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The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous 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. .
• . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated

The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval.

The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

The Cordis OptEase Retrieval Catheter is indicated for the retrieval of the Cordis OptEase Vena Cava Filter from the inferior vena cava. Retrieval of the OptEase Filter is possible only from the femoral vein approach.

The subject OptEase Filter is identical to the predicate OptEase Permanent Vena Cava Filter with the exception of the addition of the retrievability option to the labeling. The OptEase Vena Cava Filter is packaged with a filter introduction kit that includes the Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.

The subject OptEase Filter is substantially equivalent to the predicate devices (i.e., OptEase Permanent Vena Cava Filter, TrapEase Permanent Vena Cava Filter, Recovery Filter System, and Günther Tulip™ Vena Cava Filter and Retrieval Set).

The subject OptEase Retrieval Catheter is an 80 cm long, 10F catheter with radiopaque tip. The subject device is packaged separately and is intended for the percutaneous retrieval of the OptEase Filter from the inferior vena cava when used with an appropriate Endovascular snare. The subject device is substantially equivalent to the predicates devices (i.e., the Günther Tulip™ Vena Cava Filter and Retrieval Set and the VISTA BRITE TIP® Guiding Catheter).

Here's a breakdown of the acceptance criteria and the study that proves the Cordis OptEase™ Vena Cava Filter and OptEase™ Retrieval Catheter met those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Failure of anticoagulant therapy in thromboembolic diseases
• Emergency treatment following massive pulmonary embolism where anticipated
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated | The reported indications for use of the Cordis OptEase Vena Cava Filter are identical to the acceptance criteria, indicating the device performs as intended for these specific situations. |
  | Retrieval Catheter: Indication for Use - Retrieval of the Cordis OptEase Vena Cava Filter from inferior vena cava via femoral vein approach | - Retrieval of the Cordis OptEase Vena Cava Filter from the inferior vena cava.
• Retrieval possible only from the femoral vein approach. | The reported indications for use of the Cordis OptEase Retrieval Catheter are identical to the acceptance criteria, indicating the device performs as intended for this specific retrieval method. |
  | Retrieval Safety & Effectiveness | (Implied through "safety and effectiveness... demonstrated via data collected from in-vitro, animal and clinical testing and analyses" for retrieval) | - Prospective Clinical Study: 21 retrieval patients. Time to retrieval: 5-14 days (mean 11.1 ± 1.8 days).
• Retrospective Clinical Experience: 40 retrieval patients. Time to retrieval: 3-48 days in 29 patients (mean 16.4 ± 7.2 days).
• 11 patients in retrospective study had filter captured and redeployed (4-30 days, mean 13.8 ± 6.1 days) and subsequently retrieved. |
  | Substantial Equivalence (General) | Based on comparison to predicate devices for design, material, components, fundamental technology, and intended use. | - OptEase Filter: Substantially equivalent to OptEase Permanent Vena Cava Filter (except for retrievability option), TrapEase Permanent Vena Cava Filter, Recovery Filter System, and Günther Tulip™ Vena Cava Filter and Retrieval Set.
• OptEase Retrieval Catheter: Substantially equivalent to Günther Tulip™ Vena Cava Filter and Retrieval Set and VISTA BRITE TIP® Guiding Catheter. |

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

• Test Set (Clinical Data for Retrieval Safety and Effectiveness):
  • Sample Size:
    • Prospective Clinical Study: n = 21 retrieval patients
    • Retrospective Clinical Experience: n = 40 retrieval patients
  • Data Provenance: The document does not explicitly state the country of origin.
    • Prospective Clinical Study: Prospective
    • Retrospective Clinical Experience: Retrospective

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

The document does not provide information on the number of experts used to establish ground truth for the clinical studies, nor their qualifications. The clinical data appears to be observational (retrieval attempts) rather than a consensus-based ground truth establishment by experts for specific outcomes.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set. The data presented are reported outcomes of retrieval procedures.

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

This section is not applicable. The device is a medical implant (vena cava filter) and its associated retrieval catheter, not an AI or imaging diagnosis system that would typically involve human readers.

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

This section is not applicable. The device is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the clinical studies on retrieval, the "ground truth" is the observed clinical outcome of the retrieval procedure (e.g., successful retrieval, time to retrieval, filter capture and redeployment). It is not based on expert consensus, pathology, or separate outcomes data in the traditional sense of diagnostic studies. The safety and effectiveness are derived directly from the reported performance in patient cases.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The term "training set" is typically used for developing algorithms. In this context, the device's design, materials, and initial performance (in-vitro, animal testing) would constitute the development and validation phase, prior to clinical testing.

9. How the Ground Truth for the Training Set was Established

As there's no mention of a "training set" in the context of an algorithm, this question is not applicable. The development and design of the physical device would have been guided by engineering specifications, material science, and pre-clinical testing, rather than a "ground truth" derived from patient data in a training set.

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