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This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.

The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.

The provided text describes a 510(k) premarket notification for various microcatheters (ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3). This document serves as a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device cannot be extracted from this document. The document primarily focuses on the mechanical, material, and biocompatibility performance of a physical medical device (microcatheter) and its substantial equivalence to existing devices.

However, I can extract the information related to the performance testing and acceptance criteria for the physical microcatheter device as detailed in the document.

Acceptance Criteria and Device Performance (for the physical microcatheter device)

The document details non-clinical laboratory testing and biocompatibility testing conducted to demonstrate the substantial equivalence of the ASAHI microcatheters.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific details (Items 2-9 from your prompt):

The provided document is a 510(k) summary for a physical medical device (microcatheter), not an AI/ML-driven software device. Therefore, information related to:

2. Sample size for test set and data provenance: Not applicable. Tests were bench/in-vitro and animal studies for device performance and biocompatibility.
3. Number of experts and qualifications for ground truth: Not applicable. Performance data is from physical tests. Biocompatibility standards are specific laboratory tests.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device.
7. Type of ground truth used: For non-clinical tests, the ground truth is the physical measurement and functional assessment against specified engineering criteria. For biocompatibility, it's defined by the specific ISO standards and their pass/fail criteria.
8. Sample size for training set: Not applicable (no AI/ML model training).
9. How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates the safety and effectiveness of a microcatheter through standard predicate comparison, non-clinical bench testing, and biocompatibility studies, which are typical requirements for such devices. It does not contain any information about an AI/ML component or its associated validation studies.

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The Echelon Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or 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 Echelon Micro Catheter is packaged with an ev3 Syringe Adapter. This device, attached to an ev3 1ml syringe filled with Onyx®, will reduce the dead space within the micro catheter luer hub. Reducing the dead space within the hub is intended to minimize the potential mixing of Onyx® and DMSO in the hub of the catheter during connection and injection.

The provided document is a 510(k) Premarket Notification for a medical device, specifically a micro catheter, and its accessory. It focuses on demonstrating substantial equivalence to existing predicate devices. This type of document does not contain the detailed information required to answer most of your questions about acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance.

Here's why and what information can (and cannot) be extracted:

• Device Type: The Echelon Micro Catheter is a physical medical device (catheter) used for infusion. It is not an AI/ML device or a diagnostic device that produces images or interpretations. Therefore, concepts like "acceptance criteria for device performance" in terms of sensitivity, specificity, accuracy, or expert ground truth are not applicable in the way you've framed them for AI.
• Study Focus: The "Performance Data" section explicitly states: "Because the Echelon catheter itself has not changed, the scope of design verification focused on performance and compatibility of the Syringe Adapter accessory device." This means the studies performed were engineering/design verification tests on the physical properties and functionality of the catheter and its new accessory (e.g., dimensional checks, luer fitting integrity, pressure tests), not clinical trials or diagnostic performance studies involving human readers or AI.

Given this context, I will address your questions to the best of my ability based only on the provided text, explaining why certain information is absent.

Acceptance Criteria and Study for K090870 (Echelon Micro Catheter with Syringe Adapter)

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

Note: The document provides general categories of verification studies but does not detail specific quantitative acceptance criteria values (e.g., "burst pressure > X psi") or precise reported performance values. It states these studies were conducted and, implicitly, that the device met these criteria to achieve substantial equivalence.

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

• Sample Size for Test Set: Not specified in the provided document. The studies were "design verification" tests, likely involving multiple units or repetitions, but the exact sample sizes are not given.
• Data Provenance: Not specified. These are engineering design verification tests typically conducted by the manufacturer (Micro Therapeutics dba ev3 Neurovascular, located in Irvine, CA, USA). They would be considered prospective in the sense that they were conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a physical medical instrument (catheter and accessory), not a diagnostic tool requiring expert interpretation as ground truth. The "ground truth" for the performance studies would be objective engineering measurements and specified design parameters.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus builds a "ground truth," typically in diagnostic imaging or clinical trials. These were engineering performance tests.

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 describes a physical medical device, not an AI or diagnostic imaging system. No MRMC study was performed, and no AI component is involved.

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

• Not Applicable. There is no algorithm or AI component in this device.

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

• Engineering Specifications and Material Properties: The "ground truth" for these design verification studies would be based on established engineering specifications, material properties, and functional performance requirements for medical devices of this type. For example, a "Luer Fitting Integrity" test would verify the fitting meets ISO standards for Luer connections.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" as it's a physical device, not an AI model.

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

• Not Applicable. There is no "training set" for this device.

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