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The TRUSELECTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

The TRUSELECT™ Microcatheter is a low profile 2.0F microcatheter intended for use in the peripheral vasculature. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Diagnostic, therapeutic and embolic agents such as heparinized saline, contrast media, chemotherapy agents such as doxorubicin and irinotecan, polyvinyl alcohol (PVA) flakes and polymer and hydrogel spherical embolics (microspheres) can be delivered to targeted vessels. The microcatheter maintains chemotherapy chemical compatibility.

It has a straight internal diameter design (021" ID, (0.53 mm)) with a 2.0F OD tapered tip. The microcatheter includes eight UPNs, covering a range of lengths (105, 130, 155 and 175cm) and tip shapes (straight or bern), and is compatible with 0.040" ID guide catheters and 0.014" & 0.016" quidewires. It is compatible with embolic particles of up to 700 microns and 0.018" (0.46 mm) embolic coils.

The TRUSELECT™ Microcatheters are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize HydroPass Hydrophillic Coating for the reduction of surface friction during placement.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the TRUSELECT™ Microcatheter in the form of thresholds or target values. Instead, it details a comprehensive list of non-clinical (bench) tests and biocompatibility tests that were performed to demonstrate conformance to requirements for its intended use and substantial equivalence to the predicate device (Direxion™ Microcatheter, K163701).

The "reported device performance" is summarized by the statement: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies that the device met the internal design and performance specifications that correspond to each test.

Here's a table based on the tests conducted:

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

• Sample Size: The document does not specify the exact sample size for each individual test. It mentions "bench testing and biocompatibility testing were performed," implying that appropriate sample sizes were used for each test according to relevant standards (e.g., ISO, ASTM, or internal test protocols).
• Data Provenance: This was a non-clinical study (bench and biocompatibility testing). Therefore, there is no "country of origin of the data" in the sense of patient data. The tests were conducted in a lab setting, presumably by Boston Scientific or a contracted lab. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission.

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

N/A. This was a non-clinical (bench) study, not a clinical study involving experts establishing ground truth from patient data. The "ground truth" for these tests would be the established scientific and engineering principles, material specifications, and regulatory standards (e.g., ISO 10993 series) against which the device's performance was measured.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers or observers. This document describes non-clinical testing where objective measurements and observations are made against predetermined specifications.

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

No. An MRMC comparative effectiveness study was not done. This document focuses solely on non-clinical (bench) testing and biocompatibility.

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

N/A. This device is a physical medical device (microcatheter), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the biocompatibility tests, the ground truth is based on the requirements and methodologies outlined in the ISO 10993 series of standards. For the in-vitro performance tests, the ground truth would be the engineering specifications, design requirements, and relevant industry standards for microcatheters, ensuring the device performs as intended for its specified uses. It's essentially "conformance to specifications."

8. The Sample Size for the Training Set

N/A. This is not a study involving machine learning or AI where a "training set" would be used. The document describes a physical medical device submission based on non-clinical testing.

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

N/A. As there is no training set for an AI/ML algorithm involved, this question is not applicable.

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