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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.

Device Description

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.

AI/ML Overview

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.

Test Category	Reported Device Performance
Dimensional Inspection	Performed (details not provided, but implies measurements were within specifications or comparable to predicate).
Visual Analysis	Performed (details not provided, but implies visual characteristics were acceptable or comparable to predicate).
Tensile Strength Tests	Performed (details not provided, but implies tensile strength was within specifications or comparable to predicate).
Tip Tensile Strength	Performed (details not provided, but implies tip tensile strength was within specifications or comparable to predicate).
Burst Pressure Tests	Performed (details not provided, but implies burst pressure was within specifications or comparable to predicate).
Flow Rate Tests	Performed (details not provided, but implies flow rates were within specifications or comparable to predicate).
Torque Tests	Performed (details not provided, but implies torque characteristics were within specifications or comparable to predicate).
Tip Reshape-ability/Retention	Performed (details not provided, but implies tip could be reshaped and retained shape as expected or comparable to predicate).
Tip Offset Distances Measurement	Performed (details not provided, but implies offset distances were within specifications or comparable to predicate).
Tip Length Measurement Specification	Performed (details not provided, but implies tip length met specifications or was comparable to predicate).
Guidewire Friction	Performed (details not provided, but implies guidewire friction was acceptable or comparable to predicate).
Coil Friction	Performed (details not provided, but implies coil friction was acceptable or comparable to predicate).
Performance under Simulated Conditions	Performed (details not provided, but implies the device performed acceptably in simulated use conditions or comparably to predicate).
Biocompatibility	Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility as an external communicating, blood contact, limited exposure (<24 hrs) device.

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

The document does not specify sample sizes for each of the in-vitro tests.
The data provenance is not stated, but the testing would have been in-vitro (laboratory-based) performance testing, not involving human clinical data.

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

Not applicable. This is a physical device, and the "ground truth" for in-vitro performance tests is determined by validated test methods and measurement equipment, not expert human assessment.

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

Not applicable. Adjudication methods are typically for clinical studies with human assessors, not in-vitro physical 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 is not an AI/SaMD device, and no MRMC study was performed.

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

Not applicable. This is not an AI/SaMD device.

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

Not applicable in the context of clinical "ground truth." For the in-vitro performance tests, the "ground truth" is derived from established engineering test methods, material specifications, and comparisons to predicate device performance.

8. The sample size for the training set:

Not applicable. There is no "training set" for an AI algorithm for this physical device.

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

Not applicable. There is no "training set" or associated ground truth for an AI algorithm for this physical device.

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