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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

• 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 Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

· 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 Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.

The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

This document describes a 510(k) premarket notification for the Option™ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the Instructions for Use (IFU).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not include a specific table of acceptance criteria or reported device performance metrics in the traditional sense of a performance study. This submission is for incorporating existing clinical study results (PRESERVE study) into the device's labeling, rather than presenting new performance data for a modified device. The document explicitly states:

"No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study."

Because no new performance testing was conducted for this specific 510(k) submission, there are no new device performance metrics to report against an acceptance criterion in this document. The existing performance would be based on the prior clearance of the predicate devices and the PRESERVE study.

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

The document refers to the "PRESERVE study." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for this study within the provided text. To obtain this information, one would need to consult the original PRESERVE study documentation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided document does not contain information on the number of experts used to establish ground truth or their qualifications for the PRESERVE study's test set.

4. Adjudication Method for the Test Set

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

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

An MRMC comparative effectiveness study is typically used for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. Since the device is a Vena Cava Filter System, it is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, no MRMC comparative effectiveness study was done for this device.

6. Standalone (Algorithm Only) Performance

The device is a physical Vena Cava Filter System, not an algorithm or software-only device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this device.

7. Type of Ground Truth Used

Given that this is a physical medical device (vena cava filter) and the PRESERVE study would be a clinical trial, the "ground truth" would likely be derived from patient outcomes, imaging data, and clinical assessments related to the filter's effectiveness in preventing pulmonary embolism and its safety profile. However, the document does not explicitly state the type of ground truth used for the PRESERVE study.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the device is a physical medical device and not an AI/ML product, no training set was used in the context of algorithm development. Clinical trials, like PRESERVE, gather data for validation and effectiveness, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As noted above, no training set was used in the context of an algorithm for this physical device. Therefore, how ground truth for a training set was established is not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device and incorporating pre-existing clinical study (PRESERVE study) data into the device's labeling. It does not present new performance data or detail the methodology of the PRESERVE study in the way one might expect for a new device's initial clearance or an AI/ML product. To get specific details about the PRESERVE study (sample size, ground truth, expert involvement, etc.), one would need to refer to its full study report or publications.

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