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The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

The provided text describes a 510(k) submission for the React™ 71 Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in device length. The information primarily covers non-clinical bench testing.

Here's an analysis of the provided information against your requested categories:

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

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

• Sample Size: Not explicitly stated. The text mentions "non-clinical bench testing was conducted," but does not provide details on the number of devices tested for each criterion.
• Data Provenance: Not specified. "Non-clinical bench testing" typically implies laboratory-based tests. The country of origin of the data is not mentioned. The data is prospective in the sense that new tests were conducted for this submission, but it's not clinical human data.

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 section is not applicable as the study described is non-clinical bench testing, not a study involving human or animal data requiring expert ground truth for interpretation.

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

This section is not applicable as the study described is non-clinical bench testing against predefined performance criteria, not a study involving subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-powered diagnostic device.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (catheter), not an algorithm or software.

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

For the non-clinical bench tests, the "ground truth" is defined by the acceptance criteria established in the test methods, based on FDA Guidance 1757 and FDA Recognized Consensus Standards 5-125 & 5-129. These are objective engineering and performance standards, not clinical ground truths like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This section is not applicable for the reasons stated in point 8.

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Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.

The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.

The provided text describes the regulatory clearance for the "Phenom Catheters" and includes performance data from bench testing. However, it does not describe any study involving AI, human readers, or the establishment of ground truth for such a study. Therefore, I cannot fulfill your request for information related to AI or human-in-the-loop performance.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. There is no mention of acceptance criteria or performance metrics in the context of an AI-based device, a multi-reader multi-case (MRMC) study, or standalone algorithm performance.

Here's a breakdown of the information that is present in the document, framed against your request:

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

The document provides a table of "Tests" with "Test Method Summary" and "Results." The "Results" column implicitly indicates that the acceptance criteria were met for each test, as it states "The Phenom™ Catheters met the acceptance criteria for..." or "acceptable friction force," "compatible for use," etc.

Regarding the other points of your request, the document does not provide this information because it's for a medical device (catheter) and not an AI-based system:

• 2. Sample size used for the test set and the data provenance: Not applicable. The testing described is bench testing of physical devices, not a test set of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for data interpretation is not relevant for this type of device submission.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the catheter is its ability to perform according to engineering specifications and biocompatibility standards.
• 8. The sample size for the training set: Not applicable. This is not an AI model requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (catheter) based on non-clinical performance and biocompatibility testing, not an AI software/device.

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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ and X-pedion™ Hydrophilic Guidewires, asserting their substantial equivalence to a predicate device. The information primarily focuses on bench testing rather than AI/ML algorithm performance. Therefore, many of the requested details, such as those related to AI model training, expert ground truth, and human reader studies, are not applicable or cannot be extracted from this document.

Here's the relevant information based on the provided text:

1. A 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 (number of guidewires) used for each bench test. The data provenance is from non-clinical bench testing conducted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (the applicant).

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 medical device clearance based on substantial equivalence demonstrated through non-clinical bench testing, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" for these tests would be the physical properties and performance measurements of the guidewires against engineering specifications.

4. Adjudication method for the test set

Not applicable, as this is bench testing of physical device properties, not a study involving human interpretation of data where adjudication would be necessary.

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 guidewire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

Not applicable. This is for a physical medical guidewire.

7. The type of ground truth used

The "ground truth" for the bench tests would be the physical and mechanical specifications for guidewires, as referenced by standards such as ISO 11070 and USP , as well as internal quality procedures (QP50324, TM0047). The tests evaluated observed performance against these predefined criteria.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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 Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

1. Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
3. Adjudication method for the test set: Not applicable for non-AI bench testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
7. The sample size for the training set: Not applicable; this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

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