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The MegaVac Mechanical Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• The non-surgical removal of thrombi from synthetic grafts.
• Use in temporary blood vessel/graft occlusion.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft
• Catheter placement over a guidewire

The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.

The provided document is a 510(k) Summary for the MegaVac Mechanical Thrombectomy System. This regulatory submission primarily focuses on establishing substantial equivalence to predicate devices based on design, function, materials, sterilization, and in vitro testing. It does not contain information about clinical studies (comparative effectiveness or standalone), sample sizes for test or training sets for AI devices, expert qualifications for ground truth establishment, or adjudication methods, as these are typically associated with performance evaluations of AI/ML-based devices or clinical trials rather than a 510(k) submission for a traditional medical device demonstrating substantial equivalence through bench testing.

Therefore, many of the requested details related to AI device performance evaluation are not present in this document.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance

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

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements." However, specific numerical acceptance criteria for each test are not provided. The table below lists the tests performed and the general statement about meeting acceptance criteria.

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 does not specify sample sizes for any of the in vitro tests. The testing was in vitro (bench testing) and therefore does not have "country of origin" or "retrospective/prospective" data provenance in the clinical sense.

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)

Not applicable. This was in vitro (bench) testing of a physical medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data.

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

Not applicable. This was in vitro (bench) testing of a physical medical device.

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. The document explicitly states: "No Clinical Data was generated to establish substantial equivalence. Bench data and pre-clinical data are considered adequate to support a determination of substantial equivalence." Therefore, no MRMC study, AI assistance, or effect size was reported.

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

No. This device is not an algorithm or AI product. It is a physical mechanical thrombectomy system.

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

For the in vitro tests, "ground truth" would be established by the pre-determined product specifications, engineering designs, and industry standard requirements. For example, for "diameters, length," the ground truth would be the design specifications for those dimensions.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device.

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

Not applicable. This device is not an AI/ML device.

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