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The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, in the following situations:

· Pulmonary thromboembolism when anticoagulants are contraindicated;

· Failure of anticoagulant therapy in thromboembolic diseases;

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.

The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).

The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone that is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.

The provided text describes the Sentry Inferior Vena Cava Filter and summarizes the performance data used to support its 510(k) submission. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the pre-determined acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed. Without specific numerical or qualitative targets, a detailed table cannot be created.

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

• Clinical Study Test Set Sample Size: 129 subjects.
• Data Provenance: Prospective, multi-center, single-arm clinical study. The document does not specify the country of origin, but generally, FDA submissions involve studies conducted in various countries, potentially including the US or Ireland (where the submitter is based).

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

The document does not specify the number of experts used to establish the ground truth for the clinical study's endpoints or their specific qualifications. Clinical studies typically involve physicians and other healthcare professionals at investigational centers who assess patients and determine clinical outcomes. These would be considered the "experts" for clinical ground truth.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) for the clinical study's endpoints. In multi-center clinical trials, independent adjudication committees are common for critical endpoints, but this is not mentioned.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an IVC filter, not an AI-powered diagnostic tool. The clinical study focused on the device's physical performance, safety, and effectiveness in patients.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not conducted as this is a medical device (an IVC filter), not an algorithm or AI software.

7. Type of Ground Truth Used (Clinical Study)

For the clinical study, the ground truth was based on clinical outcomes data from patients, assessed by healthcare professionals (investigators) at 23 investigational centers. This included:

• Technical success of placement.
• Occurrence of symptomatic pulmonary embolism (PE).
• Occurrence of IVC filter-related complications (e.g., tilting, migration, embolization, fracture, perforation, death).

8. Sample Size for the Training Set

The document does not specify a training set size. This is a medical device, and the evaluation involved pre-clinical (bench and animal) testing and a clinical trial. The term "training set" is typically used for machine learning models, which is not applicable here.

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

Not applicable, as there was no "training set" in the context of machine learning. The clinical performance was assessed prospectively based on patient outcomes. For pre-clinical studies (bench and animal), "ground truth" would be established by direct observation, measurement, and histological analysis of the devices and biological responses according to established experimental protocols and standards.

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