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The Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The MTI Echelon™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.

The provided text describes a 510(k) submission for the Echelon™ Micro Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through in-vitro performance testing and biocompatibility testing.

Medical device submissions like this typically involve engineering performance testing rather than studies involving AI algorithms, human readers, or complex ground truth establishment as would be seen in software as a medical device (SaMD) or AI/ML-based diagnostic tools. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of device and submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria for medical devices like this typically involve meeting pre-defined mechanical, chemical, and biological performance specifications that ensure safety and effectiveness. The reported performance confirms that the device met these criteria for various in-vitro tests and biocompatibility. Specific numerical acceptance criteria and their corresponding reported performance values are not provided in this summary document, but the fact that the device was deemed "substantially equivalent" implies these criteria were met.

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: The text states "In-vitro performance testing" and "Biocompatibility testing" were conducted. For in-vitro mechanical tests, samples typically involve multiple units of the device to ensure consistency and statistical significance. Biocompatibility tests also involve a specified number of samples for each test (e.g., cytotoxicity, irritation, sensitization). However, the specific number of samples for each test is not mentioned in this summary.
• Data Provenance: The testing was "in-vitro" (laboratory-based) and conducted by the manufacturer, Micro Therapeutics, Inc., located in Irvine, CA. This constitutes prospective testing conducted specifically for the regulatory 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)

• Not Applicable. This submission is for a physical medical device (catheter) and relies on objective, measurable engineering and biological performance metrics rather than interpretation of data by clinical experts to establish ground truth.

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

• Not Applicable. See point 3.

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 device or a diagnostic imaging device requiring human reader studies.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device refers to established engineering standards, specifications, and biological safety limits (e.g., ISO 10993-1 for biocompatibility). The device's performance was measured against these objective criteria rather than subjective expert consensus or clinical outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set."

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