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The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

• Clear proximal polycarbonate female luer lock,
• -Stainless steel braid,
• Clear Pebax and Vestamid Shafts, -
• -Embedded platinum iridium radiopaque marker,
• Clear polycarbonate barrel piston syringe. -

Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process.

Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.

The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Aspire MAX Aspiration Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) device. Therefore, the information provided for acceptance criteria and study that proves the device meets the acceptance criteria is framed within the context of substantial equivalence testing and non-clinical performance, rather than a clinical study with human patients.

Based on the document, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present a formal table of "acceptance criteria" with specific quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, or clinical outcome improvements). Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to legally marketed predicate devices through a series of non-clinical tests and comparisons of design, materials, and operating principles.

The "Device Performance" is demonstrated by passing these non-clinical tests, indicating the device functions as intended and is comparable to predicate devices.

Table of Comparison (derived from the document):

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study. Therefore, some of the requested information (like expert consensus for ground truth or MRMC studies) is not applicable in this context.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state "sample sizes" in terms of number of devices tested for each non-clinical test. It states "Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications."
   • Data Provenance: The tests were conducted as part of the regulatory submission process for the device manufacturer, Control Medical Technology. The location of the testing facilities (e.g., Ethox and Nelson Labs mentioned for biocompatibility) would likely be in the US, but this is not explicitly stated as the origin of data.
   • Retrospective or Prospective: The testing was prospective, specifically conducted for this 510(k) submission.

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

   • Not applicable. This was a non-clinical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined specifications and parameters of the tests (e.g., tensile strength, aspiration volume, particulate limits) which are derived from industry standards (e.g., ISO, AAMI) and predicate device characteristics, not expert clinical consensus on patient data.

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

   • Not applicable. As this was non-clinical testing, there was no adjudication of expert opinions. Test results are objectively measured against defined specifications.

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:

   • Not applicable. This is a medical device (catheter and aspirator), not an AI/imaging device, and no clinical study was performed. The concept of "human readers" and "AI assistance" is not relevant to this submission.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for this 510(k) submission is established by engineering specifications, performance metrics derived from industry standards (ISO), and the characteristics of predicate devices that have already been legally marketed. For example, catheter dimensions, material properties, aspiration volume, and leak integrity are measured and compared against established parameters or the performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a training set. The device design and manufacturing process are established through engineering and validated through non-clinical testing.

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

   • Not applicable. No training set was involved.

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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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