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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 FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.

The system consists of a fiber filter on a 0.014" guidewire with attachable actuator tool (capture wire) and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529). System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40µm cell strainer cup.

Here's an analysis of the provided information regarding the FiberNet® Embolic Protection System and its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria with specific thresholds for the FiberNet® Embolic Protection System. Instead, it refers to meeting a "performance goal based on ARCHeR3."

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

• Test Set Sample Size: The document does not explicitly state the exact sample size (number of patients) in the clinical study (EPIC Trial).
• Data Provenance: The EPIC Trial was a "non-randomized multi-center study." This indicates that the data was collected prospectively from multiple clinical sites. The country of origin is not specified, but typically for FDA submissions, studies are either conducted in the US or in countries with comparable regulatory and ethical standards.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the EPIC Trial. Clinical studies for such devices typically involve expert clinicians (e.g., interventional cardiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the document does not specify a separate "ground truth" establishment process by a distinct panel of experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set in the clinical study. Clinical trials typically have independent clinical events committees (CECs) to adjudicate adverse events, but this is not explicitly detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described (EPIC Trial) focused on the safety and performance of the FiberNet EPS itself, comparing its performance against a statistical performance goal derived from a predicate study (ARCHeR3), not a comparison between human readers with and without AI assistance or any multi-reader setup involving different interpretations.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the FiberNet® Embolic Protection System. This is a medical device (physical product), not an artificial intelligence algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Given that this is a clinical trial for a physical medical device, the "ground truth" would be based on:

• Clinical Outcomes: Observed patient outcomes related to device safety (e.g., adverse events, stroke rates) and performance (e.g., successful embolic material capture and removal, procedural success).
• Imaging Interpretation: For assessing device placement and effectiveness, imaging (angiography, ultrasound) would be used, interpreted by the treating physicians and potentially reviewed by an independent core lab, though specifics are not provided.
• Pathology/Histology: If embolic material was retrieved, it would likely be sent for pathological analysis, but the document does not elaborate on this.

The primary "ground truth" for the overall device performance would be the clinically observed event rates and outcomes in the study population.

8. Sample Size for the Training Set

This question is not applicable as the FiberNet® Embolic Protection System is a physical medical device, not an AI/software product requiring a "training set." The clinical study (EPIC Trial) serves as the primary evidence for its safety and effectiveness.

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

This question is not applicable, as there is no "training set" for this physical medical device.

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