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The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

The document you provided is a 510(k) premarket notification for a medical device (Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical study data often seen for novel devices that might require a PMA (Premarket Approval) or de novo classification.

Therefore, the information typically requested in your prompt (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set size for AI, etc.) is not present in this document because it is not a study assessing the performance of an AI/ML-driven device or an imaging diagnostic tool. Instead, this is a clearance for a physical medical catheter and tubing set.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biological performance testing, not AI/ML model validation.

Here's a breakdown based on the document, addressing what is present and explaining why other points are absent:

Device: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Regulatory Classification: Class II Percutaneous Catheter (Product Code: NRY)

Purpose of Submission: Demonstrate substantial equivalence to the SOFIA Plus Aspiration Catheter (K173200).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their conclusions, acting as the "acceptance criteria" and "reported device performance." Since this is not an AI/ML device, the criteria are physical and functional, rather than diagnostic accuracy metrics.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for kink resistance). However, for the animal study, it mentions "two comparative animal studies conducted under Good Laboratory Practices in a porcine model." The exact number of animals is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated for bench testing, but Perfuze Ltd. is based in Galway, Ireland, suggesting testing likely occurred there or at contracted labs.
  • Retrospective/Prospective: All described tests and the animal study are prospective design, as they were specifically conducted to support this premarket notification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable for this type of device. This device is a physical catheter and tube set, not a diagnostic AI/ML system. There is no "ground truth" to be established by human experts in the context of image interpretation or disease diagnosis. The "ground truth" here is the physical measurement, functional performance (e.g., flow rate), or biological response (e.g., non-cytotoxic).

4. Adjudication Method for the Test Set

• Not applicable. As there are no human expert readers establishing a diagnostic "ground truth," there is no need for an adjudication method. The test results are objective measurements or observations during laboratory testing.

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

• Not applicable. This is not an AI-assisted diagnostic device. Its function is direct mechanical aspiration. No MRMC study was conducted or is relevant.

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

• Not applicable. This is not an algorithm or software device. Its performance is evaluated through bench testing and animal studies as described.

7. The Type of Ground Truth Used:

• For Biocompatibility: Laboratory assays and histological/pathological evaluation (e.g., for pyrogenicity, cytotoxicity, systemic toxicity, sensitization, irritation, hemocompatibility in vitro/in vivo, and animal tissue analysis).
• For Performance Testing: Objective measurements (e.g., dimensions, flow rates, tensile strength), functional assessments (e.g., kink resistance, leakage), and simulated use observations against pre-defined engineering specifications.
• For Animal Study: Angiographic and histological evaluations of the porcine model.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve an AI/ML model that requires a training set.

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

• Not applicable. No training set for an AI/ML model is involved.

Summary regarding AI/ML related questions: The questions about experts, adjudication, MRMC studies, standalone algorithms, and training sets are relevant for submissions of Artificial Intelligence / Machine Learning (AI/ML) enabled diagnostic devices or software as a medical device (SaMD). The provided document is for a traditional, physical interventional device (catheter and tube set), and therefore, the testing described focuses on its physical, mechanical, and biological properties, as well as its functional similarity to predicate devices.

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