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The Mini-ClotTriever Thrombectomy System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

The Mini-ClotTriever (“MCT”) Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of two main components packaged separately:
Mini-ClotTriever Sheath (8 Fr)
Mini-ClotTriever Catheter (8 Fr)
The MCT Sheath is placed in the target vessel, and, after its funnel is expanded, the MCT Catheter is inserted through the sheath and advanced past the thrombus. The MCT Catheter coring element is deployed to engage the clot and retracted into the MCT Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the MCT Catheter and MCT Sheath are removed from the patient.

The provided text describes the 510(k) premarket notification for the Mini-ClotTriever Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device (Inari ClotTriever Thrombectomy System, K210689) through non-clinical testing. It does not present a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document primarily covers:

• Device Description: A mechanical thrombectomy system for non-surgical removal of emboli and thrombi from blood vessels in the peripheral vasculature.
• Comparison to Predicate: Details on the similarities and differences in design, materials, and operational principles between the Mini-ClotTriever and its predicate device.
• Non-Clinical Testing: A list of bench tests performed (e.g., biocompatibility, sterilization, dimensional inspections, simulated use, tensile testing, corrosion testing) to demonstrate that the device conforms to established product specifications and the modifications do not raise new questions of safety or effectiveness.
• Conclusion: The device is substantially equivalent to the predicate device based on non-clinical testing, and neither animal nor clinical testing was required for this determination.

Based on the provided text, none of the specific information requested about AI/algorithm acceptance criteria and performance (e.g., sample size for test sets, expert consensus, MRMC studies, standalone performance, training set details) can be extracted because the device is a medical instrument, not an AI/algorithm-based diagnostic or therapeutic tool for which such criteria would apply.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance. The document describes a mechanical device and its testing, not an AI study.

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The Artix Thrombectomy Device is indicated for:

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

The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature.
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and advanced to the thrombus. A self-expanding nitinol element is deployed to engage thrombus by retracting the outer delivery catheter. Artix is then retracted into the sheath to capture the targeted thrombus. Additional clot may be removed by aspiration with a Luer syringe (not provided). After the procedure is complete, the Artix and sheath are removed from the patient.

The provided document is a 510(k) summary for the Artix Thrombectomy Device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set information for an AI/CADe device.

The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Instead, it relies on non-clinical testing to demonstrate substantial equivalence to the predicate device.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/CADe device cannot be extracted from this document because it describes a medical device (thrombectomy catheter), not an AI/CADe system.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance of the device against those criteria. It only confirms that some acceptance criteria (identified through Design Failure Modes and Effects Analysis) were met by non-clinical testing.

2. Sample size used for the test set and the data provenance

N/A. The document describes non-clinical bench testing for a physical medical device, not a diagnostic AI/CADe system. Therefore, there is no "test set" in the context of image data or clinical data for an AI algorithm. The document mentions "verification and validation testing" but does not specify sample sizes or data provenance for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. As this is not an AI/CADe system, there's no "ground truth" for a test set established by experts in the context of diagnostic interpretation.

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

N/A. Not applicable for a physical medical device clearance based on non-clinical 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. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Therefore, no MRMC study was conducted.

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 AI algorithm.

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

N/A. No clinical "ground truth" was used for this device clearance, as it relied on non-clinical bench testing to demonstrate substantial equivalence.

8. The sample size for the training set

N/A. This is a physical medical device, not an AI/CADe system, so there is no training set.

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

N/A. Not applicable.

In summary, the provided FDA 510(k) document is for a physical medical device (thrombectomy catheter) and does not contain the information typically required for an AI/CADe device, as it did not involve clinical trials, expert reviews of diagnostic images, or AI algorithm performance evaluation.

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