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The Recovery® G2® Filter System – Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated. .
• Failure of anticoagulant therapy for 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.
• Recovery® G2® Filter may be removed according to the instructions supplied . under the section labeled: Optional Procedure for Filter Removal.

The Recovery® G2 Filter consists of 12, shape-memory nitinol wires emanating from a central nitinol sleeve. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The Recovery® G2® Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm. The predicate device filter is identical to the subject device filter.

The Recovery® G2® Filter System - Femoral Delivery Kit consists of a 7 French I.D. introducer catheter and dilator set (Kit A) and a storage tube preloaded with the Recovery® G2® Filter and pusher system (Kit B). Kit A (introducer catheter and dilator) is used to gain access to the inferior vena cava via a femoral approach. The dilator accepts a 0.038" guidewire and the introducer catheter has 2 radiopaque marker bands on the distal end to assist in filter delivery. The pusher system (Kit B), designed to pass through the introducer catheter, consists of a grooved segment designed to hold and properly orient the filter legs and a flexible nitinol wire with a pad at the end that pushes on the filter apex.

The Recovery® G2® Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the Recovery® G2® Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular or subclavian approach. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and consists of a side port for saline infusion and a delivery mechanism to deploy the Recovery® G2® Filter. The delivery device contains a spline cap that mechanically separates the filter hooks from one another in a unique pattern to properly orient the filter legs and contains a pusher wire consisting of a flexible nitinol wire with a pad at the end that pushes on the filter sleeve.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Recovery® G2® Filter System

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document focuses heavily on the retrieval aspect as a key new feature and therefore the primary performance metric. The acceptance criteria for other aspects of the device's function (e.g., preventing pulmonary embolism) are implicitly covered by demonstrating substantial equivalence to the predicate devices, which were presumably approved based on their own performance data.

2. Sample Size and Data Provenance for the Test Set:

• Sample Size: The document does not explicitly state the total number of subjects in the prospective clinical study. It only mentions "95.1% of the study subjects undergoing a retrieval procedure," implying that the sample size is the number of subjects who underwent an attempt at retrieval. To calculate this, if X is the total number of subjects in the study and Y is the number of subjects undergoing retrieval, then 95.1% of Y were successfully retrieved. Without Y, the exact sample size for the retrieval test is unknown, but it is the number of retrieved subjects.
• Data Provenance: The study was a "prospective, multi-center, nonrandomized clinical study." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting it was likely conducted in the U.S. or under U.S. regulatory guidelines.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of a clinical study for a medical device like this, ground truth would likely be established through clinical outcomes and assessments performed by medical professionals (e.g., interventional radiologists, cardiologists), but specific details are not provided in this summary.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not conducted or reported in this summary. The study described is a clinical study evaluating the device's retrieval success rate. There is no mention of comparing human readers with and without AI assistance, as this is solely a medical device (filter) submission, not an AI software submission.

6. Standalone Performance Study:

The primary performance study reported is a standalone clinical study evaluating the retrieval safety and success rate of the Recovery® G2® Filter in human subjects. This is an "algorithm only (device only)" performance in the context of device function, not an AI algorithm. Bench and animal testing were also performed, indicating standalone performance in controlled environments.

7. Type of Ground Truth Used:

The ground truth used for the reported retrieval success rate was clinical outcome data. Specifically, it was the observable success or failure of the filter retrieval procedure in human patients.

8. Sample Size for the Training Set:

The document does not report a "training set" as this is a medical device (filter) submission, not a machine learning or AI software submission. The "training set" concept is typically relevant to AI models.

9. How Ground Truth for the Training Set Was Established:

As there is no training set in the context of this device submission, this question is not applicable.

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