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

The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.

The provided text is a 510(k) summary and FDA clearance letter for the EKOS NeuroWave Micro-Infusion System. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not include specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Data: The document states "Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters," but it does not specify what "operates as intended" quantitatively means, nor does it provide any numerical performance metrics (e.g., accuracy, precision, flow rates, efficacy).
• No Clinical Study Details: The document explicitly mentions that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary..." This directly indicates that a study proving clinical effectiveness and safety, which would typically involve acceptance criteria, was not conducted or presented in this 510(k). The clearance is based on substantial equivalence to predicate devices for its stated intended uses, not on a new clinical efficacy study.

Without this missing information, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

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

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the EKOS Micro-Infusion System. It details:

• Device Description and Intended Use: The system is for controlled and selective infusion of fluids into peripheral vasculature and regional infusion of contrast materials into selected neurovasculature vessels, not for coronary use.
• Predicate Device: The device is considered substantially equivalent to a previously cleared EKOS Micro-Infusion System (K051225 and K050563).
• Testing: It states that testing and evaluations were performed, and the results support substantial equivalence, but it does not specify what tests were done, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
• FDA Clearance and Limitations: The FDA clearance includes a box warning that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)." This indicates that for this specific application (thrombolytic therapy in neurovasculature), the device's safety and effectiveness were not fully proven at the time of clearance, and further studies were required.

Therefore, I cannot populate the table or answer most of the questions you've asked because the provided text does not contain that level of detail about performance criteria or studies.

Here's what I can extract based on the limitations of the provided text:

Acceptance Criteria and Device Performance Study

The provided text does not explicitly state specific acceptance criteria or report detailed device performance against such criteria. It broadly mentions "results of the testing and evaluations performed" supporting substantial equivalence to a predicate device, but no quantitative or qualitative performance metrics are given.

The FDA letter, however, imposes a limitation for a specific use case, indicating that for "thrombolytic therapy in the neurovasculature," safety and effectiveness have not been established, and further clinical studies are necessary. This implies that for this particular application, the device did not meet implicit criteria for established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing and evaluations" but not the type or source of data.

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

• Not specified.

4. Adjudication method for the test set

• Not specified.

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 mentioned. This document describes a medical device for infusion, not an AI or imaging diagnostic device where MRMC studies are typically performed.

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

• Not mentioned. This document describes a medical device for infusion, not an algorithm.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This document is about a hardware device, not a machine learning algorithm with a training set.

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

• Not applicable/Not specified.

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

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.

This document is a 510(k) notification for a medical device called the EKOS Micro-Infusion System. It is a submission to the FDA requesting clearance to market the device, demonstrating its substantial equivalence to previously cleared devices. It is not a study reporting on the performance of an AI/ML device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.

The document describes a medical device (a catheter system), its intended use, technological characteristics, and its comparison to predicate devices, primarily focusing on hardware and safety/equivalence as per regulatory requirements for a 510(k) submission. It does not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or AUC, established by expert consensus or pathology, which are typically found in studies for AI/ML diagnostic or predictive devices.

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The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The EKOS Micro-Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver angiographic contrast material into the neurovasculature.

The provided text describes the 510(k) summary for the EKOS Micro-Infusion System. It details the device's intended use and the studies conducted to support its substantial equivalence.

Here's an analysis of the provided information, framed by your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The summary states that "EKOS has conducted preclinical bench and animal studies." It does not specify the sample sizes used for these studies (e.g., number of animals, number of bench tests). The data provenance is from preclinical bench and animal studies, implying a prospective and controlled experimental setup rather than retrospective human data.

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

This information is not provided in the document. As the studies were preclinical (bench and animal), the concept of "experts" in the context of human data ground truth (like radiologists) does not directly apply. The "ground truth" would have been established by the experimental design and measurements conducted by the study investigators.

4. Adjudication Method for the Test Set

This information is not provided. Given the preclinical nature of the studies, formal adjudication methods typically used for human clinical data (like 2+1 or 3+1 for discrepancies) would not be applicable in the same way. The results of the bench and animal studies would have been assessed against predetermined performance metrics.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infusion system, not an AI-powered diagnostic or interpretive device, so the comparison of human readers with and without AI assistance is irrelevant here.

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

This question is not applicable as the EKOS Micro-Infusion System is a physical medical device (catheter system for infusion), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established by direct experimental measurements and observations from preclinical bench and animal studies. This likely involved:

• Bench Test Results: Measuring parameters like flow rates, pressure resistance, structural integrity, and material compatibility under simulated conditions.
• Animal Study Observations: Assessing safety (e.g., tissue damage, adverse events) and effectiveness (e.g., successful infusion, distribution of contrast material) in a living system.

8. The Sample Size for the Training Set

This question is not applicable as the EKOS Micro-Infusion System is a physical device and not an AI or machine learning model that requires a "training set."

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

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

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