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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 six Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone 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.

This 510(k) is submitted to support a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.

The provided text is a 510(k) summary for the Sentry Inferior Vena Cava Filter, specifically concerning a modification to its Introducer Sheath. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets clinical acceptance criteria for its intended use through human studies.

Therefore, the information required to answer your prompt, particularly regarding multi-reader multi-case (MRMC) studies, expert ground truth, and comprehensive performance data for an AI/algorithm-based device, is not available in this document. This document describes a medical device, an IVC filter, which is a physical implant used to prevent pulmonary embolism, not a diagnostic AI or imaging device that would typically undergo the types of studies you are asking about.

However, I can extract the acceptance criteria and performance data for the specific modification described in this 510(k) submission:

The acceptance criteria here pertain to the Introducer Sheath of the delivery system, not the filter itself or its clinical efficacy in preventing PE. The study proves the modified Introducer Sheath functions equivalently to the previous version.

Here's what can be extracted from the provided text regarding the Acceptance Criteria and the study for the modified Introducer Sheath:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document confirms that all tests "met the pre-determined acceptance criteria," but it does not specify the quantitative values for these criteria (e.g., specific pressure limits for integrity, flow rates for patency) or the exact numerical results obtained.

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

• Sample Size: Not explicitly stated. The document refers to "Bench studies" and "design verification program," implying a laboratory setting with test articles.
• Data Provenance: The studies were undertaken as part of Novate Medical Ltd.'s design verification program. Location is likely Ireland, where the submitter is based. The data is prospective in the sense that it was generated specifically for this submission to assess the design modification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device modification, and the "ground truth" for its performance (integrity, patency) would be established through engineering specifications and objective measurements, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Performance was assessed via objective bench testing against pre-determined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. This document describes a physical medical device.

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

Not applicable. This is a physical medical device, not an algorithm. Bench tests were performed on the device itself.

7. The Type of Ground Truth Used

The ground truth was based on engineering specifications and measurable physical properties (e.g., material strength, dimensions, fluid flow characteristics) of the Introducer Sheath.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical device modification and bench testing for substantial equivalence.

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

Not applicable.

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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 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.

Here's an analysis of the provided text regarding the Sentry Inferior Vena Cava Filter's acceptance criteria and the study proving its compliance, framed within your requested structure.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's comprehensive clinical trial results. Therefore, details regarding extensive clinical studies with specific performance metrics against pre-defined acceptance criteria (especially for a new AI/software device, which this is not) are limited. The information primarily pertains to bench testing and biocompatibility.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various evaluations performed but does not explicitly state quantitative acceptance criteria or specific performance values for the modified Sentry IVC Filter. It generally states that "All tests met the pre-determined acceptance criteria." and that "Test results demonstrate that the modified device meets the established specifications and is comparable to the predicate device."

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench studies" and "design verification results."
• Data Provenance: The data is generated from bench studies and biocompatibility evaluations within the context of the manufacturer's design verification and validation program. This is not human patient data. There is no mention of country of origin for this testing, but the submitting company is based in Galway, Ireland, implying the testing was likely overseen by them or conducted by their chosen labs. The data is retrospective in the sense that the testing was performed to validate a modified device against pre-existing standards.

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

• This question is not applicable in the context of this 510(k) summary. The document describes bench testing and biocompatibility studies for a physical medical device (Inferior Vena Cava Filter), not an AI/software device that requires expert-established ground truth from images or clinical data. The "ground truth" for these tests would be the physical properties and performance measured against engineering specifications, often established by engineers and scientists, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials or studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a gold standard. The tests mentioned here are primarily objective, quantitative engineering and laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

• This question is not applicable. The device is a physical medical implant (an IVC filter), not an AI system. Therefore, no MRMC study or AI-assisted human reader improvement analysis would have been conducted or applicable for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" refers to pre-established engineering specifications, material properties, and performance standards (e.g., specific dimensions, fatigue limits, corrosion resistance measured in a lab, and successful deployment as per design).
• For biocompatibility, the ground truth is based on international standards (ISO 10993 series) and regulatory guidance from the FDA, evaluating the biological response of materials.

8. The Sample Size for the Training Set

• This question is not applicable. This refers to a physical medical device, not a machine learning model that requires a training set.

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

• This question is not applicable, as there is no training set for a physical medical device.

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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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