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The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.

The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.

The Marathon 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 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/ev3 micro catheters are single-lumen, end-hole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheters incorporates a standard luer adapter to facilitate the attachment of accessories. The catheters have single or dual radiopaque markers at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheters are coated to increase lubricity.

The provided document, K093750, is a Special 510(k) submission for ev3 Micro Catheters. It explicitly states:

"The micro catheter devices have not changed; there is no performance data included in this submission. The Instructions for Use have been revised to remove the pediatric and neonatal contraindication."

"The devices have not changed and no new risks have been identified. The indications for use demonstrate the MTI/ev3 Micro Catheters are substantially equivalent to the predicate devices."

Therefore, based on the provided text, the following information cannot be extracted:

1. Table of acceptance criteria and the reported device performance: No performance data is included as the device has not changed.
2. Sample size used for the test set and the data provenance: No test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test data is provided.
4. Adjudication method for the test set: Not applicable as no test data is provided.
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 document describes a micro catheter, not an AI or imaging device, so MRMC studies involving human readers and AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no performance data is provided.
8. The sample size for the training set: Not applicable as no performance data or machine learning components are described.
9. How the ground truth for the training set was established: Not applicable as no performance data or machine learning components are described.

The submission focuses on demonstrating substantial equivalence to predicate devices because the micro catheter devices themselves have not changed. The only change mentioned is a revision to the Instructions for Use to remove pediatric and neonatal contraindications.

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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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The MTI 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 Echelon Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. 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 document is a 510(k) summary for a medical device (MTI Echelon Micro Catheter) and does not describe acceptance criteria or a study proving the device meets those criteria in the way typically required for AI/software-as-a-medical-device (SaMD).

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility testing for a physical catheter. The "acceptance criteria" here are implied by the successful completion and comparison of these physical tests to the predicate device, not statistical performance metrics of an algorithm.

Therefore, many of the requested categories for AI/SaMD studies are not applicable to this 510(k) submission. I will address only the relevant information from the provided text.

Relevant Information from the 510(k) Summary for the MTI Echelon™ Micro Catheter Family (K051990):

1. Table of acceptance criteria and the reported device performance:

The document lists the types of in-vitro performance tests conducted rather than explicit acceptance criteria with numerical performance data. The implicit acceptance criterion is that the new device performs comparably to the predicate devices in these tests.

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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.

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The MTI Echelon™ Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

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 Special 510(k) submission for the Echelon™ Micro Catheter, which is a modification to the previously cleared Rebar® Micro Catheter (K993672). As such, the submission focuses on demonstrating substantial equivalence to the predicate device through performance testing rather than establishing de novo clinical efficacy for a novel device. Therefore, many of the requested categories related to clinical studies, AI performance, and expert ground truth are not applicable to this type of submission.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes in-vitro performance testing and biocompatibility testing. The "acceptance criteria" themselves are not explicitly detailed as quantitative thresholds in the provided text, but rather implied by successful completion of these tests to demonstrate substantial equivalence to the predicate device.

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