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The FlowTriever Retrieval/Aspiration System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.

This document is a 510(k) summary for a medical device (FlowTriever Retrieval/Aspiration System) and describes updates to its indications for use. It is not a study report proving the device meets acceptance criteria through performance evaluation.

Therefore, I cannot provide the requested information as the document does not contain a study that demonstrates device performance against specific acceptance criteria.

The submission focuses on a modification to the contraindications for the device, specifically removing "chronic clot" from the examples of material not to be removed. The core of this 510(k) summary is to demonstrate that this change does not raise new questions of safety or effectiveness compared to the predicate device.

The document explicitly states:

• "Non-Clinical Testing Non-clinical testing was not required to support the change to the contraindications."
• "Clinical Testing No clinical data was required to support the change to the contraindications."

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Triever Catheters are indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are also intended for use in transit in the right atrium, but not in conjunction with FlowTriever Catheters.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately: Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr) FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15- 18 mm, and 19-25 mm) Triever Catheters are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.

The provided document is a 510(k) summary for the Triever Catheters. It describes a device modification to include "clot in transit in the right atrium" in the Indications for Use (IFU) statement. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in a quantitative manner typical of performance studies for AI software.

However, based on the information provided, we can extract the following:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Clinical data was collected and evaluated for 47 patients.
• Data Provenance: The nature of the study (evaluating use of Triever Catheters in the right atrium from approximately 7,650 venous thromboembolism procedures performed) suggests this data is retrospective, compiled from existing patient records where the device was used in this specific scenario. The country of origin is not specified, but the submission is to the FDA, suggesting a US context or data relevant to US regulatory standards.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The assessments appear to be based on clinical outcomes and "Inari Account Managers' assessment of clinician satisfaction."

4. Adjudication method for the test set

The document does not describe an adjudication method. The clinical data appears to be a review of outcomes from actual patient cases.

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

No, an MRMC comparative effectiveness study was not done. This study is focused on the safety and effectiveness of a medical device (catheter) for a specific indication, not on the performance of an AI algorithm or human reader improvement with AI assistance.

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

No, this document describes a medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for effectiveness (clot removal) appears to be based on outcomes data from patient treatments and possibly clinical assessment during or after the procedure. For safety, it relies on the absence of reported adverse events like heart damage.

8. The sample size for the training set

This document does not describe the development or training of an algorithm, so there is no mention of a training set sample size.

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

Not applicable, as no algorithm training set is described.

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The FlowTriever2 Catheter is indicated for:

• · The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The FlowTriever2 Catheter is intended for use in the peripheral vasculature.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever2 Catheter

The FlowTriever2 Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding disk(s) are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever2 Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever2 Catheter are removed from the patient.

The provided text does not describe a study involving an AI/Machine Learning device or any associated acceptance criteria for such a device. The document is an FDA 510(k) clearance letter for the FlowTriever Retrieval/Aspiration System, a medical device used for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

The acceptance criteria and study described in the document relate to the mechanical and functional performance of the medical device itself, not to the performance of an AI algorithm.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies. The document only mentions "Non-Clinical Testing" and "Animal testing" that met predetermined acceptance criteria for the physical device.

Here's what can be extracted from the document regarding the device's acceptance:

The "Non-Clinical Testing" section describes the verification and validation tests performed to support the substantial equivalence of the modified FlowTriever Retrieval/Aspiration System. These tests demonstrated compliance with relevant product specifications and met predetermined acceptance criteria.

A table of the acceptance criteria (tests performed) and the reported device performance (met criteria) is as follows:

Regarding the other requested information for an AI study:

• Sample sized used for the test set and the data provenance: Not applicable. The document discusses in vitro and animal testing for a physical device, not an AI test set.
• Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device's mechanical performance is established through engineering specifications and quantifiable measurements, not expert consensus on image interpretation.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for an AI device. The document states "Clinical testing was not required for the determination of substantial equivalence" for this physical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For this physical device, the ground truth is based on engineering specifications, physical measurements, and performance benchmarks in controlled environments (e.g., in vitro and animal models).
• The sample size for the training set: Not applicable for this type of device submission.
• How the ground truth for the training set was established: Not applicable.

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The FlowTriever Retrieval/Aspiration System is indicated for:

• · The non-surgical removal of emboli and thrombi from blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)

The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.

The provided text describes a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System (K191710). This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data typically found in a clinical study report for an AI-powered device.

Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device are not applicable or cannot be extracted from this particular document.

However, I can extract information related to the device's performance based on the non-clinical testing performed to support substantial equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list specific numerical acceptance criteria or detailed performance metrics for each test. The tests performed are verification and validation tests to ensure the modified device meets specified requirements.

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

• Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved various non-clinical engineering and bench tests, as well as an animal study. The number of units or repetitions for each test is not provided.
• Data Provenance: The testing was "non-clinical testing" and "animal testing." No human data or specified country of origin for data is mentioned. It is implied the testing was conducted by the manufacturer, Inari Medical, Inc.

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

• Not Applicable. This document describes the evaluation of a medical device (embolectomy catheter) through non-clinical and animal testing, not an AI or imaging device requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

• Not Applicable. As above, the document details non-clinical and animal testing, not a study involving human readers or requiring adjudication for a test set in the context of AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This document does not mention any MRMC study or AI assistance. The device is a physical medical device.

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

• Not Applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• For Non-Clinical Tests: Engineering specifications, physical measurements, and performance standards.
• For Animal Testing: Observation of device safety and performance in an animal model.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device trained on a dataset.

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

• Not Applicable. As above, this is not an AI device.

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The FlowTriever Retrieval/Aspiration System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.

• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 2 sizes: 16 Fr and 20 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may also be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.

This document is a 510(k) Premarket Notification from the FDA regarding the Inari Medical FlowTriever Retrieval/Aspiration System (K191368). It is a submission for a device modification, specifically, providing a Large Bore 60 cc Syringe in the sterile package of the Triever16 catheter.

Based on the provided text, the device in question is a medical device, not an AI/ML powered device. As such, the typical acceptance criteria and study designs relevant to AI/ML device performance (like sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts, etc.) are not applicable here.

The 510(k) submission states:

• "Clinical testing was not required for the determination of substantial equivalence."
• "No modifications have been made to the previously cleared Triever16 nor the Large Bore 60 cc Syringe. Design verification for inclusion of the Large Bore 60 cc Syringe with the Triever16 was limited to packaging evaluation after simulated shipping."
• "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications."

Therefore, I cannot provide the detailed information requested for an AI/ML driven device based on this document. The acceptance criteria and performance data for this submission are focused on the safety and effectiveness of a physical medical device, specifically related to a change in packaging for an already cleared component, rather than the performance of an AI algorithm.

However, I can extract the general "acceptance criteria" and "device performance" in the context of this specific 510(k) submission, understanding that they relate to a non-AI device modification:

Acceptance Criteria and Study for K191368 (FlowTriever Retrieval/Aspiration System Modification)

Since this is a physical medical device and the submission pertains to a packaging change, the "acceptance criteria" and "device performance" relate to the physical integrity, sterility, and functionality of the device components as a result of that change, rather than diagnostic or analytical performance metrics typically associated with AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated numerically for the packaging evaluation or shelf-life testing. The document mentions "sample size for design verification testing" was determined based on "risk category" and "confidence/reliability percentages," which is standard for medical device testing but the specific number is not provided.
• Data Provenance: The studies were conducted by Inari Medical as part of their design verification and validation process for a 510(k) modification. The nature of the tests (packaging, shelf-life) implies laboratory-based or simulated environment testing, not patient data from a specific country. The studies are prospective in the sense that they were designed and executed to evaluate the specific modification.

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

• Not applicable. For a physical device modification focused on packaging and shelf-life, "ground truth" as established by medical experts (like radiologists for AI/ML) is not a relevant concept. The ground truth would be the objective physical properties and performance characteristics determined through engineering and materials testing (e.g., package seal integrity, sterility, burst strength, material degradation over time).

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in human expert assessments, typically in diagnostic or clinical settings. This is not relevant for the type of engineering and physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement with AI vs. without AI Assistance

• No. This is a physical medical device, not an AI/ML device. Therefore, no MRMC study was conducted or is relevant.

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

• Not applicable. This is a physical medical device. There is no algorithm to test standalone.

7. The Type of Ground Truth Used

• For this device modification, the "ground truth" was established through engineering specifications, physical testing standards, and established material science practices. It involves objective measurements and assessments of physical attributes like package integrity, material degradation, and maintenance of sterility, rather than clinical outcomes or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

• Not applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment in the context of machine learning.

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The FlowTriever Retrieval/Aspiration System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Not Found

This is an FDA clearance letter for a medical device, the FlowTriever Retrieval/Aspiration System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is provided here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The FlowTriever Retrieval/Aspiration System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of two main components packaged separately: Aspiration Guide Catheter FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Aspiration Guide Catheter to capture the targeted thrombus. Additional clot may also be removed by aspiration with the provided 60 cc syringe. After the procedure is complete, the Aspiration Guide Catheter and FlowTriever Catheter are removed from the patient.

The provided document is a 510(k) premarket notification for a medical device called the FlowTriever Retrieval/Aspiration System. It is not an AI/ML device, therefore, the information requested in the prompt, such as acceptance criteria and studies proving the device meets it, in the context of AI/ML, isn't directly applicable or present in this document.

However, I can extract information about the non-clinical testing performed to establish substantial equivalence for the modified device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document broadly states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide a specific table of acceptance criteria with corresponding performance values.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable as this is not an AI/ML device and therefore no "test set" in that context. The testing mentioned in the document is non-clinical performance and safety testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable as this is not an AI/ML device and therefore no "ground truth" establishment by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as this is not an AI/ML device.

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:

Not applicable as this is not an AI/ML device and no human reader studies are mentioned.

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

Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of AI/ML. For this medical device, the "ground truth" for its performance is established through adherence to engineering and safety specifications validated by the non-clinical tests listed.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device and therefore no "training set."

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

Not applicable as this is not an AI/ML device.

Information on Non-Clinical Testing (relevant to device performance):

The document mentions several non-clinical tests performed to support the substantial equivalence of the modified FlowTriever Retrieval/Aspiration System:

• Packaging Testing
• Leak Testing
• Vacuum Testing
• Tensile Testing
• Simulated Use Testing
• Accelerated 2-year shelf-life testing (specifically for the modification to the 60 cc syringe)

These tests were performed in accordance with a Design Failure Modes and Effects Analysis (DFMEA) and demonstrated compliance with relevant product specifications, indicating that all acceptance criteria were met.

Important Note: The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This further emphasizes that the device's performance was evaluated through non-clinical means for this 510(k) submission.

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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.

• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately:
Aspiration Guide Catheter
FlowTriever Catheter (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer Delivery Catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

The provided text details a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System, specifically for a modification to increase the diameter of the disks of the FlowTriever Catheter. The document does not describe an acceptance criteria table or a study proving the device meets specific performance criteria in the context of diagnostic accuracy, which would include metrics like sensitivity, specificity, or AUC usually associated with AI/ML devices.

Instead, the document focuses on non-clinical testing to ensure the modified device still functions as intended and is substantially equivalent to its predicate devices. The "acceptance criteria" here refers to whether the device meets its predefined engineering and safety specifications through various mechanical and material tests.

Here's an breakdown based on the provided text, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table with quantitative acceptance criteria and their corresponding reported performance values. It states generally: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

The types of tests performed indicate the areas where acceptance criteria would have been set:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each of the non-clinical tests. It refers to these as "verification and validation testing." The data provenance for such tests would typically be from in-house lab testing, not human patient data, and therefore country of origin in that context is not usually relevant. These are benchtop tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to the non-clinical testing described. "Ground truth" in the context of device function and safety for this type of submission is established by engineering specifications and industry standards, not by expert medical interpretation of images or patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for clinical studies or studies involving human assessment of data (e.g., image interpretation). This submission details non-clinical, benchtop testing.

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

Not applicable. This is a medical device for mechanical thrombus removal, not an AI/ML diagnostic tool. There is no mention of human readers or AI assistance.

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

Not applicable. This device is not an algorithm. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests would have been the engineering specifications and intended functional performance criteria established during the device's design and development, as well as adherence to relevant standards for biocompatibility and materials.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component to this device that would require a "training set."

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

Not applicable, as there is no training set for this device.

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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately: Aspiration Guide Catheter FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm) Retraction Aspirator The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, as it pertains to an AI/ML medical device. The document is an FDA 510(k) clearance letter for the Inari Medical FlowTriever Retrieval/Aspiration System, which is a physical medical device (an embolectomy catheter system), not an AI/ML-based device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for the test set or data provenance for an AI/ML model.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance results for an AI algorithm.
7. Type of ground truth used for an AI/ML study.
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The document focuses on demonstrating substantial equivalence of a modified version of the FlowTriever system to a previously cleared predicate device, based on the physical and functional aspects of the catheter system and leveraging prior non-clinical testing. It explicitly states: "The FlowTriever Retrieval/Aspiration System is identical to the version cleared under K173672. Appropriate rationales were provided to support that the testing provided under K173672 may be appropriately leveraged to support clearance of this device for the proposed intended use. Therefore, additional verification testing is not necessary to establish compliance to design specifications." This indicates that no new in vivo or in vitro performance studies, let alone AI/ML studies, were conducted for this specific 510(k) submission.

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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:
The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of pulmonary embolism. The system is comprised of three main components packaged separately:
● Aspiration Guide Catheter
● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm)
● Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

The provided text describes a 510(k) premarket notification for the FlowTriever Retrieval/Aspiration System. The information focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving the device meets specific acceptance criteria in the context of an AI/ML device.

However, based on the information provided, I can extract details about the clinical study conducted for the FlowTriever Retrieval/Aspiration System and present them as if they were acceptance criteria and performance data for a device, even though it's a medical device, not an AI/ML system.

Here's an attempt to structure the information as requested, interpreting the clinical study's endpoints as "acceptance criteria" for the device and its performance against those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the study "met the performance goals" but does not provide the specific numerical threshold for these goals or the exact numerical results obtained.

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

• Sample Size for Clinical Study (Test Set): 106 subjects
• Data Provenance: Prospective, single-arm, multicenter study. The country of origin of the data is not explicitly stated, but given the FDA submission, it is likely that the study was primarily conducted in the United States or included US sites.

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

This information is not provided in the document. The study evaluates the safety and effectiveness of a physical medical device (FlowTriever System) for treating acute pulmonary embolism (PE) by measuring clinical endpoints (MAE, RV/LV ratio), rather than assessing an AI's performance against expert-annotated ground truth. Therefore, the concept of "experts establishing ground truth for the test set" in the context of an AI/ML device is not directly applicable to this information.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the document. For clinical trials like this, adverse events and endpoint evaluations are typically adjudicated by clinical events committees (CECs) or independent core laboratories, but the specific method (e.g., 2+1, 3+1) is not detailed.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This submission is for a physical medical device (catheter system) for treating pulmonary embolism, not an AI/ML diagnostic or assistive device.

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

No, a standalone algorithm-only performance study was not done. This is a physical medical device, not an algorithm. The clinical study evaluated the device's performance in actual patients.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study described was based on clinical outcomes data from patients, including:

• Incidence of major adverse events (MAE), such as device-related death, major bleeding, and specific treatment-related adverse events.
• Measured physiological changes, specifically reduction in RV/LV ratio.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is a physical medical device. The concept of a "training set" typically applies to AI/ML models that learn from data. The device itself does not have a training set in this context. The clinical study mentioned (FLARE Study) served as the primary clinical validation (test set) for the device's safety and effectiveness.

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

This information is not applicable/not provided for the same reasons as #8.

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