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The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area.

The Soldier Microcatheter is intended for Prescription Use Only.

The Soldier is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.

This document is a 510(k) summary for the Embolx Soldier Microcatheter, seeking substantial equivalence to a predicate device (Progreat catheter). As such, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing. It does not contain information about an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, I am unable to provide information on acceptance criteria and study details for an AI/ML device from this document.

The document primarily details the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device through bench testing and biocompatibility assessments, rather than an AI/ML study.

Here's an analysis of the provided text, focusing on the available information regarding the "Soldier Microcatheter" as a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML context):

The document does not present a formal table of "acceptance criteria" versus "reported device performance" in the typical sense of numerical thresholds met by specific metrics from a study. Instead, it lists various non-clinical tests performed and states that "Results from each test met the defined acceptance criteria" for biocompatibility and "All tests met the pre-defined performance criteria" for shelf-life. For design verification, it states "Performance testing was conducted to ensure the safety and effectiveness of the Soldier Microcatheter and to demonstrate substantial equivalence to the predicate device: Progreat catheter."

Below is a summary of the types of tests conducted and the general performance statement, as the specific numerical acceptance criteria and results are not detailed in this public summary.

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

The document describes non-clinical bench testing. Therefore, the concept of "test set" in the context of data (images, records) for an AI/ML algorithm is not applicable. The sample sizes would refer to the number of physical devices tested for each bench-top, biocompatibility, and sterilization test. These specific numbers are not provided in this summary.

• Data Provenance: Not applicable in the context of this non-AI/ML device. The "data" comes from laboratory bench testing of physical devices, not from patient-derived data (e.g., medical images). The testing was for a physical medical device (microcatheter).

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

This is not applicable for a physical medical device. Ground truth, in the context of AI/ML, refers to expert-labeled data for training and evaluating algorithms. For this microcatheter, performance is evaluated through objective physical and chemical tests, not human expert interpretation of data.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human review of "data" from the test set for an AI/ML system. The tests are bench-top, objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (microcatheter), not an AI/ML-driven device or diagnostic tool that would involve human readers interpreting cases.

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

No, this is not applicable. The Soldier Microcatheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For this physical device, "ground truth" doesn't refer to clinical outcomes or expert consensus on patient data. Instead, it refers to:

• Established laboratory standards and validated test methods (e.g., ISO 10993, ASTM F1980) for evaluating physical and chemical properties.
• Engineering specifications and design requirements for the device, against which performance is measured (e.g., burst pressure, flow rate, dimensions).

8. The Sample Size for the Training Set:

This is not applicable. There is no software algorithm or "training set" for a physical microcatheter.

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

This is not applicable as there is no training set for a physical microcatheter.

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Sniper Infusion Catheter with Balloon Occlusion is intended for use in the peripheral vasculature where temporary occlusion is desired and offers vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Sniper Infusion Catheter with Balloon Occlusion is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.

The Sniper" Infusion Catheter with Balloon Occlusion is a coaxial dual lumen catheter with an occlusion balloon located at the distal end to provide temporary complete occlusion or limitation of blood flow in peripheral blood vessels as well as provide a delivery conduit for diagnostic agents such as contrast media and therapeutic agents such as embolization particles into the peripheral vasculature. One lumen is dedicated to balloon inflation and deflation, the other lumen is intended to accommodate the guide wire and delivery of fluids and other diagnostic and therapeutic agents. Device placement in the target location is achieved using a guiding catheter that has been placed through an introducer. A guidewire is threaded through the device's lumen for navigating the device to the selected vessel location. Device visualization is provided by two radiopaque bands using fluoroscopy. One radiopaque band is located on the distal tip of the device, and one on the distal end of the balloon, which is 1 cm proximal to the distal tip. Through the guidewire (perfusion) lumen, the clinician can deliver diagnostic or therapeutic agents into the selected blood vessel. After treatment, the balloon is deflated and blood flow resumes.

The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by ETO and is intended for single use.

This document is a 510(k) summary for a medical device (Sniper Infusion Catheter with Balloon Occlusion) applying for substantial equivalence to a predicate device. It describes performance data but does not describe an AI/ML device or its acceptance criteria in the manner requested.

The document details performance testing that was performed to ensure the device meets safety and performance standards for its intended use as a medical catheter, but these are general engineering and material performance tests, not AI/ML model performance metrics.

Therefore, I cannot extract the requested information such as a table of acceptance criteria for AI/ML performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, or training set sample sizes because this document does not pertain to an AI/ML device.

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The Embolx Occlusion Balloon Catheter is intended for use in the peripheral vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Embolx Occlusion Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.

The Embolx Occlusion Balloon Catheter is a coaxial dual lumen device that consists of an occlusion balloon at the distal end with two embedded radiopaque bands to allow for visualization and positioning of the device under fluoroscopic guidance. The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by EtO and is intended for single use. The occlusion catheter has an outside diameter of 2.9F proximally and 2.2F distally. The occlusion balloon on the distal end can be inflated up to 5mm in diameter and 11mm in length. The usable length of the device is 110cm. The device can withstand an infusion pressure up to 900 psi.

This document is a 510(k) premarket notification for a medical device called the Embolx Occlusion Balloon Catheter. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative testing rather than detailed novel performance criteria and studies as would be expected for a de novo submission or a device with new indications.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner for many of the tests listed. Instead, it states that "all testing was conducted on sterilized and aged test articles" and that "Substantial equivalence was demonstrated through the following non-clinical testing." This implies that the device met whatever internal or recognized standard criteria existed for each test to demonstrate equivalence.

Here's a table based on the "Summary of Supporting Data" with reported performance being that the device "demonstrates substantial equivalence" or "is as safe, as effective, and performs as well as or better than the predicate device."

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

The document mentions "non-clinical testing" which typically refers to bench testing, in-vitro (e.g., cytotoxicity, hemolysis), and animal studies (in-vivo thrombogenicity in canine).

• Sample sizes: Specific sample sizes for each test are not provided in this summary.
• Data provenance: Not specified. Given it's a 510(k) for a US market, the testing likely adheres to US or international standards (e.g., ISO for biocompatibility). The in-vivo thrombogenicity study was done using canine models, which is an animal model. All tests appear to be prospective in nature, as they were conducted to support the submission.

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 is a medical device submission, not an AI software submission. Therefore, the concept of "ground truth" as established by human experts (e.g., radiologists) for a test set of images or data relevant to an AI algorithm does not apply here. The "truth" for these tests is based on objective laboratory measurements, physical testing parameters, and established biocompatibility standards.

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

This question is also not applicable as it pertains to expert consensus for data labeling (ground truth) relevant to AI/diagnostic software. The testing outlined for this medical device involves physical, mechanical, and biological evaluations, not expert adjudication of clinical cases.

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

This question is not applicable. This is a submission for a physical medical device (an occlusion balloon catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance would have been performed or relevant.

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

This question is not applicable. No algorithm performance is being evaluated for this physical medical device.

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

As explained in point 3, the concept of "ground truth" for expert consensus on images or outcomes data for an AI algorithm is not applicable. The "truth" in this context is defined by:

• Physical measurements: For dimensional verification, tensile strength, burst pressures, flow rates.
• Chemical/Biological assays: For cytotoxicity, sensitization, irritation, acute systemic toxicity, complement activation, LAL (pyrogenicity), PTT/PT.
• In-vivo observations/histopathology: For in-vivo thrombogenicity in canine models.
• Industry/Regulatory Standards: Adherence to recognized standards for sterility, packaging, and biocompatibility.

8. The sample size for the training set

This question is 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

This question is not applicable. No training set or associated ground truth for an AI algorithm is involved in this medical device submission.

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