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The EkoSonicTM Endovascular System is indicated for the:
· Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
· Controlled and selective infusion of physician-specified fluids, into the pulmonary arteries and or peripheral vasculature.

The EKOS+ Endovascular System is indicated for the:
· Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
· Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

The sterile, single-use EkoSonic Endovascular Device consists of an Infusion Catheter (IC) and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.

The sterile, single-use EKQS+ Endovascular Device consists of an Infusion Catheter (IC),and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance metrics. Instead, it is a 510(k) premarket notification for the EkoSonic Endovascular Device and EKOS+ Endovascular Device, which are medical devices for intravascular infusion, not AI/ML software.

The document discusses expanding the Indications for Use to include Deep Vein Thrombosis (DVT), stating that this change does not impact the technological characteristics of the device. It references a systematic literature review, including data from the ACCESS-PTS trial and CAVA studies, to support the inclusion of DVT in the indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not relevant to the content of this document.

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The EkoSonic Endovascular System is indicated for the:

• Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
• Infusion of solutions into the pulmonary arteries.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The provided document is a 510(k) premarket notification letter and summary for the Boston Scientific EkoSonic Endovascular Device. This document does not describe an AI/ML-based medical device study. Instead, it's a notification for a medical device (a catheter) with modifications to a previously cleared predicate device.

Therefore, the information requested about acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML performance (e.g., sample size, ground truth, experts, MRMC studies) is not applicable to this document.

The document discusses non-clinical performance data which focuses on physical and biological safety testing for the catheter.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The EkoSonic Endovascular Device is described as a single-use, disposable infusion catheter with a removable ultrasound core, used for infusing fluids into the vasculature. Its function is mechanical and ultrasound-based, not AI/ML-driven.
• Modifications: The changes from the predicate device are listed as: an updated luer design (ISO 80369-7 compliant), a luer material change (Cyrolite® Polymer), and updated packaging and labeling. These are physical modifications, not AI/ML algorithm changes.
• Performance Data: The "Non-Clinical Performance Data" section explicitly states that "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including bench-top performance evaluations and biological safety." It further details "Bench Testing" (physical integrity, functionality, burst pressure) and "Biological Safety Testing" (biocompatibility, bioburden, endotoxin, pyrogenicity, sterility).
• Clinical Testing: The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of EkoSonic Endovascular Device." This confirms that the approval is not based on a clinical efficacy study often associated with AI/ML device performance.

In summary, there is no AI/ML component described in this FDA submission for the EkoSonic Endovascular Device. Therefore, I cannot provide information on acceptance criteria, test sets, ground truth establishment, MRMC studies, or training sets in the context of AI/ML for this particular device.

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The EkoSonic® Endovascular System is indicated for the:

• Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
• Infusion of solutions into the pulmonary arteries.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and the Control System (Control Unit and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

This notification is being made due to the modification of the MSD hub portion of the EkoSonic Endovascular Device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EkoSonic Endovascular Device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several device-level and system-level tests performed to demonstrate substantial equivalence, particularly focusing on modifications to the MSD hub portion of the device. The reported performance for all tests is "Pass," indicating that the device met the established acceptance criteria for each test.

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

The document states "Testing has confirmed that the EkoSonic Endovascular Device functions as intended and is substantially equivalent to the predicate device." However, it does not explicitly state the sample sizes used for each of the various tests (e.g., tensile strength, burst strength). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The nature of the tests (physical and electrical performance) generally implies laboratory testing rather than clinical data provenance.

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

The study described is focused on the physical and electrical performance of the device components due to a modification. It is not a diagnostic device study that would typically involve establishing ground truth based on expert consensus of medical images or patient outcomes. Therefore, there is no mention of experts or their qualifications for establishing ground truth in the context of these engineering performance tests. The "ground truth" here is the expected physical and electrical performance as defined by engineering specifications and standards.

4. Adjudication Method for the Test Set:

Given that this is a technical performance study of device components, an "adjudication method" in the clinical sense (like 2+1 or 3+1 consensus for medical image interpretation) is not applicable and not mentioned. The results of these engineering tests ("Pass") would be determined by whether the device meets pre-defined quantitative or qualitative engineering specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed. The device is an EkoSonic Endovascular Device used for ultrasound-facilitated, controlled, and selective infusion of fluids. It's a therapeutic device, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone Performance Study:

The study is inherently about the standalone performance of the modified device components and its integration with the control unit. The listed tests (tensile strength, impedance, electrical isolation, etc.) evaluate the device's intrinsic physical and electrical characteristics. There is no "algorithm only" aspect as it's a physical medical device. It's not an AI-driven diagnostic tool that would have a separate standalone algorithm performance.

7. Type of Ground Truth Used:

The ground truth for this type of performance study is based on engineering specifications, design requirements, and established industry standards for medical device safety and functionality. For example, burst strength would have a defined pressure threshold, and electrical isolation would have maximum leakage current limits. The "Pass" results indicate that the device met these predefined engineering criteria.

8. Sample Size for the Training Set:

This document describes a study for a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence. The performance data presented are for validation testing of the modified device.

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

As there is no training set for this type of device performance study, this question is not applicable. The "ground truth" for evaluating the test items relates to engineering specifications as described in point 7.

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The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for the:

• Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
• Infusion of solutions into the pulmonary arteries.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

It is the modifications to the Control System 4.0 that are the subject of this submission.

The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for ultrasound-facilitated infusion of fluids, including thrombolytics, into the vasculature for pulmonary embolism treatment, infusion into pulmonary arteries, and controlled infusion into the peripheral vasculature.

The device's substantial equivalence to its predicate (EKOS EkoSonic Endovascular Device with CU 4.0, K162771) was established based on performance data provided in the submission. The modifications in this submission specifically relate to the Control System 4.0.

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists various hardware and software tests conducted, with the reported performance being "Pass" for all of them, indicating compliance with internal standards for the modifications made to the Control System 4.0.

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

The document does not specify the sample sizes used for the various hardware and software tests, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The tests were likely conducted internally by the manufacturer, EKOS Corporation, Inc.

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)

The document does not mention the use of experts to establish a "ground truth" for the test set in the context typically seen for diagnostic or AI-based devices. The performance data here pertains to engineering and software validation of device functionality, not clinical outcome or diagnostic accuracy. Therefore, the concept of expert-established ground truth as a comparison point is not applicable to the type of testing described.

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

Not applicable. The reported tests are engineering and software verification and validation, not clinical studies requiring adjudications by experts for a test set.

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 device is an endovascular catheter system with a control unit, not an AI-assisted diagnostic or imaging device that would typically undergo MRMC studies with human readers.

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

The device itself is a physical medical device (catheter and control unit) that requires physician involvement. The "standalone" performance in this context refers to the functionality of the device components as tested in isolation or in simulated environments, as reflected in the hardware and software tests. The document confirms that "Testing has confirmed that the EkoSonic Endovascular Device with CU 4.0 functions as intended."

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

The concept of "ground truth" in the context of clinical outcomes or pathology is not directly applicable to the performance data presented. The "ground truth" for these engineering and software tests would be the established design specifications, functional requirements, and recognized industry standards for safety and performance of such medical devices. The predicate device (K162771) serves as the basis for demonstrating substantial equivalence based on technological characteristics and intended use.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device, if any, would be its design and manufacturing processes, which are verified through the listed tests.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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