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The ClotTriever Thrombectomy System is indicated for:

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

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.

The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

The provided text is a 510(k) summary for the Protrieve Sheath, a medical device. It details the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to a predicate device.

Crucially, this document states: "Clinical testing was not required to support substantial equivalence." This means there was no clinical study involving human subjects for this specific submission to prove the device meets performance criteria, especially as it relates to AI/machine learning performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device, as the provided document does not pertain to an AI/ML device or a clinical study for performance.

The acceptance criteria mentioned in the document relate to the non-clinical (engineering and material) testing of the physical device to demonstrate mechanical and material properties are consistent with the predicate device, not performance benchmarks for an AI algorithm.

If you would like to know about the non-clinical acceptance criteria and the tests performed for this specific device, I can provide that information based on the text. However, it will not involve AI/ML performance, ground truth, expert consensus, or clinical effectiveness studies in the way your prompt describes.

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The Triever20 Curve is used coaxially within the Triever24 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 Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters.

The Triever20 Curve is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism.

The Triever20 Curve Catheter is inserted through the Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Vacuum syringe. After the procedure is complete, the Triever Catheters are removed from the patient.

The provided text describes a 510(k) premarket notification for the Triever20 Curve Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an algorithm or artificial intelligence (AI).

Therefore, I cannot provide information on acceptance criteria and a study proving a device meets those criteria in the context of AI performance. The information requested regarding AI performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is not present in the provided document.

Instead, the document details non-clinical testing performed to demonstrate that modifications to the Triever20 Curve Catheter did not change its intended use or fundamental scientific technology, thereby demonstrating substantial equivalence to the predicate device (Inari FlowTriever Retrieval/Aspiration System, K191710).

Here's the relevant information about the acceptance criteria and the study performed, based only on the provided text, but explicitly noting its non-AI context:

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 the quantitative acceptance criteria for each test or the specific numerical performance results. It lists the types of tests performed.

Specific tests conducted (implying the acceptance criteria for each were met):

• Package Integrity Inspection
• Visual & Dimensional Inspection
• Guidewire and Dilator Compatibility Verification
• Triever20 Curve Dilator Insertion and Removal
• Triever20 Curve Insertion into Triever24 and Retraction
• Triever20 Curve Rotation inside Triever24
• Triever20 Curve recovery angle
• Kink Radius
• Torque Test 1
• Torque Test 2
• Resistance to collapse under vacuum
• Determination of Flowrate Through Catheters & Dilator Burst Testing – Triever20 Curve Catheter
• Clot Burden Removal Validation
• Simulated Use and Tensile Testing - Torque
• Simulated Use and Tensile Testing - Tensile
• Simulated Use and Tensile Testing – Triever20 Curve Dilator
• Particulate Matter Determination

Tests leveraged from K173672 (implying acceptance criteria for these were also met):

• Pouch Seal Visual Inspection and Dye Penetration
• Pouch, Peel, Seal Strength
• Test Conical Fittings with 6% Luer taper
• Corrosion Resistance
• No air bubbles from fluid drawback
• Hemostasis
• Priming of the system
• Snap fit
• Sufficient vacuum
• Pyrogenicity
• Device Insertion
• Luer Lock Connection
• Dilator: Hub to Shaft attachment; Proximal shaft to Distal shaft attachment; Tip to Shaft attachment
• Hub and Catheter Leakage
• Dilator Burst

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

• Sample size: Not explicitly stated for each test. The document mentions "verification and validation testing" and "test results" in general but does not provide specific numbers of devices or tests conducted for each category.
• Data provenance: N/A, as this refers to non-clinical, in-vitro/benchtop testing of a physical medical device, not data for an AI algorithm.

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

• Not applicable. This was non-clinical engineering and performance testing of a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

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

• Not applicable. This refers to adjudication of expert opinions for AI ground truth, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not the subject of this document.

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

• No, a standalone algorithm performance study was not done. The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on established engineering and material specifications, regulatory standards, and the physical performance observed during the benchtop and in-vitro tests (e.g., flow rate measurements, tensile strength, burst pressure, clot removal efficacy in a simulated environment). It is not pathology, outcomes data, or expert consensus in an AI context.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI algorithm that would require a training set.

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

• Not applicable. No training set was used for an AI algorithm.

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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 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 ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of soft thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.

The ClotTriever Thrombectomy System underwent non-clinical testing to demonstrate substantial equivalence to its predicate device, specifically ClotTriever Thrombectomy System (K173470). The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels and for the injection/aspiration of fluids in the peripheral vasculature.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text lists numerous tests conducted to ensure the device's performance meets established specifications. For each test, the "reported device performance" is a blanket statement indicating that: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

Without specific numerical or qualitative results for each individual test, a detailed table with specific acceptance criteria and performance metrics cannot be generated. However, the types of tests conducted serve as proxies for the acceptance criteria for various aspects of the device's functionality and safety.

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

The provided information focuses on non-clinical testing (e.g., bench testing, mechanical tests). There is no information provided regarding a "test set" in the context of patient data.

• Sample Size: Not applicable for a clinical test set as no clinical testing was performed for this submission. For the non-clinical tests, specific sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were used to meet the verification and validation requirements.
• Data Provenance: Not applicable for a clinical test set. For the non-clinical tests, the data provenance is from the manufacturer's (Inari Medical) internal testing.

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

This information is not applicable as the submission states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no clinical ground truth was established by experts for a test set in this context.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication was utilized.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This implies no human-in-the-loop performance evaluation or comparison with AI assistance.

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

This information is not applicable. The ClotTriever Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the non-clinical testing conducted, the "ground truth" used was established product specifications, engineering standards, and the performance of the predicate device (K173470). In other words, the device's performance was compared against predetermined acceptance criteria derived from its design requirements and the known characteristics of equivalent devices.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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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