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· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.

The Merlin Aspiration System is comprised of two devices:

• Merlin Aspiration Catheter
• High Flow Tubing
  The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
  Merlin Aspiration Catheter
  The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
  High Flow Tubing
  The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.

The provided text describes the MIVI Merlin Aspiration System and its premarket notification (K213771) to the FDA, demonstrating substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance (in quantitative metrics), human reader studies, or detailed information about the ground truth establishment in the manner typically associated with studies proving device performance against acceptance criteria for AI/ML-based devices.

The provided text focuses on the mechanical and material performance of a medical device (aspiration catheter and tubing), not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

The document instead provides information about engineering bench testing, animal testing, and biocompatibility, which are standard for physical medical devices.

Here's a summary of the information that is available, formatted to address the relevant parts of your request, and explicitly stating where information is not applicable (N/A) based on the nature of the device described:

Acceptance Criteria and Device Performance (for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are implied by the "established criteria" that the device was tested against. The "reported device performance" is simply that the device "Met established criteria" for each test. Specific quantitative criteria and performance values are not provided in this summary.

Information for AI/ML Device Evaluation (Not Applicable for this Device)

The following points are primarily relevant for AI/ML-based medical devices, which the Merlin Aspiration System is not. Therefore, specific details for these points are Not Applicable (N/A) based on the provided text. The device is a physical aspiration system, and its evaluation focuses on mechanical performance, biocompatibility, and animal testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. This device is a physical medical device (aspiration system), not an AI/ML device that uses a "test set" of data in the common sense for diagnostic or prognostic purposes. Performance was evaluated through bench testing and animal testing.
• For animal testing: 8 animals (porcine carotid, renal, and subclavian vasculature). This is prospective testing in an animal model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. Ground truth establishment for a "test set" of data points is not relevant for the physical device performance testing described.

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

• N/A. Not relevant for the type of device testing described.

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

• N/A. This is a physical medical device, not an AI-assisted diagnostic or therapeutic tool.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A. For the bench testing, the "ground truth" would be established engineering specifications and physical measurements. For animal testing, it would be direct observation of the device's performance in vivo concerning safety and effectiveness in removing emboli/thrombi.

8. The sample size for the training set

• N/A. This device is not an AI/ML product developed using a training set.

9. How the ground truth for the training set was established

• N/A. Not applicable as there is no training set for this physical device.

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