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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 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 aspiration 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 Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. 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 for the JETi AIO Peripheral Thrombectomy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria based on patient outcomes or detailed performance metrics.

Specifically, the document 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." This means there isn't a study that directly proves the device meets acceptance criteria related to efficacy or clinical performance in a rigorous, quantitative manner as one might expect for a novel device or a device requiring a PMA.

The Summary of Non-Clinical Performance Data section only vaguely mentions: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not specify what those "acceptance criteria" were, nor does it present the "reported device performance" against those criteria.

Therefore, I cannot provide the requested information from the given text regarding the acceptance criteria and a study proving the device meets those criteria, as such a study with detailed reporting is explicitly stated as not having been conducted for this 510(k) submission.

To directly answer your request based on the provided text, I must state that the information is not available. The document focuses on demonstrating substantial equivalence to a predicate device, and the "studies" mentioned are largely bench testing and design validation, which are not detailed enough to fulfill your specific requirements about clinical performance or acceptance criteria as you've outlined them.

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The JETi 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 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set, one JETi Peripheral Saline Drive Unit (SDU), one Peristaltic Pump, and an Accessory Stand. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the peristaltic pump. 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 peristaltic pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, peristaltic pump, an adjustable mounting arm, an accessory basket, and an IV pole are contained on an accessory stand.

The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.

For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.

For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow.

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter.

The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Aspiration is achieved with a peristaltic pump that is connected to the SDU and is also turned on/off with the foot pedal. The pressure sensor is connected to the suction tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and pressure to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The provided text describes the JETi Peripheral Thrombectomy System and its 510(k) premarket notification (K192439) to the FDA. The document primarily focuses on demonstrating substantial equivalence to a predicate device (JETi 88 Peripheral Thrombectomy System, K183403) through non-clinical performance data.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and mentions that the results were compliant.

The table below presents the functional specifications of the device that can be inferred from the comparison table between the predicate and subject device, along with the implied "acceptance criteria" (i.e., that the new device met these specifications, often matching the predicate or a new measured value).

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The JETi 88 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 88 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi 88 Pump Set, one JETi 88 Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the vacuum pump. 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 vacuum pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, an adjustable mounting arm, a mounting bracket for vacuum canisters, an IV pole and a vacuum pump are contained on an accessory cart.

The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.

For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.

For infusion through the saline lumen, a clamp is used on the suction tubing to cut off vacuum.

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter.

The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Vacuum is achieved with a vacuum pump, turned on/off with the pinch valve on the side of the SDU, which is also controlled by the foot pedal. The vacuum sensor is connected to the vacuum tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

This document is a 510(k) premarket notification for a medical device called the JETi 88 Peripheral Thrombectomy System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document, as this type of information is typically found in clinical trial reports or detailed performance verification documents, not in a 510(k) summary focused on substantial equivalence.

Here's an analysis of what can be extracted from the provided text based on your request:

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

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, the specific acceptance criteria (e.g., "thrombus removal efficiency > X%") and the quantitative reported device performance against those criteria are not provided in this summary. The summary lists the types of tests performed but doesn't detail the pass/fail thresholds or the actual results.

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

This information is not provided in the summary. The testing mentioned (Design Verification) is "in vitro testing", implying laboratory bench testing. The data provenance is not specified.

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 as there is no human-involved ground truth assessment in the described in-vitro verification tests.

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

This is not applicable as there is no human-involved ground truth assessment or adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical thrombectomy system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is mentioned.

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

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

For the "in vitro testing" performed, the "ground truth" would be established by the engineering specifications and external standards (e.g., a specific pressure reading, flow rate, or bond strength). It is not expert consensus, pathology, or outcomes data, as these are not clinical or biological tests.

8. The sample size for the training set

This is not applicable as this is a physical device and not a machine learning algorithm that requires a training set.

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

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

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The ClearLumen II 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 ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation.

The ClearLumen II Peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.

For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.

For infusion through the saline lumen, a non-vented Luer cap is placed between the rotating hemostasis valve (RHV) side arm and the pressure monitor tubing.

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter.

The peripheral SDU is a reusable, IV pole mounted device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

This document, K172000, is a 510(k) premarket notification for the ClearLumen II Peripheral Thrombectomy System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study where the device meets specific acceptance criteria in a clinical or standalone setting with performance metrics.

Therefore, the requested information elements such as device performance, sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth, training set size, and how ground truth for training data was established are not present in this document. This submission primarily relies on non-clinical (in vitro) testing and a comparison of design features and intended use with a predicate device.

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" in the context of this 510(k) submission, which focuses on design verification and substantial equivalence.

Here's the breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified for any of the in vitro tests.
• Data Provenance: The tests are described as "in vitro testing performed pursuant to Walk Vascular's risk analysis." This indicates the data was generated internally by the manufacturer, Walk Vascular, LLC. It is therefore de-facto prospective for the purposes of this submission, as it was conducted specifically to support this application. The country of origin is implicitly the United States, given the company's address and FDA submission.

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

• Not applicable. The "ground truth" for these in vitro tests would typically be defined by engineering specifications and physical measurements, not expert clinician consensus.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessments. These were in vitro engineering tests.

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 MRMC study was done. This document describes a medical device (thrombectomy system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable.

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

• Not applicable. This is not an algorithm or AI device. The tests described are for the physical properties and functionality of a mechanical device.

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

• For the in vitro tests, the "ground truth" would be the established engineering specifications and physical measurement standards relevant to flow rates, pressure, etc. It's based on engineering measurement and pre-determined product specifications.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI 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 mentioned or implied for this device.

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The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature.

The ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation.

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter.

The peripheral SDU is a reusable, IV pole mounted device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The provided document describes the ClearLumen II Peripheral Thrombectomy System (K163051). The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance and a pre-clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test or the exact performance metrics achieved. Instead, it lists the types of tests performed.

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

• Non-Clinical (Design Verification, Biocompatibility, Sterilization, Transportation, Shelf Life): The document does not specify the sample sizes (e.g., number of catheters, pump sets, etc.) used for these in vitro tests. The provenance is internal company testing ("Walk Vascular's risk analysis"). These are laboratory/bench studies, not patient data.
• Pre-Clinical Study: The document states "A pre-clinical study was conducted to evaluate the safety of the peripheral catheter." It does not specify the sample size (e.g., number of animals) or the provenance (e.g., specific animal model, institution). This study is prospective in nature as it evaluates the device in an animal model before human use.

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

• Non-Clinical Tests: No explicit mention of external experts or their qualifications for establishing ground truth for these engineering or material science tests. These typically rely on defined industry standards, internal specifications, and trained technicians/engineers.
• Pre-Clinical Study: Ground truth was established through "Histological evaluation." While this implies expertise in pathology, the document does not specify the number of experts or their qualifications (e.g., board-certified pathologists with X years of experience).

4. Adjudication Method for the Test Set

Not applicable for the described non-clinical and pre-clinical studies. These types of studies typically involve direct measurement against defined criteria or single expert evaluation (e.g., a pathologist for histology), rather than an expert consensus/adjudication process commonly used in clinical image interpretation studies.

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

No MRMC study was done. The document explicitly states: "No clinical data were generated to establish substantial equivalence." This means there was no study involving human readers (e.g., physicians interpreting images) to assess the effectiveness of the device, with or without AI assistance. The device is a thrombectomy system, not an AI-assisted diagnostic tool.

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

Not applicable. The ClearLumen II Peripheral Thrombectomy System is a medical device for mechanical clot removal, not a diagnostic algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

• Non-Clinical (Design Verification): Ground truth was based on pre-determined product specifications and external standard requirements (e.g., for strength, flow, kink resistance). For "Performance (simulated clot removal)," the ground truth would be the extent of clot removal in a simulated environment, measured against a benchmark or expected outcome.
• Biocompatibility: Ground truth was established against ISO 10993-1 standards.
• Sterilization: Ground truth was established against AAMI TIR 28.
• Transportation and Shelf Life: Ground truth was based on ISTA 2A standards and the device maintaining its specified qualities over time.
• Pre-Clinical Study: "Histological evaluation" was used as the ground truth to assess the safety and tissue response in peripheral arteries. This represents a form of pathology ground truth.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for mechanical medical devices.

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

Not applicable, as no training set was used.

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The ClearLumen II Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

The ClearLumen II Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.

The system is comprised of three components: The ClearLumen II Catheter, the ClearLumen II Pump Set, and the ClearLumen Saline Drive Unit (SDU). Additional off-the-shelf accessory components are required for device operation and include a vacuum syringe, one way stopcock, aspiration extension tubing and a vacuum sensor.

The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter inner diameter, to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's 0.014" wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The proximal in-line Luer port connects to the pump set, while the Y-connector connects to the vacuum sensor, extension tube, stopcock, vacuum syringe assembly (supplied separately).

The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the SDU. The cassette is powered by the motor contained in the SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the catheter and delivers the saline to the catheter.

The SDU is a reusable, IV pole mounted device. The fork drive of the SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the catheter. The SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The provided text describes a 510(k) premarket notification for the ClearLumen II Thrombectomy System. This type of FDA submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, the document does not contain information typically found in studies designed to prove device performance against specific clinical acceptance criteria. Instead, it details non-clinical (bench) testing to support its substantial equivalence claim.

Here's an analysis based on your requested information, highlighting what is and is not present in the provided text:

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

The document does not present a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) like those found in a diagnostic device study. Instead, it states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, the specific values of these criteria and the quantified reported performance against them are not provided for the individual tests.

It lists types of tests performed:

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 explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence." This means there was no "test set" in the sense of patient data. The testing was all in vitro (bench testing). Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size for a clinical test set are not applicable and not provided.

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

Since no clinical data or patient test set was used, there were no experts establishing ground truth in a clinical context (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been established by engineering specifications and standard test methods.

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

No adjudication method was used, as there was no clinical test set requiring expert consensus for ground truth.

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 MRMC study was conducted. The device is a thrombectomy system, not a diagnostic AI device that assists human readers.

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

Not applicable. The device is a physical medical device, not an algorithm. Bench testing evaluates its physical and functional performance.

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

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and design requirements: For tests like pull strength, pressure, flow, kink resistance, and saline stream containment.
• International standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11135), and electrical safety (IEC 60601-1).
• Validated test methods: For embolic analysis and transportation/shelf life.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product that requires 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.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence through non-clinical (bench) testing, rather than establishing clinical efficacy or performance against specific (e.g., diagnostic) acceptance criteria typically found in clinical studies. The "acceptance criteria" referred to are those for engineering and safety performance established through predetermined product specifications and external standards.

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The ClearLumen Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

The ClearLumen Thrombectomy System consists of a thrombectomy catheter, saline drive unit ("SDU") and aspirate collection vacuum bottles. The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter I.D., to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's .014″ wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The catheter's proximal polycarbonate hub connects to the SDU and provides coaxial access to the infusion and aspiration lumens. The ClearLumen Catheter is connected to the battery operated SDU, which includes a pump to generate pressurized saline and conduit/collection of aspirate. The SDU uses a toggle switch to turn the pump on and off and actuate a valve in line to a pre-charged vacuum bottle (aspiration source). The SDU connects via spike to a standard saline bag (saline source).

The provided text describes a 510(k) premarket notification for the ClearLumen Thrombectomy System, establishing its substantial equivalence to predicate devices based on non-clinical and clinical performance data.

Here's the information requested, extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate devices and meeting pre-determined product specifications and external standard requirements. The reported device performance indicates that all testing conducted met these criteria. Specific quantitative acceptance criteria or precise numerical performance targets are not explicitly detailed in the provided summary.

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

• Test Set (Human Clinical Study):
  • Sample Size: 20 subjects
  • Data Provenance: Prospective, single-center human clinical study. The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or in countries with an ethical and regulatory framework comparable to the US.

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

The document does not explicitly state the number of experts or their qualifications who established the ground truth for the test set (human clinical study). The study endpoints (Myocardial Blush Grade (MBG) and Thrombolysis In Myocardial Infarction (TIMI) flow grade) are typically determined by cardiologists or interventional radiologists reviewing angiographic images.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set's clinical outcomes.

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

There is no mention of an MRMC comparative effectiveness study, nor any discussion of AI assistance or its effect size on human reader performance. This device is a mechanical thrombectomy system, not an AI diagnostic tool.

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

This question is not applicable as the device is a medical instrument (thrombectomy system), not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For In-Vitro Testing: Ground truth was based on pre-determined product specifications and external standard requirements, as well as accepted engineering and biological testing methodology (e.g., ISO standards for biocompatibility and sterilization).
• For In-Vivo (Animal) Study: Ground truth was based on observed safety and performance metrics in the animal model.
• For Human Clinical Study: Ground truth was based on clinical outcomes data, specifically:
  • Myocardial Blush Grade (MBG) ≥ 2
  • Final Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3
  • Absence of Major Adverse Coronary Events (MACE)
  • Absence of device-related Significant Adverse Events (SAE)
    These are objective clinical endpoints typically assessed by trained medical professionals.

8. The Sample Size for the Training Set

The document describes a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than training a novel algorithm. Therefore, there is no mention of a "training set" in the context of device development or evaluation for this thrombectomy system. The studies described are for verification and validation.

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

As there is no mention of a "training set" for this device, this question is not applicable.

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The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.

The ClearLumen Thrombectomy Device consists of a thrombectomy catheter, saline drive unit ("SDU") and waste collection bottles. The thrombectomy catheter is a multi-lumen 6F or 7F guide compatible, 135 cm in length and is used over the wire. The catheters have a 7 cm rapid exchange length. The device is intended for use with conventional 0.014″ guidewires. The proximal end of the catheter contains a polycarbonate hub that connects to the SDU and provides access to the infusion and aspiration lumens. The distal end of the catheter shaft is comprised of an atraumatic tip. The ClearLumen Catheter is connected to the battery operated SDU which allows for simultaneous lysing and aspiration of thrombus from the treatment site. The SDU contains a port for connection to a standard saline bag. The device uses a toggle switch to turn the pump on and off.

Here's an analysis of the provided text regarding the ClearLumen Thrombectomy System, focusing on the acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the document does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria, study methodologies (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies. The summary focuses on establishing substantial equivalence to predicate devices through non-clinical performance data.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states, "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." However, no specific quantitative or qualitative acceptance criteria are provided within this summary.

Reported Device Performance:
The summary broadly claims that "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." This is a general statement and no specific performance metrics or data points are reported for characteristics like thrombus removal efficiency, time taken, safety parameters, or comparability to predicate devices.

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

The document mentions "Design verification testing" and "functional testing performed pursuant to Walk Vascular's [standard/protocol - cut off in the text]."

• Sample Size for Test Set: Not specified.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. This appears to be internal company testing, likely conducted within the US (where the company is based), but no explicit details are given. It is non-clinical testing, meaning it's not patient data.

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

• For non-clinical performance data, the concept of "ground truth established by experts" as typically applied in clinical studies (e.g., radiologists interpreting images) is not applicable in this context. The testing would have involved engineering and laboratory personnel verifying device specifications and performance against pre-defined engineering requirements. There is no mention of external clinical experts reviewing this non-clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Given that the testing is described as "Design verification testing" and "functional testing," an "adjudication method" in the sense of resolving discrepancies among human readers (like 2+1 or 3+1) is not applicable. This would involve standard engineering and quality control verification processes.

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

• No. The provided text explicitly states "Non-Clinical Performance Data" and describes these evaluations as "Design verification testing" and "functional testing." This indicates laboratory and bench testing, not clinical studies involving human readers or patient cases. Therefore, an MRMC study and effects of AI assistance are not relevant or discussed in this document.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Not applicable. The ClearLumen Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, a "standalone" performance study for an algorithm is not relevant to this device.

7. The Type of Ground Truth Used

• For the non-clinical "Design verification testing" and "functional testing," the "ground truth" would be engineering specifications, performance standards, and established laboratory measurement techniques. For example, if testing flow rate, the ground truth is the measured flow rate compared to a defined specification. If testing thrombus removal, it would be the objective measurement of removed material against a target. No specific type of ground truth (e.g., pathology, outcomes data) is mentioned from clinical data, as this is non-clinical testing.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical thrombectomy system, not an AI/machine learning model. Therefore, there is no "training set" in the context of data for an algorithm.

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

• Not applicable. As above, there is no "training set" for this type of device.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the performance studies. It serves to inform the FDA that design verification and functional testing were performed but does not delve into the detailed methodology, specific quantitative results, or the precise acceptance criteria used in those non-clinical tests. For a clinical device, especially one involving patient interaction, detailed clinical study data would be expected, which is not present in this non-clinical submission summary.

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