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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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Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.

The provided text describes the 510(k) summary for the Cook Incorporated Performer® Introducer (K173068). It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing against established standards rather than clinical studies involving human readers or extensive ground truth adjudication.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. The testing described is primarily laboratory-based physical and material testing, not human clinical trials or analysis of patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The "test set" refers to the manufactured device units subjected to the various physical performance tests.

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

This information is not applicable. The device is a physical medical instrument (catheter introducer), and its performance acceptance criteria are based on engineering standards (e.g., ISO, BS EN ISO) and functional requirements, not on interpretations or diagnoses by medical experts. "Ground truth" for these tests is defined by the objective measurements and adherence to the physical and material properties specified in the standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers in diagnostic studies. Here, the "test set" involves objective physical and material tests with predefined acceptance criteria. The results are either "met" or "not met" based on measurements against those standards.

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 such study was done. This 510(k) summary is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool.

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

No such study was done. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for the Performer® Introducer's performance is based on objective engineering and material test standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070-1:2014 for leakage and tensile testing, BS EN ISO 11070 for rollback and kink testing) and predetermined functional requirements (e.g., preventing flow, proper dimensions, visibility under fluoroscopy). It is not pathology, expert consensus, or outcomes data in the typical sense of a diagnostic device.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured following a design and tested against established performance standards.

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

This information is not applicable as there is no "training set."

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