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The EKOS PE Endovascular Device with CU 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 EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE 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 20 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 text is related to a 510(k) premarket notification for a medical device called the EKOS PE Endovascular Device with Control Unit 4.0. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the information provided does not contain acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (EkoSonic Endovascular Device with CU4.0) through a comparison of technological characteristics and performance testing against internal specifications and external standards (like ISO and IEC).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance (in the context of clinical efficacy or diagnostic accuracy, as implied by "device performance" in your prompt). The table provided in the document (Table 1) lists "Product Specification" and "Purpose" with "Pass" results, which are more akin to design verification tests rather than clinical performance metrics.
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The device described is an "Embolectomy Catheter" used for ultrasound-facilitated infusion of fluids (including thrombolytics) for the treatment of pulmonary embolism and in peripheral vasculature. It is a physical medical device, not a diagnostic algorithm or AI system that would typically require the detailed clinical validation studies you're asking about.

What the document does provide regarding performance:

The document includes a "Performance Data" section (Section VII) which states: "Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device."

It then presents Table 1: Testing Overview Supporting the EKOS PE Endovascular System. This table lists various engineering and safety-related tests, their purpose, and the outcome ("Pass" for both initial and accelerated aged conditions). These are verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.

Table 1: Testing Overview Supporting the EKOS PE Endovascular System (from the document)

The "acceptance criteria" here are generally that the device "Passed" these various engineering and safety tests, demonstrating it functions as intended and is safe for its intended use, aligning with the standards and the predicate device's characteristics. There's no further detail on the methodology of these "Pass" assessments (e.g., specific quantitative thresholds beyond meeting standard requirements).

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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.

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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."

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The EndoWave 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 catheter temperature.

This document, a Special 510(k) Notification for the EndoWave™ Infusion System (K080392), is a very limited submission focused on a modification to an already cleared device. It primarily addresses a change in an "acoustic protocol" and confirms continued safety and function.

Therefore, the information you're requesting regarding detailed acceptance criteria, study methodologies, sample sizes, expert ground truth, and AI/MRMC studies is not present in this type of submission. Special 510(k)s are for minor changes that don't significantly alter the device's fundamental technology or intended use, and thus do not typically require extensive new clinical or performance studies like a de novo submission or a traditional 510(k) for a novel device would.

Here's a breakdown of why this document doesn't contain the requested information:

• Focus of a Special 510(k): "The device modification described in this notification does not affect the technological characteristics for the EndoWave Infusion System." This indicates the change is minor, likely to manufacturing processes, materials, software (within a controlled scope), or, in this case, an "acoustic protocol." Such minor changes usually rely on existing performance data and verification/validation testing showing that the change doesn't negatively impact safety or effectiveness.
• "Test Summary": "Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol." This is a very high-level summary. It implies some testing was done, but doesn't detail what tests, methodologies, acceptance criteria, or sample sizes were used. It's a statement of compliance rather than a detailed study report.
• No AI Component: The device described (an infusion catheter with an ultrasound core for fluid delivery) is a medical device, not an AI/ML-based diagnostic or therapeutic system. Therefore, questions about MRMC studies, standalone AI performance, training sets, or AI ground truth are not applicable.

To directly answer your request based only on the provided text, many fields simply cannot be filled in.

Here's what can be extracted and inferred, with explicit notes about missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific, quantifiable acceptance criteria (e.g., specific thresholds for acoustic energy output, temperature limits, flow rates, etc.) that were used to confirm safety and "as required" operation. These details would be in internal testing protocols, not typically summarized in a Special 510(k).

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. (Likely laboratory-based bench testing or in-vitro models, rather than clinical data for a Special 510(k) focusing on an acoustic protocol change.)
• Retrospective/Prospective: Not specified. (Again, likely validation/verification testing, not a clinical study.)

3. Number of Experts Used to Establish Ground Truth & Qualifications

• Not applicable. This submission describes verification/validation testing related to a device change, not a diagnostic or prognostic study requiring expert consensus for ground truth.

4. Adjudication Method for Test Set

• Not applicable. This refers to clinical studies with ambiguous cases, which is not the case here.

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

• No. This device is not an AI diagnostic tool and the submission does not describe such a study.

6. Standalone (Algorithm Only) Performance Study

• No. This device is not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable. The "ground truth" for this type of verification testing would be engineering specifications, established safety limits, and documented performance requirements for the device. The document states "Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required." This implies testing against predefined engineering and safety standards.

8. Sample Size for Training Set

• Not applicable. This device does not use a training set in the context of machine learning or AI.

9. How Ground Truth for Training Set Was Established

• Not applicable. (See point 8.)

Summary of Device and Context from the Document:

• Device Name: EndoWave™ Infusion System
• Intended Use: Controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature.
• Key Components: Disposable infusion catheter with removable ultrasound core, and an instrument to generate and control energy delivery. The catheter has side holes, and the ultrasound core contains up to 30 ultrasound elements and thermal sensors.
• Modification: A revised "acoustic protocol."
• Conclusion of Testing: The revised protocol remains safe, and the ultrasound core operates as required.

This document serves to demonstrate that a minor change to an existing, cleared device does not raise new questions of safety or effectiveness, thus allowing for a streamlined regulatory review process.

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The EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EndoWaveTM Infusion system 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 EndoWaveTM 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.

The provided text is a 510(k) summary for the EKOS EndoWave Infusion System. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and limitations of the device. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) related to a new performance study.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

The closest information available is:

• "Performance: EKOS has conducted preclinical bench and animal studies with the EndoWave™ Infusion System. These studies demonstrate that the performance of the EndoWave™ Infusion System meets its design specifications for its intended use."

This statement confirms that studies were done and that the device met its design specifications, but it does not provide any specifics about those specifications (acceptance criteria) or the studies themselves. Without these details, the requested table and accompanying study information cannot be generated.

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The EndoWave® 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 text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily a notification from the FDA regarding an administrative change to a previously issued substantial equivalence letter for the EndoWave Infusion System. It mentions the device's intended use and briefly describes its components, but it does not detail any performance metrics, studies, or results that would correspond to the questions asked.

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The EndoWave® 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,

This FDA 510(k) summary for the EndoWave Infusion System (K071933) indicates that the submission is for an administrative correction to an already cleared device, primarily for a product code update (page 0). The original substantial equivalence (SE) determination was made in 2007 (page 1). Because this is an administrative update, the provided information does not describe a new study conducted to establish acceptance criteria for the device's performance in the context of an AI/ML algorithm.

The document discusses the EndoWave Infusion System which is a medical device for controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature (page 3, 4). The "device" in the context of the question refers to this physical system, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance related to AI/ML algorithm.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information.
• Type of ground truth used for AI/ML.
• Sample size for the training set for AI/ML.
• How ground truth for the training set was established for AI/ML.

The document briefly mentions a "Test Summary" on page 5, which states: "The proposed EndoWave Infusion System is considered to be substantially equivalent to the currently marketed EndoWave Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." However, it does not provide details about the specific tests, acceptance criteria, or their results. It instead points to "Substantial Equivalence" as the basis, comparing it to a previously cleared device (K060422). This implies that performance was assessed against the predicate device rather than through a new, full-blown clinical study with specific acceptance criteria that would typically be described for a novel device or AI/ML product.

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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.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

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.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

The EKOS Micro-Infusion System is an infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.

This document is a 510(k) premarket notification for the EKOS Micro-Infusion System. It is an administrative letter from the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The document states that the EKOS Micro-Infusion System is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The basis for this determination is often through bench testing and, in some cases, animal studies to demonstrate that the device meets design specifications and performs as intended.

Here's what can be extracted from the provided text, while also noting what is not present:

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

This information is not provided in the document. The document refers to "preclinical bench and animal studies" that demonstrate the "performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." However, the specific acceptance criteria (e.g., flow rate, infusion accuracy, ultrasound power output, etc.) and the quantitative results of those performance tests are not included.

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

This information is not provided in the document. The general statement "preclinical bench and animal studies" does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document. Ground truth establishment typically applies to studies involving human interpretation or categorization, which is not described here.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of cases, which is not detailed in this premarket notification.

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:

This information is not provided in the document. An MRMC study would be relevant for evaluating AI-assisted diagnostic devices. The EKOS Micro-Infusion System is an infusion catheter system, not an AI diagnostic device.

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

This information is not provided in the document. A standalone performance evaluation would be relevant for an algorithm or AI system. The EKOS Micro-Infusion System is a physical medical device.

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

This information is not explicitly stated in the document beyond the mention of "preclinical bench and animal studies." For a medical device like an infusion system, the "ground truth" would likely involve engineering specifications, physical measurements of fluid delivery, and physiological responses observed in animal models.

8. The sample size for the training set:

This information is not provided in the document. Training sets are relevant for machine learning or AI models, which is not the primary focus of this device's evaluation.

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

This information is not provided in the document, as it pertains to training AI models, which is not applicable here.

Summary of Device Information Available:

• Device Name: EKOS Micro-Infusion System
• Intended Use:
  • Regional infusion of contrast materials into selected vessels in the neurovasculature.
  • Controlled, regional infusion into selected vessels.
  • Deliver physician-specified fluids to the coronary vasculature.
  • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
• Device Description: An infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.
• Predicate Devices: EKOS Micro-Infusion System (K053437, K053432, K062507, K062508), Endeavor Infusion Catheter (K972110), PV 0.018 F/X (K944004), Renegade Hi-Flo Microcatheter (K000177), TurboTracker 18 Infusion Catheter (K960806), FasTracker 10 Infusion Catheter (K926243).
• Performance Data Mentioned: "EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. These studies demonstrate that the performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." Specific details of these studies are not provided.
• Labeling Limitation: "The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established." This indicates a specific disclaimer regarding certain uses, rather than a performance claim.

In conclusion, the provided FDA 510(k) clearance letter confirms the substantial equivalence of the EKOS Micro-Infusion System but does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth information typically found in a comprehensive study report. This type of information would be found in the original 510(k) submission documentation, which is more detailed than the FDA's clearance letter.

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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 is a 510(k) summary for the EKOS Micro-Infusion System and does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving their fulfillment. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance study results against specific acceptance criteria.

However, I can extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the device modification is for the PT-2B Control Unit, a second-generation version of the PT-2. The "acceptance criteria" presented are functional ("operates as intended") rather than quantitative performance metrics.

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

This information is not provided in the document. The text mentions "electrical safety and system testing" but does not specify the sample size, the type of test set (e.g., in vitro, in vivo), or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The "testing" mentioned appears to be engineering/functional testing, not a clinical study involving experts establishing ground truth for a diagnostic or treatment outcome.

4. Adjudication Method for the Test Set

This information is not provided in the document. As there's no mention of expert review or clinical trial for establishing ground truth, adjudication methods are not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided in the document. The document describes a "SPECIAL 510(k) Notification" for a device modification, which typically relies on demonstrating equivalence rather than conducting a full-scale MRMC comparative effectiveness study to show improvement over human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not provided in the document. The device is a "Micro-Infusion System," an electro-mechanical device for delivering fluids. The concept of "algorithm only" or "human-in-the-loop performance" as applied to software or AI is not relevant to this type of medical device in the context presented.

7. The Type of Ground Truth Used

The "ground truth" for the testing performed appears to be functional verification that the PT-2B unit correctly interfaces and operates with the Micro-Infusion Catheters, demonstrated through "electrical safety and system testing." It's not a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is not described as involving machine learning or AI that would require a "training set."

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

This information is not provided in the document, as there is no mention of a "training set" or AI/machine learning components.

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