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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 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 Bashir™ Plus Endovascular Catheters are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Bashir™ Plus Endovascular Catheter is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There are four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the Bashir™ Plus Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, 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. The physician-specified solution is delivered via multiple laserdrilled holes through the infusion limbs of the Bashir™ Plus Endovascular Catheter after placement.

The Bashir™ Plus Endovascular Catheter has a second Shaft Port, for delivery of infusion solutions into the shaft lumen where multiple laser-drilled holes cover 10 cm of length (Ref. No. 7210), 20 cm (Ref. No. 7220), 30 cm (Ref. No. 7230) or 40 cm (Ref. No. 7240).

After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ Plus Endovascular Catheter is retracted into the sheath and removed.

The Bashir™ Plus Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

I apologize, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets these criteria in the context of an AI/human reader performance study. The document is an FDA 510(k) clearance letter for a medical device called the "Bashir Plus Endovascular Catheter," which is a physical device used for infusing fluids into the peripheral vasculature.

The text describes:

• The device's intended use and mechanism of action.
• Regulatory information (product codes, classification).
• Comparison to a predicate device.
• General information about the submitter and correspondent.

It does not include any details related to:

• Performance metrics for an AI system.
• Acceptance criteria for an AI system's performance.
• Description of a study involving human readers or AI assistance.
• Sample sizes for test or training sets for an AI.
• Ground truth establishment methods for AI datasets.
• MRMC studies or effect sizes of AI assistance.
• Standalone AI performance.

Therefore, I cannot fulfill your request for the specific information regarding AI performance studies based on the provided text.

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The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Bashir™ S-B Endovascular Catheter (Model 7101) is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The design of the Bashir™ S-B Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ S-B Endovascular Catheter after placement. After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ S-B Endovascular Catheter is retracted into the sheath and removed.

The Bashir™ S-B Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

This document describes the Bashir™ S-B Endovascular Catheter (Model 7101) and its substantial equivalence to a predicate device. The information provided primarily focuses on technical specifications and bench testing, rather than clinical study data involving human readers or AI.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

Since the performance testing primarily involved bench testing of the physical device, the concept of a "test set" in the context of clinical data or image-based AI is not directly applicable. The text mentions "performance data repeated for the modified device," implying a certain number of devices were produced and tested, but the exact sample sizes for each bench test are not specified.

The Usability Testing involved "ten (10) intended users." The provenance of this user data (e.g., country of origin, retrospective/prospective) is not specified, but it was likely prospective testing conducted by the manufacturer.

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

Not applicable. This device is an endovascular catheter, and the evaluation did not involve establishing ground truth from images or clinical data by experts in the context of an AI study. Usability testing involved "intended users," whose specific qualifications (beyond being "intended users") are not detailed.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned, as the evaluation type was primarily physical device performance and usability.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No. This submission does not describe an AI medical device, nor does it present any MRMC comparative effectiveness study involving human readers with or without AI assistance.

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

Not applicable. This device is a medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

• For Mechanical Performance: The "ground truth" would be established by engineering specifications, physical measurements, and industry standards for catheter performance (e.g., force required for advancement, flow rates).
• For Sterilization: The "ground truth" is adherence to ISO 11135:2014 and achieving a Sterility Assurance Level (SAL) of 10^-6.
• For Shelf Life: The "ground truth" is the stability of the device over time, established through accelerated aging studies predicting a 2-year shelf life.
• For Usability Testing: The "ground truth" is the "pre-defined acceptance criteria" for the usability of the device handle by intended users.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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Bashir™ Endovascular Catheter: The Bashir™ Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Bashir™ N-X Endovascular Catheter: The Bashir™ N-X Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature.

Thrombolex developed the Bashir™ Endovascular Catheter (Model 7201) to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The Bashir™ N-X Endovascular Catheter (Model 7200) is a second model developed for infusion of physician-specified fluids in the pulmonary artery. The Bashir™ N-X differs from the Bashir™ Endovascular Catheter in that the infusion limbs do not expand into an infusion basket but remain collapsed in a straight configuration. The two device models have a different appearance, namely in the handle design and color, which ensures appropriate use and identification.

The design of the Bashir™ Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is then delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ Endovascular Catheter. After the completion of solution delivery, the infusion limbs are collapsed to a straight position in the case of peripheral vasculature, and then the Bashir™ Endovascular Catheter is retracted into the sheath and removed.

The handle of the Bashir™ N-X Endovascular Catheter has been modified to disable expansion of the basket. The Bashir™ N-X Endovascular Catheter, unexpanded, is thus similar to other straight infusion catheters including the predicate device.

Delivery of the Bashir N-X™ Endovascular Catheter into the pulmonary artery is accomplished using a long guide sheath using standard interventional techniques. The Bashir™ Endovascular Catheter is placed over a guidewire inside the sheath to the desired location under fluoroscopic guidance. The catheter does not come in direct contact with the right atrium, tricuspid valve, right ventricle or pulmonic valve at any time, as it is within a guide sheath.

The Bashir™ Endovascular Catheter and Bashir™ N-X Endovascular Catheter are comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

The provided text describes the Bashir Endovascular Catheter and Bashir N-X Endovascular Catheter and their substantial equivalence to a predicate device, the Ekosonic Endovascular System. However, it does not contain information about acceptance criteria or a study that uses a standalone AI algorithm, or a multi-reader, multi-case comparative effectiveness study with human readers.

Based on the provided text, the following information can be extracted regarding the device performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any of the performance tests. The text mentions "participants" for human factors testing and a "GLP porcine study" but does not quantify the number of subjects/samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. The animal study is described as a "GLP porcine study," implying a prospective, controlled study conducted under Good Laboratory Practice regulations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily bench, animal, and usability tests, not diagnostic accuracy studies that would typically involve expert-established ground truth. Expert involvement is implied in assessing usability criteria and potentially in interpreting animal study results, but no specifics are given.

4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (bench, animal, usability), formal adjudication methods like 2+1 or 3+1 (common in diagnostic accuracy studies) would not typically be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described. The document focuses on demonstrating substantial equivalence of a medical device (catheter) through bench, animal, and usability testing, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm study was not done. The device is a mechanical endovascular catheter, not an AI algorithm.

7. Type of Ground Truth Used

• Bench Testing: Ground truth is established by physical measurements, engineering specifications, and validated test methods (e.g., verifying flow rates against expected values, measuring device dimensions, checking for leaks).
• Animal Study: Ground truth is established by physiological and pathological assessments in the porcine model (e.g., absence of systemic or pathological adverse effects).
• Human Factors Testing: Ground truth is established by predefined acceptance criteria for task performance and user feedback, evaluated against the device's intended use.

8. Sample Size for the Training Set
This is not applicable as the device is a mechanical catheter and does not involve AI or machine learning algorithms that require 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 does not involve AI or machine learning algorithms that require a training set.

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