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The Lysus® Infusion 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 clements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

This document is a 510(k) premarket notification for the EKOS Lysus Infusion System. It is an administrative change notice from the FDA to update the product code of the device, not a re-review of the submission. Therefore, it does not contain the detailed information about acceptance criteria and study results typically found in an initial 510(k) summary that demonstrates a device meets performance criteria.

However, based on the provided text, I can extract what is mentioned about testing:

Key Takeaways from the document:

• The initial 510(k) for the EKOS Lysus Infusion System (K060422) was a "Special 510(k) Notification." Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device. This implies that the core performance and safety were established in a prior 510(k) (K052071, mentioned as the predicate device reference).
• The current submission (K060422) specifically addresses a device modification: an "increase in power."
• The "Test Summary" explicitly states: "Testing previously performed and presented to FDA demonstrated safety of the power increase. New testing demonstrated the USC has sufficient durability to be operated with increased power."

Given this, I cannot provide a comprehensive answer to your request regarding acceptance criteria and a detailed study report that proves the device meets those criteria from this specific document. This document is focused on an administrative correction and a previously cleared modification.

Based only on the provided text, the answer to your questions would be as follows:

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

   • Not available in this document. The document refers to "previously performed testing" and "new testing" for a power increase and durability, but it does not specify the acceptance criteria or reported performance metrics for these tests.

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

   • Not available in this document.

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):

   • Not available in this document. The device is an "Embolectomy catheter" / "Continuous Flush Catheter" for DVT/thrombolytic therapy, which typically wouldn't involve expert ground truth establishment in the same way an AI diagnostic device would.

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

   • Not available in this document.

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/Not available in this document. This device is a medical device (catheter system) for infusion, not an AI diagnostic tool that assists human readers.

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

   • Not applicable/Not available in this document. This is a hardware device for infusion, not an algorithm, so "standalone performance" in the AI sense is not relevant.

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

   • Not available in this document. The testing mentioned (safety of power increase, durability of USC) would likely rely on engineering/bench testing metrics rather than clinical "ground truth" derived from patient data.

8. The sample size for the training set:

   • Not applicable/Not available in this document. This is a hardware device, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not applicable/Not available in this document. (See above, no training set).

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The Lysus® Infusion 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 transducer temperature.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The documents are FDA letters regarding a 510(k) premarket notification for the Lysus Infusion System. They confirm substantial equivalence to a predicate device and provide administrative details, but do not outline performance acceptance criteria or study results.

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The Lysus® Infusion 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 transducer temperature.

The provided text is a 510(k) premarket notification letter and summary for the EKOS Lysus Infusion System. It details an administrative change related to a product code update and references a previous substantial equivalence determination. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC study results for device performance.

The document primarily focuses on the regulatory aspects of the device, its intended use, and a general statement about previous safety and durability testing.

Therefore, I cannot provide the requested information from the given text.

Specifically, the following information is missing:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present. The text only mentions "Testing previously performed" and "New testing demonstrated the USC has sufficient durability."
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: Not applicable as this is a medical device (infusion system), not an AI algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable/not present.
9. How the ground truth for the training set was established: Not applicable/not present.

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The Lysus® Infusion 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 transducer temperature.

The provided text is a 510(k) summary for the Lysus Infusion System, primarily concerning a software upgrade and associated revisions to the Instructions for Use. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The document explicitly states:

• "The software was validated prior to release of the upgraded version." This is a general statement about validation but provides no specifics about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
• "Performance standards have not been promulgated for continuous flush catheters." This reinforces that there aren't formal, publicly available performance benchmarks for this device category.
• "The software upgrade and revisions to the Instructions for Use described in this notification do not affect the technological characteristics for the Lysus Infusion System." This indicates that the core functionality and performance characteristics proven in a previous 510(k) (K042456) are considered unchanged by this specific submission.

To answer your questions, one would need access to the original 510(k) submission (K042456) for the Lysus Infusion System, as that would likely contain the performance data and acceptance criteria that established its substantial equivalence. The current document is an administrative update for a software change.

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The Lysus® Infusion 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 transducer temperature.

The provided text describes a 510(k) submission for the Lysus® Infusion System, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance acceptance criteria or conducting extensive clinical efficacy studies typically found in PMA submissions.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, specific ground truth types) are not applicable to the information provided because a 510(k) summary focuses on demonstrating equivalence through design and limited testing, rather than proving new clinical performance.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated. The 510(k) summary mentions "results of the testing and evaluations performed," but does not provide specific sample sizes for any test sets. The focus is on demonstrating equivalence through design and functionality, rather than detailed clinical trial data.
• Data Provenance: Not specified, but likely internal engineering and bench testing data given the nature of a 510(k) for a minor modification.

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

• Not applicable/Not stated. In a 510(k) for a device like this, "ground truth" as it relates to expert review of output for clinical performance is not typically established or reported. The evaluation is focused on engineering and design equivalence.

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

• Not applicable/Not stated. This concept is generally relevant for clinical performance studies involving interpretation of data (e.g., medical images), which is not the primary focus of this 510(k) 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. This is a medical device, not an AI/imaging diagnostic device. MRMC studies are not relevant to this submission.

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

• No. This device is an infusion system, not an algorithm.

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

• Not applicable/Not explicitly stated. For this type of device, "ground truth" would likely refer to engineering specifications and performance benchmarks (e.g., flow rates, material compatibility, structural integrity) rather than clinical diagnostic outcomes. The summary merely states "results of the testing and evaluations performed."

8. The sample size for the training set:

• Not applicable/Not stated. This submission is for a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable/Not stated. As above, no training set for an algorithm is involved.

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The Lysus® Infusion 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 transducer temperature.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them as requested. The document is an FDA 510(k) clearance letter and a 510(k) summary for the Lysus Infusion System.

While it mentions a "Test Summary" stating that "Testing confirmed the safety and effectiveness of the Lysus Infusion System is not affected by revising the Instructions for Use," it does not provide any specific details about:

• Acceptance criteria (e.g., performance metrics, thresholds)
• Reported device performance against those criteria
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• Multi Reader Multi Case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training data was established

The document primarily focuses on the regulatory clearance of a device and an administrative change related to its product code, not on the detailed technical study results.

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The Lysus® Infusion 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 transducer temperature.

I am sorry, but based on the provided FDA documents (a 510(k) clearance letter and a 510(k) summary), the information required to answer your request about acceptance criteria and a study proving device performance is not present.

The documents indicate that the Lysus Infusion System was cleared based on substantial equivalence to a previously marketed device (K041629) and refer to "testing and evaluations performed" in the summary. However, they do not:

• Provide a table of specific acceptance criteria.
• Report detailed device performance metrics.
• Describe the sample size, data provenance, number or qualifications of experts, or adjudication methods used in any specific study.
• Mention a multi-reader multi-case (MRMC) comparative effectiveness study or report an effect size for human reader improvement with AI assistance.
• Provide details about a standalone algorithm performance study.
• Specify the type of ground truth used for any testing.
• Provide the sample size for a training set or how ground truth for a training set was established.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technological characteristics, intended use, and sometimes non-clinical performance data, rather than detailed clinical effectiveness studies with the kind of ground truth and reader studies you are asking about, especially for lower-risk devices.

Therefore, I cannot fulfill your request with the given input.

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

The Lysus® Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core 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.

This is a 510(k) premarket notification for a medical device (Lysus Infusion System), not a clinical study report. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance evaluations, is not present in the provided document.

A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. The performance section in a 510(k) summary typically references preclinical (bench and animal) studies to demonstrate design specification adherence, safety, and effectiveness.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information Extracted from the Provided Document:

• Device Name: Lysus® Infusion System
• Intended Use: "The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature."
• Device Description: "The Lysus® Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core 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."
• Type of Studies Mentioned: "EKOS has conducted preclinical bench and animal studies with the Lysus® Infusion System. These studies demonstrate that the performance of the Lysus® Infusion System meets its design specifications and is safe and effective for its intended use."

Information NOT available in the provided document (and why):

1. A table of acceptance criteria and the reported device performance: This document is a summary of the 510(k) submission, not the full submission itself, nor a clinical study report. It states that the device "meets its design specifications," but doesn't list those specifications or the performance against them.
2. Sample sizes used for the test set and the data provenance: The document mentions "preclinical bench and animal studies" but does not provide details of sample sizes, control groups, or whether the data was retrospective or prospective. It certainly doesn't mention human test sets, as this is a 510(k) premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Preclinical studies typically don't involve expert ground truth establishment in the same way clinical studies do.
4. Adjudication method for the test set: Not applicable for preclinical studies as 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: Not applicable. This device is an infusion system, not an AI diagnostic tool, and the document describes preclinical testing, not comparative clinical effectiveness.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the preclinical studies. In bench studies, "ground truth" would be engineering measurements and physical standards. In animal studies, it would be physiological and histological observations.
8. The sample size for the training set: Not applicable. This is not an AI device that undergoes a "training set" process.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory notice for a 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device via preclinical data, not on a detailed clinical study proving specific acceptance criteria in humans.

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