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The Cobra Catheter System is indicated for:

• The non-surgical removal of thrombi and emboli from venous vasculature.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from the venous vasculature.

The Cobra Catheter System (Cobra System) is a minimally invasive aspiration catheter with an integrated handle that connects to a commercially available vacuum pump. The aspiration catheter has an expanding funnel at the distal end for clot capture and features radiopaque markers for visibility under fluoroscopic quidance. The funnel resides within the outer sleeve of the aspiration catheter until it is manually deployed in the tarqet vessel using the slider on the handle. The Cobra System can be initially introduced with a 16Fr introducer sheath. The Cobra System allows for navigating to, engagement, ingestion, and transportation of the target obstructive clot out of the peripheral veins to re-establish blood flow from the lower extremities.

The Cobra System is comprised of four (4) components:
Aspiration Catheter: The Aspiration Catheter includes a catheter shaft with a funnel at the distal end an integrated handle that allows for manual control of the device features. The handle features a port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter and for measurement of intravascular pressure using a standard pressure line setup, if needed. The Aspiration Catheter is compatible with standard accessories such as a 0.035" or 0.038" quidewire.
Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter and connects to the proximal end of the handle. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter lumen during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter System during use.
Rotating Hemostasis Valve (RHV): The RHV is an accessory that attaches to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy-Borst valve to enable compatibility with the Dilator as well as sealing on ancillary devices, such as guidewires or diagnostic catheters.
Dilator: An optional accessory to the Cobra System. The Dilator is compatible with 0.035" or 0.038″ guidewires and can be used to facilitate navigation.

The provided text describes the Cobra Catheter System and its associated studies for FDA 510(k) clearance. However, it does not contain specific acceptance criteria or quantitative performance metrics for the device. The information focuses on bench testing, sterilization, biocompatibility, electrical safety, and an animal study, all of which confirm the device performs as intended and is safe, but without numerical targets or results for specific clinical or performance endpoints.

Therefore, many of the requested sections regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted directly from this document.

Here's an analysis of what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document in a quantitative format. The document states that "Bench studies indicate that the Cobra Catheter System performs as intended. Testing was performed in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices." However, it does not elaborate on what these "performance standards" are or the numerical results of the device's performance against them.

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

• Animal Study: An animal study was conducted. The sample size is not explicitly stated, nor is the country of origin. It is prospective by nature of being an "animal study."
• For other bench tests (e.g., Visual and Dimensional Inspection, Sheath Compatibility, Durability, etc.), sample sizes are not specified.

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):

This information is not provided as the document does not detail clinical or human-read imaging studies that would require expert ground truth.

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

This information is not provided as there is no mention of a human-read test set requiring adjudication.

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:

No MRMC comparative effectiveness study was mentioned. The device described is a physical medical device (catheter system), not an AI/software device intended for diagnostic assistance.

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

No standalone algorithm performance was mentioned. The device described is a physical medical device.

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

For the animal study, "post-treatment and interim angiographies, animal health conditions, and pathologic responses" were used to evaluate performance, suggesting outcomes data and potentially expert assessment of angio/pathology results. For bench tests, physical measurements and adherence to engineering specifications served as the "ground truth."

8. The sample size for the training set:

This information is not applicable/provided as the document describes a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable/provided for the same reason as above.

Summary of available information:

The FDA 510(k) summary for the Cobra Catheter System (K223891) describes a physical medical device used for thrombus and emboli removal from venous vasculature. The clearance is based on substantial equivalence to predicate devices and extensive non-clinical testing.

The document does not contain specific acceptance criteria with numerical targets and reported device performance in the way one might expect for a diagnostic or algorithmic device. Instead, it lists comprehensive bench tests confirming the device's functional integrity and safety characteristics.

Table of Acceptance Criteria and Reported Device Performance (based on provided text):

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