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The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

• FLOWRUNNER Aspiration Catheter
• FLOWRUNNER Aspiration Sheath
• Vacuum Fitting
• High Flow Stopcock Connector
• Y-Connector with Hemostatic Valve
• Hand Actuator Clip

The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The system has demonstrated compatibility with standard vascular implants, including stents and filters. It is a single use, over-the-wire, catheter-based system with the ability to infuse fluid. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 12F, 14F compatible diameters and 60cm, 80cm, 100cm and 120cm lengths.

The provided FDA 510(k) clearance letter and summary for the FLOWRUNNER Aspiration System are for a medical device (an embolectomy catheter), not an AI/ML powered device. As such, the document does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study design for AI performance, ground truth, or expert involvement in classification.

The information provided focuses on the FLOWRUNNER Aspiration System's equivalence to a predicate device (ICE Aspiration System) for its intended use in removing emboli and thrombi from peripheral vessels. The "performance data" section refers to bench testing, which is standard for hardware medical devices, not AI/ML performance metrics.

Therefore, I cannot extract the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth establishment, or training set size. This document does not describe a study involving AI/ML.

Here's a summary of what information can be extracted from the document, related to its non-AI performance claims:

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

The document summarizes the performance testing generically as "Bench testing was performed to support a determination of substantial equivalence to the predicate." It lists the types of bench tests conducted but does not provide specific acceptance criteria values or detailed reported performance results against those criteria.

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

Not applicable, as this refers to bench testing on physical components, not a clinical test set with patient data.

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

Not applicable. Ground truth for clinical data is irrelevant to bench testing of a hardware device.

4. Adjudication method for the test set:

Not applicable.

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. This device is not AI-powered, so no such study was conducted or is relevant.

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

No. This device is not an algorithm. Bench testing evaluates the physical device's performance.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For the bench testing, the "ground truth" would be engineering specifications and validated test methods to assess the physical device's capabilities (e.g., ability to capture thrombus in a model, compatibility with stents).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.

Based on the provided text, the device in question is the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System. This is a medical device, not an AI/ML powered device, therefore no acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC, human reader studies etc.) are mentioned.

The information provided describes the regulatory submission for premarket notification (510(k)) of a medical device, asserting its substantial equivalence to a legally marketed predicate device. The document details the physical and functional characteristics of the device and how they compare to the predicate, as well as the non-clinical testing performed.

Therefore, the specific information requested in the prompt about acceptance criteria and study proving AI/ML device performance (e.g., acceptance criteria for AI performance metrics, sample size for test sets, expert adjudication, MRMC studies, standalone AI performance, ground truth establishment for AI models, training set details) is not applicable to this document as it pertains to a mechanical medical device, not an AI/ML powered one.

However, I can extract the general acceptance criteria and the type of study performed to prove this mechanical device meets its intended use, based on the non-clinical testing conducted.

Acceptance Criteria and Study for the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System

Given that the device is a mechanical thrombectomy system and not an AI/ML powered device, the "acceptance criteria" discussed in this document relate to the performance and safety of the physical device compared to its predicate, rather than AI-specific metrics. The "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance (Non-Clinical)

While an explicit, quantifiable table of acceptance criteria for performance metrics is not provided in a format typical for AI/ML devices, the document states that all necessary verification steps met "pre-determined acceptance criteria" to demonstrate substantial equivalence. The reported performance refers to the device passing simulated use tests.

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

• Sample Size for Test Set: The document mentions "non-clinical testing" and refers to "test units" without specifying precise numerical sample sizes. This typically refers to a number of physical device units tested in a lab setting.
• Data Provenance: The data is generated from non-clinical bench testing rather than patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable. It's laboratory-generated data.

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

• Not Applicable. As this is a mechanical device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The "ground truth" for performance is based on direct physical measurements, simulations, and engineering specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set, as this is bench testing of a physical device. Performance is objectively measured against specifications.

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

• No. An MRMC study is not mentioned because this is a mechanical device, not an AI/ML diagnostic system intended to assist human readers with interpretation.

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

• Not Applicable. This is a mechanical medical device, not an algorithm, so independent algorithmic performance is not relevant.

7. The Type of Ground Truth Used:

• For this mechanical device, the "ground truth" for performance and substantial equivalence is established through:
  • Bench Testing: Direct physical measurements, engineered simulations (e.g., simulated vessels, simulated thrombi), and performance against predefined engineering specifications.
  • Regulatory Standards: Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility) and FDA guidance for medical device testing.
  • Predicate Device Performance: The predicate device itself serves as a "ground truth" benchmark for demonstrating substantial equivalence in function and safety.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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The Cannula is indicated for:
· the non-surgical removal of thrombi or emboli from the vasculature
· aspiration of contrast media and other fluids from the vasculature

The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:

• . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
• AlphaVac Sheath (22F)
• AlphaVac Obturator (17F) ●
• AlphaVac Handle .
• . Waste Bag and Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided text describes the 510(k) summary for the AngioDynamics AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. While it details the device and its intended use, it does not explicitly provide information on acceptance criteria for an AI/ML-based medical device, nor does it present a study proving the device meets AI/ML specific acceptance criteria. This document describes a traditional medical device (a catheter system) and its performance through bench testing and a clinical trial.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving the device meets them from the provided text.

Here's why and what information is available:

• Device Type: The AlphaVac MMA F1885 System is described as a "single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot." This is a physical, mechanical medical device, not an AI/ML software device.
• Performance Data (K): This section refers to "Comprehensive bench testing (integrity and functional performance)" and lists various engineering and mechanical tests (Dimensional Testing, Tensile Testing, Fluid Volume Removal, etc.). These are typical tests for a physical medical device.
• Clinical Testing (L): This section describes the APEX-AV trial, a multicenter pivotal study to assess the use of the device in subjects with acute intermediate-risk pulmonary embolism. The primary safety endpoint was the rate of major adverse events (MAEs), and the primary effectiveness endpoint was the reduction in RV/LV ratio. These are standard clinical trial endpoints for a physical medical device.

To answer your request, if this were an AI/ML device, the information would typically include:

1. AI/ML Specific Acceptance Criteria: Metrics like sensitivity, specificity, AUC, F1 score, precision, recall, positive predictive value (PPV), negative predictive value (NPV), often with specific thresholds (e.g., "Sensitivity must be >= 90%").
2. Study Design for AI/ML Evaluation:
   • Test Set Details: Sample size, data provenance (e.g., patient demographics, imaging modalities, data type like CT scans, X-rays), and whether it was retrospective or prospective.
   • Ground Truth Establishment: Number and qualifications of experts, the adjudication method (e.g., 2+1, 3+1 for consensus), and the nature of the ground truth (e.g., expert consensus, pathology, clinical outcomes).
   • MRMC Study: Whether a multi-reader multi-case study was performed, and its findings on human reader improvement with AI assistance.
   • Standalone Performance: Specific metrics for the algorithm-only performance.
   • Training Set Details: Sample size and how ground truth was established for the training data.

Since this document pertains to a mechanical medical device, none of the above AI/ML specific details are present.

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The JETiTM Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics with or without vessel occlusion.

The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTM Saline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

The JETi Catheter has two (2) lumens. The primary lumen (largest) is a conduit for thrombus aspiration. A secondary lumen, placed within the primary lumen, delivers saline through an orifice to break up and dilute the aspirated thrombus and facilitates rapid movement of the aspirate towards the vacuum. One (1) radiopaque (RO) marker band is located stiff proximal section which transitions to a more flexible distal section with a round, soft tip. A filter is incorporated into the catheter connector to ensure that no debris or foreign material is injected into the patient vasculature. The JETi Catheter is available in two sizes: 6 French size (6F) and 8 French size (8F). The JETi Pump Set is intended to deliver a high pressure sterile saline stream to the JETi Catheter. The pressure for the saline stream is created through the cassette's piston assembly, which snaps into the SDU.

The JETi Saline Drive Unit (SDU) is a non-sterile reusable, (multiple patient, multiple use) device that incorporates the saline pumping components and the vacuum pump within a single enclosure. The fork drive of the SDU is designed to run the JETi Pump Set piston assembly to deliver a stream of saline to the JETi Catheter when activated by the handheld switch if the vacuum is present. In conjunction with the JETi Pump Set, the SDU can sub selectively infuse / deliver diagnostics or therapeutic fluids when utilizing the optional HYPER PULSETM Fluid Delivery feature. The JETi Suction Tubing is a sterile single use device that incorporates the pressure monitoring sensor and valve into a single enclosure, that is in-line with the aspiration lumen, for the handheld switch. When the handheld switch is activated, within the aspiration lumen, the diluted thrombus and saline is then drawn back through the primary lumen of the JETi Catheter and deposited into the vacuum source (JETi Non-sterile Canister Set) via the JETi Suction Tubing. When the handheld switch is de-activated, a valve closes, stopping the flow of thrombus, and a relief valve inside the SDU briefly opens and closes to reduce foaming at the vacuum source (JETi Non-sterile Canister Set). The SDU contains a microprocessor-controller circuit board and firmware that monitors various functions of the motor and vacuum to ensure that the device is functioning as expected. A Liquid Crystal Display (LCD) screen on the front panel of the SDU indicates to the user the status of the system. Several safety features are incorporated into the firmware to ensure proper functionality. The SDU is supported by a mobile, height adjustable cart with an integrated IV pole. Energy is provided by a 24-volt external power supply, which is connected to the main supply. The external power supply is provided with the SDU and is part of the system

The provided text is a 510(k) summary for the JETi™ Hydrodynamic Thrombectomy System, which is a medical device for removing thrombus from peripheral vasculature. This document focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, information regarding acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies are not available in this document.

The document primarily details the device's technical specifications and compares them to predicate devices to establish substantial equivalence for regulatory clearance. It also mentions non-clinical testing for areas like packaging, human factors, and electromagnetic compatibility (EMC).

Here's a breakdown of the information that is available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of clinical acceptance criteria and device performance as would be seen in a study evaluating diagnostic accuracy or clinical outcomes. Instead, it focuses on non-clinical testing and substantial equivalence to a predicate device.

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

• Not Applicable / Not Provided for clinical performance. The document explicitly states "No clinical testing is provided in this pre-market notification."
• For non-clinical testing:
  • Packaging Validation: The sample size is not specified, but the data provenance would be internal Abbott testing.
  • Human Factors Evaluation: The sample size (number of users) is not specified, but the data provenance would be from the human factors study conducted by Abbott.
  • EMC Testing: The sample size is not specified (typically one or a few devices tested), and the data provenance would be from laboratory testing conforming to IEC standards.

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

• Not Applicable / Not Provided. This information is relevant for clinical studies involving expert interpretation for ground truth, which were not part of this submission.

4. Adjudication method for the test set:

• Not Applicable / Not Provided. This information is relevant for clinical studies that involve multiple readers and potentially discrepancies in their assessments for ground truth, which were not part of this submission.

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. The document explicitly states "No clinical testing is provided in this pre-market notification." This device is a physical thrombectomy system, not an AI-assisted diagnostic or treatment planning tool for which MRMC studies would typically be conducted.

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, so "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used:

• Not Applicable / Not Provided for clinical performance. For the non-clinical tests mentioned:
  • Packaging Validation: Ground truth is based on established ASTM standards and internal product specifications.
  • Human Factors Evaluation: Ground truth relates to adherence to human factors principles and user understanding, evaluated through methods like usability testing.
  • EMC Testing: Ground truth is defined by the limits and methodologies specified in the IEC 60601-1-2 standard.

8. The sample size for the training set:

• Not Applicable / Not Provided. This device is not an AI/ML algorithm that would typically use a "training set."

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

• Not Applicable / Not Provided. As this is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply.

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The Cannula is indicated for
- · the non-surgical removal of thrombi or emboli from venous vasculature.
- · aspiration of contrast media and other fluids from venous vasculature.

The Cannula is intended for use in the venous system.

The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:

• . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
• AlphaVac Sheath (22F)
• AlphaVac Obturator (17F) ●
• AlphaVac Handle .
• . Waste Bag and Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided document is a 510(k) Premarket Notification from the FDA for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. It describes the device, its indications for use, and the studies performed to demonstrate its substantial equivalence to a predicate device.

There is no information in this document related to any AI/ML model, ground truth, expert readers, or retrospective/prospective studies on patient data. This document focuses on the mechanical and functional performance of a medical device (aspiration catheter) and its substantial equivalence to a predicate device.

Therefore, I cannot provide a response that includes information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device. The request specifically asks for details pertinent to AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.), which are not present in this document.

The document outlines the following performance data to support substantial equivalence for the device itself (not an AI/ML component):

Acceptance Criteria and Device Performance (Mechanical/Functional Device)

The document states that "Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA F1885 System met all specified design and performance requirements below."

The acceptance criteria are implied to be the successful demonstration that the device performs according to its design and functional requirements. The reported device performance is that it "met all specified design and performance requirements."

Non-Applicable AI-Specific Information from the Document:

The following points are not addressed or are not applicable based only on the provided text, as the document describes a mechanical medical device, not an AI/ML system:

• Sample size used for the test set and data provenance: No information on patient data test sets as it's a mechanical device.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a mechanical device.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a physical medical device (aspiration catheter) based on a demonstration of substantial equivalence through bench testing, biocompatibility, and sterilization validation, not an AI/ML product.

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The JETi AIO Peripheral Thrombectomy System is intended to:

• remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
• subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi All In One (AIO) Peripheral Thrombectomy System consists of one catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Kit and Sterile Kit are supplied for user convenience. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. Infusion is achieved by activating the Hyper Pulse® rocker switch. When in Hyper Pulse® mode, activating the handheld switch activates the SDU motor to infuse/deliver diagnostic or therapeutics to the targeted site. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart.

The provided text is a 510(k) Premarket Notification from the FDA, indicating the premarket clearance of the JETi AIO Peripheral Thrombectomy System by Walk Vascular, LLC.

However, the document does not contain information related to acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy, etc.), test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device approval.

Instead, this document describes a traditional 510(k) clearance based on substantial equivalence to a predicate device (JETi AIO Peripheral Thrombectomy System K201998). The evaluation primarily focused on:

• Device Description and Comparison: Detailing the components and comparing the new device (subject device) to the predicate device, highlighting key differences like the addition of a 6 Fr catheter size and a Hyper Pulse® rocker switch.
• Non-Clinical Performance Data: Summary of bench testing (e.g., catheter design verification, fluid flow rate, system leak testing, clot removal, electrical safety), indicating that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements."
• Biocompatibility and Sterilization: Stated that these tests were "not conducted, as the catheter and pump set materials/designs are identical/comparable to the predicate device."
• Transportation and Shelf Life: Not conducted for similar reasons or because the change (Hyper Pulse®) was deemed not to impact these.
• Pre-Clinical and Clinical Data: Explicitly states, "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/ML device, as this document pertains to a traditional medical device clearance where such metrics are not typically required or presented in this format.

The questions in your prompt (e.g., sensitivity, specificity, expert consensus, MRMC studies, training set details) are highly relevant to the clearance of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, which undergo a different type of evaluation process. This document describes the clearance of a mechanical thrombectomy system, not an AI/ML diagnostic or therapeutic device.

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The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit ASAPLP™ Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets

This document is a 510(k) premarket notification for a medical device (ASAP® Aspiration Catheter and ASAPLP™ Aspiration Catheter). The document does not describe a study that proves the device meets specific performance acceptance criteria for an AI/ML or diagnostic application.

Instead, this 510(k) notification focuses on demonstrating substantial equivalence to a predicate device. The "Performance Data" section primarily addresses biocompatibility and bench testing related to the physical integrity and safety of the catheter, rather than clinical or diagnostic performance criteria as you might see for an AI/driven device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, human reader improvement with AI, ground truth, or training/test set data because this type of information is not present in the provided text.

The document states:

• "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." (Page 5)
• Performance testing was "conducted based on the risk analysis and based on the requirements of the following international standards" related to biocompatibility and physical characteristics (ISO 10555-1, ISO 80369-7, ISO 10993 series, USP 43-NF 37). (Page 5-6)
• "The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." However, the specific quantitative acceptance criteria for "safety and efficacy" related to the device's function (e.g., thrombus removal capabilities) are not detailed, nor is there a study described as you might see for a diagnostic AI. (Page 6)

The document is a regulatory submission for a physical medical device (catheter) based on substantial equivalence, not a performance study of a diagnostic or AI-powered device.

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The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral vasculature.

Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.

Apologies, but the provided text from the FDA 510(k) Premarket Notification for the Thrombuster II Aspiration Catheter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria from the perspective of an AI/ML medical device.

The document describes the physical medical device (a catheter for removing thrombi) and its substantial equivalence to a predicate device based on engineering performance testing (trackability, dimensional verification, aspiration performance).

Therefore, I cannot fulfill your request to populate the table or answer the questions related to AI/ML device acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies. The content simply does not address these topics as it is about a non-AI medical device.

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The Cannula is indicated for
· the non-surgical removal of thrombi or emboli from vasculature.
· aspiration of contrast media and other fluids from vasculature.
The Cannula is intended for use in the venous system.
The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together:

• a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
• . AlphaVac Sheath
• . AlphaVac Obturator
• AlphaVac Handle
• Waste Bag and Tubing
  The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e. Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured within the waste bag for disposal. Target vessels for include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.

The provided text is a 510(k) summary for the AlphaVac Multipurpose Mechanical Aspiration (MMA) System. It details information typically included in a regulatory submission for medical devices to prove substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria for device performance studies, nor does it describe a study that explicitly demonstrates the device "meets" those acceptance criteria in the way a clinical trial or a performance study with defined endpoints would.

Instead, the document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization, and a comparison of technological characteristics with a predicate device. It briefly mentions "Previous animal studies also contributed to demonstrating substantial equivalence," but no details on the study design, acceptance criteria, or results are provided.

Therefore, many of the requested pieces of information cannot be extracted from the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Device Performance for AlphaVac Multipurpose Mechanical Aspiration (MMA) System

The provided 510(k) summary does not explicitly list acceptance criteria in terms of specific performance thresholds for a study designed to prove the device meets those criteria. Instead, it outlines a series of tests performed to support substantial equivalence to a predicate device (FlowTriever Retrieval/Aspiration System). The "reported device performance" is described as successfully meeting "all specified design and performance requirements" for these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not provided, this table will summarize the types of tests performed and the general outcome as stated in the document.

2. Sample size used for the test set and the data provenance:
The document refers to "comprehensive bench testing" and "previous animal studies." However, no specific sample sizes for these tests are provided. Data provenance is not explicitly stated beyond "performed by AngioDynamics and independent test houses" for sterilization/shelf life and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical engineering and biological tests, not a clinical study with expert-established ground truth. Human Factors/Usability Evaluation was performed, which would typically involve users, but the details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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 not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical aspiration device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO, FDA guidance). For biocompatibility, it's ISO 10993 standards. For animal studies, the ground truth would be based on physiological observations and post-mortem analysis.

8. The sample size for the training set:
Not applicable. This refers to a medical device's non-clinical performance and substantial equivalence, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable.

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