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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 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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