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The Recovery Filter System is 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 filter may be removed according to the instructions supplied in the Section labeled: Optional Procedure for Filter Removal. Data from removals in a 58 patient study suggests that the device can be safely removed (mean of 60 days; range 1-161 days).

The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches.

The provided text indicates that the Recovery Filter System is "identical to the cited predicate device with the exception of the removal of labeling limitations and the addition of specific instructions to allow for safe removal of the device." Therefore, the primary acceptance criterion is safe removal of the device.

Here's the information about the study that proves the device meets this acceptance criterion, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 58 patients.
• Data Provenance: Clinical testing. The document doesn't specify the country of origin, but it's presented in a US FDA submission, implying compliance with US regulatory standards. It's a prospective study as it involves the removal of the device in these patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study focuses on the "confirmatory experience" of patients regarding the safety of removal, implying observational data rather than a judgment based on a specific ground truth as would be established by experts for diagnostic performance.

4. Adjudication method for the test set:

This information is not provided in the document. Given the nature of the study (safety of device removal), an adjudication method in the form of multiple expert reviews might not have been directly applicable. The "safety" would likely be assessed through clinical outcomes and adverse events.

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 was not a MRMC comparative effectiveness study. The device is an intravascular filter, not an AI-assisted diagnostic tool.

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

This was not a standalone performance study. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The ground truth for the safety of removal was based on clinical outcomes and observations in patients, specifically the successful and safe retrieval of the filter, as well as the absence of unacceptable risks. Animal testing (including histology) also contributed to the safety assessment.

8. The sample size for the training set:

This information is not applicable/not provided. The study described is a clinical validation of device safety, not a machine learning model, and therefore does not have a "training set" in that context. There were "animal and clinical testing" which would have informed the device design and instructions for removal, but these wouldn't be referred to as a "training set" in this context.

9. How the ground truth for the training set was established:

This information is not applicable/not provided as there is no "training set" in the context of device approval for an intravascular filter. Safety was established through a combination of animal and clinical testing.

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The Recovery™ Filter System is 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 anticoagulation 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.

The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches. The filter consists of twelve, shape memory nitinol wires emanating from a central nitinol sleeve. The wires form two levels of filtration: six arms and six legs. The delivery system is used to place the filter into the inferior vena cava.

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Bench testing was performed per the FDA guidance document, 'Guidance for Cardiovascular Intravascular Filter 510(k) Submission'". However, it does not provide specific details on the sample size used for the test set during this bench testing. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for this bench testing is not specified.

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

This information is not provided in the document. The study described is bench testing, which typically involves engineering and material science evaluations rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document. As stated above, the study is bench testing, not clinical evaluation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on bench testing for substantial equivalence.

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

The device is a physical medical device (vena cava filter) and not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance evaluated was the physical characteristics and function of the filter.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" would be engineering specifications, material properties, and performance benchmarks established by the FDA guidance document for cardiovascular intravascular filters. The device's performance was compared against these established standards and the characteristics of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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