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The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria related to AI/algorithm performance.

Instead, the document is a 510(k) summary for a medical catheter (Versus™ Catheter (VS110-8B)), comparing it to predicate devices to establish substantial equivalence.

The performance testing section (Section VII) outlines several non-clinical tests performed, including:

• Sterilization and Shelf Life: Validated per ISO 11135:2014, with a sterility assurance level of 10^-6 and a shelf life of 3 months established through accelerated aging studies.
• Biocompatibility: Evaluated against ISO 10993 and FDA Draft Guidance, including tests for acute systemic toxicity, complement activation, cytotoxicity, hemolysis, heparinized blood platelet and leukocyte count, intracutaneous irritation, material-mediated pyrogenicity, maximization sensitization, partial thromboplastin time (PTT), and particulate infrared spectroscopy.
• Human Factors Testing (Usability): Conducted per IEC 62366-1:2015 and FDA Guidance, demonstrating that intended users could perform critical tasks in a simulated environment. The results met predefined acceptance criteria, but the specific criteria and performance metrics are not detailed in this document.
• Performance Testing - Bench: Included tests for kink radius, trackability, advancement force, retraction force, infusion uniformity, pressure lumen measurement, dimensional and visual verification, luer hub compatibility, balloon inflation and integrity, corrosion resistance, and radiopacity.
• Performance Testing – Animal: A GLP porcine study comparing the Versus™ Catheter to the primary predicate device. The study met all success criteria established.

Crucially, there is no mention of:

• AI/algorithm performance: The device is a physical catheter, not an AI software.
• Test set sample size and data provenance for AI: Not applicable as it's not an AI device.
• Number of experts and their qualifications for ground truth: Not applicable for device testing of this nature.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth (e.g., expert consensus, pathology, outcomes data): Not applicable in the context of AI. The ground truth for biocompatibility and bench testing is established through standardized testing methodologies and material properties. For the animal study, the ground truth would be the physiological and pathological outcomes observed in the animals.
• Training set sample size and how ground truth was established for the training set: Not applicable as it's not an AI/machine learning device.

Therefore, I cannot populate the table or answer the questions related to AI/algorithm performance as the provided text pertains to a physical medical device (catheter) and its substantial equivalence testing, not an AI or software as a medical device.

The only "acceptance criteria" mentioned are that the human factors testing and animal study "met the predefined acceptance/success criteria," but the specific numerical or qualitative details of those criteria are not provided in this summary.

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The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the:

• · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
• · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIRTM .035 Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B .035 Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same. The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient. The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

The provided text is a 510(k) summary for a medical device (BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter) seeking clearance for market, based on substantial equivalence to a predicate device (BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter, K222095).

The document details performance testing for biocompatibility, sterility, bench performance, animal studies, and clinical studies. However, it does not explicitly present acceptance criteria for each of these tests in a quantifiable manner, nor does it provide a direct comparison of specific numerical performance metrics against predefined acceptance thresholds in a table format.

Instead, the document states that "All tests passed" for biocompatibility and sterility, and for bench performance, it indicates that the subject devices "meet product requirements and design specifications" and that simulated use studies "confirmed functionality." For animal studies, it notes "no adverse effects systemically, on gross or histopathology evaluation, and resulted in no animal mortality." For clinical studies, it mentions leveraging data from a "First in Human (FIH)" study with 9 patients and a "pivotal study with 109 patients."

Therefore, I cannot create the requested table of acceptance criteria and reported device performance with specific numerical values from the given text, as these are not explicitly provided in a comparative, quantitative format. The document focuses on demonstrating substantial equivalence by stating that various tests were performed and their outcomes were satisfactory or met requirements, rather than listing specific numerical criteria and results.

However, I can extract the information requested for other sections of your prompt based on the general descriptions of the studies.

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

As explained above, the document does not explicitly list quantitative acceptance criteria and corresponding reported device performance values in a table. It generally states that tests "passed" or "met requirements."

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

The document mentions several types of studies, some of which are leveraged from the predicate device.

• Biocompatibility: Studies leveraged from the predicate device. Sample size not specified, but likely involved multiple samples for each test type (cytotoxicity, sensitization, etc.).
• Sterility: Studies leveraged from the predicate device. Sample size not specified, but involved testing to achieve a Sterilization Assurance Level (SAL) of 10^-6 CFU.
• Bench Performance Tests (Subject Devices): "Design verification bench performance testing conducted with the subject devices." Sample size not specified, but covered various mechanical and functional aspects such as kink radius, trackability, advancement force, etc.
• Simulated Use Studies (Predicate Devices): Performed with predicate devices. Confirmed functionality over 20 hours. Sample size not specified.
• In-Use Study (Predicate Devices): Performed with predicate devices to evaluate cumulative impact on a representative drug. Sample size not specified.
• Animal Study (Predicate Device): A GLP animal study performed with the predicate device in a swine model. Sample size not specified, but implied to be sufficient for a GLP study.
• Clinical Performance (Predicate Device):
  • First in Human (FIH): 9 patients.
  • Pivotal study: 109 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective for all studies). The clinical studies are implied to be 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. The studies described are primarily technical performance, animal, and clinical outcome studies, not diagnostic interpretative studies requiring expert consensus on ground truth.

4. Adjudication method for the test set

This information is not provided in the document, as the studies described do not involve interpretative ground truth establishment that would require an adjudication method like 2+1 or 3+1.

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

There is no mention of an MRMC study or AI assistance in the provided text. The device is a mechanical thrombolysis catheter, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a mechanical catheter and not an algorithm.

7. The type of ground truth used

For the clinical performance data leveraged from the predicate device:

• The ground truth would likely be clinical outcomes related to the treatment of pulmonary embolism and venous thrombus, such as thrombus reduction, restoration of blood flow, adverse events, etc., as assessed by clinical investigators and objective measurements (e.g., imaging studies, physiological parameters). The document does not specify the exact ground truth endpoints or how they were established, but medical device trials typically use objective clinical and imaging assessments.

For the bench, animal, biocompatibility, and sterility studies, the "ground truth" is established by adherence to predefined standards, specifications, and observed physical, chemical, and biological responses.

8. The sample size for the training set

This is not applicable. The device is a mechanical catheter, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is a mechanical catheter and not an AI/ML algorithm.

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The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter are mechanical thrombolysis catheters indicated for the:

• · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
• · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIR™ Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same.

The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient.

The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Bashir Endovascular Catheter) submitted to the FDA. It details information about the device, its intended use, comparison to predicate devices, and various performance tests (biocompatibility, sterility, bench testing, animal testing, and clinical testing).

However, this document does not contain information about an AI/ML powered device, specifically:

• Acceptance criteria and reported device performance for an AI/ML model
• Sample sizes for test sets and data provenance for an AI/ML model
• Number and qualifications of experts for ground truth establishment for an AI/ML model
• Adjudication methods for an AI/ML model
• Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/ML model
• Standalone performance of an AI/ML algorithm
• Type of ground truth used for an AI/ML model
• Sample size for the training set of an AI/ML model
• How ground truth for the training set was established for an AI/ML model

Therefore, I cannot fulfill your request based on the provided text as it does not describe an AI-powered device or its associated study results.

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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 BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheter are continuous flush catheters designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There is one model of the BASHIR™ Endovascular Catheter (Ref. No. 7201) and four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the catheters allow for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. The infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. When the infusion basket is expanded into a clot, the clot is fragmented and a channel created, providing an opportunity for restoration of endogenous blood flow. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the catheters after placement.

The BASHIR™ Plus Endovascular Catheters have a second Shaft Port, for delivery of infusion solutions into the shaft lumen adjacent to the infusion basket where multiple laserdrilled holes extend over 10 cm (BASHIR+10), 20 cm (BASHIR+20), 30 cm (BASHIR+30) or 40 cm (BASHIR+40) of shaft length.

After the completion of solution delivery, the infusion limbs are collapsed to a closed position and the BASHIR™ Endovascular Catheter and/or BASHIR™ Plus Endovascular Catheter are retracted into the sheath and removed.

The catheters are comprised of common materials used in vascular catheters are mechanical and contain no electrical components.

The provided text is a 510(k) summary for the BASHIR™ Endovascular Catheter and BASHIR™ Plus Endovascular Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a study with a defined test set, ground truth experts, and statistical analysis as would be done for an AI/ML medical device.

Therefore, the information required to answer the prompt (acceptance criteria, specific study design elements like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided document. The document describes a medical device, not an AI/ML algorithm.

The "Performance Testing" section primarily refers to prior comprehensive testing (animal, bench, biocompatibility, sterilization, packaging) and then mentions "Clinical Evidence" from "Real-World use" by "15 different institutions" involving "45 patients with venous thrombus." This clinical evidence is presented to support a change in labeling (adding specific mention of venous thrombus) and demonstrate that no new safety or effectiveness issues are raised, rather than as a study designed to meet pre-defined acceptance criteria for a novel AI/ML algorithm's performance.

In summary, this document does not contain the information requested in your prompt regarding an AI/ML device's acceptance criteria and its validating study.

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The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment.

The provided text describes the UNIFUSE Infusion System with Cooper Wire and the study conducted to demonstrate that proposed longer infusion segment lengths (10cm and 15cm) are substantially equivalent to previously cleared shorter lengths (2cm and 5cm) for use in the pulmonary artery vasculature.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document states that "multiple practicing physicians" participated in the human factors study. It does not specify the exact number of physicians or the number of tests performed.
• Data Provenance: The study was a "simulated-use vascular model" study. The provenance is internal testing performed by AngioDynamics, Inc. It does not specify the country of origin of the data beyond the company's address in Massachusetts, USA. The study is prospective in the sense that it was conducted specifically to evaluate the new configurations.

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

• Number of Experts: "multiple practicing physicians experienced in the use and placement of infusion catheters." The exact number is not provided.
• Qualifications of Experts: They were "practicing physicians experienced in the use and placement of infusion catheters." No further specific details like years of experience or sub-specialty (e.g., interventional radiology, cardiology) are given.

4. Adjudication Method for the Test Set:

• The document implies that the observed performance of the device by the physicians in the simulated environment was directly assessed against the criteria. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) being used to establish a "ground truth" for the test results themselves. The "ground truth" (or the desired outcome) was the ability of the device to perform as intended and for the DFU to be adequate, which was observed and concluded by the study conductors.

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 comparative effectiveness study was not done. This study is for a medical device (infusion system), not an AI-assisted diagnostic tool. The "human factors" testing involved physicians using the device on a simulated model, not "reading" cases with or without AI assistance.

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

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device (catheter system), not an algorithm. The human factors testing necessarily involved human operation of the device.

7. The Type of Ground Truth Used:

• The ground truth for the human factors study was essentially expert observation and assessment in a simulated environment. The "truth" being confirmed was the device's functional performance in the intended use environment (pulmonary artery vasculature) by experienced users (physicians). This includes the ability to navigate, place, use, and image the device.

8. The Sample Size for the Training Set:

• The concept of a "training set" is not directly applicable here as this is a physical medical device and a human factors study, not a machine learning model. Therefore, no training set was used in the context of the study described for the K202347 submission. The study aimed to demonstrate the performance characteristics of the physical device.

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

• Given that there was no training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and previous iterations (predicate device K192864) was established through a series of performance tests (listed in Table 2) covering various physical and functional aspects, along with human factors testing. For the current submission, the "ground truth" was established by comparing the performance of the new configurations to the established performance characteristics of the predicate device through the human factors study.

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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 UNI*FUSE™ Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNI*FUSE™ Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm and 5cm lengths. The active infusion area can be identified under imaging by means of radiopaque markers on the catheter shaft at the distal and proximal ends of the infusion segment.

This document is a 510(k) Summary for a medical device called the UNI*FUSE™ Infusion System with Cooper Wire. It demonstrates the substantial equivalence of the proposed device to a predicate device, which is a common pathway for FDA clearance for Class II medical devices.

The information provided does not describe an acceptance criteria table or a study that proves the device meets specific performance criteria in the way typically seen for a novel or AI-powered diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. This means the manufacturer is showing that their modified device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined quantitative acceptance criteria through a specific clinical study with human readers and ground truth, as would be the case for an AI/ML medical device.

The "studies" described here are related to proving the safety and effective use of the device when its intended use is expanded (specifically, to include the pulmonary artery vasculature). This is achieved through:

1. Comparison to a Predicate Device: Showing that the modified device has substantially equivalent technological characteristics and performance to a legally marketed predicate device.
2. Bench Testing and Human Factors Study: Verifying that the device can navigate, be placed, and function as intended in the newly added anatomical location (pulmonary artery).
3. Clinical Literature Review: Evaluating existing literature to demonstrate that the expanded indication (use in the pulmonary artery) does not introduce new risks or increase existing risks compared to other anatomical locations or other types of catheters.

Therefore, providing a table of acceptance criteria and reported device performance in the context of an AI/ML study, as requested in the prompt, is not directly applicable to this document. The "performance" being evaluated here is related to the physical and functional aspects of a catheter and its safe deployment, not the diagnostic accuracy of an algorithm.

However, I can interpret the request in the spirit of the prompt by extracting the closest analogous information to "acceptance criteria" and "study results" as presented in this 510(k) summary:

Interpretation for a Non-AI Device Substantial Equivalence (as per the provided document):

The acceptance criteria for this device are not framed as quantitative metrics for diagnostic output (like sensitivity, specificity for an AI model) but rather as qualitative demonstrations of safety and efficacy compared to a predicate device and for the expanded indication. The "study" described is a combination of:

• Comparative Assessment: Against a predicate device (Bashir™ N-X Endovascular Catheter Model 7200, K183290) and a reference device (PULSESPRAY™ and UNIFUSE™ Infusion Catheters, K163356).
• Human Factors Study & Bench Testing: To support the expanded indication to the pulmonary artery.
• Clinical Literature Review: To support the safety profile for the expanded indication.

1. Table of "Acceptance Criteria" (interpreted as aspects needing demonstration of substantial equivalence or safety/efficacy for new indication) and "Reported Device Performance" (interpreted as the outcome of the comparative assessment or studies):

2. Sample Size and Data Provenance:

• Test Set (for Human Factors Study): "multiple practicing physicians" (specific number not given)
• Data Provenance: The human factors study involved "simulated-use vascular model" and practicing physicians. The clinical literature review uses publicly available articles, presumably from global or diverse sources, but the document does not specify country of origin for the underlying patient data. The studies are described as both retrospective and prospective in the text (e.g., Kuo, W. et al. – 2009 for clinical literature review).

3. Number of Experts and Qualifications:

• Human Factors Study: "multiple practicing physicians experienced in the use and placement of infusion catheters." (Specific number and detailed qualifications/experience not specified beyond "practicing physicians"). These experts essentially acted as the "readers" evaluating the device's usability in the simulated environment.
• Clinical Literature Review: No specific experts were used to establish "ground truth" here; rather, the company (Angiodynamics, Inc.) performed the literature review to support their conclusions on safety.

4. Adjudication Method for Test Set:

• Human Factors Study: Not explicitly stated. The study aimed to demonstrate usability and navigability. It's implied that the observations from the "multiple practicing physicians" were collectively assessed to reach the stated conclusions about navigability, imaging clarity, and DFU adequacy. It was not a comparative diagnostic reading study.

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

• No, not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic algorithm. There was no MRMC study to compare human readers with and without AI assistance, as AI is not a component of this device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical medical device. No algorithm is being assessed.

7. Type of Ground Truth Used:

• Human Factors Study & Bench Testing: The "ground truth" was established by the physical and simulated performance of the device itself (e.g., was it navigable, was it visible under fluoroscopy, could fluids be administered successfully). This is a functional and usability "ground truth."
• Clinical Literature Review: The ground truth was based on the published findings and conclusions of peer-reviewed medical literature concerning catheter-directed interventions in the pulmonary artery, particularly regarding complications and safety.

8. Sample Size for Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. No training set for an AI/ML algorithm was used.

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