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The MTI Nautica™ 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. Not intended for use in the coronary vasculature.

The MTI Nautica™ 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.

This document is a 510(k) Pre-market Notification for a medical device called the MTI Nautica™ Micro Catheter, dated December 12, 2002. It outlines the device description, indications for use, and a summary of substantial equivalence to predicate devices. The document also includes the FDA's acceptance letter from March 7, 2003, confirming the substantial equivalence.

Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are described as follows:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes the regulatory submission for a Class II medical device, specifically a 510(k) Pre-market Notification. For this type of submission, extensive clinical studies with human participants are often not required if the device can demonstrate "substantial equivalence" to a legally marketed predicate device. The "study" in this context primarily refers to the bench testing and biocompatibility testing performed to support the claim of substantial equivalence.

1. Sample sizes 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 the in-vitro performance tests (e.g., how many catheters were tested for tensile strength or burst pressure).
   • The data provenance is not explicitly stated as country of origin, but the testing was conducted by Micro Therapeutics, Inc. (Irvine, CA, USA) and reviewed by the FDA (USA). The testing is prospective for the device being submitted.
   • For biocompatibility, the testing was conducted in accordance with ISO 10993-1. Sample sizes for specific biocompatibility tests (e.g., cytotoxicity, sensitization) are not provided in this summary.

2. 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):

   • This question is not directly applicable to the type of testing described in this 510(k) summary. The "ground truth" for bench testing is defined by engineering specifications and industry standards (e.g., ISO 10993-1 for biocompatibility). There were no human expert assessments of images or patient outcomes.

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

   • Not applicable as this involves bench testing and biocompatibility assessment, not clinical image interpretation or patient outcome adjudication.

4. 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:

   • No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or described. This submission is for a catheter, a physical medical device, not a diagnostic or AI-powered imaging tool.

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

   • Not applicable. This device is a physical catheter, not an algorithm or software-only device.

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

   • For the in-vitro performance tests, the "ground truth" is defined by established engineering and performance specifications, often derived from industry standards or internal design requirements for similar devices.
   • For biocompatibility, the "ground truth" is compliance with the requirements and acceptance criteria of ISO 10993-1.

7. The sample size for the training set:

   • Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

   • Not applicable as there is no training set for this type of device submission.

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