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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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