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The VenaCore Thrombectomy Catheter is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.
The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

The VenaCore Thrombectomy Catheter is a single-use, sterile, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter is designed to remove thrombi and emboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, three coaxial catheter shafts (inner, middle, and outer), and a handle with a diameter control knob and a lever. The proximal handle controls the expansion and collapse of the coring element via the handle knob and lever. The outer shaft constrains the coring element prior to deployment. To aid in fluoroscopic visualization, the distal tip is radiopaque, and a radiopaque tip is located on the outer catheter to identify the distal end of the outer catheter.

This looks like a 510(k) submission for a medical device called the "VenaCore Thrombectomy Catheter." The provided text describes the device, its intended use, and a comparison to a predicate device. It also details the non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based only on your provided text:

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

The document states, "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, the specific quantitative acceptance criteria for each test and the corresponding reported device performance values are not provided in the text. The document lists the types of tests performed but not the pass/fail thresholds or the numerical results.

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

The document lists "Non-Clinical Testing" which means these were laboratory or bench tests, not tests on human subjects. Therefore, terms like "test set," "data provenance," "country of origin," and "retrospective or prospective" are not applicable in their usual clinical sense. The specific sample sizes for each non-clinical test (e.g., how many catheters were tested for tensile strength) are not detailed.

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 question is not applicable. The testing described is non-clinical (bench testing), not a clinical study involving expert assessment of patient data.

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

This question is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved. This document describes non-clinical engineering and material property 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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Furthermore, this is a thrombectomy catheter, not an AI-powered diagnostic device, so the concept of AI assistance for human readers is irrelevant.

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

This question is not applicable. The device is a mechanical thrombectomy catheter, not a software algorithm.

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

For the non-clinical tests, the "ground truth" would be established engineering specifications, material standards (e.g., ISO standards), and physical measurements. For example, for "Tensile Testing," the ground truth would be defined by a maximum allowable force before breakage according to the design specification. The specific standards or target values are not explicitly given in the text.

8. The sample size for the training set

This question is not applicable. The device does not involve machine learning or AI models that require a training set.

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

This question is not applicable for the same reason as point 8.

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