Search Results

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, into the peripheral vasculature.

Not Found

This document is a 510(k) clearance letter for the EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit. It primarily focuses on the regulatory aspects and indications for use, and does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the performance evaluation of the device.

Ask a specific question about this device

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, into the peripheral vasculature.

The EkoSonic Endovascular System consists of an EkoSonic Device and the Control Unit 4.0 (CU 4.0). The EkoSonic 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 CU 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The provided text describes a 510(k) premarket notification for the EkoSonic® Endovascular System with Control Unit 4.0. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with clinical endpoints and detailed acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be that the new Control Unit 4.0 (CU 4.0) functions as intended and is substantially equivalent to the predicate device, the EkoSonic Control Unit (PT-3B), without raising new questions of safety or effectiveness. The performance data presented consists of a series of hardware and software tests, all of which "Pass."

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

The document does not specify a "test set" in the context of a typical AI/ML algorithm evaluation (e.g., a set of medical images or patient data). The evaluation appears to be based on engineering verification and validation testing of the hardware and software components of the device itself. Therefore, sample sizes for data (e.g., patient data) are not applicable or provided. The data provenance is internal testing performed 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

Not applicable. This submission is for a hardware/software device modification that does not involve diagnostic interpretation using AI/ML with a ground truth established by experts.

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

Not applicable. The tests performed are engineering-based, not clinical evaluations requiring adjudication of expert opinions.

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. An MRMC study is not mentioned as this device is a continuous flush catheter system, not an AI-assisted diagnostic tool.

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

This concept is not applicable. The device is a physical system (catheter, control unit) that performs a therapeutic function (ultrasound-facilitated infusion), not a standalone algorithm. The "performance" refers to the device's functional integrity as a system.

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

Not applicable. The "ground truth" for the engineering tests performed would be the design specifications and expected functional behavior of the hardware and software components.

8. The sample size for the training set

Not applicable. This document describes a device modification, not the development or training of an AI/ML algorithm.

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

Not applicable. There is no mention of a "training set" in the context of AI/ML algorithm development.

Ask a specific question about this device

The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.

The EkoSonic Endovascular System is an infusion Device designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an MicroSonic Device which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

The provided documents are FDA 510(k) letters related to the EKOS EkoSonic Endovascular System. These documents confirm the regulatory classification and substantial equivalence of the device but do not contain information about specific acceptance criteria or the study data proving the device meets those criteria, especially not in the context of an AI/ML-driven device or study.

The description you've requested (acceptance criteria, test set details, expert qualifications, adjudication, MRMC study, standalone performance, ground truth, training set details) is typically found in detailed clinical study reports or 510(k) summaries for AI/ML devices, which this document is not. This document is a regulatory approval letter for a medical device (a catheter system), not an AI algorithm.

Therefore, I cannot fulfill your request using only the provided text. The information is not present in these FDA 510(k) general correspondence letters.

Ask a specific question about this device

The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

The EkoSonic System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. 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.

This document is a 510(k) premarket notification for the EkoSonic™ Endovascular System with Rapid Pulse Modulation. It does not describe a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it describes a "Special 510(k)" notification, which generally means changes have been made to a previously cleared device, and the submission argues that these changes do not affect the technological characteristics or safety and effectiveness, thus maintaining substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not applicable in the context of this specific regulatory submission. The document explicitly states: "The 510(k) submission was not re-reviewed." and "The device modification described in this notification does not affect the technological characteristics for the EkoSonic System."

However, based on the Test Summary provided, I can infer some general information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Implicitly, the acceptance criteria are that the modified device's electrical safety, electrical circuit qualification, software validation, and system integration demonstrate performance equivalent to the predicate device. The document does not provide quantifiable metrics or specific thresholds for these criteria.
• Reported Device Performance: The document states that "Electrical safety testing, electrical circuit qualification testing, software validation testing and system integration testing confirmed the modified EkoSonic System is substantially equivalent to the predicate EndoWave System." No specific performance data (e.g., accuracy, sensitivity, specificity, or detailed electrical safety measurements) is provided in this summary.

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

• Sample Size: Not applicable. The "Test Summary" refers to engineering and software validation tests, not a clinical test set with patient data.
• Data Provenance: Not applicable.

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

• Not applicable. This is not a clinical study involving expert interpretation of medical data. The "tests" mentioned are technical in nature.

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:

• Not applicable. This device is not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This is not an algorithm for diagnostic performance.

7. The Type of Ground Truth Used:

• For the technical tests mentioned (electrical safety, etc.), the "ground truth" would be the engineering specifications, regulatory standards, and expected behavior established for the device and its predicate. No external medical ground truth (like pathology or outcomes data) is referenced in this summary.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device involving a training set.

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

• Not applicable.

In summary:

This document is a regulatory submission focused on demonstrating substantial equivalence for a modified medical device, not a performance study for a new device, especially not an AI/ML-driven one. The "tests" mentioned are related to engineering and software validation to ensure the modified device functions as intended and safely, maintaining equivalence to its predicate. It explicitly states that "The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established." and "the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli."

Ask a specific question about this device