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The Titan 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 HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan™ Micro Catheter.

The MTI Titan™ 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 catheter is provided with a removable adapter for attachment to either standard luer fitting devices or the MTI HD Injector.
The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing needle. The connector at the distal end of the injector is threaded for connecting to the MTI Titan™ Micro Catheter.

The provided text describes a 510(k) submission for the MTI Titan™ Micro Catheter and MTI HD Injector, focusing on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility verification.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes in-vitro performance testing for both the micro catheter and the injector. While specific numerical acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly stated in the provided text, the text implies that the tests were conducted to demonstrate acceptable performance for intended use and substantial equivalence to predicate devices. The reported device performance is that the devices met these unstated criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of devices or units tested for each in-vitro performance test. It broadly states "performance testing of the MTI Titan™ Micro Catheter included..." and "The accessory MTI HD Injector underwent in-vitro performance testing including...". This implies that a sufficient sample size was used to demonstrate reliability and compliance with internal standards or good laboratory practices, but the specific numbers are not provided.
• Data Provenance: The data is retrospective in the sense that the studies were conducted as part of the 510(k) submission process for a device that was modified from previously cleared devices. The testing was conducted by Micro Therapeutics, Inc., likely at their facilities or through contracted labs. The country of origin for the data is implicitly the USA as the company is based in Irvine, CA, and the submission is to the US FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are in-vitro physical and functional performance tests and biocompatibility tests. There is no "ground truth" established by human experts in the context of clinical interpretation or diagnosis. The "ground truth" for these tests would be the established engineering specifications, published standards (like ISO 10993-1), and predicate device performance.

4. Adjudication Method for the Test Set

This is not applicable for in-vitro performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For in-vitro tests, results are typically objective measurements against predefined criteria.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This document describes the 510(k) submission for a micro catheter and injector, which are medical devices, not an AI or diagnostic software. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is for physical medical devices (catheter and syringe), not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro performance tests, the "ground truth" is based on:

• Engineering specifications and design requirements: Whether the dimensions, tensile strength, burst pressure, flow rates, and torque performance meet the predetermined acceptable ranges for the device's function.
• Established industry standards: For example, compliance with ISO 10993-1 for biocompatibility.
• Performance of predicate devices: The "ground truth" indirectly involves demonstrating similar performance characteristics to the legally marketed predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The studies involve physical testing of manufactured devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

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