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The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the following situations:

• Venous thrombosis or pulmonary thromboembolism when anticoagulants are . contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism.
• Failure of anticoagulant therapy in thromboembolic disease. .
• Emergency treatment following massive pulmonary embolism where anticipated benefits . of conventional therapy are reduced.
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated.

The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System consists of sequential vascular dilators for percutaneous access; a guide the Introducer Sheath and Dilator into place; an Introducer Sheath and Dilator to create a passageway to guide the Introducer Catheter to the implant site; and an Introducer Catheter to transport the pre-loaded fitter through the sheath and over the guidewire to the implant site for fifter deployment .

The provided text describes a medical device submission (K964284) for the "Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System". However, it does not contain the information requested in your prompt regarding acceptance criteria, device performance in clinical studies, sample sizes, expert involvement, or grand truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical trial data with specific performance metrics and acceptance criteria as you've outlined.

Here's a breakdown of why this information is missing based on the provided text:

• No detailed acceptance criteria or performance metrics: The document mentions "Safety and Performance" but only states that "Bench and Animal testing were performed and the data supported the substantial equivalence." It does not provide quantitative acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) or specific numerical performance results of the device (e.g., filter deployment success rate, complication rates, embolization prevention rates).
• No clinical study to prove acceptance criteria: The study described is limited to "Bench and Animal testing" for substantial equivalence, not a clinical study designed to measure the device's performance against pre-defined acceptance criteria in humans.
• No information on human data/experts: Since no human clinical study is described for performance evaluation, there's no mention of sample sizes for test sets, data provenance, number of experts, qualifications of experts, or adjudication methods.
• No MRMC or Standalone AI study: The device is a physical medical device (vena cava filter), not an AI/software device. Therefore, MRMC or standalone algorithm performance studies are not applicable and not mentioned.
• No ground truth establishment for performance: The "ground truth" discussed indirectly relates to the animal model (e.g., successful filter deployment or prevention of embolization in animals), but not in the context of human clinical outcomes or expert consensus for diagnosis as would be relevant for an AI device.
• No training set information: The concept of a "training set" is relevant for AI or machine learning models. This document describes a physical device, so there's no "training set" in that context. The "training" here would refer to the development and testing of the device itself, rather than an algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the updated guidewire for the filter system is substantially equivalent to a previously cleared device, based on bench and animal testing. It does not provide the detailed performance data, acceptance criteria, or study design elements typically found in clinical efficacy studies for a novel device or AI-powered system.

To fulfill your request, one would need to access different types of documentation, such as full clinical trial reports or performance evaluation reports that would detail specific endpoints, statistical analysis, and results against pre-defined acceptance criteria.

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