catheter is inserted into the vessel and past the occlusion using a standard guide catheter. Coils released from the MRD are then deployed distal to the occlusion. As the guide catheter is withdrawn, additional MRD coils are released proximal to the occlusion, thereby enmeshing the embolic material for removal.

This document describes the premarket notification (510(k)) for the NexGen Peripheral Mechanical Retrieval Device (MRD), a device intended for the removal of embolic/thrombotic material. The submission primarily relies on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available as well:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results from the bench tests. It lists the types of tests conducted to "verify the device met design specifications and its intended use." To create a table, we can list the tests performed, but without numerical criteria or outcomes, the "Reported Device Performance" would simply be a confirmation that the tests were passed.

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

• Sample Size for Test Set: Not specified. The document only mentions that "bench testing was conducted." The number of devices or iterations used for each test is not detailed.
• Data Provenance: The tests are categorized as "bench testing" and "in-vitro," indicating laboratory, non-clinical studies. There is no information regarding country of origin or whether the data is retrospective or prospective, as it's not a clinical study.

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

Not applicable. This was a non-clinical (bench and in-vitro) study. Ground truth in this context would refer to engineering specifications and performance metrics established during device design and testing, not typically clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Given this was non-clinical bench testing, an adjudication method for a test set (as typically seen in clinical studies with human assessors) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical retrieval device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical instrument, not an algorithm or software-only device.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, is based on engineering specifications, design requirements, and a demonstration of mechanical and biological performance through bench and in-vitro testing. It relies on the device meeting predefined criteria for physical characteristics, functional performance in simulated environments (e.g., embolic removal in-vitro), and biocompatibility following ISO standards. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as "No clinical evaluations of this product have been conducted."

8. The Sample Size for the Training Set

Not applicable. As this is a mechanical medical device and not an AI/ML algorithm, there is no "training set" in the conventional sense.

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

Not applicable, as there is no training set.

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Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.

The Peripheral Guide Catheter is a family of single use, catheters that are intended to facilitate introduction of interventional/diagnostic devices.

The NexGen Peripheral Guide Catheter features a proximal hub for attaching to ancillary devices such as Rotating Hemostasis Valves and Syringes and a distal, atraumatic tip that is radiopaque.

The catheter has a single lumen that can be used to facilitate introduction of interventional /diagnostic devices and injection of physician specified fluids.

The Guide Catheter comes in two profiles, 4F and 8F and multiple lengths. The 4F profile has a 65cm and 150cm working length and the 8F profile has a 20cm and 90cm working length.

Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

The provided text describes a 510(k) summary for the NexGen Peripheral Guide Catheter. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility assessments. The document does not include information about acceptance criteria and a study proving a device meets those criteria in the context of clinical performance, specifically for an AI/ML powered device.

Therefore, many of the requested sections about AI/ML specific study design (e.g., sample size for test set, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set size and ground truth establishment) cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists several performance tests conducted to verify the device met design specifications and its intended use. However, it does not explicitly state specific acceptance criteria (e.g., "tensile strength must be > X N") nor the quantitative results ("reported device performance") for each test. It only states that the tests were "successfully completed."

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

Not applicable. The document describes non-clinical bench testing of a physical medical device, not a study involving a "test set" of data or patient cases for an AI/ML algorithm.

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)

Not applicable. This is not an AI/ML study. Ground truth in this context would relate to engineering specifications and measurements, not expert clinical interpretation.

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

Not applicable. This is not an AI/ML 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 is not an AI/ML study.

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

Not applicable. This is not an AI/ML study.

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

For the non-clinical testing, the "ground truth" would be the established engineering and materials science standards and specifications against which the device's performance was measured. For example, a predefined burst pressure limit or a specific tensile strength requirement.

8. The sample size for the training set

Not applicable. This is not an AI/ML study.

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

Not applicable. This is not an AI/ML study.

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The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Not Found

I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter for the NexGen Peripheral Mechanical Retrieval Device. It discusses the device's regulatory classification, product codes, and general compliance requirements.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, test sets, expert involvement, or training data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the provided text.

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