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The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The Terumo Aspiration Catheter is a dual lumen rapid exchange catheter. The guidewire lumen is used to facilitate passage of a guide wire which must not exceed 0.014" (0.36 mm) in diameter. The larger extraction lumen allows the removal of thrombus (thrombi) by use of the included aspiration syringe through the extension line. The catheter has a proximal stiff region and a distal flexible region that is coated with hydrophilic polymer which generates lubricity when wet. On the distal tip a radiopaque marker band is incorporated. The proximal end of the catheter is equipped with a standard luer adapter to facilitate the attachment of the included extension line, stopcock and syringes. The provided stylet can be inserted in the catheter to assist in the delivery of the catheter to the vascular lesion. The included flushing tool is used to flush the guide wire lumen in preparation for use. A filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis or any thrombosis.

The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The acceptance criteria and supporting studies are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes bench testing and biocompatibility testing, not a clinical study with a "test set" in the context of patient data.

• Bench Testing: The sample sizes for each specific bench test (e.g., force at break, aspiration rate) are not explicitly stated. However, the tests were conducted using both real-time aged and accelerated aged samples to assess performance over the specified shelf life.
• Biocompatibility Testing: The number of samples for each biocompatibility test (e.g., Sensitization, Hemolysis, Pyrogen) is not explicitly stated. The tests were performed on non-aged (sterile) and aged (sterile) samples.
• Data Provenance: The studies are described as "in-house bench testing" and "biocompatibility testing." This implies the data were generated in a laboratory setting, likely at the manufacturer's (Terumo Medical Corporation) or a contracted testing facility's site, and are not derived from human patients or a specific country of origin in the clinical sense. These are pre-market studies to demonstrate safety and performance characteristics.

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

Not applicable. The reported studies are bench and biocompatibility tests, which do not involve establishing ground truth by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for these tests refers to established scientific and engineering standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

Not applicable. As these are bench and biocompatibility tests, there is no human adjudication process involved in the data collection or interpretation in the way there would be for a clinical trial or image analysis study. The results are compared against predefined pass/fail criteria from international and industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided document details pre-market bench and biocompatibility studies for a physical medical device (aspiration catheter). It does not describe an AI/software as a medical device or diagnostic imaging study that would typically involve an MRMC comparative effectiveness study to assess human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Terumo Aspiration Catheter is a physical medical device, not an algorithm or software. Therefore, there is no "standalone" algorithm performance study described.

7. Type of Ground Truth Used

The "ground truth" for the various tests were defined by:

• International Standards: ISO 10555-1, ISO 594-1 & 2, ISO 7886-1, ISO 10993 (various parts), ISO 11135, ISO 11607-1, ISO 11607-2.
• National Standards: ASTM F756, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993-7, USP 661.
• Manufacturer Specifications: In-house bench testing compared the device's performance to predicate devices and likely internal design specifications that reflect expected performance characteristics (e.g., "equivalent or superior to predicate devices" for kink resistance, aspiration rate, etc.).

8. Sample Size for the Training Set

Not applicable. The studies described are for physical device testing and do not involve machine learning algorithms that require a "training set."

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

Not applicable, for the same reason as above.

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